A Prospective, Multicenter, Randomized, Active-Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
Phase: NA
Conditions: Cataract
Sponsor: Bausch & Lomb Incorporated

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A Prospective, Multicenter, Randomized, Active-Controlled 
Clinical Study to Evaluate the Safety and Effectiveness of the 
enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular 
Lens in Subjects Undergoing Cataract Extraction 
CLINICAL STUDY PROTOCOL 
STUDY # 945 
Developmental phase of study: Pivotal IDE Trial 
Study design: 
Prospective, multicenter, randomized, active-
controlled, partially masked binocular safety 
and effectiveness study 
Date: 
24 April 2023 (Version 8) 
10 May 2022 (Version 7) 
10 December 2021 (Version 6)  
23 April 2021 (Version 5) 
13 August 2020 (Version 4) 
02 April 2019 (Version 3) 
08 February 2019 (Version 2) 
26 March 2018 (Version 1) 
Sponsor1  
Bausch + Lomb Incorporated 
 
1400 North Goodman Street 
Rochester, NY 14609 US 
 
  
 
This clinical investigation is being conducted in accordance with 21CFR Parts 11, 50, 54, 56, 
and 812, ISO 14155 (2020 (E)) Clinical Investigation of Medical Devices for Human Subjects 
– Good Clinical Practice, ISO 11979-7:2006/Amd 1:2012(E) Ophthalmic implants — 
Intraocular lenses — Part 7, ISO 11979-9: 2006/Amd 1:2014 Ophthalmic implants — 
Intraocular lenses — Part 9, ANSI Z80.12-2007 (R2012), 42 USC 282(j), and applicable local 
regulations.  
 
1 The Sponsor, Bausch & Lomb, Inc., is the sole funding source for this clinical investigation. 
NCT03603600

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Nothing herein is to be disclosed without prior approval of the sponsor. 

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Protocol Review and Approvals 
A Prospective, Multicenter, Randomized, Active-Controlled Clinical Study to Evaluate the 
Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular 
Lens in Subjects Undergoing Cataract Extraction 

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Personnel Responsible for Conducting the Study 
 
A Prospective, Multicenter, Randomized, Active-Controlled Clinical Study 
to Evaluate the Safety and Effectiveness of the enVista® One-Piece 
Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing 
Cataract Extraction 
 
Contract Research Organization / Medical Monitor 

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Principal Investigator Protocol Agreement Page 
 
COMMITMENTS OF THE INVESTIGATOR: 
I agree to conduct the study in accordance with the relevant, current protocol(s) and will only make 
changes in a protocol after being notified by the Sponsor, except when necessary to protect the safety, 
rights, or welfare of subjects.  I agree to comply with all requirements regarding the obligations of clinical 
investigators and all other pertinent requirements in 21 CFR Part 812.  
I agree to personally conduct or supervise the described investigation.  I agree to ensure that all associates, 
colleagues, and employees assisting in the conduct of the study are adequately trained and qualified to 
fulfill their responsibilities and are informed about their obligations in conducting the study. 
I agree to inform any patients, or any persons used as controls, that the device(s) are being used for 
investigational purposes and I will ensure that the requirements relating to obtaining informed consent in 
21 CFR Part 50 and institutional review board (IRB) review and approval in 21 CFR Part 56 are met. 
I agree to report to the Sponsor adverse experiences that occur in the course of the investigation(s) in 
accordance with 21 CFR Part 812.150.  
I agree to disclose to the Sponsor accurate financial information to allow the Sponsor to submit complete 
and accurate certification or disclosure statements required under 21 CFR Part 54.  I agree to promptly 
update this information if any relevant changes occur during the course of the investigation and for 1 year 
following completion of the study. 
I agree to maintain adequate and accurate records in accordance with 21 CFR Part 812.140 and to make 
those records available for inspection in accordance with 21 CFR Part 812.145 and if I transfer custody of 
the records to any other person I will notify the Sponsor. 
I will be responsible for the control of devices under investigation and will ensure that the investigational 
device is used only with subjects under my supervision.  Upon completion or termination of the clinical 
investigation, I will either return all investigational devices to the Sponsor or dispose of the device as 
instructed by the Sponsor. 
I will ensure that an IRB that complies with the requirements of 21 CFR Part 56 will be responsible for the 
initial and continuing review and approval of the clinical investigation. I also agree to report to the IRB all 
deviations in the research activity and all unanticipated problems involving risks to human subjects or 
others, per IRB requirements. Additionally, I will not make any changes in the research without IRB 
approval, except where necessary to eliminate apparent immediate hazards to human subjects. 
I have never been disqualified as an Investigator or had a research study terminated by the FDA, IRB/IEC 
or a Sponsor for noncompliance of an investigator agreement, investigational plan, IRB/IEC requirements 
or the requirements of 21 CFR Part 50, 21 CFR Part 54, 21 CFR Part 56, 21 CFR Part 312, or 21 CFR Part 
812.  If an investigation or other research was terminated, I will provide an explanation of the 
circumstances that led to termination.  
A current Curriculum Vitae has been provided to the Sponsor to demonstrate education, training, and 
experience that qualifies me to conduct clinical research as an expert in the field related to the device 
under investigation. 
 
 
 
Principal Investigator (print name) 
 
 
 
 
Principal Investigator (signature) 
 
Date 

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2 
Synopsis 
Name of Sponsor/Company: Bausch & Lomb Incorporated  
Name of Investigational Device: enVista® Trifocal Intraocular Lens  
 
Title of Study: A Prospective Multicenter, Randomized, Active-Controlled Clinical Study to 
Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal 
Intraocular Lens in Subjects Undergoing Cataract Extraction 
 
Number of clinical centers: Approximately twenty (20) clinical centers in North America 
 
Objectives: To evaluate the safety and effectiveness of the enVista trifocal intraocular lens (IOL) 
when implanted in the capsular bag.  
 
Methodology:  The study purpose, procedures, and subject responsibilities will be explained to the 
potential participant. The subject's willingness and ability to meet the treatment and follow-up 
requirements will be determined.  Written informed consent will be obtained from each study 
subject prior to performing any study-specific procedures that are not part of the Investigator’s 
routine standard of care. Enrolled subjects who meet eligibility criteria will be seen at 11 or 12 
visits according to the following schedule:  
 
Visit Name 
Eyes Evaluated  
Visit Window  
Preoperative Visit 0A/B 
Both Eyes  
Day -30 to -5 
Operative Visit 00A 
1st Eye  
Day 0  
Post-Operative Visit 1A  
1st Eye  
Day 1 to 2 post Visit 00A  
Post-Operative Visit 2A  
1st Eye  
Day 7 to 14 post Visit 00A  
Post-Operative Visit 3A 
1st Eye 
Day 30 to 60 post Visit 00A 
Operative Visit 00B 
2nd Eye  
Day 7 to 30 post Visit 00A  
Post-Operative Visit 1B  
2nd Eye  
Day 1 to 2 post Visit 00B  
Post-Operative Visit 2B  
2nd Eye  
Day 7 to 14 post Visit 00B 
Post-Operative Visit 3B 
2nd Eye 
Day 30 to 60 post Visit 00B 
Post-Operative Visit 4 
Both Eyes  
Day 120 to 180 post Visit 00B 
Post-Operative Visit 5 
Both Eyes 
Day 330 – 420 post Visit 00B 
Post-Operative Visit 6 
(subjects that consent at 
participating sites) 
Both Eyes 
Day 2- 30 post Visit 5 
 
Approximately five hundred and one (501) subjects (approximately 1,002 eyes) will be enrolled in 
this study to obtain complete follow-up for one year on at least 300 Test subjects and 150 active 
Control subjects: 
- 
Group 1 (Test): Approximately 334 subjects will be treated bilaterally with the enVista 
MX60EF (trifocal) multifocal IOL (MIOL); 
- 
Group 2 (Control): Approximately 167 control subjects will be implanted bilaterally with 
the enVista MX60E monofocal IOL 
 
“Treatment” is defined here as the IOL touching the eye. Subjects who meet eligibility criteria will 
be randomly assigned to Group 1 or 2 in a 2:1 ratio.  Enrollment and randomization will occur at 
the first eye’s Operative Visit (Day 0).  Subjects and designated postoperative evaluator(s) will be 

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masked to the IOLs assigned.  The Investigator implanting the IOL and designated site personnel 
will be unmasked to the Group assignment for a subject.   
 
The first eye implanted will be designated eye A, and the second eye implanted will be designated 
eye B.  The eye with the worse best-corrected distance visual acuity (BCDVA, CDVA) at the 
Preoperative Visit will be treated first (eye A) and used in the primary monocular evaluations. Glare 
testing of both eyes will be done if either requires it to determine eligibility. If the qualifying visual 
acuity is obtained with a glare source, the eye with the worse BCDVA with glare will be designated 
as eye A.  If BCDVA is the same for both eyes, the right eye will be treated first. Postoperatively, 
all eyes will undergo ophthalmic examinations at regular intervals per the study visit schedule 
through Visit 5 (330 - 420 days after second eye IOL implantation).   
 
Study enrollment will occur in three Phases as follows:   
Phase I/Pilot – Approximately 27 Group 1 (Test IOL) subjects will be enrolled and followed 
to Post-Operative Visit 3B (30 to 60 days after second eye IOL implantation) before a decision 
is made to initiate Phase II enrollment.  Approximately 14 subjects will also be randomized to 
Group 2 (Control IOL) during this phase.  A designated unmasked statistician(s) will 
summarize Phase I/Pilot distance-corrected near visual acuity (DCNVA) and distance-
corrected intermediate visual acuity (DCIVA) data from Group 1 first implanted eyes for 
review by a clinical team not associated with the study, and the best near and intermediate 
distances will be selected for Phase II and Phase III evaluation. Phase I safety data will also be 
summarized for review by an unmasked clinical reviewer not associated with the study, and a 
decision to initiate Phase II will be made by the FDA based on Phase I data. 
Phase II – Approximately 48 additional Group 1 subjects will be enrolled.  Approximately 24 
subjects will also be randomized to Group 2 during this phase.  When a minimum of 50 Phase 
I and Phase II Group 1 subjects have been enrolled and followed through Visit 4, summaries 
and/or listings of all available safety data through Visit 4 will be prepared by an unmasked 
statistical team.  Aggregated safety data for the minimum first 50 Phase I and Phase II Group 
1 subjects who complete Visit 4 will be presented to the FDA to request expansion to Phase 
III.  Safety data for approximately the corresponding minimum first 25 Phase I and Phase II 
Group 2 subjects who complete Visit 4 also will be submitted concurrently to the FDA.  While 
safety data submission and FDA review for these subjects is occurring, additional subjects may 
be enrolled up to a maximum of approximately 72 Phase II subjects (including those whose 
data were submitted to FDA).    
Phase III - Remainder of subjects will be enrolled and followed to Post-Operative Visit 5 or for 
subjects who have consented and enrolled in the Trial Frames Astigmatism sub-study, to Visit 
6.  
 
 
 
 
 
 
 
 

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Planned enrollment in all Phases is schematized in the following diagram.   
 
A pilot test will be conducted as Phase I/Pilot to identify the best near and intermediate distances 
to be tested during Phases II – III. Fixed near and intermediate distances of 40 cm and 66 cm, 
respectively, will be measured for all enrolled subjects.  During Phase I/Pilot, DCNVA will be 
collected at three candidate distances: 30 cm, 35 cm, and 40 cm, and DCIVA will be collected at 
three candidate distances: 56, 66 and 76 cm. This phase will include approximately the first 27 
subjects implanted with the enVista trifocal MIOL in Group 1 and approximately the first 14 
subjects implanted with the enVista monofocal IOL in Group 2. Photopic monocular DCNVA and 
DCIVA will be assessed at each candidate distance at Visit 3A using ETDRS charts normalized for 
letter size as a function of distance tested. The near and intermediate distance VA data from Phase 
I/Pilot subjects will be excluded from near and intermediate VA hypothesis testing and will be 
summarized separately from the near and intermediate distance VA data of the other subjects. For 
all assessments other than near and intermediate VA measurements, Phase I/Pilot subjects’ data 
will be pooled with the other subjects’ data. 
The best distances of 40 cm and 66 cm will be used for near and intermediate visual acuity testing, 
respectively, in Phases II and III of the study, and intermediate visual acuity will also be tested at 
60 cm in Phases II and III.   
 
Number of Subjects Planned:  Approximately five hundred and one (501) subjects 
(approximately 1,002 eyes) will be treated in this study. Approximately 334 subjects will be 
implanted bilaterally with the enVista MX60EF trifocal MIOL, and approximately 167 control 
subjects will be implanted bilaterally with the enVista MX60E monofocal IOL. 
 
Diagnosis and Criteria for Inclusion:  
This study will include subjects who meet all of the following inclusion criteria: 
1. Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is 
signed.  

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2. Subjects must have the capability to understand and provide written informed consent on the 
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed 
Consent Form (ICF) and authorization as appropriate for local privacy regulations.  
3. Subjects must have a BCDVA equal to or worse than 20/40 in each eye, with or without a glare 
source, due to a clinically significant cataract (cortical, nuclear, subcapsular, or combination) 
that is considered amenable to treatment with standard phacoemulsification cataract extraction 
and capsular IOL implantation.  
4. Subjects must have a BCDVA projected to be better than 20/32 after IOL implantation in each 
eye, as determined by the medical judgment of the Investigator or measured by potential acuity 
meter (PAM) testing, if necessary. 
5. Subjects must have clear intraocular media other than the cataract in both eyes. 
6. Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere and 
cylinder) in both eyes, as determined by distance manifest refraction on two consecutive 
examination dates after discontinuation of contact lens wear. 
7. Subjects must require an IOL power from +16.0 diopter (D) to +24.0 D in both eyes. 
8. Subjects must be willing and able to comply with all treatment and follow-up study visits and 
procedures, and to undergo second eye surgery within 7-30 days of the first eye surgery. 
 
Exclusion Criteria:  
This study will exclude subjects (or eyes) who meet any of the following exclusion criteria: 
1. Subjects who have used an investigational drug or device within 30 days prior to entry into 
this study and/or will participate in another investigation during the period of study 
participation.  
2. Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, 
edema, dystrophy, etc.) in either eye.  
3. Subjects who have significant anterior segment pathology that might increase intraoperative 
risk or compromise IOL stability (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, 
traumatic cataract, lens subluxation, traumatic zonulolysis, zonular dialysis, evident zonular 
weakness or dehiscence, hypermature or brunescent cataract, etc.) in either eye.  
4. Subjects who have uncontrolled glaucoma in either eye. 
5. Subjects who have previous retinal detachment or clinically significant retinal pathology 
involving the macula in either eye. 
6. Subjects who have proliferative or non-proliferative diabetic retinopathy in either eye. 
7. Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract) in either 
eye. 
8. Subjects using any systemic or topical drug known to interfere with visual performance, pupil 
dilation, or iris structure within 30 days of enrollment or during the study (refer to the 
relevant attachment of the Study Reference Manual). 
9. Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g., iritis, 
scleritis, iridocyclitis, or rubeosis iridis) in either eye.  
10. Subjects who have a visual disorder, other than cataracts, that could potentially cause future 
acuity losses to a level of 20/100 or worse in either eye. 
11. Subjects who have had previous intraocular or corneal surgery in either eye, with the 
exception of laser trabeculoplasty. 
12. Subjects with any preoperative infectious conjunctivitis, keratitis, or uveitis in either eye. 
13. Subjects who have a preoperative corneal astigmatism > 1.0 D in either eye, irregular 
astigmatism, or skewed radial axis (note: corneal incisions intended specifically to reduce 
astigmatism are not allowed during the study). 
14. Subjects who cannot achieve a minimum pharmacologic pupil dilation of 5.0 mm in both 
eyes. 

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15. Subjects who may be expected to require a combined or other secondary surgical procedure 
in either eye. 
16. Subjects who during the first cataract extraction experience an anterior or posterior capsule 
tear or rupture, zonular dialysis, significant iris trauma, or other complication that may cause 
untoward effects in the judgment of the Investigator.  
17. Females of childbearing potential (those who are not surgically sterilized or at least 12 
months postmenopausal) are excluded from enrollment in the study if they are currently 
pregnant or plan to become pregnant during the study.  Females of childbearing potential 
must be willing to practice effective contraception for the duration of the study. 
18. Subjects with any other serious ocular pathology or underlying systemic medical condition 
(e.g., uncontrolled diabetes) or circumstance that, based on the Investigator’s judgment, poses 
a concern for the subjects’ safety or could confound the results of the study.  
19. Subjects who have current or previous usage of an alpha-1-selective adrenoceptor blocking 
agent or an antagonist of alpha 1A adrenoceptor (e.g., Flomax® (tamsulosin HCl), Terazosin, 
or Cardura).  
Study Materials:  
 
Test Article: The enVista® one-piece hydrophobic acrylic trifocal MIOL (MX60EF) is an 
apodized, diffractive, trifocal version of the enVista® MX60E one-piece hydrophobic acrylic IOL.  
Test lenses will be available in powers +16.0 D to +24.0 D. 
 
Test Article Proposed Intended Use:  The enVista one-piece hydrophobic acrylic trifocal 
intraocular lens (IOL) is intended to replace the natural crystalline lens and is indicated for primary 
implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has 
been removed.  The lens is intended for placement in the capsular bag. 
 
Active Control: The enVista® one-piece hydrophobic acrylic monofocal IOL (MX60E) is an 
aspheric optic one-piece lens with a square posterior edge. The biconvex lens optic has a body 
diameter of 6.0 mm, and the overall length (diameter) of the IOL is 12.5 mm.  Control lenses will 
be available in powers +16.0 D to +24.0 D. 
 
Duration of Treatment:  Eligible subjects who are enrolled in the study will be followed for up 
to 12 months after second eye IOL implantation. 
 
Clinical Parameters: 
• 
Slit lamp examination 
• 
Visual acuity 
• 
Refractive status 
• 
Intraocular pressure 
• 
Pupil size 
• 
Lens stability (decentration and tilt) 
• 
Subject Questionnaires [Quality of Vision (QoV) Questionnaire and Near Activity Visual 
Questionnaire (NAVQ)2] 
• 
Fundus visualization 
• 
Incidence of posterior capsulotomy 
• 
Adverse events  
 
2 Use of the exploratory NAVQ subject questionnaire will be discontinued after written FDA acceptance of  
protocol version 5.0, with the exception that subjects who have completed the NAVQ pre-operatively at the 
time of NAVQ discontinuation (protocol version 5.0)  also will be asked to complete the NAVQ at Visit 4 (120 
days to 180 days after second IOL implantation).  

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• 
OCT imaging 
• 
Defocus curves 
• 
Contrast sensitivity 
• 
Visual acuity at near, intermediate, and distance under varying levels of simulated astigmatism 
using trial frames (if subject consents to sub-study) 
 
The above evaluations will be performed as described in ISO 11979-7 1, ISO 11979-9 2, and ANSI 
Z80.12 3 unless otherwise specified in the protocol. 
 
Study Endpoints: 
Primary Safety Endpoints 
• 
The incidence of all serious adverse events, including secondary surgical interventions 
(SSIs) related to the optical properties of the IOL, in first eyes through study exit  
• 
The rate of secondary surgical interventions due to the optical properties of the lens for 
first eyes through study exit  
• 
The incidence of adverse events in first eyes compared to ISO Safety and Performance 
Endpoint (SPE) rates as defined in ISO 11979-7 through study exit 
 
Secondary Safety Endpoints  
• 
The rates of visual disturbances reported as “severe” by subjects, as well as the rates of 
visual disturbances reported as “very” bothersome by subjects, using the QoV 
questionnaire measure through Post-Operative Visit 4 (Day 120 to 180 after second eye 
IOL implantation) 
• 
Mean photopic contrast sensitivity with glare and mesopic contrast sensitivity with and 
without glare at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
and Post-Operative Visit 5 (Day 330 to 420 after second eye IOL implantation) 
• 
Incidence of the types of AEs specified in the co-primary safety endpoints, but for fellow 
and “all” eyes 
• 
Incidence of all other types of adverse events in primary eyes, fellow eyes, and “all” eyes 
 
 
Primary Effectiveness Endpoints 
• 
Photopic monocular best-corrected distance visual acuity (BCDVA) in first eyes at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• 
Photopic monocular distance-corrected near visual acuity (DCNVA) in first eyes at 40 cm 
at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• 
Photopic monocular distance-corrected intermediate visual acuity (DCIVA) in first eyes at 
66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)   
 
Secondary Effectiveness Endpoints 
• 
Photopic binocular distance-corrected near visual acuity (DCNVA) at 40 cm at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• 
Photopic binocular uncorrected near visual acuity (UCNVA) at 40 cm at Post-Operative 
Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• 
Photopic binocular distance-corrected intermediate visual acuity (DCIVA) at 66 cm at 
Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)  
• 
Photopic binocular uncorrected intermediate visual acuity (UCIVA) at 66 cm at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 

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• 
First eye BCDVA, DCNVA, and DCIVA evaluated at Visit 5 
 
Statistical Methods:  
 
The statistical analyses described in ISO 11979-7 1, ISO 11979-9 2, and ANSI Z80.12 3 will be 
performed unless otherwise specified in the statistical analysis plan. 
 
Summaries for continuous variables will include the sample size, mean, standard deviation, median, 
minimum, and maximum. Summaries for discrete (categorical) variables will include the tabulation 
of frequencies and percentages. 
 
After IOL implantation for Phase I/Pilot subjects, enrollment will pause until the Phase I/Pilot 
subjects have completed Visit 3B (30 to 60 days after second eye IOL implantation) and their data 
have been reviewed. Data listings and/or summaries of test lens DCNVA and DCIVA data will be 
prepared by an unmasked statistician and presented for review by an unmasked clinical reviewer 
not associated with the study, and the best distances for near and intermediate VA testing will be 
determined. Safety data will also be prepared by an unmasked statistician and presented for review 
by the unmasked clinical reviewer not associated with the study. Phase I safety and VA data will 
be submitted to the FDA for review and acceptance to initiate Phase II.  Statistical comparisons 
between Group 1 and Group 2 will not be made or evaluated. The decision to proceed or not to 
proceed to Phase II will not be based on formal statistical stopping rules. 
 
When a minimum of 50 Phase I and Phase II Group 1 subjects have been enrolled and followed 
through Visit 4, summaries and/or listings of all available safety data through Visit 4 will be 
prepared by an unmasked statistical team. Aggregated safety data for the minimum first 50 Phase 
I and Phase II Group 1 subjects who complete Visit 4 for these subjects will be presented to the 
FDA to request expansion to Phase III.  Safety data for approximately a corresponding minimum 
first 25 Phase I and Phase II Group 2 subjects who complete Visit 4 also will be submitted 
concurrently to the FDA.   While safety data submission and FDA review for these subjects is 
occurring, additional subjects may be enrolled up to a maximum of approximately 72 Phase II 
subjects (including those whose data were submitted to FDA).  Statistical comparisons between 
Group 1 and Group 2 will not be made or evaluated. The decision to proceed or not to proceed to 
Phase III will not be based on formal statistical stopping rules.  Phase III enrollment will be initiated 
only after acceptance to proceed is received from FDA. 
 
Primary Safety Analyses 
 
The proportion of first modified Intent-to-Treat (mITT) eyes with at least one serious adverse event 
will be summarized using categorical summary statistics by treatment received. Each eye will be 
counted only once in the calculation of the rate.  
 
Secondary surgical interventions related to the optical properties of the IOL will be summarized 
categorically by treatment received for first mITT Set eyes. Non-inferiority of the test lens 
compared to the control lens will be evaluated.  
 
Adverse events in first mITT Set eyes will be compared to the ISO Safety and Performance Rates 
(SPE) as described in ISO 11979-7.  
 
Secondary Safety Analyses 
 

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The rates of visual disturbances reported as “severe” by subjects, as well as the rates of visual 
disturbances reported as “very” bothersome by subjects, using the QoV questionnaire measure 
through Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) will be 
summarized categorically by treatment received for Modified Safety Set subjects. Each subject will 
be counted only once in the calculation of the rate.  
 
Contrast sensitivity will be summarized using continuous summary statistics by lighting condition, 
spatial frequency, treatment group and visit.  
 
The incidence of the type of AE specified in each co-primary safety endpoint will be summarized 
by treatment for fellow and “all” eyes. 
 
The incidence of all other types of AEs will be summarized by treatment for primary eyes, fellow 
eyes, and “all” eyes for the mITT Set. 
 
Additional supportive safety analyses are described in Section 13.5.5 and/or the study Statistical 
Analysis Plan (SAP). 
  
Primary Effectiveness Analyses 
 
The statistical success of the trial will depend on the statistical success of all three primary 
effectiveness endpoints. 
 
Photopic monocular logMAR BCDVA in first implanted eyes at Post-Operative Visit 4 will be 
summarized using continuous summary statistics by treatment group for the mITT Set. Imputation 
of missing data is not conservative in non-inferiority testing. Therefore, missing data will not be 
imputed for a BCDVA non-inferiority test. The treatment effect (mean Test group IOL VA minus 
mean Control group IOL VA) in logMAR units will be estimated in addition to a two-sided 90% 
confidence interval. If the upper confidence limit (equivalent to a one-sided upper 95% confidence 
limit for the treatment effect) is less than 0.1, then the Test lens will be statistically non-inferior to 
the Control lens.4 
 
 
The previous continuous summary statistics will also be provided for the Per Protocol Set. 
However, non-inferiority will not be evaluated with the PP Set, and statistical success will not 
depend upon the results of the PP analysis.  
 
BCDVA at Visit 4 for the Test group will be summarized categorically (20/20 or better, 20/25 or 
better, 20/32 or better, 20/40 or better, and worse than 20/40) for the mITT and Best Case Sets.  
Two-sided exact binomial 90% confidence intervals around the proportions of eyes 20/40 or better 
will be presented. 
 
For the analyses of the mITT and Best Case Sets, one-sided exact binomial tests comparing the 
proportion of multifocal IOL eyes with BCDVA 20/40 or better to the relevant control rate (92.5% 
for all eyes and 96.7% for best case eyes) will be performed and p-values will be presented. If the 
p-value is less than or equal to 0.05, then the null hypothesis will be rejected. If the null hypothesis 
is not rejected for the mITT and Best Case Sets in the primary analyses, then it will be concluded 
that the multifocal IOL is statistically successful in this outcome. 
 
Photopic monocular distance-corrected near visual acuity (DCNVA) at 40 cm, and distance-
corrected intermediate visual acuity (DCIVA) at 66 cm, in first eyes at Post-Operative Visit 4 will 
be summarized using continuous summary statistics in logMAR units by treatment assignment for 

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the mITT Set Phase II and III subjects (combined). The DCNVA and DCIVA data from the Phase 
I/Pilot subjects will be excluded from hypothesis testing and will be summarized separately from 
the data of the other subjects. 
 
If there are missing mITT analysis set monocular DCNVA or DCIVA data at Visit 4, then missing 
data will be imputed using the Markov chain Monte Carlo multiple imputation method. After 
imputation of missing data, the statistical hypotheses will be tested using two-sided two-sample t-
tests by imputation.  
 
