Clinical Investigation of the TECNIS Next-Generation Intraocular Lens
Phase: NA
Conditions: Cataract
Sponsor: Abbott Medical Optics

 
 
Study Protocol 
 
 
CLINICAL INVESTIGATION OF THE TECNIS® 
NEXT-GENERATION INTRAOCULAR LENSES  
 
 
 
NCT Number: NCT03372434 
Document date: 14 Dec 2017 
 
 
 
 
 
 

JOHNSON & JOHNSON VISION                                                                                                            CONFIDENTIAL 
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CONFIDENTIAL 
The following contains confidential, proprietary information  
that is the property of Johnson & Johnson Vision 
Clinical Investigation of the  
TECNIS® Next-Generation Intraocular Lenses 
 
PROTOCOL NUMBER:  SUR-CAT-652-1001 
 
SPONSOR:  Abbott Medical Optics Inc./Johnson & Johnson Vision 
1700 E. St. Andrew Place 
Santa Ana, CA 92705 
714-247-8200 
 
Investigator Agreement 
 
As an Investigator, I agree to: 
• Implement and conduct this study diligently and in strict compliance with this 
agreement; the protocol; Good Clinical Practices; 21CFR812, ISO 14155:2011 
and all other applicable FDA regulations; conditions of approval imposed by the 
reviewing Institutional Review Board (IRB), FDA or other regulatory authorities; 
and all other applicable laws and regulations. 
• Supervise all testing of the device where human subjects are involved. 
• Ensure that the requirements for obtaining informed consent are met. 
• Obtain authorization for use/disclosure of health information (e.g., HIPAA 
authorization or equivalent). 
• Maintain all information supplied by Johnson & Johnson Vision in confidence 
and, when this information is submitted to an independent IRB or any other 
group, it will be submitted with a designation that the material is confidential. 
 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
   
   
 
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Date 
 
 
   
   
 
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Signature 
Date 
 
 
   
   
 
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JOHNSON & JOHNSON VISION                                                                                                            CONFIDENTIAL 
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TABLE OF CONTENTS 
TITLE 
PAGE 
Table of Contents 
.......................................................................................................... 
ii 
Personnel and Facilities............................................................................................... 
iv 
1. 
Synopsis 
............................................................................................................. 1 
2. 
Background/Introduction .................................................................................. 5 
3. 
Clinical Hypothesis 
............................................................................................ 6 
4. 
Study Design 
...................................................................................................... 6 
5. 
Acronyms 
........................................................................................................... 6 
6. 
Study Objectives and Endpoints ...................................................................... 7 
6.1 Primary Effectiveness Endpoints ....................................................................... 7 
6.2 Primary Safety Endpoints .................................................................................. 7 
6.3 Other Endpoints 
................................................................................................. 7 
7. 
Study Products .................................................................................................. 8 
7.1 Intraocular Lenses 
............................................................................................. 8 
7.2 IOL Implantation Systems 
................................................................................ 
14 
8. 
Study Population ............................................................................................. 
14 
8.1 Inclusion Criteria 
.............................................................................................. 
14 
8.2 Exclusion Criteria 
............................................................................................. 
15 
9. 
Investigator Selection 
...................................................................................... 
16 
9.1 Investigator Qualifications 
................................................................................ 
16 
9.2 Investigator Obligations 
................................................................................... 
16 
9.3 Investigator Approval 
....................................................................................... 
17 
10. 
Experimental Plan 
............................................................................................ 
18 
10.1 Overview ......................................................................................................... 
18 
10.2 Visit Schedule 
.................................................................................................. 
19 
10.3 Preoperative Procedures 
................................................................................. 
20 
10.4 Randomization and Masking 
............................................................................ 
22 
10.5 Study Lens Supply 
........................................................................................... 
23 
10.6 Operative Procedures 
...................................................................................... 
23 
10.7 Postoperative Procedures ............................................................................... 
25 
10.8 Exit of Subjects 
................................................................................................ 
31 
10.9 Unscheduled Visits 
.......................................................................................... 
32 
10.10 Protocol Deviations 
.......................................................................................... 
33 
11. 
Adverse Events and Product Complaints 
...................................................... 
33 
11.1 Adverse Event Definitions 
................................................................................ 
33 
11.2 Product Complaint/Device Deficiency Definition .............................................. 
35 
11.3 Adverse Event and Complaint Reporting Requirements 
.................................. 
35 
11.4 Causal Relationship 
......................................................................................... 
36 
11.5 Adverse Event Follow-up 
................................................................................. 
37 
12. 
Protocol Changes/Amendments 
..................................................................... 
37 