For each endpoint, an overall p-value resulting from the multiple imputation method will be 
estimated. The treatment effect (mean Test group IOL VA minus mean Control group IOL VA) in 
logMAR units will be summarized using continuous summary statistics and a two-sided 95% 
confidence interval. If the p-value from the multiple imputation analysis of treatment effect is less 
than or equal to 0.05 and the treatment effect is less than or equal to -0.10 logMAR units for DCIVA 
(i.e., the Test lens mean logMAR VA is at least 0.10 less than the mean for the control) or less than 
or equal to -0.20 logMAR units for DCNVA, then it will be concluded that the Test IOL is 
statistically and clinically successful in the corresponding outcome. 
 
The previous continuous summary statistics will also be provided for the Per Protocol Set. 
However, superiority will not be evaluated with the PP Set, and statistical success will not depend 
upon the results of the PP analysis. 
 
Secondary Effectiveness Analyses 
 
Photopic binocular DCNVA, UCNVA, DCIVA, and UCIVA at 40 cm and 66 cm for near and 
intermediate VA, respectively, at Post-Operative Visit 4 will be compared between treatments 
using the methods described above for monocular DCNVA and DCIVA. The endpoints will be 
evaluated hierarchically in the following order: DCNVA, UCNVA, DCIVA, and UCIVA. 
 
First eye BCDVA, DCNVA, and DCIVA (all in logMAR units) at Visit 5 will be summarized using 
descriptive statistics (mean, standard deviation, minimum, and maximum) for the ITT Set by 
treatment group (MX60EF Trifocal MIOL, MX60E Monofocal IOL). The means at Visit 5 for each 
of these outcomes will be compared between the treatment groups qualitatively. 
 
Any additional supportive effectiveness analyses will be described in Section 13.5.5 and/or the 
SAP. 
 
Sample size calculations: 
 
General Justification 
 
The sample size of 300 Test lens group subjects and 150 Control group subjects is specified in 
ANSI Z80.12-2007 (R2012) and ISO 11979-9:2006. Moreover, ISO 11979-7 specifies that a 
minimum of 300 subjects should complete a clinical evaluation of an IOL.  
 
To allow for losses of up to 10%, approximately ⌈300/(1 −0.1)⌉ = 334 Test group subjects and 
approximately  ⌈150/(1 −0.1)⌉ = 167 Control group subjects will be enrolled.  
 
Phase I/Pilot Phase to Select Distances for Near and Intermediate VA Testing 
 

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A sample size of 24 DCNVA measurements at each of three distances will yield a probability of at 
least 98% of selecting the best distance when the difference (in logMAR units) between the best 
distance and the second best distance is at least 0.1 and the data are normally distributed with a 
standard deviation of 0.15. The first 27 Test group subjects will be enrolled in Phase I/Pilot to allow 
for at least 24 Test group subjects at Visit 3A. 
 
A sample size of 24 DCIVA measurements at each of three distances will yield a probability of at 
least 98% of selecting the best distance when the difference (in logMAR units) between the best 
distance and the second best distance is at least 0.1 and the data are normally distributed with a 
standard deviation of 0.15. The first 27 Test group subjects will be enrolled in Phase I/Pilot to allow 
for at least 24 Test group subjects at Visit 3A. 
 
Primary Safety Endpoints 
 
Regarding the rate of all serious adverse events in first eyes, for a sample size of 300 subjects, the 
probability of observing at least one event will be at least 95% when the probability of an event is 
1% or greater.  
 
Regarding the rate of secondary surgical interventions due to the optical properties of the lens, the 
expected Control group rate is 0.1% and the expected Test group rate is 0.5%. With 150 eyes in the 
Control group and 300 eyes in the Test group, the upper limit of the observed one-sided 95% 
confidence interval will be expected to be less than 0.034 with 99% power when the Control 
proportion, 𝝅𝝅𝑪𝑪, is 0.001 and the Test expected proportion, 𝝅𝝅𝑻𝑻, is 0.005; results are based on 10000 
simulations using the Newcombe-Wilson score method to construct the confidence interval. 
 
ISO 11979-7 Annex B shows the relevant sample size calculations and assumptions for the ISO 
grid safety endpoints. 
 
Secondary Safety Endpoints 
 
Regarding the rates of visual disturbances reported as “severe” by subjects, as well as the rates 
of visual disturbances reported as “very” bothersome by subjects, using the QoV questionnaire 
measure through Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation), no 
statistical hypotheses will be tested. Therefore, no sample size calculation is required. 
 
Regarding mean contrast sensitivity at Post-Operative Visit 4 (Day 120 to 180 after second eye 
IOL implantation) and Post-Operative Visit 5 (Day 330 to 420 after second eye IOL implantation), 
no statistical hypotheses will be tested. Therefore, no sample size calculation is required.  
 
Primary Effectiveness Endpoints 
 
The primary effectiveness objectives are to demonstrate non-inferiority of the Test lens when 
compared to the Control lens and satisfactory performance of the Test lens when compared to the 
ISO grids (ISO 11979-7 Safety and Performance Endpoints) in photopic monocular best-corrected 
distance visual acuity (BCDVA) and to demonstrate superiority of the Test lens over the Control 
lens in distance-corrected near visual acuity (DCNVA) at 40 cm, and distance-corrected 
intermediate visual acuity (DCIVA) at 66 cm, in first eyes at Post-Operative Visit 4 (Day 120 to 
180 after second eye IOL implantation). Approximately the first 24 evaluable Test group subjects 
and first 12 evaluable Control group subjects will be excluded from the near and intermediate visual 
acuity hypothesis tests, leaving an expected evaluable sample size of approximately 276 Test group 

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subjects implanted with the Test IOL and 138 Control group subjects to be included in the near and 
intermediate visual acuity effectiveness hypothesis tests. 
 
Regarding the non-inferiority test of BCDVA, when the sample sizes in the groups are 300 (Group 
1) and 150 (Group 2), a two group 0.050 one-sided t-test will have 99% power to reject the null 
hypothesis that the Test and Control IOLs are not equivalent (the difference in means, µT - µS, is 
0.10 or farther from zero in the same direction) in favor of the alternative hypothesis that the means 
of the two groups are equivalent, assuming that the expected difference in means is 0.000 and the 
common standard deviation is 0.150.  
 
Regarding the comparisons of BCDVA to the ISO grid, ISO 11979-7 specifies a sample size of 
approximately 300 completed subjects for this type of investigation. 
 
Regarding statistical superiority tests of DCNVA and DCIVA, a two-group t-test with a 0.05 two-
sided significance level will have 99% power to detect a difference in means of -0.10, assuming 
that the common standard deviation is 0.15, when the sample sizes in the two groups are 276 and 
138 subjects, respectively (a total sample size of 414 subjects). 
 
Regarding the assessment of clinical superiority in DCNVA and DCIVA, the probability that the 
Test group’s mean logMAR VA will be at least 0.1 units less than the Control group’s mean 
logMAR VA will be 89% if the true difference is -0.12 units, 97% if the true difference is -0.13 
units, and 99% if the true difference is -0.14 units, assuming that the common standard deviation 
is 0.15 when the sample sizes in the two groups are 276 and 138 subjects, respectively (a total 
sample size of 414 subjects). 
 
Secondary Effectiveness Endpoints 
 
Secondary effectiveness endpoint hypotheses will be tested hierarchically in the order: DCNVA, 
UCNVA, DCIVA, and UCIVA. 
 
All Phase I evaluable Test group subjects evaluable Control group subjects will be excluded from 
the near and intermediate visual acuity hypothesis tests, leaving an expected evaluable sample size 
of approximately 276 Test group subjects and 138 Control group subjects to be included in the near 
and intermediate visual acuity hypothesis tests. 
 
Regarding photopic binocular distance-corrected near visual acuity (DCNVA) at 40 cm at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation), a two-group t-test with a 
0.050 two-sided significance level will have 99% power to detect a difference in means of -0.10 
logMAR units, assuming that the common standard deviation is 0.20 units, when the sample sizes 
in the two groups are 276 and 138 subjects, respectively (a total sample size of 414 subjects). 
 
Regarding photopic binocular uncorrected near visual acuity (UCNVA) at 40 cm at Post-Operative 
Visit 4 (Day 120 to 180 after second eye IOL implantation), a two-group t-test with a 0.050 two-
sided significance level will have 99% power to detect a difference in means of -0.10 logMAR 
units, assuming that the common standard deviation is 0.20 units, when the sample sizes in the two 
groups are 276 and 138 subjects, respectively (a total sample size of 414 subjects). 
 
Regarding photopic binocular distance-corrected intermediate visual acuity (DCIVA) at 66 cm at 
Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation), a two group t-test with 
a 0.050 two-sided significance level will have 99% power to detect a difference in means of -0.10 

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logMAR units, assuming that the common standard deviation is 0.15 units, when the sample sizes 
in the two groups are 276 and 138 subjects, respectively (a total sample size of 414 subjects). 
 
Regarding photopic binocular uncorrected intermediate visual acuity (UCIVA) at 66 cm at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation), a two group t-test with a 
0.05 two-sided significance level will have 99% power to detect a difference in means of -0.10 
logMAR units, assuming that the common standard deviation is 0.20 units, when the sample sizes 
in the two groups are 276 and 138 subjects, respectively (a total sample size of 414 subjects). 
 

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3 
Table of Contents  
1 
TITLE PAGE ...........................................................................................................1 
2 
SYNOPSIS ...............................................................................................................7 
3 
TABLE OF CONTENTS .......................................................................................19 
4 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ........................24 
5 
INTRODUCTION .................................................................................................26 
6 
STUDY OBJECTIVES AND PURPOSE .............................................................27 
6.1 
Study Endpoints .........................................................................................27 
7 
INVESTIGATIONAL PLAN ................................................................................28 
7.1 
Overall Study Design and Plan: Description .............................................28 
7.2 
Investigators ...............................................................................................28 
7.3 
Study Duration ...........................................................................................29 
8 
SELECTION AND WITHDRAWAL OF SUBJECTS .........................................29 
8.1 
Subject Inclusion Criteria ..........................................................................29 
8.2 
Subject Exclusion Criteria .........................................................................30 
8.3 
Subject Disposition Criteria .......................................................................31 
8.3.1 Subject Enrollment.........................................................................31 
8.3.2 Subject Screen Failures ..................................................................31 
8.3.3 Subject Completion ........................................................................31 
8.3.4 Subject Discontinuation .................................................................31 
8.3.5 Lost to Follow-Up ..........................................................................32 
9 
TREATMENT PLAN ............................................................................................32 
9.1 
Methods of Assigning Subjects to Treatment Groups ...............................32 
9.1.1 Treatment Allocation .....................................................................32 
9.1.2 Randomization Rationale & Method .............................................33 
9.1.3 Treatment or Subject Replacement ................................................33 
9.2 
Masking and Postoperative Masked Examiner(s) ......................................33 
9.3 
Concomitant Medications ..........................................................................33 
9.4 
Protocol Deviations ....................................................................................33 
10 
STUDY MATERIALS AND MANAGEMENT ...................................................34 
10.1 
Description of Test Article and Intended Use............................................34 
10.2 
Description of Active Control ....................................................................35 
10.3 
Packaging and Labeling .............................................................................35 
10.3.1 Packaging.. .....................................................................................35 
10.3.2 Labeling…. ....................................................................................35 
10.4 
Storage of Study Device ............................................................................35 

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10.5 
Surgical Directions.....................................................................................35 
10.6 
Study Device Accountability .....................................................................35 
10.7 
Other Materials ..........................................................................................36 
11 
STUDY PROCEDURES AND EVALUATIONS ................................................36 
11.1 
Schedule of Evaluations and Procedures ...................................................36 
11.1.1 Mitigation of COVID-19 Related Disruption to Study Visits .......37 
11.1.2 Preoperative Visit 0: Day -30 to -5 ................................................38 
11.1.3 Operative Visit 00A: Day 0 ...........................................................38 
11.1.4 Operative Visit 00B: Day 7 to 30 ..................................................38 
11.1.5 Postoperative Visits (1A through 5): Day 1 to Day 420 ................38 
11.1.6 Postoperative Visit 6: Day 2- 30 post Visit 5 ................................39 
11.1.7 Unscheduled Visit(s) ......................................................................39 
11.1.8 Missed Visit(s) ...............................................................................39 
11.2 
Post-Study Follow-Up ...............................................................................39 
11.3 
Study Completion ......................................................................................39 
11.3.1 Early Study Termination ................................................................39 
12 
PRIMARY AND SECONDARY SAFETY AND EFFECTIVENESS 
VARIABLES .........................................................................................................40 
12.1 
Evaluation of Safety ...................................................................................40 
12.2 
Evaluation of Effectiveness .......................................................................40 
12.3 
Risk Assessment, Risk Mitigation, and Anticipated Benefit .....................41 
12.3.1 Risk Assessment of COVID-19 Specific Risks .............................42 
12.4 
Adverse Events ..........................................................................................43 
12.4.1 Adverse Events Definitions ...........................................................43 
12.4.2 Identification and Collection..........................................................47 
12.4.3 Evaluations .....................................................................................47 
12.4.4 Reporting........................................................................................48 
12.4.4.1 On-Site SAE and UADE Reporting ..............................49 
12.4.4.2 Off-Site UADE Reporting.............................................50 
12.4.4.3 Reporting Device Deficiencies .....................................50 
12.4.5 Adverse Events at Subject Exit ......................................................50 
12.4.6 Pregnancy .......................................................................................50 
13 
STATISTICS .........................................................................................................51 
13.1 
Study Endpoints .........................................................................................51 
13.1.1 Safety Endpoints ............................................................................51 
13.1.1.1 Primary Safety Endpoints .............................................51 
13.1.1.2 Secondary Safety Endpoints .........................................51 
13.1.2 Effectiveness Endpoints .................................................................52 

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13.1.2.1 Primary Effectiveness Endpoints ..................................52 
13.1.2.2 Secondary Effectiveness Endpoints ..............................52 
13.2 
Hypotheses .................................................................................................52 
13.2.1 Safety Endpoints ............................................................................52 
13.2.2 Effectiveness Endpoints .................................................................53 
13.3 
Sample Size Determination........................................................................57 
13.3.1 Phase I / Pilot .................................................................................57 
13.3.2 Primary Safety Endpoints ..............................................................57 
13.3.3 Secondary Safety Endpoints ..........................................................57 
13.3.4 Primary Effectiveness Endpoints ...................................................58 
13.3.5 Secondary Effectiveness Endpoints ...............................................58 
13.3.6 Sub-Studies ....................................................................................59 
13.3.6.1 Defocus Curves .............................................................59 
13.3.6.2 Contrast Sensitivity .......................................................59 
13.3.6.3 Optical Coherence Tomography (OCT) Imaging .........60 
13.3.6.4 Trial Frame Astigmatism Simulation ............................60 
13.3.7 Overall Sample Size and Adjustment for Dropouts .......................60 
13.4 
Analysis Populations ..................................................................................60 
13.4.1 Intent-to-Treat (ITT) Set ................................................................60 
13.4.2 Modified Intent-to-Treat Set ..........................................................60 
13.4.3 Modified Safety Set .......................................................................60 
13.4.4 Per Protocol Set..............................................................................60 
13.4.5 Best Case Set..................................................................................61 
13.5 
Statistical Analysis .....................................................................................61 
13.5.1 Primary Safety Analyses ................................................................61 
13.5.1.1 First Eyes with at Least One Serious Adverse Event ....61 
13.5.1.2 Secondary Surgical Interventions Related to the 
Optical Properties of the IOL ........................................61 
13.5.1.3 ISO Grid Adverse Events ..............................................62 
13.5.2 Secondary Safety Analyses ............................................................62 
13.5.2.1 Rates of Severe or Very Bothersome Visual 
Disturbances ..................................................................62 
13.5.2.2 Contrast Sensitivity .......................................................63 
13.5.2.3 Incidence of the Types of AEs Specified in the Co-
primary Safety Endpoints ..............................................63 
13.5.2.4 Incidence of All Other Types of Ocular AEs ................63 
13.5.3 Primary Effectiveness Analyses ....................................................63 
13.5.3.1 Photopic Monocular BCDVA .......................................63 
13.5.3.2 Photopic Monocular DCNVA .......................................64 

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13.5.3.3 Photopic Monocular DCIVA ........................................65 
13.5.4 Secondary Effectiveness Analyses ................................................65 
13.5.5 Other Analyses ...............................................................................65 
13.5.5.1 Clarity of Fundus Visualization ....................................65 
13.5.5.2 Adverse Events..............................................................66 
13.5.5.3 Subject Questionnaires ..................................................66 
13.5.5.4 Trial Frame Astigmatism Simulation ............................66 
13.5.5.5 Additional Outcomes ....................................................67 
13.5.5.6 Additional Analyses ......................................................67 
13.5.6 Subject Disposition ........................................................................67 
13.5.7 Demographics and Baseline Characteristics ..................................68 
13.5.8 Protocol Deviations ........................................................................68 
13.5.9 Interim Analyses ............................................................................68 
13.6 
Additional Statistical Considerations .........................................................69 
13.6.1 Handling of Missing Data ..............................................................69 
13.6.2 Multicenter Issues ..........................................................................69 
13.6.3 Multiplicity Issues ..........................................................................69 
13.6.4 Visit Windows ...............................................................................69 
13.6.5 Management of Bias ......................................................................70 
13.6.6 Management of Potential Confounding Factors ............................70 
14 
QUALITY CONTROL AND QUALITY ASSURANCE .....................................70 
14.1 
Study Monitoring .......................................................................................70 
14.2 
Source Documentation ...............................................................................71 
14.3 
Case Report Forms and Data Verification .................................................71 
14.4 
Recording of Data and Retention of Documents .......................................71 
14.5 
Audits and Inspections ...............................................................................72 
15 
ETHICS AND ADMINISTRATIVE ISSUES ......................................................72 
15.1 
Ethical Conduct of the Study .....................................................................73 
15.2 
Ethics Review ............................................................................................73 
15.3 
Written Informed Consent .........................................................................73 
15.4 
Financial Disclosure, Clinical Trial Agreements, and Site Contact 
Information ................................................................................................73 
15.5 
Confidentiality/Publication of the Study ...................................................74 
16 
REFERENCES ......................................................................................................75 
17 
APPENDICES .......................................................................................................78 
 
 

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List of Tables 
Table 1.   Non-serious Adverse Events ..............................................................................48 
Table 2.   Serious Adverse Events .....................................................................................49 
Table 3.  logMAR to Snellen Conversion Table................................................................64 
Table 4.  Trial Frame Testing ............................................................................................95 
 

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4 
List of Abbreviations and Definitions of Terms 
 
Abbreviation or 
specialist term 
Definition or Explanation 
ADE Adverse Device Effect 
AE Adverse Event 
ANSI American National Standards Institute 
BCDVA Best-corrected Distance Visual Acuity, synonymous with CDVA 
C Centigrade 
cd/m2 Candela per Square Meter  
CDVA Corrected Distance Visual Acuity, synonymous with BCDVA 
CME Cystoid Macular Edema 
CFR Code of Federal Regulations 
cpd Cycles Per Degree 
 
CRF Case Report Form 
CRO Clinical Research Organization 
D Diopter 
DCIVA Distance-corrected Intermediate Visual Acuity 
DCNVA Distance-corrected Near Visual Acuity 
ETDRS Early Treatment Diabetic Retinopathy Study 
DFU Directions for Use 
F Fahrenheit 
FDA Food and Drug Administration 
FDF Financial Disclosure Form 
GCPs Good Clinical Practices 
HEMA Hydroxyethyl Methacrylate 
HIPAA Health Insurance Portability and Accountability Act 
ICF Informed Consent Form 
ICH International Council for Harmonization 
IDE Investigational Device Exemption 
IOL Intraocular Lens 
IOP Intraocular Pressure 
IEC Institutional Ethics Committee 
IRB Institutional Review Board 
IRT Interactive Response Technology 
ISO International Organization for Standardization 
ITT Intent to Treat 
LASEK Laser-assisted subepithelial keratectomy 
LASIK Laser-assisted in situ keratomileusis 
LOCF Last Observation Carried Forward 
logMAR Logarithm of the Minimum Angle of Resolution 
MCMC Markov chain Monte Carlo  
MIOL Multifocal Intraocular Lens 
mITT Modified Intent to Treat 

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Abbreviation or 
specialist term 
Definition or Explanation 
MTF Modulation Transfer Function 
NAVQ  Near Activity Visual Questionnaire 
Nd:YAG Neodymium:Yttrium Aluminium Garnet 
ND Not Done 
OCT  Optical Coherence Tomography 
OVD Ophthalmic Viscoelastic Device 
PAM Potential Acuity Meter 
PCO Posterior Capsular Opacification 
PMA Pre-market Approval 
polyEGPEA Polyethylene Glycol Phenyl Ether Acrylate 
PP Per Protocol 
QoV Quality of Vision  
SAE Serious Adverse Event 
SAP Statistical Analysis Plan 
SPK Superficial Punctate Keratitis 
SOP Standard Operating Procedure 
SPE Safety and Performance Endpoint 
SSI Secondary Surgical Intervention 
SUN Standardization of Uveitis Nomenclature 
TASS Toxic Anterior Segment Syndrome 
UADE Unanticipated Adverse Device Effect 
UCDVA Uncorrected Distance Visual Acuity 
UCIVA Uncorrected Intermediate Visual Acuity 
UCNVA Uncorrected Near Visual Acuity 
US United States 
VA Visual Acuity 
 

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5 
Introduction 
Cataracts are a common condition in adults over 40 years of age, and surgical replacement of 
the cataractous lens with an intraocular lens (IOL) remains an effective way to restore vision 
to cataract patients.4  Monofocal IOLs provide adequate distance vision but require spectacle 
use for near or intermediate distance vision activities.  Subsequent to monofocal IOL 
development and commercialization, multifocal intraocular lenses (MIOLs), including bifocal 
and trifocal IOLs, have been successfully developed to improve near and intermediate distance 
vision and increase spectacle independence following cataract surgery. 5-9   
There are currently no approved trifocal IOLs available in the United States, despite a desire 
by cataract surgery patients for a product that provides improved near and intermediate vision 
in comparison to a conventional monofocal IOL without compromising distance vision. 
Clinical studies have shown that intermediate add power trifocal diffractive IOLs have 
substantially improved intermediate vision compared to bifocal IOLs, resulting in better visual 
quality and excellent spectacle independence for individuals with active lifestyles. 10-14 
Observational clinical studies and clinical studies comparing trifocal to bifocal IOLs also have 
shown high patient satisfaction in patients with trifocal MIOLs. 11, 15, 16  These studies and 
others indicate contrast sensitivity and levels of photic phenomena in patients with trifocal 
MIOL implants are similar to that of patients with bifocal MIOLs under both photopic and 
mesopic conditions, and spectacle independence in up to 100% of the patients has been 
reported. 12-19    
The enVista® MX60EF trifocal MIOL is a 1-piece hydrophobic acrylic ultraviolet-absorbing 
lens with aspheric biconvex optics, designed to have -0.15 µm of spherical aberration, with 
apodized diffractive structures on the anterior surface, a square edge on the posterior surface 
and modified C-loop haptics. The design and material of the lens allow it to be folded and 
inserted into the capsular bag through a small incision to minimize the possibility of surgically 
induced astigmatism.  The MX60EF lens is a modification to the Bausch + Lomb enVista® 1-
piece hydrophobic acrylic monofocal IOL, model MX60E, approved under PMA Supplement 
P920056/S024 by the FDA on 05/23/2017 as an update to PMA P910056/S010, approved on 
05/30/2012 for the parent enVista MX60 monofocal IOL.  PMA P910056/S010 approved a 
material change and design modifications to the previously approved Bausch + Lomb model 
C31UB IOL, including a design change from 3-piece to 1-piece design and the addition of 
aspheric optics with zero spherical aberration. 
The enVista® Trifocal Model MX60EF will be manufactured, packaged and sterilized with 
the same materials and processes used for the enhanced enVista® IOL Model MX60E.  The 
enVista Model MX60E lens material is a modification to the enVista Model MX60 material, 
designed to enhance the unfolding rate of the lens at the lower eye temperature encountered 
during surgical procedures. 
The induced -0.15 µm negative spherical aberration MX60EF trifocal MIOL lens design 
(incorporated on the enVista EF base refractive design to give a residual spherical aberration 
of ~0.10µm) is expected to produce comparable decentration performance to a spherical 
aberration-free lens design and best contrast-related performance in the presence of other 
higher order aberrations.  Mathematical modeling and optical bench experiments have shown 
that increased depth of focus due to residual spherical aberration comes at the cost of lower 
modulation transfer function (MTF). 20-22 Since the enVista® MX60EF lens is distance 

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dominant under mesopic (low light) conditions, any level of corneal spherical aberration 
compensation using the MX60EF trifocal MIOL should result in improving the MTF. 
 
Thus, the rationale for the investigation described in this document is to collect and analyze 
data suggesting potential clinical benefit that clearly outweighs any potential risks associated 
with use of the MX60EF product. 
 
6 
Study Objectives and Purpose 
The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal 
intraocular lens when implanted in the capsular bag.  
 
6.1 
Study Endpoints 
The following primary and secondary safety and effectiveness endpoints will be evaluated.  
 
6.1.1  Safety   
The primary safety endpoints will be: 
• The incidence of all serious adverse events, including SSIs related to the optical 
properties of the IOL, in first eyes through study exit 
• The rate of secondary surgical interventions due to the optical properties of the lens for 
first eyes through study exit  
• The incidence of adverse events in first eyes compared to ISO Safety and Performance 
Endpoint (SPE) rates as defined in ISO 11979-7 through study exit 
 
The secondary safety endpoints will be: 
• The rates of visual disturbances reported as “severe” by subjects, as well as the rates of 
visual disturbances reported as “very” bothersome by subjects, using the QoV 
questionnaire measure through Post-Operative Visit 4 (Day 120 to 180 after second eye 
IOL implantation) 
• Mean photopic contrast sensitivity with glare and mesopic contrast sensitivity with and 
without glare at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL 
implantation) and Post-Operative Visit 5 (Day 330 to 420 after second eye IOL 
implantation) 
• Incidence of the types of AEs specified in the co-primary endpoints, but for fellow and 
“all” eyes 
• Incidence of all other types of adverse events in primary eyes, fellow eyes, and “all” 
eyes 
 
6.1.2  Effectiveness   
The primary effectiveness endpoints will be: 
• Photopic monocular best-corrected distance visual acuity (BCDVA) in first eyes at 
Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• Photopic monocular distance-corrected near visual acuity (DCNVA) in first eyes at 40 
cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 

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• Photopic monocular distance-corrected intermediate visual acuity (DCIVA) in first 
eyes at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL 
implantation) 
Secondary effectiveness endpoints will be: 
• Photopic binocular distance-corrected near visual acuity (DCNVA) at 40 cm at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• Photopic binocular uncorrected near visual acuity (UCNVA) at 40 cm at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• Photopic binocular distance-corrected intermediate visual acuity (DCIVA) at 66 cm at 
Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)  
• Photopic binocular uncorrected intermediate visual acuity (UCIVA) at 66 cm at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• First eye BCDVA, DCNVA, and DCIVA evaluated at Visit 5 
7 
Investigational plan 
7.1 
Overall Study Design and Plan: Description 
This will be a prospective, multicenter, randomized, active-controlled binocular study of the 
enVista one-piece hydrophobic acrylic trifocal MIOL (model MX60EF) in subjects 
undergoing cataract extraction compared to the enVista one-piece hydrophobic acrylic 
monofocal intraocular lens (model MX60E).  
Subjects scheduled to undergo cataract surgery by phacoemulsification and implantation of 
bilateral intraocular lenses (IOLs) will be screened for eligibility. Subjects will be examined 
preoperatively to obtain a medical history, establish a baseline for ocular condition, and 
determine eligibility. Both eyes of each subject will be included in the study and must meet 
eligibility criteria at the Pre-Operative Visit. At the time of the first surgery, subjects will be 
enrolled and randomly assigned by an interactive response technology (IRT) system in a 2:1 
ratio to either the enVista trifocal MIOL or the enVista monofocal IOL, respectively.  
Postoperatively, subjects will undergo ophthalmic examinations at regular intervals per the 
study visit schedule. The Investigator will provide standardized pre-, peri-, and postoperative 
care for all study subjects at his/her clinical site (refer to Section 11 for additional information). 
A delegated examiner(s) at each site who is masked to the randomized assignment of each 
subject will perform postoperative measurements.  Every effort will be made to ensure that 
postoperative assessments for a subject are completed by the same examiner.  
7.2 
Investigators 
The clinical investigation will be conducted at approximately twenty (20) investigative sites in 
North America.  
The clinical investigation will be conducted by Investigators who are determined by the 
Sponsor to be suitably qualified by training and experience to conduct this study in compliance 
with all applicable GCPs and FDA Federal Regulations or local regulations and who are 
willing to demonstrate use of the MX60E product, if they have not already done so.  
Additionally, the Device Investigator Agreement (on file for each site) also verifies 
Investigator obligations.   

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Each Investigator site will attempt to enroll approximately twenty-five (25) subjects. In the 
event that selected sites do not meet expected enrollment, the Sponsor may decide to increase 
enrollment as needed at other currently active sites, replace non-enrolling sites and/or add 
additional site(s) for a total of up to 25 actively enrolling sites, to satisfy study enrollment 
requirements. No Investigator shall contribute more than 10% of the total number of treated 
subjects in the study.  
7.3 
Study Duration 
Eligible subjects who are enrolled in this study will be followed for approximately one year 
following the second eye surgery. 
8 
Selection and Withdrawal of Subjects 
Approximately five hundred and one (501) subjects (approximately 1,002 eyes) at 
approximately twenty (20) clinical sites in North America scheduled to undergo bilateral 
phacoemulsification cataract surgery and IOL implantation will be enrolled in this clinical 
study.  
The study purpose, procedures, and subject responsibilities will be explained to the potential 
participant. The subject's willingness and ability to meet the follow-up requirements will be 
determined. When it has been established that the subject is willing to participate, written 
informed consent will be obtained (Section 15.3). In order to determine eligibility, written 
informed consent must be obtained from each study subject prior to performing any study 
specific procedures that are not part of the Investigator’s routine standard of care. Enrollment 
will be consecutive enrollment of all eligible subjects. A complete ophthalmic examination 
will be done at the Preoperative Visit scheduled within 30 days before the first eye surgery. 
Application of the inclusion and exclusion criteria in the following sections will result in the 
selection of an investigational population which is representative of the intended target 
population. 
8.1 
Subject Inclusion Criteria 
This study will include subjects who meet all of the following inclusion criteria: 
1. Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is 
signed.  
2. Subjects must have the capability to understand and provide written informed consent on 
the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved 
Informed Consent Form (ICF) and authorization as appropriate for local privacy 
regulations.  
3. Subjects must have a BCDVA equal to or worse than 20/40 in each eye, with or without a 
glare source, due to a clinically significant cataract (cortical, nuclear, subcapsular, or 
combination) that is considered amenable to treatment with standard phacoemulsification 
cataract extraction and capsular IOL implantation.  
4. Subjects must have a BCDVA projected to be better than 20/32 after IOL implantation in 
each eye, as determined by the medical judgment of the Investigator or measured by 
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5. Subjects must have clear intraocular media other than the cataract in both eyes. 
6. Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere 
and cylinder) in both eyes, as determined by manifest refraction on two consecutive 
examination dates after discontinuation of contact lens wear.  
7.  Subjects must require an IOL power from +16.0 diopter (D) to +24.0 D in both eyes. 
8. Subjects must be willing and able to comply with all treatment and follow-up study visits 
and procedures, and to undergo second eye surgery within 7-30 days of the first eye 
surgery. 
8.2 
Subject Exclusion Criteria 
This study will exclude subjects (or eyes) who meet any of the following exclusion criteria: 
1. Subjects who have used an investigational drug or device within 30 days prior to entry into 
this study and/or will participate in another investigation during the period of study 
participation.  
2. Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, 
edema, dystrophy, etc.) in either eye.  
3. Subjects who have significant anterior segment pathology that might increase 
intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome, 
synechiae, iris atrophy, traumatic cataract, lens subluxation, traumatic zonulolysis, zonular 
dialysis, evident zonular weakness or dehiscence, hypermature or brunescent cataract, etc.) 
in either eye.  
4. Subjects who have uncontrolled glaucoma in either eye.  
5. Subjects who have previous retinal detachment or clinically significant retinal pathology 
involving the macula in either eye.  
6. Subjects who have proliferative or non-proliferative diabetic retinopathy in either eye.  
7. Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract) in either 
eye. 
8. Subjects using any systemic or topical drug known to interfere with visual performance, 
pupil dilation, or iris structure within 30 days of enrollment or during the study.  
9. Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g., iritis, 
scleritis, iridocyclitis, or rubeosis iridis) in either eye.  
10. Subjects who have a visual disorder, other than cataracts, that could potentially cause future 
acuity losses to a level of 20/100 or worse in either eye.  
11. Subjects who have had previous intraocular or corneal surgery in either eye, with the 
exception of laser trabeculoplasty.  
12. Subjects with any preoperative infectious conjunctivitis, keratitis, or uveitis in either eye.  
13. Subjects who have a preoperative corneal astigmatism > 1.0 D in either eye, irregular 
astigmatism, or skewed radial axis (note: corneal incisions intended specifically to reduce 
astigmatism are not allowed during the study).  

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14. Subjects who cannot achieve a minimum pharmacologic pupil dilation of 5.0 mm in both 
eyes.  
15. Subjects who may be expected to require a combined or other secondary surgical procedure 
in either eye.  
16. Subjects who during the first cataract extraction experience an anterior or posterior capsule 
tear or rupture, zonular dialysis, significant iris trauma, or other complications that may 
cause untoward effects in the judgment of the Investigator. 
17. Females of childbearing potential (those who are not surgically sterilized or at least 12 
months postmenopausal) are excluded from enrollment in the study if they are currently 
pregnant or plan to become pregnant during the study.  Females of childbearing potential 
must be willing to practice effective contraception for the duration of the study.  
18. Subjects with any other serious ocular pathology or underlying systemic medical condition 
(e.g., uncontrolled diabetes) or circumstance that, based on the Investigator’s judgment, 
poses a concern for the subjects’ safety or could confound the results of the study.  
19. Subjects who have current or previous usage of an alpha-1-selective adrenoceptor 
blocking agent or an antagonist of alpha 1A adrenoceptor (e.g., Flomax® (tamsulosin 
HCl), Terazosin, or Cardura).  
8.3 
Subject Disposition Criteria 
8.3.1 
Subject Enrollment 
The subject is considered enrolled in the study at the time of randomization at the first 
Operative Visit (Visit 00A).  Randomization should follow the completion of uncomplicated 
cataract extraction in the first eye.  
8.3.2 
Subject Screen Failures 
A subject who fails to meet eligibility criteria and/or discontinues from the study before 
randomization will be considered a screen failure.  
8.3.3 
Subject Completion 
For those who are eligible and have consented to participate in the sub-study, a Visit 6 (Day 
2- 30 post Visit 5) will be conducted as the final visit to complete the study.  For those subjects 
who have not consented to the sub-study, Visit 5 will be the final visit to complete their 
participation.  If the subject consented to Visit 6 but did not complete the final Visit 6, Visit 5 
will be considered as the final visit for that subject, ending their participation in the study. 
A subject who has missed visits or is missing study measurements will remain in the study. 
Subjects who require further follow-up for an AE will be followed according to Section 12.4.    
8.3.4 
Subject Discontinuation 
A subject may be discontinued prior to the final study visit for any of the following reasons, 
including but not limited to: 
• 
Investigator’s request (e.g., subject non-compliance or medical decision) 
• 
voluntary withdrawal (subject’s request)  

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• 
death  
• 
lost to follow-up 
• 
study terminated by Sponsor 
Prior to discontinuing a subject, every effort should be made to contact the subject, schedule a 
final study visit, and obtain as much follow-up data as possible. Adverse events will be 
followed as described in Section 12.4. Subject withdrawals will be documented clearly on the 
source document and applicable Case Report Form (CRF).  Subjects who discontinue from the 
study should be seen for routinely scheduled visits according to the standard of care by the 
Investigator or their ophthalmologist. 
Notification of subject withdrawals will be made immediately to the Sponsor.  
Only subjects who are randomized but did not have the lens inserted into the eye may be 
replaced. Subjects for whom the lens was inserted but not implanted will not be replaced.  A 
new subject number will be assigned, as long as the total number of treated subjects at the site 
does not exceed 10% of the total treated eyes in the study. Subjects who are discontinued from 
the study following treatment will not be replaced.  
Discontinued subjects should be followed outside of the study protocol according to the 
Investigator’s normal standard of care. 
8.3.5 
Lost to Follow-Up 
Subjects who do not return for scheduled Postoperative Visit(s), as defined by the visit 
window, and cannot be contacted, may be considered lost to follow-up.  The investigator will 
try at least twice to reach the subject by telephone and/or electronic mail and will send a follow-
up letter by certified mail before considering the subject lost to follow-up. These actions will 
be recorded in the source documents and a copy of the follow-up letter maintained in the 
investigator’s file. The date of discontinuation for subjects lost to follow-up will be seven days 
after the date that the unanswered certified letter was sent.   
Efforts shall be made to keep the number of subjects lost to follow-up to a minimum, below 
10% of the number of subjects treated.   
9 
Treatment Plan 
9.1 
Methods of Assigning Subjects to Treatment Groups 
Approximately 501 subjects (1,002 eyes) will be randomized in a 2:1 ratio to receive the 
enVista trifocal (Test) IOL or enVista monofocal (Control) IOL in both eyes. 
9.1.1 
Treatment Allocation 
At the time of the first surgery following uncomplicated cataract extraction, subjects will be 
randomly assigned to either the enVista trifocal MIOL or enVista monofocal IOL in a 2:1 ratio 
based upon a predetermined randomization scheme.  

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9.1.2 
Randomization Rationale & Method 
Randomization of subjects is performed to reduce potential bias.  Subjects will be randomly 
assigned to receive either the trifocal (Test) IOL bilaterally or the monofocal (Control) IOL 
bilaterally according to the randomization scheme to be provided.  
IRT will be utilized for randomization in this study. The randomization codes will be stratified 
by site such that the ratio of subjects assigned to the Test MX60EF trifocal MIOL or Control 
MX60E IOL at each site will be approximately 2:1.  
Randomization will occur following uncomplicated cataract extraction on the date of first 
surgery. 
9.1.3 
Treatment or Subject Replacement 
There is no treatment or subject replacement planned for this study. 
9.2 
Masking and Postoperative Masked Examiner(s) 
The Investigator implanting the IOL and designated site personnel will be unmasked to the 
assignment of IOLs.  Subjects and designated postoperative evaluator(s) will be masked to the 
IOLs assigned.    
A qualified masked examiner at each site, who is unaware of which IOL has been implanted 
for each subject, shall perform post-operative measurements including manifest refraction, 
visual acuity, contrast sensitivity, and defocus curves. Every attempt should be made to have 
the same masked examiner perform the same post-operative measurements for an individual 
subject throughout the subject’s study participation. 
 
 Pupil size measurements should be taken by an unmasked staff member. 
9.3 
Concomitant Medications 
Documentation of all medications used by the subject within 30 days of informed consent and 
during the study will be made in study source documents.  
Pre-, intra-, and postoperative medications may be administered per the Investigator’s standard 
of care.  A complete list of the Investigator’s standard regimen of these medications will be 
provided to the Sponsor or its designee and approved by the Medical Monitor prior to initiation 
of the study.  All Investigators will be required to use Amvisc® Plus viscoelastic (see Appendix 
C). 
Medications known to interfere with visual performance, pupil dilation, or iris structure are 
prohibited within 30 days of enrollment and for the duration of the study.  A list of prohibited 
medications (including alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 
1A adrenoceptor (e.g., Flomax® (tamsulosin HCl), Terazosin, or Cardura) will be included as 
part of the Study Reference Manual provided to the site. 
9.4 
Protocol Deviations  
A deviation from the protocol is an unintended and/or unanticipated departure from the 
procedures and/or processes approved by the Sponsor and the IRB/IEC and agreed to by the 
Investigator.  

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The investigator or designee must document and explain in the subjects’ source documentation 
any deviation from the approved protocol. Protocol waivers will not be allowed under any 
circumstances.  The investigator may implement a deviation from, or a change of, the protocol 
to eliminate an immediate hazard to study subjects without prior IRB/IEC approval. As soon 
as possible after such an occurrence, the implemented deviation or change, the reasons for it, 
and any proposed protocol amendment(s) should be submitted to the IRB/IEC for review and 
approval, to the Sponsor for agreement, and to the regulatory authorities, if required. 
Documentation of the deviation process and follow up (as applicable) can be found in the Study 
Refence Manual.  Deviation impact on data analysis is described in Section 13.5.8.   The date 
of, and reason for, deviations in all cases will be documented. Protocol deviations affecting the 
safety of the subject or the integrity of the study must be reported by the Investigator to the 
IRB/IEC promptly. Reporting of all other protocol deviations must adhere to the requirements 
of the governing IRB/IEC.   
Protocol assessments will continue for a subject until the end of the study, unless the protocol 
deviation puts the subject at risk or the subject’s condition requires that he/she be discontinued 
from the study.   
Scheduled assessments missed or conducted out of window due to COVID-19 disruption will 
be recorded as protocol deviations. 
10 
Study Materials and Management 
To maintain product integrity and sterility, the investigational devices will be used according 
to the device instructions and as supplied in their original pouch and outer packaging. At each 
site, the investigational device will be dispensed by an appropriately qualified member of the 
study staff assigned by the Investigator to this task. 
10.1 Description of Test Article and Intended Use 
The enVista MX60EF Trifocal MIOL is manufactured by Bausch & Lomb (Clearwater, FL) 
and is a one-piece hydrophobic acrylic ultraviolet-absorbing lens with aspheric biconvex optics 
designed to have -0.15 µm of spherical aberration, with apodized diffractive structures on the 
anterior surface and modified C-loop haptics.  The posterior aspheric optic is designed with a 
360 degree square edge, to help prevent Posterior Capsular Opacification (PCO), and modified 
C-loop haptics.  The design and material of the lens allow it to be folded and inserted into the 
capsular bag through a small incision to minimize the extent of surgically induced astigmatism.  
The enVista Trifocal MIOL (Model MX60EF) is sterile, non- pyrogenic and packaged in 0.9% 
saline solution, contained in a gamma grade polypropylene vial (with a heat-sealed foil lid) 
that is then sealed in a Tyvek peel pouch.  Test lenses will be available in powers +16.0 D to 
+24.0 D, in 0.5 D increments. 
 
The enVista one-piece hydrophobic acrylic trifocal intraocular lens (IOL) is intended to replace 
the natural crystalline lens and is indicated for primary implantation for the visual correction 
of aphakia in adult patients in whom the cataractous lens has been removed.  The lens is 
intended for placement in the capsular bag.  Additional details regarding this product can be 
found in the Investigator’s Brochure for it. 

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10.2 
Description of Active Control 
The enVista One-Piece Hydrophobic Acrylic IOL (Model MX60E) is a one-piece foldable, 
hydrophobic acrylic, ultraviolet (UV) absorbing posterior chamber IOL with an aspheric optic 
and a 360-degree square edge, to help prevent PCO.  The biconvex lens optic has a body 
diameter of 6.0 mm, and the overall length (diameter) of the IOL is 12.5 mm.  Control Model 
MX60E lenses will be available in powers +16.0 D to +24.0 D; in 0.5 D increments. The 
Directions For Use for the MX60E are shown in Appendix E.  
10.3 Packaging and Labeling 
The study materials will be packaged and labeled in a manner consistent with the study design.  
10.3.1 
Packaging  
EnVista trifocal MX60EF and enVista monofocal MX60E lenses will be non-pyrogenic, 
packaged sterile in 0.9% saline solution, and contained in a gamma grade polypropylene vial 
(with a heat-sealed foil lid) that is sealed in a Tyvek peel pouch.  The lens is sterilized using 
gamma irradiation. 
10.3.2 
Labeling  
Study lens labeling will include the following information:  
• 
Study number  
• 
Sponsor name and address 
• 
Product identifier  
• 
Quantity of contents 
• 
Directions for use (DFU)  
• 
Statement indicating: “Caution – Investigational Device. Limited by Federal 
Law to investigational use.”  
• 
Storage conditions  
• 
Lot number 
• 
Expiration date 
• 
Lens number 
 
10.4 Storage of Study Device  
Store study IOLs at room temperature.  Do not store study IOLs at a temperature greater than 
43°C (110°F).  DO NOT FREEZE.  Do not autoclave the IOLs.  
 
10.5 Surgical Directions 
Refer to Appendix C for surgical directions/procedures for the MX60EF and MX60E IOLs.   
 
10.6 Study Device Accountability 
The Investigator will be responsible for keeping current and accurate records of the number of 
IOLs received, implanted and returned to Sponsor. The IOLs must be stored under the 
appropriate conditions in a secure area and are to be implanted only in subjects enrolled in the 
study, in accordance with the conditions specified in this protocol. During the course of the 

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study, the Investigator must maintain an inventory of all investigational IOLs implanted, 
including subject identifiers.  
 
Accountability records will include:  
• 
the lens numbers of all IOLs received, the receipt date, and the quantity 
received  
• 
the names of all site personnel who received, used, or disposed of the IOLs  
• 
the dates of use, disposal, or return of each IOL  
• 
a record of each subject implanted with a Test or Control IOL  
• 
why and how many IOLs are returned to the Sponsor  
• 
explanation for reconciliation of discrepancies 
 
At various time points throughout the study and/or upon completion of the study, the Sponsor 
or Sponsor’s representative will review and verify the Investigator’s accountability records. 
Following verification, and as directed by the Sponsor, unused study devices must be returned 
to the Sponsor. 
10.7 Other Materials 
Study materials provided by Bausch + Lomb will include: 
• Bausch & Lomb single-use IOL injection system (BLIS) 
• Bausch & Lomb Amvisc® Plus viscoelastic 
• Visual acuity and contrast sensitivity instrumentation  
• Subject questionnaires: the Quality of Vision (QoV) questionnaire 23,24 and Near 
Activity Visual Questionnaire 25-28 (paper forms)  
• Accessory to enable capture of slit-lamp biomicroscope photos, as needed 
• A digital pupillometer 
 
11 
Study Procedures and Evaluations 
Subjects will be examined and evaluated according to the study schedule provided in  
Appendix A. 
11.1 Schedule of Evaluations and Procedures 
Enrolled subjects who meet eligibility criteria will be seen according to the following schedule:  
Visit Name 
Eyes Evaluated  
Visit Window  
Preoperative Visit 0A/B 
Both Eyes  
Day -30 to -5  
Operative Visit 00A 
1st Eye  
Day 0  
Post-Operative Visit 1A  
1st Eye  
Day 1 to 2 post Visit 00A  
Post-Operative Visit 2A  
1st Eye  
Day 7 to 14 post Visit 00A  
Post-Operative Visit 3A  
1st Eye  
Day 30 to 60 post Visit 00A  
Operative Visit 00B 
2nd Eye  
Day 7 to 30 post Visit 00A  
Post-Operative Visit 1B  
2nd Eye  
Day 1 to 2 post Visit 00B  
Post-Operative Visit 2B  
2nd Eye  
Day 7 to 14 post Visit 00B 
Post-Operative Visit 3B 
2nd Eye 
Day 30 to 60 post Visit 00B 

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Post-Operative Visit 4 
Both Eyes  
Day 120 to 180 post Visit 00B 
Post-Operative Visit 5 
Both Eyes 
Day 330 – 420 post Visit 00B 
Post-Operative Visit 6 
(subjects that consent at 
participating sites) 
Both Eyes 
Day 2- 30 post Visit 5 
  
Refer to Appendix B for the schedule of visits and procedures and Appendix B for methods 
of clinical evaluation. 
 
Following identification of a potential subject, the Investigator (or designee) will explain the 
purpose of the study, procedures, risks/benefits.  and subject responsibilities to the potential 
subject. The subject’s willingness and ability to meet the follow-up requirements of the study 
will be determined. If the subject chooses to participate in the investigation, written informed 
consent will be obtained. The subject or his/her legal representative and the person obtaining 
written consent will sign and date the IRB/IEC approved ICF, at which point the subject is 
considered part of the study population. The original signed document will be retained in the 
subject records, and a copy will be provided to the subject. In addition, the applicable privacy 
regulation requirements must be met. 
 
The subject identification number will be assigned by IRT, which will consist of a 3-digit site 
number (pre-assigned) and a 3-digit chronological order screening number, assigned by IRT 
and starting with 001 (e.g., 101-001, 101-002; in this example the site number is 101). That 
subject number will be used to identify the subject throughout the study. It will not be necessary 
for the surgical procedures to occur in subject number order.  
 
11.1.1 
Mitigation of COVID-19 Related Disruption to Study Visits 
Study procedures performed during the COVID-19 pandemic will be conducted in accordance 
with medical guidance to reduce risk of COVID-19 transmission between study staff and 
subjects (available at www.aao.org/covid-19).  It is recommended Investigators periodically 
revisit the aao.org/covid-19 website to identify and implement any updated recommendations 
made by AAO.  Local, state, and federal public health guidance also will be followed, and it is 
recommended these guidances also be visited once a month to see if they have changed. 
 
Where in-person study visits are not possible due to the pandemic, remote contact with subjects 
may be instituted by the investigational site, as feasible, to collect any relevant safety data on 
health and medication changes.   The decision to conduct a remote contact in lieu of an in-
person visit will be made using the professional judgment of the PI - prioritizing safety, as well 
as adherence to local, state, and federal guidelines related to COVID-19, and in consideration 
of relevant guidance from national, professional ophthalmic organizations, including the 
American Academy of Ophthalmology and the American Society of Cataract and Refractive 
Surgeons.  
 
Remote contacts will limit data collection to safety oversight and medication changes. 
Scheduled assessments missed or conducted out of window due to COVID-19 disruption will 
be recorded as protocol deviations. 

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11.1.2 
Preoperative Visit 0: Day -30 to -5 
Informed consent must be obtained prior to the Investigator performing study specific 
procedures that are not part of his/her routine standard of care. After obtaining written informed 
consent, prospective subjects will be screened to determine whether they meet the entry criteria 
for the study. Demographic information, medical history, and current medication use will be 
collected. The preoperative clinical evaluation will be conducted no more than 30 days prior 
to the first surgery and will consist of a complete ophthalmic examination.   
Note: Potential subjects may be identified for screening in conjunction with routine clinic 
cataract evaluations involving standard of care testing. To avoid having to repeat this testing 
within a short time period to qualify for the study, standard of care measurements, including 
corneal topography, targeted refraction / IOL power calculation / axial length determination / 
anterior chamber depth / chord length µ, keratometry, IOP, slit-lamp examination, and dilated 
fundus exam, may be used as qualifying pre-operative assessments, provided they meet the 
following criteria:  
• Performed by a qualified investigator who is participating in the study; 
• Performed as specified in the protocol to verify subject eligibility; 
• Conducted within the pre-operative window specified in the protocol. 
11.1.3 
Operative Visit 00A: Day 0 
Subjects will be assessed to reconfirm eligibility. In addition, any changes in concomitant 
medications or AEs will be recorded. If the subject is no longer eligible, he/she will be screen 
failed from the study. If the subject is eligible, surgery will be performed using the surgical 
procedure described in Appendix C. If the subject continues to meet eligibility criteria after 
cataract extraction, the subject will be randomized. 
 
The eye with the worse best-corrected distance visual acuity (BCDVA) or worse BCDVA with 
glare at the Preoperative Visit will be treated first (eye A) and used in the primary monocular 
evaluations. If BCDVA is the same for both eyes, the right eye will be treated first. 
11.1.4 
Operative Visit 00B: Day 7 to 30 
Subjects will undergo the second eye surgery (eye B) between 7 and 30 days from the first eye 
surgery.  Postoperative Visit 2A must be completed before Visit 00B. These visits may be 
performed the same day at the Investigator’s discretion, provided that Visit 2A is done first, 
and both visits are performed within window.  If the subject continues to meet eligibility 
criteria, surgery will be performed using the surgical procedure described in Appendix C. 
11.1.5 
Postoperative Visits (1A through 5): Day 1 to Day 420 
All treated subjects will be seen for a minimum of eight (8) postoperative visits. Postoperative 
Visits 3A and 3B may be performed the same day at the Investigator’s discretion, provided 
that Visit 3A is done first, and both visits are performed within window.   
 

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11.1.6 
Postoperative Visit 6: Day 2- 30 post Visit 5 
This visit applies to those subjects who have consented to Visit 6 at investigative sites where 
the trial frame astigmatism simulation sub-study is being performed.  The procedure for this 
visit is described in Section 8.0 of Appendix B.  
 
11.1.7 
Unscheduled Visit(s) 
Additional visits may be scheduled, as necessary, to ensure the safety and well-being of 
subjects. All additional examinations should be fully documented in the source documents and 
on Unscheduled Visit CRFs, as appropriate. Visits intended to fulfill scheduled visit 
requirements that fall outside the designated scheduled visit window will be collected and 
transcribed to the appropriate visit CRF.  
 
If a subject is seen for multiple visits during a given visit timeframe, the data from the visit 
that is intended to meet the protocol requirements for the scheduled visit will be captured on 
the visit CRF. Where such a determination cannot be made, the first visit within the scheduled 
visit interval will be used for completion of the protocol required scheduled visit CRF. Data 
from any additional visits within a scheduled visit interval will be captured on an Unscheduled 
Visit CRF. 
11.1.8 
Missed Visit(s) 
If a subject misses any scheduled follow-up visit and cannot be seen prior to the start of the 
visit range for the next scheduled follow-up visit, the visit is considered missed.   
11.2 Post-Study Follow-Up 
If a subject requires further follow-up upon discontinuation or completion of the study, the 
Investigator should schedule post-study follow-up visits, as necessary. Refer to Section 12.4.5 
for follow-up of AEs following study exit. 
 
Post-surgical follow up study visits are described in the protocol sections above. Once 
participation in the study is complete the subjects are encouraged to see their ophthalmologist 
for routinely scheduled standard of care visits. 
11.3 Study Completion 
The Sponsor or its representative will notify the Investigator or the IRB/IEC, as applicable, to 
inform them when the study is complete. 
11.3.1 Early Study Termination 
If during the study it becomes evident to the Sponsor that the study should be stopped 
prematurely, the study will be terminated and appropriate notification will be given to the 
Investigator(s), IRB/IEC, and FDA or Local Health Authority, as applicable. The Sponsor or 
its representative will instruct the Investigators to stop enrolling and dispensing study 
materials/treatment and to arrange for study closeout at each site as appropriate. 