JOHNSON & JOHNSON VISION                                                                                                            CONFIDENTIAL 
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13. 
Ethics Review and Patient Welfare 
................................................................. 
38 
13.1 Institutional Review Board (IRB) 
...................................................................... 
38 
13.2 Informed Consent 
............................................................................................ 
38 
14. 
Documentation 
................................................................................................. 
38 
14.1 Source Documents 
.......................................................................................... 
38 
14.2 Subject Confidentiality 
..................................................................................... 
39 
14.3 Case Report Form Completion ........................................................................ 
39 
14.4 Study Summary 
............................................................................................... 
40 
15. 
Monitoring 
........................................................................................................ 
40 
15.1 Data Monitoring 
............................................................................................... 
40 
15.2 Administrative Monitoring ................................................................................ 
40 
15.3 Safety Monitoring 
............................................................................................. 
42 
16. 
Publications ..................................................................................................... 
42 
17. 
Risk Analysis ................................................................................................... 
42 
18. 
Records Retention 
........................................................................................... 
43 
19. 
Termination of the Investigation 
..................................................................... 
44 
20. 
Statistical Methods .......................................................................................... 
44 
20.1 Analysis Population ......................................................................................... 
44 
20.2 Primary Study Endpoints ................................................................................. 
45 
20.3 Additional Endpoints 
........................................................................................ 
47 
20.4 Visual  Acuity conventions and General Statistics 
............................................ 
48 
20.5 Interim Reports 
................................................................................................ 
49 
20.6 Sample Size Calculations 
................................................................................ 
49 
Appendix A Summary of Procedures Required at Each Visit .................................. 
50 
Appendix B Equipment List 
........................................................................................ 
51 
Appendix C Maximum Plus Manifest Refraction Technique with 
Cylinder Refinement 
............................................................................. 
52 
Appendix D Refraction Adjustments 
.......................................................................... 
53 
Appendix E Instructions for Using the M&S System ................................................ 
54 
Appendix F Instructions for Distance Visual Acuity Testing 
.................................... 
56 
Appendix G Instructions for Intermediate Visual Acuity testing 
.............................. 
58 
Appendix H Instructions For Near Visual Acuity Testing 
......................................... 
59 
Appendix I Instructions for Depth of Focus Testing 
................................................. 
61 
Appendix J Instructions for Pupil Size Measurements 
............................................. 
62 
Appendix K Instructions for Contrast Sensitivity Testing 
........................................ 
63 
Appendix L Slit-Lamp Exam Ratings ......................................................................... 
65 
 
 
 