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12 
Primary and Secondary Safety and Effectiveness Variables 
12.1 Evaluation of Safety 
The primary safety endpoints will be: 
• The incidence of all serious adverse events, including SSIs related to the optical 
properties of the IOL, in first eyes through study exit 
• The rate of secondary surgical interventions due to the optical properties of the lens for 
first eyes through study exit 
• The incidence of adverse events in first eyes compared to ISO Safety and Performance 
Endpoint (SPE) rates as defined in ISO 11979-7 through study exit  
 
The secondary safety endpoints will be: 
• The rates of visual disturbances reported as “severe” by subjects, as well as the rates of 
visual disturbances reported as “very” bothersome by subjects, using the QoV 
questionnaire measure through Post-Operative Visit 4 (Day 120 to 180 after second eye 
IOL implantation) 
• Mean photopic contrast sensitivity with glare and mesopic contrast sensitivity with and 
without glare at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL 
implantation) and Post-Operative Visit 5 (Day 330 to 420 after second eye IOL 
implantation) 
• Incidence of the types of AEs specified in the co-primary safety endpoints, but for 
fellow and “all” eyes 
• 
Incidence of all other types of adverse events in primary eyes, fellow eyes, and “all” 
eyes 
 
12.2 Evaluation of Effectiveness  
The primary effectiveness endpoints will be: 
• Photopic monocular best-corrected distance visual acuity (BCDVA) in first eyes at 
Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• Photopic monocular distance-corrected near visual acuity (DCNVA) in first eyes at 40 
cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• Photopic monocular distance-corrected intermediate visual acuity (DCIVA) in first 
eyes at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL 
implantation) 
 
Secondary effectiveness endpoints will be: 
• Photopic binocular distance-corrected near visual acuity (DCNVA) at 40 cm at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• Photopic binocular uncorrected near visual acuity (UCNVA) at 40 cm at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• Photopic binocular distance-corrected intermediate visual acuity (DCIVA) at 66 cm at 
Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 

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• Photopic binocular uncorrected intermediate visual acuity (UCIVA) at 66 cm at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• First eye BCDVA, DCNVA, and DCIVA evaluated at Visit 5 
12.3 Risk Assessment, Risk Mitigation, and Anticipated Benefit 
The model MX60EF IOL has similar properties to the FDA approved model MX60 IOL that 
has been shown to be safe for implantation in humans. 29, 30   Reduced contrast sensitivity and 
increased visual disturbances, such as glare and halo, are known to occur more frequently with 
multifocal IOLs and will be evaluated in this study through subject questionnaires and a 
contrast sensitivity sub-study. 
The known risks of multifocal IOL implantation that exist in addition to the risks of monofocal 
IOL surgeries (cf. ISO standard 11979-7 Annex Table B.1) include the following: 
• Under scotopic and mesopic conditions the patient has reduced contrast sensitivity, and 
• There is an increased risk of post-operative photic effects such as halos and glare. 
Studies on other adverse perception effects following multifocal IOL implantation, such as 
stereo acuity disturbances and aniseikonia, have generally indicated an acceptable performance 
range. 31  
Multifocal IOLs achieve correction of presbyopia by dividing incoming light into two or more 
focal points.  Patient selection and counselling are particularly important with these IOLs. 
There may be a symptomatic reduction in the quality of distance vision, particularly if other 
ocular pathology is present. Therefore, the candidacy of patients with amblyopia or 
abnormalities of the cornea, optic disc, and macula for a multifocal IOL must be carefully 
considered.  Although uncommon, explantation of multifocal IOLs may become necessary if 
optical side effects are intolerable. 32  
A Cochrane systematic review concluded that multifocal IOLs are effective at improving near 
vision relative to monofocal IOLs, although there is uncertainty as to the size of the effect. 
Whether that improvement outweighs the adverse effects of multifocal IOLs, such as glare and 
haloes, will vary between people. Motivation to achieve spectacle independence is likely to be 
a deciding factor. 33  
Mitigation of the risks related to undesirable optical phenomena of multifocal IOLs includes 
exclusion of potential subjects with ocular pathology which may limit the quality of 
postoperative vision such as abnormalities of the cornea, lens capsule-zonular apparatus and 
macula, as well as thorough discussion of the characteristics of dysphotopsia such as halos, 
glare and reduced contrast sensitivity during the informed consent process.  As noted above, 
candidacy of patients for multifocal IOL implantation depends not only on objective findings 
during a complete ophthalmologic examination, but also on patients’ motivation to achieve 
spectacle independence.  The risks and benefits must be weighed on an individual basis by the 
investigator in consultation with each potential subject.  Ensuring the subject’s thorough 
understanding of the optical side-effects of multifocal IOLs and ascertaining the subject’s 
degree of enthusiasm for spectacle independence form the basis of informed consent and risk 
mitigation.  
Despite concern about risks of multifocal IOL implantation, the value of conducting a clinical 
study to support approval of a multifocal IOL is substantial in terms of assessing potential 

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continuing or new patient vision difficulties and possible improved near vision as well as 
providing another IOL option to increase potential patient satisfaction and improved near and 
intermediate vision while maintaining good distance vision.  Prior studies of multifocal IOLs 
have shown a high degree of patient satisfaction, both in absolute terms and in comparison to 
monofocal IOLs, improved near vision, and a very low rate of IOL explantation due to optical 
side-effects. 33-36  
These results indicate that application of the principles of informed consent and patient 
selection to the risk of dysphotopsia and contrast sensitivity reduction will provide greater 
benefit than risk and justify the enrollment of subjects in this study of a multifocal IOL.  
 
Another anticipated benefit which a subject may experience from participation in this study is 
an improvement of their vision as a result of the removal of cataracts.  If the subject is 
randomized to receive the enVista MX60E monofocal IOL, it is expected they may have 
improvement in their distance vision and would then only require the use of corrective lenses 
(such as glasses or contact lenses) for near and intermediate vision. If a subject is randomized 
to receive the enVista MX60EF trifocal IOL, they may have improvement in their near and 
intermediate vision while maintaining distance visual acuity comparable to a monofocal IOL, 
possibly allowing them to be able to read, use a computer, and watch television without reading 
glasses or bifocals.  
 
Further discussion of potential or actual risks during cataract surgery and with the use of 
multifocal or monofocal enVista IOLs as well as IOL injectors to be used in this study can also 
be found in the study Investigator’s Brochure.   
 
12.3.1 
Risk Assessment of COVID-19 Specific Risks  
New and unforeseen risks have arisen during the COVID-19 pandemic, including risk of 
infection and disruptions or delays in study conduct.   
 
To reduce the risk of coronavirus transmission, careful precautions for interactions between 
subjects and study personnel, and study personnel and Sponsor and/or CRO staff must be taken 
when in contact, including following local, state, and national recommendations and guidance 
found at www.aao.org/covid-19.  It is recommended Investigators periodically revisit the 
aao.org/covid-19 website to identify and implement any updated recommendations made by 
AAO.     
 
New risks to all study participants beyond those described in the preceding section include: 
 
• Possible transmission of Coronavirus infection, and possible further complications 
(including but not limited to hospitalization and/or death), beyond the risk of adverse 
events due to the investigational test lens and/or procedure(s). 
• Risk will be higher in an ophthalmic clinical study because of the close contact subjects 
will have with health care professionals during in-clinic procedures and assessments 
(since Investigators and post-surgical examiners must make measurements close to the 
face of subjects), in addition to the need for multiple follow-up visits/examinations 

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which will expose individuals to other study participants or patients and/or healthcare 
professionals who could be transmitting the virus even if they do not have symptoms. 
• Potential disruptions to the study due to current or future pandemic-related emergency 
restrictions, such as possible disruption of the study as a result of COVID-19 control 
measures (e.g., quarantining of subjects or study staff) that may lead to delays in 
scheduled follow-up visits.  
• If a subject experiences an adverse safety event (i.e., a safety complication) and they 
delay seeing their doctor because of COVID-19 restrictions and/or have concerns or 
fears about COVID-19 risk, a dangerous situation with serious permanent visual side 
effects including loss of vision could potentially occur.  Adverse outcomes typically 
require subjects to return for additional and possibly frequent follow-up office visits 
and examinations, thus increasing COVID-19-related risks to subjects, Investigators, 
and study staff. 
• If subjects are found to have contracted COVID-19 or feel ill with flu-like symptoms 
during participation in the study, they may not be permitted to continue routine 
scheduled study follow-up, thereby increasing the risk that diagnosis and treatment of 
potential adverse safety outcomes will be missed or delayed. 
12.4 Adverse Events 
Each subject eye treated must be examined for the presence/absence of adverse events at all 
visits, whether scheduled or not.  If an adverse event (AE) occurs, the first concern will be the 
safety and welfare of the subject; treatment should be provided as appropriate for the event.  
12.4.1 
 Adverse Events Definitions 
For the purposes of this study, adverse events include: all ocular AEs; all ocular and non-ocular 
serious adverse events (SAEs); adverse device effects (ADEs); and unanticipated adverse 
device effects (UADEs).  AEs, SAEs, ADEs and UADEs are defined as follows. 
 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical sign (including abnormal laboratory finding) in a subject, user or other 
persons, whether or not related to the investigational medical device.  This definition includes 
events related to the medical device or procedures involved.  For users or other persons, this 
definition is restricted to events related to the study device. 
 
A Serious Adverse Event (SAE) is an AE that leads to:  
• 
death 
• 
a serious deterioration in the health of the subject that either results in:  
o a life-threatening illness or injury, or 
o a permanent impairment of a body structure or body function (e.g., blindness), or 
o in-patient or prolonged hospitalization, or 
o a potentially vision-threatening condition, or  
o medical or surgical intervention to prevent life- or vision-threatening illness or 
injury or permanent impairment to a body structure or a body function  
• 
fetal distress, fetal death, or a congenital abnormality or birth defect  
 

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An Adverse Device Effects (ADE) is any adverse event related to the use of an investigational 
medical device.  This definition includes any events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation or operation, or any malfunction of 
the investigational medical device.  This definition also includes any event resulting from use 
error or from intentional misuse of the investigational medical device. 
 
An Unanticipated Adverse Device Effect (UADE) is any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with a device, if that 
effect, problem, or death is not previously identified in nature, severity or degree of incidence 
in the investigational plan or application (including a supplementary plan or application), or 
any other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects. 
 
Anticipated AEs associated with cataract surgery and/or premium IOL implantation that might 
reasonably be expected to occur in this study are listed below and include, but are not limited 
to, the following:  
 
Anterior capsule tear 
Anterior uveitis (including iritis and iridocyclitis) *  
Capsular block syndrome 
Choroidal detachment/hemorrhage 
Corneal edema *  
Cystoid macular edema (CME) * 
Difficulty with tasks in dim light resulting in secondary surgical intervention1 
Elevated IOP *  
Endophthalmitis (intraocular inflammation requiring vitreous tap and use of intraocular 
antibiotics) 
Events resulting in unplanned secondary surgical intervention other than paracentesis 
to relieve pressure prior to 1 week postoperative or Nd:YAG capsulotomy 
Flat anterior chamber  
Hyphema  
Hypopyon  
Incorrect IOL power resulting in secondary surgical intervention * 
Increased glare or halos 
Infectious keratitis 
IOL damage resulting in secondary surgical intervention * 
IOL malposition resulting in secondary surgical intervention * 
Iris or pupil damage 

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Loss of BCDVA3 
Mechanical pupillary block (A shallowing of the peripheral and/or central anterior 
chamber with or without elevation of IOP by obstruction of the flow of aqueous humor 
from the posterior chamber through the pupil to the anterior chamber). This may be 
induced by the crystalline lens, vitreous face, or implanted devices.)  
Multiple (or “ghost”) images 
Pain*  
Posterior capsular rupture 
Progression or onset of diabetic retinopathy  
Progression or onset of macular degeneration 
Reduced contrast sensitivity 
Retained lens material 
Retinal detachment (partial or complete RD associated with retinal tear) 
Secondary IOL intervention (reposition, exchange or removal)  
Synechiae formation   
Thermal injury (phaco burn) 
Toxic anterior segment syndrome (TASS) (An acute, noninfectious inflammation of 
the anterior segment of the eye that develops within 24 to 48 hours after surgery and is 
characterized by corneal edema and accumulation of white cells in the anterior chamber 
of the eye)  
Undesirable optical phenomena assessed as severe by the Investigator (note; these 
events are to be treated as serious AEs; see Section 12.4.4 for reporting requirements) 
Vitreous prolapse  
Wound leak (positive Seidel) 
* These events only need to be reported as AEs/SAEs if present as specified below: 
• Iritis/cells/flare characterized by grade 1+ cells or greater using SUN criteria37 if 
persistent for greater than 3 months after surgery, or relapses in less than 3 months after 
discontinuation of therapy, or the subject is maintained on therapy for more than 3 
months to control inflammation 
• Corneal or corneal wound edema resulting in BCDVA of ≤20/40 at Visit 3A or later in 
the first implanted eye or at Visit 3B or later in the second implanted eye, or any 
persistent corneal or corneal wound edema present at Visit 5 
• Cystoid macular edema diagnosed by clinical exam and adjunct testing (eg. OCT, FA 
or other method), resulting in BCDVA of ≤ 20/40 at Visit 3 or later 
 
3 Monocular BCDVA decrease of equal to or greater than 2 lines (≥ 10 letters) from any 
previous visit not secondary to any underlying condition, or any monocular BCDVA 
decrease from any previous visit of ≥ 10 letters if persistent to the subject’s last visit in the 
study. 
 

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• Difficulty with tasks in dim lighting resulting in secondary surgical intervention 
• Elevation of IOP by ≥ 10 mmHg above baseline (pre-operative) to a minimum of 25 
mmHg  (Masket S, et al. Special Report: The American Academy of Ophthalmology Task Force 
Consensus Statement on Adverse Events with Intraocular Lenses. Ophthalmology 
2017;124(1):142-144) after IOL implantation, or elevated IOP requiring treatment if 
present at Visit  5 
• Postoperative refractive error different from predicted, and not due to calculation or 
other user error, resulting in secondary surgical intervention 
• Crack, breakage or deformity of IOL haptic or optic resulting in secondary surgical 
intervention 
• IOL decentration or tilt likely to affect visual outcome and resulting in secondary 
intervention 
• Pain, per subjective patient reporting, graded as ≥ 4 on the standardized pain rating 
scale (from 0 to 10) 
• Mild superficial punctate keratitis (SPK) present at Visit 3A or later in the first 
implanted eye or at Visit 3B or later in the second implanted eye, or moderate, severe, 
or very severe SPK at any post-operative visit (note: if SPK is present pre-operatively, 
adverse event must be reported only if there is a worsening) 
Note: Posterior capsular opacification (PCO) is NOT to be reported as an AE, per ISO 11979-
7.   
Severe or Very Bothersome Visual Disturbances on the Quality of Vision questionnaire 
Visual  disturbances reported will be evaluated by the PI through further clinical investigation 
to determine if the reported symptoms are related to the optical properties of the IOL (Section 
13.5.1.2).  Any visual disturbance that leads to secondary surgical intervention should be 
considered a serious adverse event; however, the following conditions may lead to visual 
disturbance and secondary surgical intervention but may or may not be considered related to 
the optical properties of the IOL. Detailed case narratives will be created for each of these 
subjects for future analyses and final determination as to whether the AE is related to the optical 
properties of the IOL. 
1) Residual refractive error which can be corrected with spectacles 
2) Posterior capsular opacification evident on slit lamp examination  
3) Macular edema confirmed by optical coherence tomography and/or fluorescein 
angiography 
4) Corneal edema, punctate keratopathy due to dry eye syndrome or other corneal 
irregularities 
5) Pre-existing or newly developed ocular pathologies, including those related to 
decentration, tilt or rotation of the IOL.  

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6) Surgical complications noted at the operative visit that may reasonably be expected to 
affect postoperative outcomes. 
The investigator should consult with the Medical Monitor to determine if an SSI is warranted.  
If there is any uncertainty as to whether the SSI is related to the optical properties of the IOL 
or to some other unrelated factor, the Investigator should consult with the Medical Monitor.   
12.4.2 
Identification and Collection 
Identification and collection of an AE begins after informed consent has been obtained and 
documented. Standard sources of identifying AEs include:  
• 
direct observation by the Investigator  
• 
asking the study participant a non-specific question (e.g., “Have you had any 
problems since the last visit?”)  
• 
unsolicited volunteering of information by the study participant (e.g., “Doctor, I have 
had blurred vision since I started using this lens.”)  
• 
laboratory or test results that meet protocol requirements for classification as an AE  
 
Specific to this protocol, ocular AEs in the study eye(s) and all SAEs (ocular and non-ocular) 
observed or elicited by the Investigator, reported by the subject, or resulting from a test result, 
etc., occurring during the clinical investigation must be reported in the CRF. During the study, 
the Investigator should treat the study subject as appropriate to ensure his/her safety and 
welfare. Refer to Section 12.4.5 for additional information pertaining to ongoing AEs at subject 
exit.  
 
Pre-existing conditions will not be considered AEs but will be collected at the Preoperative 
Visit as medical history. A worsening of a pre-existing condition during the study should be 
documented as an AE and evaluated accordingly.  
Hospitalizations for admission without a medical AE should be captured as a serious AE until the 
cause of hospitalization can be identified. However, the following reports of hospitalization 
without a medical AE should not be considered either serious or an AE: 
• Admission for treatment of a pre-existing condition not associated with the 
development of a new AE or with worsening of the pre-existing condition (e.g., for 
work-up of persistent pretreatment lab abnormality)  
• Social admission (e.g., subject has no place to sleep)  
• Administrative admission (e.g., for yearly physical exam)  
• Optional admission not associated with a precipitating medical AE (e.g., for elective 
cosmetic surgery)  
12.4.3 
Evaluations 
When evaluating AEs, the Investigator must determine if the event is serious (refer to Section 
12.4.1 for criteria), assess the severity of symptoms, and determine the relationship of the event 
to the device, using the following guidelines:  
a. Severity  

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- 
Mild: Subject awareness of a sign or symptom that is easily tolerated, requires no 
treatment, and does not interfere with subject’s daily activities  
- 
Moderate: Subject awareness of a sign or symptom which may be a low level of 
concern to the subject and may interfere with daily activities, but can be relieved by 
simple therapeutic care  
- 
Severe: A sign or symptom that interrupts the subject’s daily activity and requires 
systemic therapy or other treatment 
 
b.  Relationship to Study Device or Surgical Procedure 
- 
Related: There is at least a reasonable possibility the AE is related to the study device 
or surgical procedure.  Reasonable possibility means there is evidence to suggest either 
a causal relationship or association between the study device or surgical procedure and 
the AE.  
- 
Unrelated: There is little or no reasonable possibility the AE is related to the study 
device or surgical procedure.  No reasonable possibility means there is no evidence to 
suggest either a causal relationship or association between the study device or surgical 
procedure and the AE. 
 
12.4.4 
Reporting 
Actions required by Investigators for reporting non-serious ocular adverse events are 
summarized in Table 1 below. 
Table 1.   Non-serious Adverse Events 
 
Actions required by Investigators for reporting all serious adverse events are summarized in  
Table 2 below. 
Non-serious ocular 
AEs  
 
Non-device-related 
 
Device-related 
 
Required Action 
 
Recorded on Adverse Event CRF only; 
no expedited report to Sponsor;  
no report to IRB 
 

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Table 2.   Serious Adverse Events 
 
SAEs 
(ocular and non-
ocular) 
 
 
Non-device-
related 
 
 
 
Device-related 
 
Anticipated 
 
Unanticipated 
 
 
 
 
 
Required Action 
 
Recorded on SAE/UADE Report 
Form and AE CRF 
 
Investigator submits expedited 
report to Sponsor and its 
representative within 48 hours;   
report to IRB, if required per IRB 
policy 
 
 
Recorded on SAE/UADE 
Report Form and AE CRF 
 
Investigator submits expedited 
report to Sponsor and its 
representative within 48 
hours; Investigator reports to 
IRB within 10 working days or 
per IRB policy, whichever is 
shorter 
 
 
Sponsor Conducts Evaluation 
 
Sponsor or its representative 
reports to FDA, all IRBs & all 
Investigators within 10 
working days 
12.4.4.1 
On-Site SAE and UADE Reporting 
The Investigator must report any adverse event to the Sponsor and its representative in an 
expedited manner if it meets the criteria for a SAE or UADE.  The Investigator must forward 
the SAE/UADE Report Form and any available supporting documents to the Sponsor or its 
designee within 48 hours of becoming aware of an event.  
The contacts for reporting SAEs/UADEs are: 
The Investigator must also report UADEs to the reviewing IRB/IEC within 10 working days 
following awareness of the UADE or according to the established reporting procedures of the 
IRB, whichever is shorter.  The Investigator should also complete applicable CRFs within 3 
working days of event identification.  The Sponsor or its representative will report the UADE 

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to the FDA, all other IRBs, and all Investigators within 10 working days after first being 
informed by the Investigator. 
12.4.4.2 
Off-Site UADE Reporting 
When participating in multicenter clinical investigations, Principal Investigators may receive 
off-site UADE reports. These are Sponsor reports of UADEs which occurred at other clinical 
sites for the same trial, or in different trials using the same test article, that met the criteria for 
reporting to a regulatory agency. These should be reported to the reviewing IRB/IEC within 
10 working days or per their established reporting procedures, whichever is shorter. 
12.4.4.3 
Reporting Device Deficiencies 
A device deficiency is defined as an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance.  Device deficiencies include 
malfunctions, use errors, and inadequate labeling. 
 
Investigators 
must 
evaluate, 
record, 
and 
report 
via 
applicable 
forms 
any 
complaints/deficiencies or malfunctions experienced with a Test or Control lens during this 
trial to the Sponsor and its representative promptly.   The Sponsor shall review all device 
deficiencies, and, upon the Sponsor’s request, Investigators must supply any additional 
information related to the safety reporting of a particular event. 
The contact for reporting device deficiencies is: 
12.4.5 
Adverse Events at Subject Exit 
Ongoing AEs will be followed until resolution, no further change in the condition is expected 
(i.e., event stabilized), or as dictated by standard of care. Documentation in the CRF of this 
follow-up is not required although subject care should continue as appropriate.  
Ongoing UADEs will be followed by the Sponsor and its representative(s) and the Investigator 
until the outcome is determined or until no further change in the condition is expected.  
12.4.6 
Pregnancy 
During the study, all female subjects of childbearing potential should be instructed to contact 
the investigator immediately if they suspect they might be pregnant (e.g., missed or late 
menstrual period).  Female subjects who become pregnant during the study will be followed 
until completion of pregnancy. Every effort will be made to obtain the health status of the 
mother and infant or fetus (in cases of miscarriage or therapeutic abortion) at term.  Pregnancy 
itself is not considered an AE. 
 
All confirmed pregnancies must be immediately reported to the medical monitor and CRO 
contact within 48 hours of the investigator’s awareness of the pregnancy. All confirmed 
pregnancies must be reported via confirmed facsimile or email transmission and must be 

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submitted on a Pregnancy Report form to the Sponsor or designee within 48 hours of the 
investigator’s awareness of the pregnancy. 
The contacts for reporting pregnancies are: 
 
 
 
 
13 
Statistics 
Additional details regarding statistical analyses will be provided in the statistical analysis plan 
(SAP), which will be prepared and approved prior to database lock.  
13.1 Study Endpoints 
13.1.1 
Safety Endpoints 
13.1.1.1 
Primary Safety Endpoints 
• The incidence of all serious adverse events, including SSIs related to the optical 
properties of the IOL, in first eyes through study exit 
• The rate of secondary surgical interventions due to the optical properties of the lens for 
first eyes through study exit 
• The incidence of adverse events in first eyes compared to ISO Safety and Performance 
Endpoint (SPE) rates as defined in ISO 11979-7 through study exit  
13.1.1.2 
Secondary Safety Endpoints 
• The rates of visual disturbances reported as “severe” by subjects, as well as the rates of 
visual disturbances reported as “very” bothersome by subjects, using the QoV 
questionnaire measure through Post-Operative Visit 4 (Day 120 to 180 after second eye 
IOL implantation) 
• Mean photopic contrast sensitivity with glare and mesopic contrast sensitivity with and 
without glare at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL 
implantation) and Post-Operative Visit 5 (Day 330 to 420 after second eye IOL 
implantation) 
• Incidence of the types of AEs specified in the co-primary endpoints, but for fellow and 
“all” eyes 
• Incidence of all other types of adverse events in primary eyes, fellow eyes, and “all” 
eyes 

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13.1.2 
Effectiveness Endpoints 
13.1.2.1 
Primary Effectiveness Endpoints 
• Photopic monocular best-corrected distance visual acuity (BCDVA) in first eyes at 
Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• Photopic monocular distance-corrected near visual acuity (DCNVA) in first eyes at 40 
cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• Photopic monocular distance-corrected intermediate visual acuity (DCIVA) in first 
eyes at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL 
implantation)  
13.1.2.2 
Secondary Effectiveness Endpoints 
• Photopic binocular distance-corrected near visual acuity (DCNVA) at 40 cm at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• Photopic binocular uncorrected near visual acuity (UCNVA) at 40 cm at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• Photopic binocular distance-corrected intermediate visual acuity (DCIVA) at 66 cm at 
Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)  
• Photopic binocular uncorrected intermediate visual acuity (UCIVA) at 66 cm at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
• First eye BCDVA, DCNVA, and DCIVA evaluated at Visit 5 
13.2 Hypotheses 
The critical region for rejection of null hypotheses will be a p-value ≤ 0.05 unless otherwise 
specified. 
13.2.1 Safety Endpoints 
First Primary Safety Endpoint 
There is no statistical hypothesis associated with the proportion of first mITT eyes with at 
least one serious adverse event. 
Second Primary Safety Endpoint 
The second primary safety endpoint is the rate of secondary surgical interventions due to the 
optical properties of the lens. The null and alternative hypotheses are as follows. 
𝐻𝐻0: 𝜋𝜋𝑇𝑇−𝜋𝜋𝐶𝐶≥0.034 
𝐻𝐻1: 𝜋𝜋𝑇𝑇−𝜋𝜋𝐶𝐶< 0.034 
 
Where: 
• 𝜋𝜋𝑇𝑇 = the proportion of the Test (trifocal) group first eyes that underwent at least one 
secondary surgical intervention related to the optical properties of the IOL, and 
• 𝜋𝜋C = the proportion of the Control (monofocal) group first eyes that underwent at least 
one secondary surgical intervention related to the optical properties of the IOL 

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• 0.034 is the non-inferiority margin 
 
Third Primary Safety Endpoint 
For each ISO 11979-7 SPE grid AE, the null and alternative hypotheses are as follows: 
 
𝐻𝐻0: 𝜋𝜋≤𝜋𝜋0 
𝐻𝐻1: 𝜋𝜋> 𝜋𝜋0 
Where: 
• 𝜋𝜋 = the proportion of Test (trifocal) eyes with the adverse event, and 
• 𝜋𝜋0 = the historical control proportion of eyes with the adverse event given in the ISO 
11979-7 SPE grid 
If none of the null hypotheses are rejected, then it will be concluded that the Test IOL is 
statistically successful in these outcomes. 
 
First Secondary Safety Endpoint 
There is no hypothesis associated with the incidence of subjects reporting rates of visual 
disturbances reported as “severe” by subjects, as well as the rates of visual disturbances 
reported as “very” bothersome by subjects, using the QoV questionnaire measure through Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation).   
Second Secondary Safety Endpoint 
There is no hypothesis associated with mean photopic or mesopic contrast sensitivity at Post-
Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) and Post-Operative Visit 
5 (Day 330 to 420 after second eye IOL implantation). 
Third and Fourth Secondary Safety Endpoints 
There are no hypotheses associated with these endpoints. 
13.2.2 Effectiveness Endpoints 
The statistical success of the trial will depend on the statistical success of all three primary 
effectiveness endpoints. 
First Primary Effectiveness Endpoint 
For the first primary effectiveness endpoint, photopic monocular logMAR BCDVA in first 
eyes at Post-Operative Visit 4, there are three hypotheses to be tested. The Test IOL must be 
successful in all three hypothesis tests to achieve success in this endpoint.  
 
The first null (𝐻𝐻0) and alternative (𝐻𝐻1) hypotheses are as follows: 

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𝐻𝐻0: 𝜇𝜇𝑇𝑇−𝜇𝜇𝐶𝐶≥0.10 
𝐻𝐻1: 𝜇𝜇𝑇𝑇−𝜇𝜇𝐶𝐶< 0.10 
 
Where: 
• 𝜇𝜇𝑇𝑇 = the mean logMAR BCDVA of the Test (trifocal) group, and 
• 𝜇𝜇C = the mean logMAR BCDVA of the Control (monofocal) group 
If the null hypothesis is rejected, then it will be concluded that the Test IOL is statistically 
successful in this evaluation. 
 
The second null (H0) and alternative (H1) hypotheses are as follows: 
 
𝐻𝐻0: 𝜋𝜋𝑇𝑇≥ 0.925 
𝐻𝐻1: 𝜋𝜋𝑇𝑇< 0.925 
 
Where πT = the proportion of mITT Set Test (trifocal) group eyes with BCDVA 20/40 or 
better. The ISO standard specifies a nontraditional evaluation of these hypotheses, with 
failure to reject the null hypothesis indicating success. If the null hypothesis is not rejected, 
then it will be concluded that the Test IOL is statistically successful in this evaluation. 
 
The third null (H0) and alternative (H1) hypotheses are as follows: 
 
𝐻𝐻0: 𝜋𝜋𝑇𝑇≥ 0.967 
𝐻𝐻1: 𝜋𝜋𝑇𝑇< 0.967 
 
Where πT = the proportion of Best Case Set Test (trifocal) group eyes with BCDVA 20/40 or 
better. The ISO standard specifies a nontraditional evaluation of these hypotheses, with 
failure to reject the null hypothesis indicating success. If the null hypothesis is not rejected, 
then it will be concluded that the Test IOL is statistically successful in this evaluation. 
 
 
Second Primary Effectiveness Endpoint 
For the second primary effectiveness endpoint, photopic monocular logMAR DCNVA in first 
eyes at Post-Operative Visit 4, the null and alternative hypotheses are as follows: 
 
𝐻𝐻0: 𝜇𝜇𝑇𝑇= 𝜇𝜇C 
𝐻𝐻1: 𝜇𝜇𝑇𝑇≠𝜇𝜇C 
 
Where: 
• 𝜇𝜇𝑇𝑇 = the mean logMAR DCNVA of the Test (trifocal) group, and 
• 𝜇𝜇C = the mean logMAR DCNVA of the Control (monofocal) group 

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If the null hypothesis is rejected and the mean for the Test group is less than the mean for the 
Control group, then it will be concluded that the Test IOL is statistically successful in this 
outcome. 
Third Primary Effectiveness Endpoint 
For the third primary effectiveness endpoint, photopic monocular logMAR DCIVA in first 
eyes at Post-Operative Visit 4, the null and alternative hypotheses are as follows: 
 
𝐻𝐻0: 𝜇𝜇𝑇𝑇= 𝜇𝜇C 
𝐻𝐻1: 𝜇𝜇𝑇𝑇≠𝜇𝜇C 
 
Where: 
• 𝜇𝜇𝑇𝑇 = the mean logMAR DCIVA of the Test (trifocal) group, and 
• 𝜇𝜇C = the mean logMAR DCIVA of the Control (monofocal) group 
If the null hypothesis is rejected and the mean for the Test group is less than the mean for the 
Control group, then it will be concluded that the Test IOL is statistically successful in this 
outcome. 
First Secondary Effectiveness Endpoint 
For the first secondary effectiveness endpoint, photopic binocular DCNVA at Visit 4, the null 
and alternative hypotheses are as follows: 
 
𝐻𝐻0: 𝜇𝜇𝑇𝑇= 𝜇𝜇C 
𝐻𝐻1: 𝜇𝜇𝑇𝑇≠𝜇𝜇C 
 
Where: 
• 𝜇𝜇𝑇𝑇 = the mean logMAR DCNVA of the Test (trifocal) group, and 
• 𝜇𝜇C = the mean logMAR DCNVA of the control (monofocal) group 
If the Test IOL is statistically successful in all primary endpoints with success criteria, the null 
hypothesis is rejected, and the mean for the Test group is less than the mean for the Control 
group, then it will be concluded that the Test IOL is statistically successful in this outcome. 
 
Second Secondary Effectiveness Endpoint 
For the second secondary effectiveness endpoint, photopic binocular UCNVA at Visit 4, the 
null and alternative hypotheses are as follows: 
 
𝐻𝐻0: 𝜇𝜇𝑇𝑇= 𝜇𝜇C 
𝐻𝐻1: 𝜇𝜇𝑇𝑇≠𝜇𝜇C 

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Where: 
• 𝜇𝜇𝑇𝑇 = the mean logMAR UCNVA of the Test (trifocal) group, and 
• 𝜇𝜇C = the mean logMAR UCNVA of the control (monofocal) group 
If the Test IOL is statistically successful in the first secondary effectiveness endpoint, the null 
hypothesis is rejected, and the mean for the Test group is less than the mean for the Control 
group, then it will be concluded that the Test IOL is statistically successful in this outcome. 
 
Third Secondary Effectiveness Endpoint 
For the third secondary effectiveness endpoint, photopic binocular DCIVA at Visit 4, the null 
and alternative hypotheses are as follows: 
 
𝐻𝐻0: 𝜇𝜇𝑇𝑇= 𝜇𝜇C 
𝐻𝐻1: 𝜇𝜇𝑇𝑇≠𝜇𝜇C 
 
Where: 
• 𝜇𝜇𝑇𝑇 = the mean logMAR DCIVA of the Test (trifocal) group, and 
• 𝜇𝜇C = the mean logMAR DCIVA of the Control (monofocal) group 
If the Test IOL is statistically successful in the second secondary effectiveness endpoint, the 
null hypothesis is rejected, and the mean for the Test group is less than the mean for the Control 
group, then it will be concluded that the Test IOL is statistically successful in this outcome. 
Fourth Secondary Effectiveness Endpoint 
For the fourth secondary effectiveness endpoint, photopic binocular UCIVA at Visit 4, the null 
and alternative hypotheses are as follows: 
 
𝐻𝐻0: 𝜇𝜇𝑇𝑇= 𝜇𝜇C 
𝐻𝐻1: 𝜇𝜇𝑇𝑇≠𝜇𝜇C 
 
Where: 
• 𝜇𝜇𝑇𝑇 = the mean logMAR UCIVA of the Test (trifocal) group, and 
• 𝜇𝜇C = the mean logMAR UCIVA of the Control (monofocal) group 
If the Test IOL is statistically successful in the third secondary effectiveness endpoint, the null 
hypothesis is rejected, and the mean for the Test group less than the mean for the Control 
group, then it will be concluded that the trifocal MIOL is statistically successful in this 
outcome. 
 
Remaining Secondary Effectiveness Endpoints 

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There are no hypothesis tests associated with the remaining secondary effectiveness 
endpoints of first eye BCDVA, DCNVA, and DCIVA evaluated at Visit 5. 
13.3 Sample Size Determination 
13.3.1 
Phase I / Pilot 
A sample size of 24 DCNVA measurements at each of three distances will yield a probability 
of at least 98% of selecting the best distance when the difference (in logMAR units) between 
the best distance and the second-best distance is at least 0.1 and the data are normally 
distributed with a standard deviation of 0.15. The first 27 Test group subjects will be enrolled 
in Phase I/Pilot to allow for at least 24 Test group subjects at Visit 3A. 
 
A sample size of 24 DCIVA measurements at each of three distances will yield a probability 
of at least 98% of selecting the best distance when the difference (in logMAR units) between 
the best distance and the second-best distance is at least 0.1 and the data are normally 
distributed with a standard deviation of 0.15. The first 27 Test group subjects will be enrolled 
in Phase I/Pilot to allow for at least 24 Test group subjects at Visit 3A. 
13.3.2 
Primary Safety Endpoints 
 
Regarding the rate of all serious adverse events, for a sample size of 300 subjects, the 
probability of observing at least one event will be at least 95% when the probability of an 
event is 1% or greater. 
Regarding the rate of secondary surgical interventions due to the optical properties of the 
lens, the expected Control group rate is 0.1% and the expected Test group rate is 0.5%. With 
150 eyes in the Control group and 300 eyes in the Test group, the upper limit of the observed 
one-sided 95% confidence interval will be expected to be less than 0.034 with 99% power 
when the Control proportion, 𝝅𝝅𝑪𝑪, is 0.001 and the Test expected proportion, 𝝅𝝅𝑻𝑻, is 0.005; 
results are based on 10000 simulations using the Newcombe-Wilson score method to 
construct the confidence interval.38 
ISO 11979-7 Annex B shows the relevant sample size calculations and assumptions for the 
ISO grid safety endpoints. 
13.3.3 
Secondary Safety Endpoints 
Regarding the rates of visual disturbances reported as “severe” by subjects, as well as the rates 
of visual disturbances reported as “very” bothersome by subjects, using the QoV questionnaire 
measure through Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation), 
no statistical hypotheses will be tested. Therefore, no sample size calculation is required. 
Regarding mean photopic (with glare) and mesopic (with and without glare) contrast 
sensitivity at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) and 
Post-Operative Visit 5 (Day 330 to 420 after second eye IOL implantation), no statistical 
hypotheses will be tested. Therefore, no sample size calculation is required. 

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Regarding the incidence of the types of AEs specified in the co-primary safety endpoints, but 
for fellow and “all” eyes, no statistical hypotheses will be tested. Therefore, no sample size 
calculation is required. 
Regarding the incidence of all other types of adverse events in primary eyes, fellow eyes, and 
“all” eyes, no statistical hypotheses will be tested. Therefore, no sample size calculation is 
required. 
13.3.4 
Primary Effectiveness Endpoints 
Approximately the first 24 evaluable Test group subjects and 12 evaluable Control group 
subjects will be excluded from the near and intermediate visual acuity hypothesis tests, leaving 
an expected evaluable sample size of approximately 276 Test group subjects and 138 Control 
group subjects to be included in the near and intermediate visual acuity hypothesis tests. 
 
Regarding the non-inferiority test of BCDVA, when the sample sizes in the groups are 300 
(Group 1) and 150 (Group 2), a two group 0.050 one-sided t-test will have 99% power to reject 
the null hypothesis that the Test and Control IOLs are not equivalent (the difference in means, 
µT - µS, is 0.10 or farther from zero in the same direction) in favor of the alternative hypothesis 
that the means of the two groups are equivalent, assuming that the expected difference in means 
is 0.00 and the common standard deviation is 0.15.  
 
Regarding the comparisons of BCDVA to the ISO grid, ISO 11979-7 specifies a sample size 
of approximately 300 completed subjects for this type of investigation. 
 
Regarding the superiority tests of DCNVA at 40 cm and DCIVA and 66 cm, a two-group t-
test with a 0.05 two-sided significance level will have 99% power to detect a difference in 
means of -0.10, assuming that the common standard deviation is 0.15, when the sample sizes 
in the two groups are 276 and 138 subjects, respectively (a total sample size of 414 subjects). 
 
Regarding the assessment of clinical superiority in DCNVA at 40 cm and DCIVA at 66 cm, 
the probability that the Test group’s mean logMAR VA will be at least 0.10 units less than the 
Control group’s mean logMAR VA will be 89% if the true difference is -0.12 units, 97% if the 
true difference is -0.13 units, and 99% if the true difference is -0.14 units, assuming that the 
common standard deviation is 0.15 when the sample sizes in the two groups are 276 and 138 
subjects, respectively (a total sample size of 414 subjects). 
13.3.5 
Secondary Effectiveness Endpoints 
Secondary effectiveness endpoint hypotheses will be tested hierarchically in the order: 
DCNVA, UCNVA, DCIVA, and UCIVA. Approximately the first 24 evaluable Test group 
(Group 1) subjects and 12 evaluable Control group (Group 2) subjects will be excluded from 
the near and intermediate visual acuity hypothesis tests, leaving an expected evaluable sample 
size of approximately 276 Test group subjects and 138 Control group subjects to be included 
in the near and intermediate visual acuity hypothesis tests. 
 
Regarding photopic binocular distance-corrected near visual acuity (DCNVA) at 40 cm at 
Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation), a two-group t-test 

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with a 0.05 two-sided significance level will have 99% power to detect a difference in means 
of -0.10 logMAR units, assuming that the common standard deviation is 0.200 units, when the 
sample sizes in the two groups are 276 and 138 subjects, respectively (a total sample size of 
414 subjects). 
 
Regarding photopic binocular uncorrected near visual acuity (UCNVA) at  
40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation), a two-
group t-test with a 0.05 two-sided significance level will have 99% power to detect a difference 
in means of -0.10 logMAR units, assuming that the common standard deviation is 0.20 units, 
when the sample sizes in the two groups are 276 and 138 subjects, respectively (a total sample 
size of 414 subjects). 
 
Regarding photopic binocular distance-corrected intermediate visual acuity (DCIVA) at 66 cm 
at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation), a two group t-
test with a 0.05 two-sided significance level will have 99% power to detect a difference in 
means of -0.10 logMAR units, assuming that the common standard deviation is 0.15 units, 
when the sample sizes in the two groups are 276 and 138 subjects, respectively (a total sample 
size of 414 subjects). 
 
Regarding photopic binocular uncorrected intermediate visual acuity (UCIVA) at 66 cm at 
Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation), a two group t-test 
with a 0.05 two-sided significance level will have 99% power to detect a difference in means 
of -0.10 logMAR units, assuming that the common standard deviation is 0.20 units, when the 
sample sizes in the two groups are 276 and 138 subjects, respectively (a total sample size of 
414 subjects). 
There are no hypothesis tests associated with first eye BCDVA, DCNVA, and DCIVA 
evaluated at Visit 5, so no sample size calculations are necessary for these endpoints. 
13.3.6 
Sub-Studies 
13.3.6.1 
Defocus Curves 
At least ten (10) Best Case Group 1 subjects and ten (10) Best Case Group 2 subjects will be 
evaluated to obtain defocus curves as described in Appendix B, Section 10.0, in each of the 
following pupil size groups: small (≤ 3.0 mm), medium (> 3.0 mm and ≤ 4.0 mm), and large 
(> 4.0 mm), as determined under photopic lighting conditions. If ten subjects are not available 
in any pupil size category for a treatment group, then the maximum number available will be 
used.  
13.3.6.2 
Contrast Sensitivity 
At least approximately 122 bilaterally implanted Group 1 subjects and 61 bilaterally implanted 
Group 2 subjects will participate in the contrast sensitivity sub-study. To allow for losses of 
up to 10%, at least approximately 136 Best Case Group 1 subjects and 68 Best Case Group 2 
subjects will be enrolled in the sub-study.  

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13.3.6.3 Optical Coherence Tomography (OCT) Imaging 
Approximately 20 Group 1 subjects and 10 Group 2 subjects will participate in OCT imaging 
at 2-3 clinical sites having similar or identical OCT equipment. Fundus photographs will be 
taken if OCT images cannot be obtained. 
13.3.6.4 Trial Frame Astigmatism Simulation 
Approximately 30 Group 1 subjects and 15 Group 2 subjects will participate in the trial frame 
astigmatism sub-study at up to 10 clinical sites.  A total of 50 subjects will be enrolled in the 
sub-study to allow for a 10% loss. Enrollment will be sequential with consecutive subjects 
enrolled onto the Trial Frame astigmatism simulation sub-study at each site in order of their 
completion of post-operative Visit 5 and based on their eligibility. The purpose of the Trial 
Frame Astigmatism Simulation sub-study is to evaluate the effect of simulated residual 
astigmatism on distance, intermediate, and near visual acuities in eyes implanted with the 
enVista trifocal toric intraocular lenses (IOLs). 
 
13.3.7 
Overall Sample Size and Adjustment for Dropouts 
The sample size of 300 study lens group subjects and 150 control group subjects is specified 
in ANSI Z80.12-2007 (R2012) and ISO 11979-9:2006. Moreover, ISO 11979-7 specifies that 
a minimum of 300 subjects should complete a clinical evaluation of an IOL.  
To allow for losses of up to 10%, approximately ⌈300/(1 −0.1)⌉ = 334 Test group subjects 
and approximately  ⌈150/(1 −0.1)⌉ = 167 Control group subjects will be enrolled. 
13.4 Analysis Populations 
13.4.1 
Intent-to-Treat (ITT) Set 
The Intent-to-Treat Set will include all randomized subjects. Summaries and analyses of the 
ITT Set will classify subjects according to the treatment to which they were randomized. 
13.4.2 
Modified Intent-to-Treat Set 
The Modified Intent-to-Treat Set will include all randomized subjects with at least one eye in 
which the IOL touches the eye with a study lens. Summaries and analyses of the mITT Set will 
classify subjects according to the treatment to which they were randomized. 
13.4.3 
Modified Safety Set 
The Modified Safety Set will include all subjects with at least one eye in which the IOL touches 
the eye with a study lens. Summaries and analyses of the Modified Safety Set will classify 
subjects according to the treatment received. 
13.4.4 
Per Protocol Set 
The Per Protocol (PP) Set will include all bilaterally implanted subjects without major protocol 
deviations. Major protocol deviations are described in Section 13.5.8. 

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13.4.5 
Best Case Set 
The purpose of the Best Case Set is to evaluate BCDVA as a part of the primary safety analysis 
as described in ISO 11979-7. The Best Case Set will include subjects with all of the following 
characteristics: 
• No clinically significant preoperative ocular pathology in the first eye, including any 
of the following present prior to the operative visit 
− 
Pseudoexfoliation 
− 
Glaucoma  
− 
Uveitis 
− 
Retinal detachment 
− 
Diabetic retinopathy 
− 
Macular degeneration 
− 
Amblyopia 
− 
Other preoperative pathologies that are likely to affect central acuity  
• No macular degeneration detected at any time in the first eye 
• No previous surgery for the correction of refractive errors in the first eye 
13.5 Statistical Analysis 
Summaries for continuous variables will include the sample size, mean, standard deviation, 
median, minimum, and maximum. Summaries for categorical variables will include the 
tabulation of frequencies and percentages.  
 
All effectiveness analyses will be presented for the ITT Set in addition to the analysis Set(s) 
mentioned below. 
13.5.1 
Primary Safety Analyses 
13.5.1.1 
First Eyes with at Least One Serious Adverse Event 
The proportion of first mITT Set eyes with at least one serious adverse event will be 
summarized using categorical summary statistics by treatment received. Each eye will be 
counted only once in the calculation of the rate. 
13.5.1.2 
Secondary Surgical Interventions Related to the Optical Properties of the 
IOL 
Secondary surgical interventions related to the optical properties of the IOL will be defined as 
IOL explantation, replacement, or repositioning due to subject intolerance of visual symptoms 
not adequately improved by spectacle correction. The investigators will apply this definition 
to classify each secondary surgical intervention as either related to the optical properties of the 
IOL or not related to the optical properties of the IOL.  
 
Each eye will be classified as either having undergone a secondary surgical intervention related 
to the optical properties of the IOL or not having undergone such an intervention. Missing data 
will not be imputed. Secondary surgical interventions related to the optical properties of the 
IOL will be summarized categorically (Yes, No) by actual treatment received for mITT 

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subjects in a table. Secondary surgical interventions will be further subcategorized and 
summarized categorically as Exchange, Removal, Repositioning, or Other. 
 
A two-sided 90% confidence interval around the difference in proportions (Test minus 
Control) will be constructed using the Newcombe-Wilson score method without continuity 
correction. If the upper confidence limit (which is equivalent to a one-sided 95% upper 
confidence limit) is less than 0.034 or if the proportion in both groups is zero, then the null 
hypothesis will be rejected and it will be concluded that the Test IOL is statistically non-
inferior to the Control IOL in this outcome.  
 
13.5.1.3 
ISO Grid Adverse Events 
Cumulative and persistent ISO grid AEs will be summarized categorically for first eyes of the 
mITT Set by treatment. Subjects will be analyzed according to treatment actually received. 
The primary statistical analysis will include first eyes of the mITT Set implanted with the Test 
IOL.  
 
The numerator for each cumulative AE will be the number of first Test group eyes reporting 
the AE at least once after surgery. The denominator for cumulative AEs will be the number of 
first Test group eyes.  
 
The numerator for each persistent AE will be the number of first Test group eyes with the event 
at Visit 5 in the first eye at exit. The denominator for persistent AEs will be the number of first 
Test group eyes present at Visit 5. 
 
For each ISO grid AE, a one-sided exact binomial test comparing the proportion of Test group 
eyes with the AE to the relevant control rate will be completed. If the resulting p-value is less 
than or equal to 0.05, then the null hypothesis will be rejected. 
 
Success with respect to comparing these endpoints to the historical controls will have been 
achieved if none of the null hypotheses are rejected for the Test IOL treatment group. 
 
13.5.2 
Secondary Safety Analyses 
13.5.2.1 
Rates of Severe or Very Bothersome Visual Disturbances 
The rates of visual disturbances reported as “severe” by subjects, as well as the rates of visual 
disturbances reported as “very” bothersome by subjects, using the QoV questionnaire 
measure through Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation) 
will be summarized categorically by treatment received for Modified Safety Set subjects. 
Each subject will be counted only once in the calculation of the rate.   
 
 

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13.5.2.2 
Contrast Sensitivity 
Mean photopic (with glare) and mesopic (with and without glare) contrast sensitivity at Post-
Operative Visits 4 or 5 will be summarized using continuous summary statistics by lighting 
condition, spatial frequency, treatment group, and visit.  Estimates of the differences between 
treatment groups, with two-sided 95% confidence intervals, will be provided by lighting 
condition and spatial frequency.  
13.5.2.3 
Incidence of the Types of AEs Specified in the Co-primary Safety Endpoints 
The incidence of the type of AE specified in each co-primary safety endpoint will be 
summarized by treatment for fellow and “all” eyes. No hypothesis tests will be conducted. 
13.5.2.4 
Incidence of All Other Types of Ocular AEs 
The incidence of all other types of AEs will be summarized by treatment for primary eyes, 
fellow eyes, and “all” eyes for the mITT Set. No hypothesis tests will be conducted. 
13.5.3 
Primary Effectiveness Analyses 
13.5.3.1 
Photopic Monocular BCDVA  
Photopic monocular BCDVA in first eyes will be assessed at Post-Operative Visit 4 using the 
methods described in Appendix B on Methods of Clinical Evaluation. The total number of 
letters correct will be entered into the electronic case report form. 
 
The number of letters correct will be converted to logMAR units using the following equation: 
 
𝑙𝑙𝑙𝑙𝑙𝑙𝑙𝑙𝑙𝑙𝑙𝑙 𝐵𝐵𝐵𝐵𝐵𝐵𝐵𝐵𝐵𝐵= 1.7 −0.02 × 𝑙𝑙𝑙𝑙𝑙𝑙𝑙𝑙𝑙𝑙𝑙𝑙𝑙𝑙 𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐 
 
Photopic monocular logMAR BCDVA in first implanted eyes at Post-Operative Visit 4 will 
be summarized using continuous summary statistics by treatment group for the mITT Set. 
Imputation of missing data is not conservative in non-inferiority testing. Therefore, missing 
data will not be imputed for the BCDVA non-inferiority test. A statistical model will be 
constructed with BCDVA as the dependent variable and treatment and site as fixed factors. 
The treatment effect (least squares mean Test group IOL VA minus least squares mean Control 
group IOL VA) in logMAR units will be estimated in addition to a two-sided 90% confidence 
interval. If the upper confidence limit (equivalent to a one-sided upper 95% confidence limit 
for the treatment effect) is less than 0.1, then the Test lens will be statistically non-inferior to 
the control lens. 
 
 
The previous continuous summary statistics will also be provided for the Per Protocol Set. 
However, non-inferiority will not be evaluated with the PP Set and statistical success will not 
depend upon the results of the PP analysis. 
 
BCDVA at Visit 4 for the Test group will be summarized categorically (20/20 or better, 20/25 
or better, 20/32 or better, 20/40 or better, and worse than 20/40) for the mITT and Best Case 
Sets.  Two-sided exact binomial 90% confidence intervals around the proportions of eyes 20/40 

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or better will be presented.  Categorical summaries will use whole line binning as shown in the 
following logMAR to Snellen conversion table (Table 3): 
 
Table 3.  logMAR to Snellen Conversion Table 
logMAR Value 
Snellen Value 
≤ 0.00 
20/20 or better 
≤ 0.10 
20/25 or better 
≤ 0.20 
20/32 or better 
 ≤ 0.30 
20/40 or better 
> 0.30 
Worse than 20/40 
   
For the analyses of the mITT and Best Case Sets, one-sided exact binomial tests comparing 
the proportion of Multifocal IOL eyes with BCDVA 20/40 or better to the relevant control rate 
(92.5% for all eyes and 96.7% for best case eyes) will be performed and p-values will be 
presented. If the p-value is less than or equal to 0.05, then the null hypothesis will be rejected.  
 
If the null hypothesis is not rejected for the mITT and Best Case Sets in the primary analyses, 
then it will be concluded that the Multifocal IOL is statistically successful in this outcome. 
13.5.3.2 
Photopic Monocular DCNVA  
Photopic monocular distance-corrected near visual acuity (DCNVA) at 40 cm in first eyes at 
Post-Operative Visit 4 will be summarized using continuous summary statistics in logMAR 
units by treatment assignment for the mITT Set Phase II and III subjects (combined). The 
DCNVA best distance data from the Phase I/Pilot subjects will be excluded from hypothesis 
testing and will be summarized separately from the data of the other subjects. 
 
If there are missing mITT analysis set monocular DCNVA data at Visit 4, then missing data 
will be imputed using the Markov chain Monte Carlo (MCMC) multiple imputation method. 
After imputation of missing data, the statistical hypotheses will be tested using a statistical 
model with treatment and site as fixed factors by imputation.  
 
An overall p-value resulting from the multiple imputation method will be estimated. The 
treatment effect (mean Test group IOL VA minus mean Control group IOL VA) in logMAR 
units will be summarized using continuous summary statistics and a two-sided 95% confidence 
interval. If the p-value from the multiple imputation analysis is less than or equal to 0.05 and 
the treatment effect is less than or equal to -0.20 (i.e., the Test lens mean logMAR VA is at 
least 0.20 less than the mean for the control), then it will be concluded that the Test IOL is 
statistically and clinically successful (i.e., superior to the Control IOL) in this outcome. 
 
The previous continuous summary statistics will also be provided for the Per Protocol Set. 
However, superiority will not be evaluated with the PP Set and statistical success will not 
depend upon the results of the PP analysis. 