JOHNSON & JOHNSON VISION                                                                                                            CONFIDENTIAL 
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1. 
SYNOPSIS 
PROTOCOL: 
Clinical Investigation of the TECNIS® Next-Generation 
Intraocular Lenses  
Protocol Number:  SUR-CAT-652-1001 
STUDY TREATMENTS: 
Investigational Lens 1:  
• TECNIS® Next-Generation IOL, Model ZFR00 
Investigational Lens 2:  
• TECNIS® Next-Generation IOL, Model ZYR00  
Control Lens:  
• TECNIS® Multifocal IOL, Model ZLB00 (Johnson & 
Johnson Vision, Santa Ana, CA), commercially 
available 
STUDY OBJECTIVE: 
The purpose of this clinical trial is to evaluate the safety 
and effectiveness of the next-generation TECNIS® IOLs. 
CLINICAL HYPOTHESIS: The next generation of TECNIS IOLs, Models ZFR00 and 
ZYR00, will provide improved intermediate (at 66 cm) 
visual acuity compared to the TECNIS Multifocal Model 
ZLB00 control IOL.   
Complication and adverse event rates associated with the 
next generation IOLs will be within the rates for posterior 
chamber IOLs given in ISO 11979-7:2006/ Amd 1:2012(E). 
OVERALL STUDY DESIGN: 
Structure: 
Prospective, multicenter, randomized, bilateral 
subject/evaluator-masked clinical trial 
Number of sites: 
Up to 14 sites in the United States 
Duration: 
6 months 
Administration: 
Surgeons will perform routine, small-incision, cataract 
surgery and implant the study lenses using a 
sponsor-recommended implantation system. The target 
for refractive outcomes will be emmetropia for both eyes. 

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Visit Schedule: 
Subjects will be bilaterally implanted with the same lens 
type; the second eye is to be implanted within 1 month of 
the first-eye surgery. 
 
All subjects will undergo a minimum of 9 visits:  
Preoperative for both eyes; Operative, 1-day and 1-week 
visits for each eye; and 1-month and 6-month visits for 
both eyes together. 
STUDY POPULATION CHARACTERISTICS: 
Condition: 
Bilateral cataracts with otherwise healthy eyes 
Number of Subjects: 
Up to 260 subjects will be enrolled to achieve 
approximately 220 randomized and bilaterally-implanted 
subjects, resulting in approximately 195 evaluable subjects 
(65 in each test group and 65 in the control group) at 1 and 
6 months. 
Each site should enroll approximately 15 subjects, and no 
site may enroll more than 25% of the enrollment total.  
 
Inclusion Criteria (all criteria apply to each study eye): 
• Minimum 22 years of age 
• Bilateral cataracts for which posterior chamber IOL implantation has been planned  
• Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or 
worse with a glare source or 20/40 Snellen or worse without a glare source  
• Potential for postoperative BCDVA of 20/30 Snellen or better 
• Corneal astigmatism: 
o Normal corneal topography 
o Preoperative corneal astigmatism of 1.00 D or less in both eyes 
• Clear intraocular media other than cataract in each eye 
• Availability, willingness and sufficient cognitive awareness to comply with 
examination procedures 
• Signed informed consent and HIPAA authorization or equivalent documentation 
necessary to comply with applicable privacy laws pertaining to medical treatment in 
the governing countries 
• Ability to understand and respond to a questionnaire in English  
 
Exclusion Criteria (all criteria apply to each study eye): 
• Requiring an intraocular lens power outside the available range of +14.0 D  
to +26.0 D 
• Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or 
abnormally-shaped pupils)  

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• Irregular corneal astigmatism 
• Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, 
nystagmus, etc.) 
• Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery. 
Note: Prophylactic peripheral iridotomies and peripheral laser retinal repairs that, in 
the opinion of the investigator will not confound study outcome or increase risk to the 
subject, are acceptable.  
• Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are 
predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the 
study 
• Inability to achieve keratometric stability for contact lens wearers (per procedure 
outlined in Section 10.3) 
• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect 
visual outcomes or increase risk to the subject 
• Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration 
or other retinal disorders) that are predicted to cause visual acuity losses to a level 
worse than 20/30 Snellen during the study 
• Subjects with conditions associated with increased risk of zonular rupture, including 
capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as 
pseudoexfoliation, trauma, or posterior capsule defects 
• Use of systemic or ocular medications that may affect vision 
• Prior, current, or anticipated use during the course of the 6-month study of 
tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of 
the investigator, confound the outcome or increase the risk to the subject (e.g., poor 
dilation or a lack of adequate iris structure to perform standard cataract surgery) 
• Poorly-controlled diabetes 
• Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the 
opinion of the investigator, would increase the operative risk or confound the 
outcome(s) of the study (e.g., immunocompromised, connective tissue disease, 
suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular 
inflammation, etc.).  Note: controlled ocular hypertension without glaucomatous 
changes (optic nerve cupping and visual field loss) is acceptable. 
• Known ocular disease or pathology that, in the opinion of the investigator,  
o may affect visual acuity 
o may require surgical intervention during the course of the study (macular 
degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled 
glaucoma, etc.) 
o may be expected to require retinal laser treatment or other surgical intervention 
during the course of the study (macular degeneration, cystoid macular edema, 
diabetic retinopathy, etc.) 
• Patient is pregnant, plans to become pregnant, is lactating or has another condition 
associated with the fluctuation of hormones that could lead to refractive changes 
• Concurrent participation or participation within 60 days prior to preoperative visit in 
any other clinical trial 
• Desire for monovision correction 