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13.5.3.3 
Photopic Monocular DCIVA  
Photopic monocular distance-corrected intermediate visual acuity (DCIVA) at 66 cm in first 
eyes at Post-Operative Visit 4 will be converted from letters correct to logMAR units using the 
method described above for BCDVA and summarized using continuous summary statistics in 
logMAR units by treatment assignment for the mITT Set Phase II and III subjects (combined). 
The DCIVA data from the Phase I/Pilot subjects will be excluded from hypothesis testing and 
will be summarized separately from the data of the other subjects. 
 
If there are missing mITT analysis set monocular DCIVA data at Visit 4, then missing data 
will be imputed using the MCMC multiple imputation method. After imputation of missing 
data, the statistical hypotheses will be tested using a statistical model with treatment and site 
as fixed factors by imputation.  
 
An overall p-value resulting from the multiple imputation method will be estimated. The 
treatment effect (mean Test group IOL VA minus mean Control group IOL VA) in logMAR 
units will be summarized using continuous summary statistics and a two-sided 95% confidence 
interval. If the p-value from the multiple imputation analysis is less than or equal to 0.05 and 
the treatment effect is less than or equal to -0.10 (i.e. the Test lens mean logMAR VA is at 
least 0.10 less than the mean for the control), then it will be concluded that the Test IOL is 
statistically and clinically successful (i.e., superior to control) in this outcome. 
 
The previous continuous summary statistics will also be provided for the Per Protocol Set. 
However, superiority will not be evaluated with the PP Set and statistical success will not 
depend upon the results of the PP analysis 
13.5.4 
Secondary Effectiveness Analyses 
Photopic binocular DCNVA, UCNVA, DCIVA, and UCIVA at Post-Operative Visit 4 will be 
converted from letters correct to logMAR units and compared between treatments using the 
methods described above for DCNVA and DCIVA. The near and intermediate VA data from 
Phase I/Pilot subjects will be excluded from near and intermediate VA hypothesis testing and 
will be summarized separately from the near and intermediate VA data of the other subjects. 
The endpoints will be evaluated hierarchically in the following order: DCNVA, UCNVA, 
DCIVA, and UCIVA.  
 
First eye BCDVA, DCNVA, and DCIVA (all in logMAR units) at Visit 5 will be summarized 
using descriptive statistics (mean, standard deviation, minimum, and maximum) for the ITT 
Set by treatment group (MX60EF Trifocal MIOL, MX60E IOL). The means at Visit 5 for each 
of these outcomes will be compared between the treatment groups qualitatively. 
13.5.5 
Other Analyses 
13.5.5.1 
Clarity of Fundus Visualization 
Clarity of fundus visualization will be presented using categorical summary statistics by 
treatment for the mITT Set. 

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13.5.5.2 
Adverse Events  
mITT Set eyes experiencing each type of adverse event at least once will be summarized 
categorically by treatment group. In addition, categorical summary statistics will be provided 
for each AE type by relationship to the study device, by relationship to surgical procedure, and 
by severity.  
The incidence of the following further defined AEs will be summarized categorically by 
treatment group. 
• Endophthalmitis - intraocular inflammation requiring vitreous tap and use of 
intraocular antibiotics 
• Toxic anterior segment syndrome (TASS) - An acute, noninfectious inflammation of 
the anterior segment of the eye that develops within 24 to 48 hours after surgery and is 
characterized by corneal edema and accumulation of white cells in the anterior chamber 
of the eye  
• Mechanical pupillary block - Mechanical pupillary block represents a shallowing of the 
peripheral and/or central anterior chamber with or without elevation of intraocular 
pressure (IOP) by obstruction of the flow of aqueous humor from the posterior chamber 
through the pupil to the anterior chamber. This may be induced by the crystalline lens, 
vitreous face, or implanted devices  
• Chronic anterior uveitis - anterior segment inflammation characterized by grade 1+ cell 
or greater (using the SUN criteria)31 persistent for greater than 3 months after surgery, 
or relapses in less than 3 months after discontinuation of therapy, or the subject is 
maintained on therapy for more than 3 months to control inflammation  
• Corneal edema - Corneal swelling (stromal or epithelial) resulting in BCDVA of 20/40 
or worse, at ≥1 month postoperatively  
• Rhegmatogenous retinal detachment (RD) – partial or complete RD associated with 
retinal tear 
• Increased IOP - Elevation of IOP > 10 mmHg above the baseline and to a minimum of 
25mmHg  
• Clinically significant cystoid macular edema - Macular edema diagnosed by clinical 
exam and adjunct testing (e.g., OCT, fluorescein angiography or other method) and 
which results in reduced BCDVA to 20/40 or worse at Visit 3A for the first eye or Visit 
3B for the second eye or later 
13.5.5.3 Subject Questionnaires 
Results of the quality of vision questionnaire and domain scores will be presented using 
descriptive statistics by treatment group and visit, and no comparison will be made between 
treatment groups.  Data from the near activity vision questionnaire will be presented in a listing. 
13.5.5.4 Trial Frame Astigmatism Simulation 
The following will be summarized by treatment group using the sample size, mean, standard 
deviation, minimum, first through third quartiles, and maximum.  

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• logMAR VA for each assess combination of distance (40 cm, 66 cm, 4 m), cylinder 
power (0 D, +1.00 D, +1.50 D, +2.00 D) and axis (90 degrees, 180 degrees) 
• The within-eye difference in logMAR VA between without astigmatic correction (0.00 
D cylinder power) and with astigmatic correction, for each combination of distance, 
non-zero cylinder power, and axis 
13.5.5.5 Additional Outcomes 
The following additional outcomes will be presented through the use of descriptive statistics 
and compared between treatment arms: 
• All categories of uncorrected visual acuities, by visit 
• All mesopic visual acuities, by visit 
• The distribution of grades of anterior chamber cells and flare, by visit 
• All cases of prolonged use of anti-inflammatory medication beyond 6 weeks 
The following safety analyses will also be performed: 
• subject-by-subject analysis of reasons why subject failed to achieve 0.3 logMAR visual 
acuity  
• rate of visual acuity decreases of 10 letters or more on an early treatment of diabetic 
retinopathy study (EDTRS) chart (or equivalent) between a form evaluation and a later 
form evaluation with the cause of the visual acuity decrease described in each case. 
Cases of such visual acuity loss will be identified programmatically from the visual 
acuity data rather than from the CRF question about 10 letter drops.  
• Posterior capsular opacification grades and rates of posterior capsulotomies. 
13.5.5.6 Additional Analyses 
The accuracy of the preliminary A-constant used in the study will be assessed in a post-hoc 
analysis to be included in a premarket approval supplement.  
Any additional supportive safety or effectiveness analyses will be described in the SAP. 
13.5.6 
Subject Disposition 
Enrollment status will be summarized in a table by investigator and overall for the mITT 
analysis set. The number of randomized subjects will be summarized as well as the number 
and percentage of subjects that completed the entire trial, discontinued before implant, 
discontinued after the first implant but before the second surgery, and discontinued after the 
second surgery. In addition, for those subjects that did not complete the entire trial, the 
reason(s) for discontinuation will be summarized.     
 
Subject and eye accountability at each visit will be summarized for the ITT, mITT, PP, and 
Best Case Sets in tables. The subject and eye accountability tables for the mITT Set will also 
be stratified by investigator and by treatment assignment. 
 

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Subjects and eyes in the ITT, mITT, PP, and Best Case analysis sets will be summarized 
categorically by treatment and overall. 
13.5.7 
Demographics and Baseline Characteristics 
Race, sex, ethnicity, and age will be presented by treatment group and overall in a table using 
discrete summary statistics. Age will also be presented using continuous summary statistics by 
treatment group. 
13.5.8 
Protocol Deviations 
The number of subjects within each type of protocol deviation will be presented using discrete 
summary statistics.  
 
A major protocol deviation will be defined as a deviation that is expected to impact the key 
safety or effectiveness outcomes, or which has an effect on subject safety. 
13.5.9 
Interim Analyses 
After IOL implantation for Phase I/Pilot subjects, enrollment will pause until the Phase I/Pilot 
subjects have completed Visit 3B (30 to 60 days after second eye IOL implantation) and their 
data have been reviewed. A snapshot of DCNVA and DCIVA data will be obtained. Data 
listings and/or summaries of Test lens DCNVA and DCIVA data will be prepared by an 
unmasked statistician and presented for review by an unmasked clinical reviewer not 
associated with the study, and the best distances for near and intermediate VA testing will be 
determined. Safety data will also be prepared by an unmasked statistician and presented for 
review by an unmasked clinical reviewer not associated with the study. Phase I safety and VA 
data will be submitted to the FDA for review and acceptance to initiate Phase II.  Statistical 
comparisons between Group 1 and Group 2 will not be made or evaluated. The decision to 
proceed or not to proceed to Phase II will not be based on formal statistical stopping rules.  
 
When a minimum of 50 Phase I and Phase II Group 1 subjects have been enrolled and followed 
through Visit 4, summaries and/or listings of all available safety data through Visit 4 will be 
prepared by an unmasked statistical team. Aggregated safety data for the minimum first 50 
Phase I and Phase II Group 1 subjects who complete Visit 4 for these subjects will be presented 
to the FDA to request expansion to Phase III. Safety data for approximately the corresponding 
minimum first 25 Phase I and Phase II Group 2 subjects who complete Visit 4 also will be 
submitted concurrently to the FDA.  While safety data submission and FDA review for these 
subjects is occurring, additional subjects may be enrolled up to a maximum of approximately 
72 Phase II subjects (including those whose data were submitted to FDA).  Statistical 
comparisons between Group 1 and Group 2 will not be made or evaluated. The decision to 
proceed or not to proceed to Phase III will not be based on formal statistical stopping rules.  
Phase III enrollment will be initiated only after acceptance to proceed is received from FDA. 
 

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13.6 Additional Statistical Considerations 
13.6.1 
Handling of Missing Data 
Imputation of missing primary endpoint data is described in Section 13.5.3 above. Unless 
otherwise specified in the SAP, missing data will not be imputed. 
13.6.2 
Multicenter Issues 
Randomization will be stratified by site.  
Consistency of treatment effects across sites will be evaluated using statistical methods that 
will be described in the SAP. A p-value less than or equal to 0.15 for treatment by site 
interactions will be considered statistically significant. 
13.6.3 
Multiplicity Issues 
As all primary safety and effectiveness endpoints with success criteria described in Section 
13.1 are required to demonstrate statistical success, adjustment for multiplicity is not necessary 
for these endpoints. 
Statistical testing of the secondary endpoints with success criteria will not be evaluated for 
success unless all primary endpoints with success criteria are met. Primary and secondary 
endpoints without success criteria will not affect the evaluation of secondary endpoints with 
success criteria. The secondary endpoint hypotheses will be evaluated hierarchically; therefore, 
adjustment for multiplicity is also not necessary for these endpoints. 
Any statistical tests of endpoints that are not primary or secondary endpoints will be considered 
exploratory and will not be adjusted for multiplicity. 
13.6.4 
Visit Windows 
Only in-window visit data will be included in the analysis of a scheduled visit’s data. All 
adverse events will be included in the safety analysis even if occurring or reported outside of 
scheduled visit windows. If a scheduled visit is completed outside of the prescribed visit 
window, then the visit and its window will be handled as follows: 
 
• 
The out-of-window scheduled visit will be reclassified as an interim (unscheduled) 
visit.  
• 
If one or more unscheduled visits occurred in the window, then the unscheduled visit 
that occurred closest to the center of the visit window will be reclassified as the in-
window (scheduled) visit.  
•     If two unscheduled visits occurred in the visit window, are the closest visits to its center, 
and are equidistant from its center, then the later of the two visits will be reclassified 
as the in-window (scheduled) visit. 
 
Each summary of unscheduled visit data will display the mean, standard deviation, median, 
minimum, and maximum of the absolute value of days outside of the visit windows that the 
summarized data were collected. 

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13.6.5 
Management of Bias 
Potential bias will be managed by randomization of subjects to treatment groups and by 
masking of examiners performing postoperative refractions and visual acuity testing.  
Randomization will be completed using a computer system so that subjects’ treatment 
assignments cannot be revealed prematurely. Each subject will be randomized independently, 
and no randomization result will be reassigned to another subject. This process should ensure 
there is no systematic bias in baseline characteristics, thus producing groups comparable in 
known and unknown potential confounding factors. The Berger-Exner test will be used to 
evaluate potential selection bias. 
The masking of subjects and postoperative examiners described in Section 9.2 of this document 
will remain in effect throughout the trial. Mean logMAR DCNVA and DCIVA by site and 
treatment, along with the difference in means between the test and control groups by site, will 
be examined to determine whether any site had an unusually large or small treatment effect.  
13.6.6 
Management of Potential Confounding Factors 
Randomization will be stratified by site. Site will be included in the statistical models for the 
analyses of continuous primary endpoints.  
14 
Quality Control and Quality Assurance 
14.1 Study Monitoring 
The Sponsor and its representatives must be allowed to visit all study site locations to assess 
the data, quality, and study integrity in a manner consistent with applicable health authority 
regulations and the procedures adopted by the Sponsor or its representative. During the 
COVID-19 pandemic, when access to study site locations may be restricted, remote monitoring 
methods may be implemented to ensure data quality and integrity, as per the monitoring plan. 
 
Prior to the start of the study, member(s) of the Sponsor (or designees) will review the protocol, 
CRF, regulatory obligations, and other material or equipment relevant to the conduct of the 
study with the Investigator/Sub-Investigator and relevant study site personnel.  
 
Monitoring visits and telephone consultations will occur as necessary, as per the monitoring 
plan, during the course of the investigation to verify the following: 
 
• The rights and well-being of subjects are protected  
• The conduct of the investigation is in compliance with the currently approved 
protocol/amendment; 21 CFR Parts 11, 50, 54, 56, and 812; ISO 14155 (2020 E) 
Clinical Investigation of Medical Devices for Human Subjects – Good Clinical 
Practice; ISO 11979-7:2006/Amd.1:2012(E) Ophthalmic implants — Intraocular 
lenses — Part 7; ISO 11979-9: 2006/Amd 1:2014 Ophthalmic implants — Intraocular 
lenses — Part 9; ANSI Z80.12-2007 (R2012), 42 USC 282(j); and IRB/IEC 
requirements  
• The integrity of the data, including adequate study documentation  
• The facilities remain acceptable  

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• The Investigator and site personnel remain qualified and able to conduct the study  
• Test article accountability  
 
During the study, if the Sponsor (or designee) determines that an Investigator is non-compliant 
with the study plan and/or applicable regulatory requirements, the Sponsor (or designee) will 
take remediation action to secure compliance. In addition, the Sponsor may terminate the 
Investigator’s participation in the study, if appropriate, if the Investigator remains non-
compliant despite the remediation actions. 
14.2 Source Documentation 
All medical information obtained at each study visit must be recorded in the subject’s record 
(source documentation) in real-time as it is collected. Source documentation consists of 
original subject documents, as well as data and records with information relevant to the subject 
and his/her participation in the study.  
 
Source documentation worksheets may be provided by the Sponsor or its designee to record 
pertinent information. The completed worksheets can then be incorporated into the subject’s 
medical chart. If it is preferred not to use the worksheets in the subject’s permanent record, 
then the worksheets should be used as a reference to determine the type of study data to record 
in the subject’s permanent record. 
14.3 Case Report Forms and Data Verification 
As used in this protocol, the term Case Report Form (CRF) should be understood to refer to an 
electronic data record developed as part of the electronic data capture method utilized in this 
study. 
 
Subject data required by this protocol are to be recorded on CRFs. The Investigator and his/her 
study site personnel will be responsible for completing the CRFs in a timely manner. The 
Investigator is required to verify that all of the requested information is accurately recorded on 
the CRFs. All information requested on the CRFs needs to be supplied, including subject 
identification and initials, date(s), assessment values, etc., and any omission or discrepancy 
will require explanation. All information on CRFs must be traceable to source documents.  
 
The study monitor will be responsible for reviewing and verifying the data recorded on the 
CRFs utilizing the original or certified copies of all source documentation and querying 
discrepant findings  
 
The Investigator and study site personnel will be responsible for answering all queries in a 
timely manner.  
14.4 Recording of Data and Retention of Documents 
Subject data recorded on CRFs during the study will be documented in a coded fashion. The 
subject will only be identified by the unique subject number. Confidentiality of subject records 
must be maintained to ensure adherence to applicable local privacy regulations. Data entry 
information and guidelines are found in the Study Reference Manual. 

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The Investigator must retain essential documents indefinitely after the completion of the study, 
unless otherwise notified by the Sponsor. The Investigator agrees to adhere to the document 
retention procedures when signing the protocol Investigator Statement of Approval.  
 
Essential documents include, but are not limited to, the following: 
• IRB/IEC approvals for the study protocol, all amendments, ICF(s), and 
advertisements  
• IRB/IEC annual study review  
• IRB/IEC correspondence and reports (e.g., SAE reports, protocol deviations, and 
safety updates)  
• Regulatory documents (e.g., financial disclosure and delegation of authority forms)  
• All source documents  
• CRFs  
• Subject’s signed ICF  
• Device Investigator Agreement  
• Accountability records for the test article(s)  
• Correspondence from and to the Sponsor and CRO 
• Any other documents relevant to the conduct of the study  
 
In the event the Investigator withdraws from the study (e.g., retirement or relocation), study 
records will be transferred to a mutually agreed upon designee (e.g., another Investigator or 
the site IRB/IEC). The Investigator will provide notice of such transfer in writing to the 
Sponsor and/or its representative. 
14.5 Audits and Inspections 
Audits of clinical research activities in accordance with the Sponsor’s internal Standard 
Operating Procedures (SOPs) to evaluate compliance with the principles of GCP may take 
place. A regulatory authority also may wish to conduct an inspection during the study or after 
its completion. If an inspection is requested by a regulatory authority and/or IRB/IEC, the 
Investigator must inform the Sponsor and its representative immediately that this request has 
been made. 
15 
Ethics and Administrative Issues 
It is the responsibility of the site’s principal investigator to assure that all aspects of the ethics 
review are conducted in accordance with ISO 14155. The protocol and any information 
supplied to the subject to obtain informed consent, including written informed consent form(s), 
subject recruitment procedures (e.g., advertisements), and written information to be provided 
to subjects (information leaflets), will be reviewed and approved by a qualified IRB/IEC prior 
to enrollment of participants in the study. Prior to initiation of the study and release of test 
articles to a clinical site, the Sponsor or its designee will receive documentation of the IRB/IEC 
approval, which specifically identifies the approved study/protocol and a list of the IRB/IEC 
committee members. Protocol amendments will be reviewed and approved by the IRB/IEC 
prior to implementation of any changes made to the study design in the amendment. 

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Investigators will submit progress reports to the IRB/IEC in accordance with the IRB/IEC 
requirements. 
15.1 Ethical Conduct of the Study 
The study will be conducted in accordance with the protocol and ISO 14155, applicable 
regulations and guidelines governing clinical study conduct, and the ethical principles that have 
their origin in the Declaration of Helsinki. 
15.2 Ethics Review 
The Investigator should ensure his/her participation in the study, the protocol, subject 
recruitment materials (e.g., written information or materials including web pages, radio 
advertisements, television spots or written text developed to encourage subject enrollment) and 
the ICF to be used in this study are approved by his/her institution IRB/IEC, or, if not using 
his/her institution’s IRB/IEC, by the reviewing central IRB/IEC prior to entering any subjects 
in the study. Documentation of IRB/IEC approval of the study protocol and informed consent 
must be provided to the Sponsor and any designee prior to initiation of the study. In addition, 
the Investigator must ensure that the reviewing IRB/IEC has provided approval for any 
protocol amendments prior to their implementation. If the amendment necessitates a revision 
to the ICF, the Investigator should ensure the revised form is also submitted to and approved 
by the Sponsor or its designee and the IRB/IEC prior to its implementation.  
15.3 Written Informed Consent 
Before entry into the study, the Investigator or an authorized member of the investigational 
staff will explain to potential subjects (or their legally acceptable representatives) the aims, 
methods, reasonably anticipated benefits, and potential hazards of the study, and any 
discomfort it may entail. The subject (or legally acceptable representative) will be given 
sufficient time to read the ICF and the opportunity to ask questions. After this explanation and 
before entry into the study, consent will be appropriately recorded by means of either the 
subject’s or his/her legally acceptable representative’s dated signature. After having obtained 
the consent, a copy of the signed and dated ICF will be given to the subject. 
 
If the subject (or legally acceptable representative) is unable to read or write, an impartial 
witness will be present for the entire informed consent process (which includes reading and 
explaining all written information) and will personally date and sign the ICF after the oral 
consent of the subject (or legally acceptable representative) is obtained. 
 
The informed consent form will be signed before the performance of any study-related activity.  
15.4 Financial Disclosure, Clinical Trial Agreements, and Site Contact Information 
An original financial disclosure Form (FDF) must be completed, signed and dated by the PI 
and any sub-investigators and study personnel listed on the Delegation of Authority Log.  All 
FDFs will be collected by the Sponsor or its designee and filed in the study Trial Master File. 
A copy of all FDFs will be retained in the Investigator Site Binder.  All contractual and 
financial agreements between clinical sites and the Sponsor will be administrated by the CRO 
as designated by the Sponsor and approved at a minimum by both Investigators and the 

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Sponsor in writing.  Indemnification information is included in contractual agreements with 
sites. 
 
A listing of site contact information is provided with the Study Reference Manual. 
15.5 Confidentiality/Publication of the Study 
All study data generated as a result of this study will be regarded as confidential until 
appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are 
completed. The results of the study may be published or presented by the Investigator(s) after 
the review by, and in consultation and agreement with, the Sponsor, and such that confidential 
or proprietary information is not disclosed.  
Prior to any publication or presentation, a copy of the final text should be forwarded by the 
Investigator(s) to the Sponsor or its designee, for comment. Such comments shall aim to ensure 
the scientific integrity of the proposed publications and/or presentations and ensure that the 
data and material referring to Bausch + Lomb Incorporated products and activities receive fair, 
accurate, and reasonable presentation.  
 

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16 
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29. Packer M, Fry L, Lavery KT, et al.  Safety and effectiveness of a glistening-free single-
piece hydrophobic acrylic intraocular lens (enVista).  Clin Ophthalmol 2013; 7:1905-1912. 
30. Heiner P, Ligabue E, Fan A, et al.  Safety and effectiveness of a single-piece hydrophobic 
acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study.  Clin 
Ophthalmol 2014; 8:629-635. 
31. Zhang F, Sugar A, Jacobsen G, et al. Visual function and spectacle independence after 
cataract surgery: bilateral diffractive multifocal intraocular lenses versus monovision 
pseudophakia. J Cataract Refract Surg. 2011 May; 37:853-858 
32. American Academy of Ophthalmology, Cataract in the Adult Eye Preferred Practice 
Pattern, 2016 

Protocol #945 
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 CONFIDENTIAL 
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33. de Silva SR, Evans JR, Kirthi V, et al. Multifocal versus monofocal intraocular lenses after 
cataract extraction. Cochrane Database Syst Rev. 2016 Dec 12;12:CD003169 
34. Cillino S, Casuccio A, Di Pace F, et al.  One-year outcomes with new-generation multifocal 
intraocular lenses.  Ophthalmology 2008; 115:1508-1516 
35. Packer M, Chu YR, Waltz KL, et al.  Evaluation of the aspheric Tecnis multifocal 
intraocular lens: one-year results from the first cohort of the food and drug administration 
clinical trial. Am J Ophthalmol 2010; 149:577-584.e1 
36. Maurino V, Allan BD, Rubin GS, et al.  Quality of vision after bilateral multifocal 
intraocular lens implantation.  Ophthalmology 2015; 122L700-710 
37. Jabs DA et al; Standardization of Uveitis Nomenclature (SUN) Working Group. Am J 
Ophthalmol 2005 Sep;140(3):509-16. 
38. Newcombe RG (1998) Interval estimation for the difference between independent 
proportions: comparison of eleven methods.  Statistics in Medicine 17:873-890. 
39. Guyton DL, Uozato H, and Wisnicki HG.  Rapid determination of intraocular lens tilt and 
decentration through the undilated pupil.  Ophthalmology 1990; 97:1259-1264. 
40. Holladay JT, Calogero D, Hilmantel G, et al.  Special Report: American Academy of 
Ophthalmology Task Force Summary Statement for Measurement of Tilt, Decentration, 
and Chord Length.  Ophthalmology 2017;124:144-146. 
41. Chang DH, Waring GO 4th. The subject-fixated coaxially sighted corneal light reflex: a 
clinical marker for centration of refractive treatments and devices.  Am J Ophthalmol 2014; 
158:863-874. 
42. Holladay JT.  Reply.  J Cataract Refract Surg. 2017 Jul;43(7):995. 
 
43. Li J, Lam CS, Yu M, Hess RF, Chan LY, Maehara G, Woo GC, Thompson B. Quantifying 
sensory eye dominance in the normal visual system- a new technique and insights into 
variation 
across 
traditional 
tests. 
Invest 
Ophthalmol 
Vis 
Sci. 
2010. 
 
 

 
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17 
Appendices 
Appendix A  STUDY FLOW CHART 
Examination 
Pre-Op 
0A/B 
(Both 
Eyes) 
Operative 
00A 
(1st Eye) 
Post-Op 1A 
(1st Eye) 
Post-Op 
2Aa 
(1st Eye) 
Post-Op 
3A 
(1st Eye) 
Operative 
00B 
(2nd Eye) 
Post-Op 
1B 
(2nd Eye) 
 
Post-Op 
2B 
(2nd Eye) 
Post-Op 
3B 
(2nd Eye) 
Post-Op 
4 
(Both 
Eyes) 
Post-Op 5 
(Both 
Eyes) 
For sub-
study only: 
Post-Op 6 
(Both 
eyes) 
Day -30 
to -5 
 
Day 0 
Day 1 to 2 
Day 7 to 
14 
Day 30 
to 60 
Day 7 to  
30 
Day 1 to 
2        
Post 
Visit 00B 
Day 7 to 
14      
Post 
Visit 00B 
Day 30 
to 60      
Post Visit 
00B 
Day 120 
to 180 
Post 
Visit 00B 
Day 330 
to 420 
Post Visit 
00B 
Day 2- 30 
post Visit 
5 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
Xo 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
Ocular and Non-Ocular 
Medical History 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion  
X 
Xb 
 
 
 
Xb 
 
 
 
 
 
Xp 
Subject Questionnairesc 
X 
 
 
 
 
 
 
 
 
X 
 
 
Potential Visual Acuity 
X 
 
 
 
 
 
 
 
 
 
 
 
Corneal Topography 
X 
 
 
 
 
 
 
 
 
 
 
 
Targeted Refraction / IOL 
Power Calculation / Axial 
Length 
Determination/Anterior 
Chamber Depth  
X 
 
 
 
 
 
 
 
 
 
 
 
Chord length µ  
X 
 
 
 
 
 
 
 
 
X 
X 
 
Keratometry 
X 
 
 
 
X 
 
 
 
X 
X 
X 
 

 
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Examination 
Pre-Op 
0A/B 
(Both 
Eyes) 
Operative 
00A 
(1st Eye) 
Post-Op 1A 
(1st Eye) 
Post-Op 
2Aa 
(1st Eye) 
Post-Op 
3A 
(1st Eye) 
Operative 
00B 
(2nd Eye) 
Post-Op 
1B 
(2nd Eye) 
 
Post-Op 
2B 
(2nd Eye) 
Post-Op 
3B 
(2nd Eye) 
Post-Op 
4 
(Both 
Eyes) 
Post-Op 5 
(Both 
Eyes) 
For sub-
study only: 
Post-Op 6 
(Both 
eyes) 
Day -30 
to -5 
 
Day 0 
Day 1 to 2 
Day 7 to 
14 
Day 30 
to 60 
Day 7 to  
30 
Day 1 to 
2        
Post 
Visit 00B 
Day 7 to 
14      
Post 
Visit 00B 
Day 30 
to 60      
Post Visit 
00B 
Day 120 
to 180 
Post 
Visit 00B 
Day 330 
to 420 
Post Visit 
00B 
Day 2- 30 
post Visit 
5 
Manifest Refraction 
(ETDRS) 
X 
 
 
X 
X 
 
 
Xd 
Xd 
X 
X 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
Operative Procedures 
 
X 
 
 
 
X 
 
 
 
 
 
 
Photopic Pupil Size  
X 
 
 
 
 
 
 
 
Xd 
X 
 
 
Mesopic Pupil Size 
X 
 
 
 
 
 
 
 
 
X 
 
 
UCDVA – photopic, 
monocular (ETDRS) 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
 
UCDVA- photopic, 
binocular (ETDRS) 
 
 
 
 
 
 
 
X 
X 
X 
X 
 
BCDVA – photopic, 
monocular (ETDRS) 
X 
 
 
X 
X 
 
 
X 
X 
X 
X 
 
BCDVA – photopic, 
binocular (ETDRS) 
 
 
 
 
 
 
 
X 
X 
X 
X 
 
UCNVAe,f – photopic, 
monocular 
 
 
 
 
X  
 
 
 
X 
X 
X 
 
UCNVAe,f – photopic, 
binocular 
 
 
 
 
 
 
 
 
X 
X 
X 
 
DCNVAe– photopic, 
monocular 
 
 
 
 
Xg 
 
 
 
Xf  
Xf 
Xf  
 

 
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Examination 
Pre-Op 
0A/B 
(Both 
Eyes) 
Operative 
00A 
(1st Eye) 
Post-Op 1A 
(1st Eye) 
Post-Op 
2Aa 
(1st Eye) 
Post-Op 
3A 
(1st Eye) 
Operative 
00B 
(2nd Eye) 
Post-Op 
1B 
(2nd Eye) 
 
Post-Op 
2B 
(2nd Eye) 
Post-Op 
3B 
(2nd Eye) 
Post-Op 
4 
(Both 
Eyes) 
Post-Op 5 
(Both 
Eyes) 
For sub-
study only: 
Post-Op 6 
(Both 
eyes) 
Day -30 
to -5 
 
Day 0 
Day 1 to 2 
Day 7 to 
14 
Day 30 
to 60 
Day 7 to  
30 
Day 1 to 
2        
Post 
Visit 00B 
Day 7 to 
14      
Post 
Visit 00B 
Day 30 
to 60      
Post Visit 
00B 
Day 120 
to 180 
Post 
Visit 00B 
Day 330 
to 420 
Post Visit 
00B 
Day 2- 30 
post Visit 
5 
DCNVAe,f – photopic, 
binocular  
 
 
 
 
 
 
 
 
 
X 
X 
 
DCNVAe,f – mesopic, 
monocular 
 
 
 
 
X 
 
 
 
X 
X 
X 
 
DCNVAe,f – mesopic, 
binocular 
 
 
 
 
 
 
 
 
 
X 
X 
 
UCIVAh,i – photopic, 
monocular  
 
 
 
 
X 
 
 
 
X 
X 
X 
 
UCIVAh,i – photopic, 
binocular  
 
 
 
 
 
 
 
 
X 
X 
X 
 
DCIVAh – photopic, 
monocular  
 
 
 
 
Xj 
 
 
 
Xi 
Xi 
Xi 
 
DCIVAh,i – photopic, 
binocular  
 
 
 
 
 
 
 
 
 
X 
X 
 
DCIVAh,i – mesopic, 
monocular  
 
 
 
 
X 
 
 
 
X 
X 
X 
 
DCIVAh,i – mesopic, 
binocular  
 
 
 
 
 
 
 
 
 
X 
X 
 
Binocular best-corrected 
distance contrast 
 
 
 
 
 
 
 
 
 
X 
Xl 
 

 
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Examination 
Pre-Op 
0A/B 
(Both 
Eyes) 
Operative 
00A 
(1st Eye) 
Post-Op 1A 
(1st Eye) 
Post-Op 
2Aa 
(1st Eye) 
Post-Op 
3A 
(1st Eye) 
Operative 
00B 
(2nd Eye) 
Post-Op 
1B 
(2nd Eye) 
 
Post-Op 
2B 
(2nd Eye) 
Post-Op 
3B 
(2nd Eye) 
Post-Op 
4 
(Both 
Eyes) 
Post-Op 5 
(Both 
Eyes) 
For sub-
study only: 
Post-Op 6 
(Both 
eyes) 
Day -30 
to -5 
 
Day 0 
Day 1 to 2 
Day 7 to 
14 
Day 30 
to 60 
Day 7 to  
30 
Day 1 to 
2        
Post 
Visit 00B 
Day 7 to 
14      
Post 
Visit 00B 
Day 30 
to 60      
Post Visit 
00B 
Day 120 
to 180 
Post 
Visit 00B 
Day 330 
to 420 
Post Visit 
00B 
Day 2- 30 
post Visit 
5 
sensitivity testing 
(photopic with glare at 3, 
6, 12 and 18 cpd)k 
Binocular best-corrected 
distance contrast 
sensitivity (mesopic with 
and without glare at 1.5, 
3, 6, and 12 cpd)k 
 
 
 
 
 
 
 
 
 
X 
Xl 
 
Binocular BCDVA 
Defocus Curvesk 
 
 
 
 
 
 
 
 
 
X 
 
 
Intraocular Pressure 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
 
Slit-Lamp Examm 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
 
Dilated Fundus Exam 
X 
 
 
 
X 
 
 
 
X 
X 
Xn 
 
OCT Imagingk 
 
 
 
 
 
 
 
 
 
X 
 
 
Trial Frame Astigmatism 
Simulation sub-study 
(assessments below) 
 
 
 
 
 
 
 
 
 
 
 
X 
BCDVA photopic 
monocular (no 
additional sphere, 
cylinder or axis) 
 
 
 
 
 
 
 
 
 
 
 
X 

 
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Examination 
Pre-Op 
0A/B 
(Both 
Eyes) 
Operative 
00A 
(1st Eye) 
Post-Op 1A 
(1st Eye) 
Post-Op 
2Aa 
(1st Eye) 
Post-Op 
3A 
(1st Eye) 
Operative 
00B 
(2nd Eye) 
Post-Op 
1B 
(2nd Eye) 
 
Post-Op 
2B 
(2nd Eye) 
Post-Op 
3B 
(2nd Eye) 
Post-Op 
4 
(Both 
Eyes) 
Post-Op 5 
(Both 
Eyes) 
For sub-
study only: 
Post-Op 6 
(Both 
eyes) 
Day -30 
to -5 
 
Day 0 
Day 1 to 2 
Day 7 to 
14 
Day 30 
to 60 
Day 7 to  
30 
Day 1 to 
2        
Post 
Visit 00B 
Day 7 to 
14      
Post 
Visit 00B 
Day 30 
to 60      
Post Visit 
00B 
Day 120 
to 180 
Post 
Visit 00B 
Day 330 
to 420 
Post Visit 
00B 
Day 2- 30 
post Visit 
5 
BCDVA photopic, 
monocular (simulated 
astigmatism 2.0 D 
plus cylinder, 180°) 
 
 
 
 
 
 
 
 
 
 
 
X 
BCDVA photopic, 
monocular (simulated 
astigmatism 2.0 D 
plus cylinder, 90°) 
 
 
 
 
 
 
 
 
 
 
 
X 
BCDVA photopic, 
monocular (simulated 
astigmatism 1.50 D 
plus cylinder, 180°) 
 
 
 
 
 
 
 
 
 
 
 
X 
BCDVA photopic, 
monocular (simulated 
astigmatism 1.5 D 
plus cylinder, 90°) 
 
 
 
 
 
 
 
 
 
 
 
X 
BCDVA photopic, 
monocular (simulated 
astigmatism 1.0 D 
plus cylinder, 180°) 
 
 
 
 
 
 
 
 
 
 
 
X 
BCDVA photopic, 
monocular (simulated 
astigmatism 1.0 D 
plus cylinder, 90°) 
 
 
 
 
 
 
 
 
 
 
 
X 

 
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Examination 
Pre-Op 
0A/B 
(Both 
Eyes) 
Operative 
00A 
(1st Eye) 
Post-Op 1A 
(1st Eye) 
Post-Op 
2Aa 
(1st Eye) 
Post-Op 
3A 
(1st Eye) 
Operative 
00B 
(2nd Eye) 
Post-Op 
1B 
(2nd Eye) 
 
Post-Op 
2B 
(2nd Eye) 
Post-Op 
3B 
(2nd Eye) 
Post-Op 
4 
(Both 
Eyes) 
Post-Op 5 
(Both 
Eyes) 
For sub-
study only: 
Post-Op 6 
(Both 
eyes) 
Day -30 
to -5 
 
Day 0 
Day 1 to 2 
Day 7 to 
14 
Day 30 
to 60 
Day 7 to  
30 
Day 1 to 
2        
Post 
Visit 00B 
Day 7 to 
14      
Post 
Visit 00B 
Day 30 
to 60      
Post Visit 
00B 
Day 120 
to 180 
Post 
Visit 00B 
Day 330 
to 420 
Post Visit 
00B 
Day 2- 30 
post Visit 
5 
DCIVA photopic 
monocular (no 
additional sphere, 
cylinder or axis) 
 
 
 
 
 
 
 
 
 
 
 
X 
DCIVA photopic, 
monocular (simulated 
astigmatism 2.0 D 
plus cylinder, 180°) 
 
 
 
 
 
 
 
 
 
 
 
X 
DCIVA photopic, 
monocular (simulated 
astigmatism 2.0 D 
plus cylinder, 90°) 
 
 
 
 
 
 
 
 
 
 
 
X 
DCIVA photopic, 
monocular (simulated 
astigmatism 1.5 D 
plus cylinder, 180°) 
 
 
 
 
 
 
 
 
 
 
 
X 
DCIVA photopic, 
monocular (simulated 
astigmatism 1.5 D 
plus cylinder, 90°) 
 
 
 
 
 
 
 
 
 
 
 
X 
DCIVA photopic, 
monocular (simulated 
astigmatism 1.0 D 
plus cylinder, 180°) 
 
 
 
 
 
 
 
 
 
 
 
X 

 
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Examination 
Pre-Op 
0A/B 
(Both 
Eyes) 
Operative 
00A 
(1st Eye) 
Post-Op 1A 
(1st Eye) 
Post-Op 
2Aa 
(1st Eye) 
Post-Op 
3A 
(1st Eye) 
Operative 
00B 
(2nd Eye) 
Post-Op 
1B 
(2nd Eye) 
 
Post-Op 
2B 
(2nd Eye) 
Post-Op 
3B 
(2nd Eye) 
Post-Op 
4 
(Both 
Eyes) 
Post-Op 5 
(Both 
Eyes) 
For sub-
study only: 
Post-Op 6 
(Both 
eyes) 
Day -30 
to -5 
 
Day 0 
Day 1 to 2 
Day 7 to 
14 
Day 30 
to 60 
Day 7 to  
30 
Day 1 to 
2        
Post 
Visit 00B 
Day 7 to 
14      
Post 
Visit 00B 
Day 30 
to 60      
Post Visit 
00B 
Day 120 
to 180 
Post 
Visit 00B 
Day 330 
to 420 
Post Visit 
00B 
Day 2- 30 
post Visit 
5 
DCIVA photopic, 
monocular (simulated 
astigmatism 1.0 D 
plus cylinder, 90°) 
 
 
 
 
 
 
 
 
 
 
 
X 
DCNVA photopic 
monocular (no 
additional sphere, 
cylinder or axis) 
 
 
 
 
 
 
 
 
 
 
 
X 
DCNVA photopic, 
monocular (simulated 
astigmatism 2.0 D 
plus cylinder, 180°) 
 
 
 
 
 
 
 
 
 
 
 
X 
DCNVA photopic, 
monocular (simulated 
astigmatism 2.0 D 
plus cylinder, 90°) 
 
 
 
 
 
 
 
 
 
 
 
X 
DCNVA photopic, 
monocular (simulated 
astigmatism 1.5 D 
plus cylinder, 180°) 
 
 
 
 
 
 
 
 
 
 
 
X 
DCNVA photopic, 
monocular (simulated 
astigmatism 1.5 D 
plus cylinder, 90°) 
 
 
 
 
 
 
 
 
 
 
 
X 

 
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Examination 
Pre-Op 
0A/B 
(Both 
Eyes) 
Operative 
00A 
(1st Eye) 
Post-Op 1A 
(1st Eye) 
Post-Op 
2Aa 
(1st Eye) 
Post-Op 
3A 
(1st Eye) 
Operative 
00B 
(2nd Eye) 
Post-Op 
1B 
(2nd Eye) 
 
Post-Op 
2B 
(2nd Eye) 
Post-Op 
3B 
(2nd Eye) 
Post-Op 
4 
(Both 
Eyes) 
Post-Op 5 
(Both 
Eyes) 
For sub-
study only: 
Post-Op 6 
(Both 
eyes) 
Day -30 
to -5 
 
Day 0 
Day 1 to 2 
Day 7 to 
14 
Day 30 
to 60 
Day 7 to  
30 
Day 1 to 
2        
Post 
Visit 00B 
Day 7 to 
14      
Post 
Visit 00B 
Day 30 
to 60      
Post Visit 
00B 
Day 120 
to 180 
Post 
Visit 00B 
Day 330 
to 420 
Post Visit 
00B 
Day 2- 30 
post Visit 
5 
DCNVA photopic, 
monocular (simulated 
astigmatism 1.0 D 
plus cylinder, 180°) 
 
 
 
 
 
 
 
 
 
 
 
X 
DCNVA photopic, 
monocular (simulated 
astigmatism 1.0 D 
plus cylinder, 90°) 
 
 
 
 
 
 
 
 
 
 
 
X 
Posterior capsulotomy 
assessment 
 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
a Must occur before Operative Visit 00B 
b Review of inclusion/exclusion criteria prior to surgery 
c To additionally be completed at any post-operative Unscheduled Visit and prior to unscheduled study exit (e.g., IOL explanation).   
d Completed for both eyes  
e Distance for Phase II and Phase III subjects of 40 cm  
f Phase I/Pilot: Distance of 40 cm 
g Phase I/Pilot: Distance of 30 cm, 35cm, and 40 cm 
h Distances for Phase II and Phase III subjects of 60 cm and 66 cm  
i Phase I/Pilot: Distance of 66 cm 
j Phase I/Pilot: Distance of 56 cm, 66 cm, and 76cm 
k Conducted on a subset of subjects 
 

 
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l Done only if subject has posterior capsulotomy after Visit 4; if subject is scheduled for posterior capsulotomy during Visit 4, testing is deferred to Visit 5 
m Includes determination of medical and lens findings/complications, including decentration, tilt and PCO (note: lens findings/complications, including 
decentration, tilt and PCO evaluated post-operatively only).   
n If clinically indicated 
0 Subjects must consent to participate in the Visit 6 Trial Frame Astigmatism Simulation sub-study.  New subjects who are enrolled in the study once protocol 
amendment 6 is instituted will consent to the Trial Frames Astigmatism Simulation sub-study at the Pre-Op Visit, if they so choose, but at a point no later than 
Visit 5.  Existing subjects who are in the study at the time protocol amendment 6 is instituted must  provide their consent to participate in the Trial Frame 
Astigmatism Simulation sub-study no later than Visit 5. 
 
pSpecific to Visit 6, overall study eligibility will be confirmed as well as criteria for participation in the Trial Frame Astigmatism Simulation sub-study.

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Appendix B  METHODS OF CLINICAL EVALUATIONS 
Any changes to the procedures described in this appendix will be provided under separate 
cover.  Study procedures performed during the COVID-19 pandemic will be conducted in 
accordance with medical guidance to reduce risk of COVID-19 transmission between study 
staff and subjects (available at www.aao.org/covid-19).  It is recommended Investigators 
periodically revisit the aao.org/covid-19 website to identify and implement any updated 
recommendations made by AAO.  Local, state, and federal public health guidance also will be 
followed, and it is recommended these guidances also be visited once a month to see if they 
have changed. 
 
1.0 MANIFEST SUBJECTIVE REFRACTION (WITHOUT CYCLOPLEGIC EYE 
DROPS) 
It is essential that a consistent and standard procedure be used to obtain manifest refraction 
measurements.  The measurements will be obtained by a qualified ophthalmologist, 
optometrist or trained ophthalmic technician using a phoropter or trial frame with loose lenses, 
in 0.25 D steps, in a calibrated refraction lane. The principal of maximum plus prescription 
while maintaining optimum visual acuity (not just darker letters) should be adhered to. At no 
time during the study will autorefraction be utilized as a final endpoint refraction. 
Autorefractor or lensometer readings may only be utilized to obtain a starting point for the 
refraction, if necessary.   
To ensure consistency, all refractions will be performed at an optical distance of 4 meters using 
the M&S Clinical Trial Suite. This refraction will be considered the “unadjusted manifest 
refraction at 4 m”.  The “adjusted manifest refraction” is the “unadjusted manifest refraction “ 
minus 0.25 D used to correct for optical infinity at 4 m.  Both “adjusted” and “unadjusted” 
manifest refraction values will be recorded on source documentation, but only the adjusted 
value will entered as eCRF data.  Note that the “adjusted manifest refraction” (“unadjusted 
manifest refraction” at 4 meters minus 0.25 D) is the value that is used for DCIVA and 
DCNVA measurements.  
1.1 Preoperative Manifest Subjective Refraction 
 
If the subject has a current pair of glasses for distance vision, they can be measured with a 
lensometer and these measurements used as the beginning approximate refraction. If the 
subject does not have glasses for distance vision, retinoscopy or autorefraction may be 
performed by an examiner proficient in this procedure as the beginning approximate refraction.  
If the subject is a contact lens wearer, they should be advised to arrive for the preoperative 
testing wearing spectacles and not their contact lenses.  
 
AUTOREFRACTION ALONE IS NOT ALLOWED AT ANY POINT IN THIS STUDY. 
RESULTS MUST BE REFINED USING SUBJECTIVE TECHNIQUES. 
 
The manifest subjective refraction at 4 meters MUST be transferred to the trial frame for 
BCDVA testing. If for any reason (e.g., dense cataract) manifest refraction cannot be obtained, 
the results should be documented as not done (ND) and not entered as zeros. In the event of 

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this occurrence, BCDVA will not be tested and the reason for ND will be required in the source 
document and eCRF. 
 
Contact lens wearers must demonstrate a stable refraction (within ± 0.50 D for both sphere and 
cylinder) on two consecutive exam dates. Stability of the refraction is determined under the 
following conditions:  
• 
Lenses are not worn for at least 1 week (rigid contact lenses) or 3 days (soft contact lenses) 
prior to the first refraction used to establish stability and through the day of surgery;   
• 
The two refractions are performed at least 7 days apart. 
 
1.2 Postoperative Manifest Subjective Refraction 
 
The subject should be refracted using the same method and procedure as described in Section 
1.1 of this appendix.  
 
2.0 VISUAL ACUITY TESTING 
It is essential that a standard procedure be used to obtain visual acuity (VA) measurements. 
The VA measurements should be obtained by a qualified ophthalmologist, optometrist or 
trained ophthalmic technician using the Clinical Trial Suite (M&S Technologies, Niles, IL) 
hardware and software that will be supplied by the Sponsor.  Training on the use of Clinical 
Trial Suite instrumentation will be conducted and documented by a qualified representative of 
M&S Technologies prior to its use with enrolled subjects.  VA testing will be performed by 
masked study personnel using a trial frame. 
Visual Acuity Testing for all subjects: 
• Best-corrected distance visual acuity (BCDVA) will be measured at distance of 4 meters 
with the manifest refraction obtained at 4 meters (Unadjusted Manifest Refraction) 
• Uncorrected distance visual acuity (UCDVA) will be measured at distance of 4 meters with 
a +0.25D lens to adjust for optical infinity 
• Distance corrected intermediate visual acuity (DCIVA) will be measured at distance(s) 
specified in Appendix A with the “adjusted manifest refraction”, which is the manifest 
refraction obtained at 4 meters minus 0.25 D to obtain the optical infinity manifest 
refraction (Adjusted Manifest Refraction) 
• Uncorrected intermediate visual acuity (UCIVA) will be measured with Phase II and Phase 
III subjects at distance(s) specified in Appendix A at 66 cm with no corrective lens 
• Distance corrected near visual acuity (DCNVA) will be measured at distance(s) specified 
in Appendix A with the “adjusted manifest refraction”, which is the manifest refraction 
obtained at 4 meters minus 0.25 D (Adjusted Manifest Refraction). 
• Uncorrected near visual acuity (UCNVA) will be measured at distance(s) specified in 
Appendix A with no corrective lens 
 
2.1 Description and Testing Methodology 
 
The Clinical Trial Suite is a computerized vision testing system consisting of a computer tablet 
and frame to hold the tablet that allows it to be stationed at different distances from a seated 

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subject.  The tablet frame also has lights attached to it that allow vision testing to be conducted 
with or without glare.  The frame can be moved so that near, intermediate, or far VA can be 
determined, with the ETDRS optotype display adjusted for distance from subject to display to 
accommodate the effect of distance of the size of the ETDRS letters.  The Clinical Trial Suite 
will use high contrast ETDRS letters and randomize the letter display during every use to 
eliminate any effect of memorization bias. The distance from subject to display for near, 
intermediate, and far distance VA testing will be standardized for all clinical sites and for all 
subjects.    
 
The chart display on the tablet should be at a comfortable viewing angle for the subject, 
approximately head high.  The subject should attempt to read each letter, line by line, left to 
right, beginning with line 1 at the top of the chart.  The subject should be told that the chart 
has letters only, no numbers.  The subject should be asked to read slowly, about 1 letter per 
second, so as to achieve the best identification of each letter.  Subjects should be instructed not 
to squint, and the tester should closely watch the subject during testing and warn him/her if 
squinting is observed.  The subject is not to proceed to the next letter until a definite response 
is given. 
 
If the subject changes a response (e.g., “that was a ‘C’ not an ‘O’) before the next letter has 
been read aloud, then the change must be accepted.  If the subject changes a response having 
read the next letter, then the change is not to be accepted.  The examiner should never point to 
the chart or to specific letters on the chart during the test.  A maximum effort should be made 
to identify each letter on the chart.  This may include encouraging the subject to guess.  If the 
subject identified a letter as 1 of 2 letters, he or she should be asked to choose 1 letter and, if 
necessary, to guess.  When it becomes evident that no further meaningful readings can be 
made, despite encouragement to read or guess, the examiner should stop the test for that eye 
and those testing conditions.  However, all letters on the last line should be attempted as letter 
difficulties vary and the last letter may be the only one read correctly.  The number of letters 
missed or read incorrectly should be noted.  In order to provide standardized and well 
controlled assessments of visual acuity during the study, all visual acuity assessments at a 
single site must be consistently done using the same lighting conditions during the entire study. 
 
2.2 Room Illumination 
 
Standard lighting conditions to be used in VA testing are Photopic: 85 (± 2) cd/m2 and Mesopic: 
3 (± 0.5) cd/m2. If an Investigator is unable to use these lighting conditions or has lighting 
conditions that vary slightly from these target illuminations, they should discuss their current 
lighting conditions with the Sponsor. 
 
2.3 Subject Instructions 
 
Subjects will be instructed that their vision will be tested at different distances, sometimes with 
the room lights on and sometimes with the room lights off.  They will be asked to sit quietly 
during testing, with no head movements relative to the chart display allowed.  If subjects need 
one or more brief breaks from the testing, this will be allowed.  
 

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2.4 Visual Acuity Assessments 
See Appendix A for schedule of VA assessments.    VA assessments should be done only once 
per visit for each eye (or subject, in the case of binocular VA), distance to eye chart, and 
lighting condition.  
   
3.0 SLIT LAMP EXAM 
Slit lamp examination will be performed using a slit lamp biomicroscope and observations 
graded per the following classification: 
 
Cataract Type 
• Nuclear  
• Cortical  
• Posterior sub-capsular  
• Combination  
 
Cataract Density 
• 1+ = Slight  
• 2+ = Moderate  
• 3+ = Dense  
• 4+ = Very dense 

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Lids – Normal / Abnormal+ 
 
Iris/Pupil – Normal / Abnormal+ 
 
Conjunctiva – Normal / Abnormal+ 
 
+Abnormal is defined as beyond the normal range encountered in healthy individuals of a 
similar age 
Hyperemia 
0 None  
1 Mild 
2 Moderate  
3 Severe 
4 Very Severe 
 
Cornea  
Superficial Punctate Keratitis 
0 None  
1 Mild 
2 Moderate  
3 Severe 
4 Very Severe 
 
Corneal Wound Edema (postoperative only) 
0 None 
1 Mild 
2 Moderate 
3 Severe 
 
Corneal Stromal Edema (preoperative and postoperative) 
0 None  
No evidence of corneal swelling with normal transparency 
1 Mild 
 
Mild corneal swelling 
2 Moderate   Moderate corneal swelling 
3 Severe  
Definite widespread cloudiness or haziness giving dull ground 
glass appearance to cornea, or numerous coalescent bullae 
 
The slit lamp examination includes the measurement of aqueous cell and flare by the SUN 
Working Group grading system. 37 For the evaluation of cells and flare, using a 1 mm x 1 mm 
slit beam, the following SUN grading scheme will be used: 
 
 
 

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Anterior Chamber Cells 
Grade  
Cells in Field 
 0  
 
     <1 
 0.5+  
     1-5 
 1+  
 
     6-15 
 2+  
 
     16-25 
 3+  
 
     26-50 
 4+  
 
     >50 
 
Anterior Chamber Flare 
Grade  
Description 
 0 
None 
 
 1+ 
Faint 
 
 2+ 
Moderate 
Iris/lens detail clear 
 3+ 
Marked 
Iris/lens details hazy 
 4+ 
Intense 
Fibrin/plastic aqueous 
 
Posterior Capsular Haze 
Assessment of the severity of any PCO will be done with pupil dilation at the slit lamp using 
the following grading scale: 
Grade 0 – None 
 
 
 
No growth is seen on any portion of the visible lens capsule. 
Grade 1 – Trace or Mild 
Lens epithelial cells can be seen in the periphery where the 
anterior capsule has retracted from the front of the IOL and is 
now interacting with the posterior capsule, but there are very few 
central cells. 
Grade 2 – Moderate 
The peripheral cells have become much denser and are starting 
to invade the central area. 
Grade 3 – Severe 
The lens epithelial cells have met one another in the middle and 
are forming a sheet over the posterior capsule. 
 
4.0 INTRAOCULAR PRESSURE (IOP) 
IOP measurements will be obtained using a calibrated Goldmann Type Applanation Tonometer 
in accordance with manufacturer's instructions. 
 
5.0 PUPIL SIZE 
Pupil size will be measured with a pupillometer at the corneal plane to the nearest 0.1 mm.  
Eye illumination for pupil measurement will be identical to the photopic and mesopic 
illumination used for visual acuity testing – 85 (± 2) cd/m2 and 3 (± 0.5) cd/m2, respectively. 
Pupil measurement will be initiated only after the eye has had time to fully adapt to the testing 
conditions (approximately 10 minutes).   
 