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EVALUATION CRITERIA: 
The purpose of this clinical study is to evaluate the safety and effectiveness of the 
next-generation TECNIS IOLs.  The primary effectiveness endpoint is mean monocular 
distance corrected intermediate visual acuity under photopic conditions at 66 cm.  Other 
effectiveness endpoints include mean monocular and binocular diopters of defocus, 
monocular and binocular uncorrected and best corrected distance, uncorrected 
intermediate, uncorrected near and distance corrected near, monocular and binocular 
10% low-contrast distance corrected visual acuities, and questionnaire responses.   
The primary safety endpoint is adverse event rates versus ISO 11979-7:2006/ 
Amd.1:2012(E) Safety and Performance Endpoint (SPE) rates. Additional safety 
endpoints include the proportion of first-implanted eyes achieving 20/40 or better 
monocular photopic best corrected distance visual acuity vs. the ISO SPE rate, 
optical/visual symptoms, medical/lens findings, binocular best corrected distance 
contrast sensitivity and visual symptoms via PRO instrument.  
DATA ANALYSIS: 
The investigational TECNIS Model ZFR00 and Model ZYR00 IOLs will each be 
compared separately to the TECNIS Multifocal Model ZLB00 control IOL.  For the 
primary effectiveness endpoints of monocular distance corrected intermediate visual 
acuity, comparisons between the Model ZFR00 group vs. the Model ZLB00 control 
group, and comparisons between the Model ZYR00 group vs. the Model ZLB00 control 
group, will be performed using one-sided, two-sample t-tests with an alpha of 0.025.  For 
the primary safety endpoints, adverse event rates, the adverse event rate of the Model 
ZFR00 IOL will be compared to the ISO grid value using one-sided exact tests with an 
alpha of 0.05 and the adverse event rate of the Model ZYR00 IOL will be compared to 
the ISO grid value using one-sided exact tests with an alpha of 0.05.  
The safety population with available data will be used for all analyses.  The key study 
timeframe for all endpoints will be the 1-month postoperative visit, although data will be 
reviewed at other time points as well.  Descriptive statistics including means, standard 
deviations, minimum and maximum values will be reported for visual acuity, refractive 
data and contrast sensitivity.  The frequency and proportion will be reported for subjects 
with adverse events, medical findings, lens findings, ocular visual symptoms and 
questionnaires data. 
STUDY VISITS AND PROCEDURES: 
Inclusion and exclusion qualifications will be assessed at the preoperative visit according 
to the inclusion/exclusion criteria.  The Informed Consent Form and Authorization for 
Use/Disclosure of Health Information form (HIPAA authorization) must be signed by any 
patients who agree to participate in the study prior to undergoing any study-specific 