6.0 DILATED FUNDUS EXAM 

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Using an Ophthalmoscope, light is shone into the eye and the retina and the optic nerve are 
examined. This exam is used to evaluate the internal structures of the eye. The Investigator 
will classify the fundus as “normal” or “abnormal.”  If abnormal, the investigator will describe 
the abnormality.  The investigator will also rate the clarity of fundus visualization as 
“adequate” or “inadequate”.   
 
7.0 OCT IMAGING 
Approximately 20 Group 1 subjects and 10 Group 2 subjects will participate in OCT imaging 
at 2-3 clinical sites having similar or identical OCT equipment.  For sites and subjects 
participating in OCT imaging, images of first implanted eye will be taken.   OCT images will 
be obtained after the dilated exam, and eyes found to have any abnormality of the visual axis 
or retinal structures will be excluded from the imaging sub-study.  For each first implanted 
eye, three images of the macula and three images of the optic nerve will be obtained by 
qualified site personnel, labeled with the Subject ID number, and submitted to the Sponsor (or 
designee) for assessment.  The image quality will be assessed to determine adequacy for 
visualization of retinal structures, with the results rated on the following scale: 
0 = Ungradable (including failure to visualize the macula or optic nerve) 
1 = Poor quality image 
2 = Fair quality image 
3 = Good quality image 
4 = Excellent quality image 
 
If difficulty with visualization is encountered during the process of obtaining OCT images, 
conventional fundus photographs will be taken.   
 
8.0 TRIAL FRAME ASTIGMATISM SIMULATION 
Participating subjects should have the following characteristics (in both eyes) upon having 
consented to the Trial Frame Astigmatism Simulation sub-study: 
1. Signed consent (no later than Visit 5) to participate in the sub-study 
2. Completed visit 5 
3. Have a best-corrected distance visual acuity of 20/25 or better as noted in each eye at 
Visit 5  
4. Subjects should not have corneal edema, increased IOP or any AE / SAE at Visit 5, as 
per the reportable AEs/ SAEs clarified in section 12.4.1 of the protocol. 
5. In addition, subjects must be willing to complete their participation on the Trial Frame 
sub-study between 2 and 30 days after completion of Visit 5. 
6. Subjects with oblique post-operative residual astigmatism (axis between 30 to 60 
degrees or 120 to 150 degrees) will be excluded from participation in the sub-study. 
Enrollment will be sequential with consecutive subjects enrolled onto the Trial Frame 
astigmatism simulation sub-study at each site in order of their completion of post-operative 
Visit 5 and based on their eligibility. The subject will provide consent for the Trial Frame 
astigmatism simulation sub-study by completion of Visit 5 and return at Visit 6 to undergo the 
trial frame evaluation to assess distance-corrected visual acuities with various amounts of 
astigmatism. Eligibility for the sub-study will be confirmed by the completion of Visit 5 and 

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subjects will be enrolled in it when the Informed Consent document is signed. Visit 6 will 
include review/update of concomitant medications, adverse events, and measurement of 
monocular distance corrected visual acuity for far (4 m), intermediate (66 cm), and near (40 
cm) distance under photopic conditions with varying degrees of simulated residual astigmatism 
with 2.00 D, 1.5 D, and 1.0 D CYL.  Participants in the sub-study will be seen at only one visit 
(Visit 6) for the trial frame evaluation which will complete their participation in the study.   
Assessments are shown in the Study Flow Chart in Appendix A. 
 
The below assessments  will be recorded: 
 
i. For the (4-meter) manifest-corrected distance (4 m) testing: 
▪ Visual acuity will be assessed without astigmatic blur; and  
▪ With astigmatic blur for each astigmatic condition (power/axis orientation);  
 
ii. For the distance corrected intermediate (66 cm) testing : 
▪ Visual acuity will be assessed without  astigmatic blur; and  
▪ With astigmatic blur for each astigmatic condition (power/axis orientation) 
 
iii. For the distance corrected near (40 cm) testing: 
▪ Visual acuity will be assessed without astigmatic blur; and  
▪ With astigmatic blur for each astigmatic condition (power/axis orientation) 
 
The order of testing will follow the A and B Eye pre-operative assignments relating to the 
order of surgical implantation of the IOL and each eye of the subject will be tested for each 
distance and astigmatic condition, followed by a repeat of the same testing with the other eye.   
 
The purpose of the Trial Frame astigmatism sub-study is to evaluate the effect of simulated 
residual astigmatism on distance, intermediate, and near visual acuities in eyes implanted with 
the enVista trifocal toric intraocular lenses (IOLs). 
 
The trial frame evaluation will assess distance-corrected visual acuities with various amounts 
of additional astigmatism at distance / far, intermediate, and near distances, in that order, for 
each eye of each subject monocularly.  ETDRS charts appropriate for each distance will be 
used in measuring visual acuity for the various cylinder power conditions.  Each eye of the 
participating subjects will be evaluated monocularly, beginning with the subject’s A eye 
(Right/ Left) and repeating for the subject’s B eye (Left/ Right).   
 
The Trial Frame is placed on the subject and adjusted to sit comfortably on the subject’s face. 
The subject’s eyes are centered relative to the lens wells of the frame via adjustments to the 
temple length, to the nose pad for frame height , pantoscopic tilt and leveling of the frame and  
the interpupillary distance. 
 
The subject’s distance-corrected refraction and testing will begin at far distance (4 m) using 
the Clinical Trial Suite system (M&S Technologies, Niles, IL) with no additional cylinder trial 
lens in the trial frame for measurement of monocular distance corrected visual acuity for each 
eye. The distance correction used in the trial frame for testing at far distance (4 m) is the 

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unadjusted manifest refraction performed at 4 m; however, the distance correction used in the 
trial frame for testing at intermediate (66 cm) and near (40 cm) distances is the adjusted 
manifest refraction (i.e., the manifest refraction at 4 m adjusted by adding an additional -0.25 
D).  See Table 4 below 
 
In order to ensure the spherical equivalent is kept at a constant,  the examiner must modify 
the spherical power with each plus cylinder power added to the trial frame. This procedure is 
necessary to avoid increasing the spherical equivalence and blurring the vision with induced 
Hyperopia. 
 
For example, when adding a residual plus cylinder power of 1.0D to the Trial Frame, 0.5D of 
spherical power must be subtracted to ensure spherical equilavence is maintained at a  constant.  
The following examples demonstrate the proper subtraction of spherical power with the 
addition of each cylindrical power to maintain a constant spherical equivalent compared to the 
manifest refraction.   
 Examples 
1)            -0.75 sph should be placed in the trial frame with the +1.50 cylinder,  
2)            -0.50 sph should be placed in the trial frame with the +1.00 cylinder, 
3)            -1.00 sph should be placed in the trial frame with the +2.00 cylinder. 
 
Residual astigmatism then will be optically simulated for each subject at distance / far (4 m), 
intermediate (66 cm), and near (40 cm) distances (in that order) using additional plus cylinder 
trial lenses placed at the 180⁰ axis (i.e., simulating ATR astigmatism) and then at the 90⁰ axis 
(i.e., simulating WTR astigmatism).  The order of trial lenses to be used with a subject will be 
the 2.00 D plus cylinder lens (placed first at 180⁰ and then at 90⁰) followed successively by use 
of the 1.50 D plus cylinder lens (placed first at 180⁰ and then at 90⁰) and then the 1.00 D plus 
cylinder lens (placed first at 180⁰ and then at 90⁰).  The A eye will be measured first, using the 
various cylinder lenses for distance / far, intermediate, and near distances.   The same order 
will then be repeated for the B eye.  
 
Table 4- Trial Frame order of testing 
 
Order of Testing Conditions 
Manifest Refraction 
Additional 
Sphere 
Adjustment 
for Cylinder 
Additional 
Cylinder 
Power 
Additional 
Cylinder 
Axis 
Far distance (4 m) without 
cylinder 
MR at 4 m (Unadjusted 
MR) 
None 
None 
None 
Far distance (4 m) with +2.00 
D cylinder 
MR at 4 m (Unadjusted 
MR) 
-1.00 D 
+2.00 D 
180 
Far distance (4 m) with +2.00 
D cylinder 
MR at 4 m (Unadjusted 
MR) 
-1.00 D 
+2.00 D 
90 
Far distance (4 m) with +1.50 
D cylinder 
MR at 4 m (Unadjusted 
MR) 
-0.75 D 
+1.50 D 
180 

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Far distance (4 m) with +1.50 
D cylinder 
MR at 4 m (Unadjusted 
MR) 
-0.75 D 
+1.50 D 
90 
Far distance (4 m) with +1.00 
D cylinder 
MR at 4 m (Unadjusted 
MR) 
-0.50 D 
+1.00 D 
180 
Far distance (4 m) with +1.00 
D cylinder 
MR at 4 m (Unadjusted 
MR) 
-0.50 D 
+1.00 D 
90 
Intermediate (66 cm) without 
cylinder 
MR at 4m with minus 0.25 
D ( Adjusted MR) 
None 
None 
None 
Intermediate (66 cm) with 
+2.00 D cylinder 
MR at 4m with minus 0.25 
D ( Adjusted MR) 
-1.00D 
+2.00 D 
180 
Intermediate (66 cm) with 
+2.00 D cylinder 
MR at 4m with minus 0.25 
D ( Adjusted MR) 
-1.00 D 
+2.00D 
90 
Intermediate (66 cm) with 
+1.50 D cylinder 
MR at 4m with minus 0.25 
D ( Adjusted MR) 
-0.75 D 
+1.50 D 
180 
Intermediate (66 cm) with 
+1.50 D cylinder 
MR at 4m with minus 0.25 
D ( Adjusted MR) 
-0.75 D 
+1.50 D 
90 
Intermediate (66 cm) with 
+1.00 D cylinder 
MR at 4m with minus 0.25 
D ( Adjusted MR) 
-0.50 D 
+1.00 D 
180 
Intermediate (66 cm) with 
+1.00 D cylinder 
MR at 4m with minus 0.25 
D ( Adjusted MR) 
-0.50 D 
+1.00 D 
90 
Near (40 cm) without cylinder 
MR at 4m with minus 0.25 
D ( Adjusted MR) 
None 
None 
None 
Near (40 cm) with +2.00 D 
cylinder 
MR at 4m with minus 0.25 
D ( Adjusted MR) 
-1.00 D 
+2.00D 
180 
Near (40 cm) with +2.00 D 
cylinder 
MR at 4m with minus 0.25 
D ( Adjusted MR) 
-1.00 D 
+2.00 D 
90 
Near (40 cm) with +1.50 D 
cylinder 
MR at 4m with minus 0.25 
D ( Adjusted MR) 
-0.75 D 
+1.50 D 
180 
Near (40 cm) with +1.50 D 
cylinder 
MR at 4m with minus 0.25 
D ( Adjusted MR) 
-0.75 D 
+1.50 D 
90 
Near (40 cm) with +1.00 D 
cylinder 
MR at 4m with minus 0.25 
D ( Adjusted MR) 
-0.50 D 
+1.00 D 
180 
Near (40 cm) with +1.00 D 
cylinder 
MR at 4m with minus 0.25 
D ( Adjusted MR) 
-0.50 D 
+1.00 D 
90 
 
   
9.0 ASSESSMENT OF LENS TILT AND DECENTRATION 
If upon postoperative examination, tilt and/or decentration of the IOL are not seen or deemed 
insignificant, rather than entering any score, a box marked “Not Detectable” will be checked.  
Otherwise, significant lens tilt and decentration will be assessed according to the method 
described by Guyton et al, 39 as refined by the American Academy of Ophthalmology Task 
Force Summary Statement for Measurement of Tilt, Decentration, and Chord Length. 40    
 

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The Guyton method is a simple, rapid and accurate procedure for determining the tilt and 
decentration of an IOL.  
 
Method of Determining Lens Tilt and Decentration 
 
Using a penlight, identify the IIIrd and IVth Purkinje images.   The relative lack of parallax 
movement of the first Purkinje image, with respect to the pupil, helps to identify it.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 3 from Chang and Waring 41 
Purkinje images as seen through a pupilometer. 
 
With the patient looking at the examiner's finger, the examiner moves his finger in the frontal 
plane until Purkinje images III and IV, as sighted by the examiner's eye, become aligned with 
one another. The apparent IOL tilt (𝚹𝚹') and decentration (Δ) are directly determined from this 
viewing situation, as described below. 
 

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Figure 6 from Guyton et al 39 
 
In Figure 6, the apparent amount of tilt of the IOL (𝚹𝚹') is equal to the angle between the patient's 
line of sight and the aligned Purkinje images III and IV. This angle is formed by the examiner's 
finger, the patient's pupil, and the penlight.   In the example in Figure 6, the direction of tilt is 
from the examiner's finger toward the penlight, directly down, in the 90° meridian.  
 
Also, illustrated in Figure 6 is the examiner's view of the Purkinje images as projected onto the 
patient's pupil. Notice that images III and IV are superimposed on each other but do not 
coincide with image I.  This is a right eye, with the first Purkinje image being displaced nasally 
from the center of the pupil. Also, the first Purkinje image is displaced downward, because it 
always falls on the line connecting the light source with the center of curvature of the 
cornea.   With the patient's eye looking upward, therefore, the first Purkinje image (the corneal 
light reflex) is displaced downward with respect to the center of the pupil. 
 
The superimposition of Purkinje images III and IV marks the optical axis of the IOL as it passes 
through the entrance pupil of the eye. Because the desired center point for the IOL is the center 
of the entrance pupil, the amount of decentration and direction of decentration of the IOL are 
immediately apparent from this view. The IOL is decentered directly upward, approximately 
0.6 mm, in Figure 6. The decentration can be measured from this vantage point, if desired, by 
holding a ruler in the frontal plane of the patient's eye, perpendicular to the patient's line of 
sight as illustrated. 
 
If the IOL is not decentered at all, but simply tilted about its anterior vertex, the relationship 
of the apparent angle of tilt to the actual angle of tilt can be calculated.   For clinical purposes, 
it is sufficient to remember that the actual tilt of a centered IOL is 80% to 85% of the apparent 
tilt (𝚹𝚹').   Pure decentration of the IOL, without actual tilt, will produce a certain amount of 
apparent tilt, because the optical axis of the IOL will no longer be perpendicular to the cornea. 
By trigonometric ray tracing analysis, l mm of decentration produces 1.7° of apparent tilt, and 
2 mm of decentration produces 4.14° of apparent tilt. 
 
10.0 CHORD LENGTH µ AND KERATOMETRY 

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Chord length μ measurements will be recorded at the Pre-Operative Visit, Visit 4 and Visit 5 
using either IOL Master or LENSTAR. Chord length μ measurements will be regarded as an 
adequate surrogate for angle kappa measurements. 41,42    
 
Keratometry values at the Pre-Operative Visit which are required for eligibility and IOL 
power calculations, as well as keratometry values at Post-Operative Visits 3, 4 and 5, may be 
obtained from automated keratometry (e.g., IOL Master or LENSTAR) or simulated 
keratometry (e.g., topography, Scheimpflug photography or optical coherence tomography).  
Note that the steep and flat axes which are reported should be orthogonal.  The same method 
should be used for a specific subject/eye throughout the study.    
 
11.0 DEFOCUS CURVES 
Subjects will be identified based on photopic pupil size to have defocus testing performed.  
Approximately 10 subjects from each lens group at each of three photopic pupil sizes (small - 
<3.0mm; medium - ≥3.0mm and ≤4.0 mm; large - >4.0 mm) will be evaluated.  If 10 subjects 
are not available in any one pupil size category, the maximum number available will be used.    
Data will be stratified by photopic pupil size (small - <3.0mm; medium - ≥3.0mm and ≤4.0 
mm; and large - >4.0 mm) and axial length (short - <21.0 mm; medium - 21.0 to 26.0 mm; and 
long - >26.0 mm). 
 
Binocular defocus testing will be performed under photopic lighting conditions using the 
Clinical Trial Suite (M&S Technologies) at Visit 4 (120-180 days after second eye IOL 
implantation). Each subject will be defocused with spherical minus trial lenses from their best 
distance-corrected (Unadjusted) manifest refraction between +1.50 D and -3.50 D in 0.5 D 
increments, except in the range of +0.50 D through -0.50 D, which will be in 0.25 D 
increments.   
 
12.0 CONTRAST SENSITIVITY 
At least approximately 136 Best Case Group 1 subjects and 68 Best Case Group 2 subjects will 
be enrolled to have contrast sensitivity testing performed.  Binocular best-corrected distance 
contrast sensitivity testing will be performed using the M&S Clinical Trial Suite at all sites, 
using the Unadjusted Manifest Refraction. The CTS is calibrated for distance-to-subject and 
pixels-per-inch so that optotypes follow ANSI and ISO standards. 
Sine-wave gratings will be produced on a high-resolution monitor. Outer edges of the grating 
will incorporate the Gabor effect, and all edges will be surrounded by a uniform field equal to 
the grating in space-averaged luminance.  Subjects will practice the contrast sensitivity test 
once at all orientations, each at a different spatial frequency, under photopic conditions before 
beginning tests for recorded data. 
Subjects undergoing contrast sensitivity testing will be dark adapted for at least 10 minutes 
before beginning testing to collect recorded data.  Mesopic contrast sensitivity testing will be 
performed before photopic contrast sensitivity testing.  Mesopic (2.5 to 3.2 cd/m2) contrast 
sensitivity with and without glare will be tested at spatial frequencies of 1.5, 3, 6 and 12 cycles 
per degree (cpd) and photopic (approximately 85 cd/m2) contrast sensitivity with glare will be 

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tested at spatial frequencies of 3, 6, 12, and 18 cpd.  Contrast sensitivity will be assessed twice 
for each subject at each test condition. 
 
 
13.0 SUBJECT QUESTIONNAIRES 
The concepts to be explored in this study with the QoV and NAVQ subject questionnaires 
(each developed using patients requiring refractive correction, including cataract surgery 
patients) are directly related to the original concepts for which the questionnaires were 
developed. Results of the QoV questionnaire will find use as a secondary safety endpoint to 
assess subject visual disturbances (see Section 13.5.5.3).  The NAVQ is being studied as an 
exploratory subject survey to assess the similarity of subject-perceived near vision functional 
task limitations and uncorrected near visual acuity (UCNVA) for subjects in both treatment 
groups, without comparison between treatment groups or seeking correlations.  
 
The QoV Questionnaire 
The QoV questionnaire 23,24 will be used to provide a standardized measure of subjective 
vision symptom and will allow for subjective evaluation of visual disturbances for the IOLs 
of each treatment group. The QoV questionnaire is specifically a non-comprehensive 
collection of visual dysphotopsias evaluated by frequency, intensity, and bothersomeness that 
may occur within a patient group.  Items in the QoV questionnaire were developed through 
extensive literature review, discussion with subject matter experts in refractive correction, 
iterative focus groups with non-experts, cognitive interviews and evaluation with 900 
subjects (150 subjects who were spectacle wearers, 150 contact lens wearers, 300 LASIK or 
LASEK or photorefractive keratectomy patients, 150 pre-operative cataract patients, and 150 
cataract surgery patients who received monofocal, multifocal, or accommodative IOLs). 
Reliability of the QoV questionnaire was obtained through Rasch analysis of person and item 
separation statistics for instrument precision, questionnaire fit statistics, correlation with 
clinical findings (visual acuity, contrast sensitivity, and visual aberrations), and test-retest 
reliability. 23    
 
The NAVQ Questionnaire 
The NAVQ25-28 will be used as an exploratory measure of difficulties completing tasks 
requiring uncorrected near vision. Its use in this study is not intended to support labeling 
claims for the enVista MX60EF IOL and is only exploratory in nature. The NAVQ use in 
this study was halted upon acceptance of version 5.0  of the #945 protocol (see footnote in 
synopsis).   
 
13.1  Subject Questionnaire Instructions 
 
Questionnaires should be completed independently by subjects in a private space at the 
beginning of each applicable visit, prior to other study assessments being performed. 
 

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1. The QoV questionnaire 23, 24 has two main elements:  
• Ten questions, each asked for frequency, intensity, and bothersomeness of the queried 
symptom and each graded on a 4-point grading scale. 
• Seven photographs which relate to the first 7 questions.  
 
Each photograph page will be printed in color and displayed on photographic paper. The 
questionnaire is Rasch-scaled based on data derived from the original validation study. The 
questionnaire is scored across three subscales with scores ranging from 0 to 100, with 
higher scores indicating worse quality of vision. Subjects will not be provided with any 
specific instructions other than to read the written instructions that are displayed at the top 
of the answer page.  No clinical staff are to help in answering the questions or respond to 
queries from subjects other than to ask subjects to answer as best they can.  The QoV 
questionnaire instructions for subjects will state: 
• Look at the pictures on the accompanying page that relate to the first 7 symptoms and 
familiarize yourself with the meaning of each symptom. 
• Now answer the questions below about your eyesight in your everyday life. 
• If you have had surgery, please respond based on how you are now, not prior to surgery. 
• Please respond based on how you feel in the past week. 
• Please circle your answer. 
2. The NAVQ  25, 26 has 10 questions, each scored on a 5-point grading scale, and a general 
vision satisfaction question.  The NAVQ questions were developed through literature 
reviews, 27 focus groups including 10 presbyopic patients, 27 refinement of the questions, 
26, 27 and test-retest reliability with 150 patients requiring vision correction, including 80 
patients receiving monofocal or multifocal IOLs. 26 Rasch analysis of the responses 
reduced the NAVQ to a 10-question data set and confirmed a 5-point grading scale was not 
different from the original 6-point NAVQ grading scale; 28 the 5-point grading scale is 
therefore being used in the present study. 
 
Verbal instructions to subjects on how to complete the NAVQ will include the following: 
 
• The questionnaire assesses how you feel about your current vision without additional 
near correction such as spectacles and how it allows you to function with near and 
intermediate tasks. 
• Please read the questions carefully and answer them as you feel is appropriate for how 
you feel – there are no right or wrong answers. If you feel a particular question in not 
applicable to your situation, please respond with the NA option, but otherwise answer 
all questions. 
• Let the coordinator know when you have finished or have any questions. 
• Please answer ALL questions for the situation IF/WHEN YOU DO THE DESCRIBED 
ACTIVITY WITHOUT EXTRA READING SPECTACLES. 
• Circle the relevant option. 

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• If you do not do the described activity or you have stopped for reasons that are not 
related to your vision then please circle the ‘N/A’ option. 
Written NAVQ questionnaire instructions will be displayed at the top of the first answer 
page and will restate:  
 
• Please answer ALL questions for the situation IF/WHEN YOU DO THE DESCRIBED 
ACTIVITY WITHOUT EXTRA READING SPECTACLES. 
• Circle the relevant option. 
• If you do not do the described activity or you have stopped for reasons that are not 
related to your vision, then please circle the ‘N/A’ option. 
 
 

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Appendix C  SURGICAL PROCEDURE 
All cataract surgical procedures will be performed by a qualified Investigator, using a 
phacoemulsification system adjusted according to the surgeon's usual settings (power 
modulation should be used).  All pre-operative, operative, and post-operative procedures 
performed during the COVID-19 pandemic will be conducted in accordance with medical 
guidance to reduce risk of COVID-19 transmission between study staff and subjects (available 
at www.aao.org/covid-19).  It is recommended Investigators periodically revisit the 
aao.org/covid-19 website to identify and implement any updated recommendations made by 
AAO.  Local, state, and federal public health guidance also will be followed, and it is 
recommended these guidances also be visited once a month to see if they have changed. 
Surgery to implant the study IOLs will be performed on Day 0 of the study for the first eye and 
Day 7 to 30 for the second eye, using standard microsurgical techniques. Surgery will be 
performed under either local or topical with or without intracameral ophthalmic anesthesia. A 
viscoelastic (Amvisc® Plus) should be used for the procedure. If the investigator determines 
that a supplemental ophthalmic viscoelastic device (OVD) is necessary, based on individual 
subject conditions or surgical circumstances, the use of a commercially available dispersive 
OVD will be permitted.  In such cases, the investigator should document the reason for use of 
a supplemental OVD in the source document.  
  
The study lens should not be implanted if there is zonular rupture or if the anterior or posterior 
capsule has been compromised, or if any complication occurs, which, in the judgment of the 
Investigator, may cause untoward effects.  
The surgical procedure will be performed as follows: 
1. The eye will be prepared for surgery and draped according to the surgeon’s standard 
procedure. 
2. Phacoemulsification and any routine adjunctive procedures will be performed according to 
the Investigator’s usual standard of care. 
3. A clear corneal or limbal incision of approximately 2.4 mm for a wound-assisted technique 
or 2.8 mm for direct in-the-bag placement will be made using the surgeon's standard 
instrumentation and technique.  
4. The anterior chamber will be entered through the incision opening and Amvisc® Plus will 
be used to fill the anterior chamber. If the investigator determines that a supplemental OVD 
is necessary, based on individual subject conditions or surgical circumstances, the use of a 
commercially available dispersive OVD will be permitted.  In such cases, the investigator 
should document the reason for use of a supplemental OVD in the source document. 
5. The cataract will be extracted by phacoemulsification. 
NOTE: The study lens should not be implanted if any of the following intraoperative 
complications occur: 
• Capsulorhexis tear, iris damage, posterior capsular rupture, vitreous prolapse, or 
zonular weakness or dehiscence 
• Zonular rupture 
• Evident zonular weakness or dehiscence 

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• Posterior capsule rupture 
• Vitreous loss 
• Significant detachment of Descemet’s membrane 
• Wound burn or damage 
• Anterior chamber bleeding 
• Iris incarceration or damage 
• Corneal endothelial touch 
• Unsuccessful/incomplete phacoemulsification 
• Posterior capsule plaque 
• Optic and/or haptic damage/amputation  
6. The study IOL will be removed from the vial and rinsed with sterile saline in accordance 
with the IOL instructions for use. The IOL is introduced into the eye using the BLIS IOL 
Injector according to inserter package insert and placed into the capsular bag.  To ensure 
the subject remains masked to the lens type assigned, the Investigator and any unmasked 
surgical personnel must not verbally or visually disclose the lens type assigned. 
7. Residual viscoelastic should be aspirated from the eye using the surgeon's preferred 
removal technique. Care should be taken during irrigation/aspiration to ensure a thorough 
removal of the viscoelastic material from both the anterior and posterior surfaces of the 
lens. It is recommended that the irrigation/aspiration handpiece be positioned behind the 
posterior surface of the IOL to ensure complete viscoelastic removal.  
8. Incision closure will be left to the discretion of the Investigator.  As a routine, no suture 
should be required.  However, depending on the needs of the case, the cornea may be 
sutured at the Investigator’s discretion.  
9. Following completion of the surgery, topical steroid, antibiotic and anti-inflammatory 
medications may be applied to the eye, followed by a patch or shield, per the Investigator’s 
standard post-operative regimen.  Additional ophthalmic medications as deemed necessary 
may be administered at the Investigator’s discretion. 
 
IOL Explantation 
The indication of IOL explantation will be made at the discretion of the Investigator if he/she 
judges it appropriate and beneficial for the safety and welfare of the subject.   
 
 
 

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Appendix D  SUBJECT QUESTIONNAIRES 
1.  Quality of Vision (QoV) Questionnaire – the questionnaire provided to 
subjects is shown below  
  
 
 
 

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Appendix E  MX60E DIRECTIONS FOR USE 
 
 
 
 

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