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procedures.  Those subjects who meet the inclusion/exclusion criteria and agree to 
participate will be randomized to receive lenses from the same lens group in both eyes, 
either Model ZFR00, Model ZYR00 or control, Model ZLB00.  The eye implanted first will 
be considered the primary study eye.  All subjects are intended to have bilateral cataract 
surgery with the second-eye surgery occurring after the 1-week exam for the first eye but 
no more than 30 days after the first-eye surgery.  Subjects and study personnel 
performing the postoperative vision testing and refractions will be masked for the 
duration of the study. 
Key preoperative data include ocular health and history, visual acuities, manifest 
refraction, keratometry, topography, biomicroscopic slit-lamp findings, ocular symptoms 
and biometry.  The operative visit will include standard procedures for cataract surgery 
and IOL implantation.  Key postoperative data collection includes monocular and 
binocular uncorrected and distance corrected visual acuities, contrast sensitivity, 
defocus curve, slit-lamp findings, non-directed visual symptoms, questionnaires and 
adverse events.   
2. 
BACKGROUND/INTRODUCTION 
Presbyopia, defined as the age-related loss of accommodative amplitude, affects 
essentially all human beings beyond the age of 45 and impacts the ability of the eye to 
focus at near distances
1,2.  Current intraocular lens options for cataract patients who 
desire improved vision across a range of distances include a choice of monovision or 
multifocality.  Patients implanted with standard monofocal lenses often need spectacles 
for reading or performing other near tasks, even if a monovision option is selected.  
Patients implanted with multifocal lenses, while being able to read and perform other 
near tasks without spectacles, sometimes experience dysphotopsias (e.g., halos), 
particularly at night, and may have limited intermediate ability (e.g., may need spectacles 
to work on a computer).  Some accommodating lenses are also available on the market, 
although their effect depends upon fit within the capsular bag or capsular bag elasticity.  
On July 15, 2016, another option was made available to cataract patients when the 
TECNIS Symfony Extended Range of Vision IOL, Model ZXR00, became commercially 
available in the United States.  Utilizing a diffractive technology to elongate the depth of 
focus, the Symfony IOLs provide cataract patients with good distance vision, and 
improved intermediate and near vision compared to standard monofocal IOLs.   
The investigational IOL devices in this protocol, Models ZFR00 and ZYR00, are 
enhanced versions of the commercially-available Symfony and Multifocal IOLs.  The 
diffractive technology on the posterior optic surface of the TECNIS Symfony IOL was 
modified for both investigational IOLs, with the goal of providing improved intermediate 
vision as compared to the Multifocal Model ZLB00 control IOL.  

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3. 
CLINICAL HYPOTHESIS 
This study will demonstrate that the TECNIS Model ZFR00 and Model ZYR00 IOLs will 
provide improved intermediate (at 66 cm) visual acuity compared to the TECNIS 
Multifocal Model ZLB00 control IOL.  Complication and adverse event rates associated 
with the next generation IOLs will be within the rates for posterior chamber IOLs given in 
ISO 11979-7:2006/ Amd 1:2012(E). 
4. 
STUDY DESIGN 
This study is a 6-month, prospective, multicenter, subject/evaluator-masked, bilateral, 
randomized clinical investigation of the TECNIS Next-Generation Model ZFR00 and 
Model ZYR00 IOLs versus the TECNIS Multifocal Model ZLB00 control IOL.   
The study will be conducted at up to 14 sites in the U.S.A and will enroll up to 
260 subjects to achieve approximately 220 randomized and bilaterally-implanted 
subjects, resulting in approximately 195 evaluable subjects (65 in each test group and 
65 in the control group) at 1 and 6 months.  Subjects are to be implanted with the same 
IOL in both eyes, the ZFR00 IOL, the ZYR00 IOL or the ZLB00 control IOL.  The eye 
implanted first will be considered the primary study eye. 
JUSTIFICATION OF STUDY DESIGN 
This study is being conducted to capture preliminary safety and effectiveness 
information on two design candidates, with the goal of selecting a final lens design.  The 
prospective, multicenter, subject/evaluator-masked, bilateral, randomized study design 
was chosen to optimize comparison of visual outcomes between the Models ZFR00 and 
ZYR00 investigational IOLs and the Model ZLB00 control IOL, while minimizing the 
number of subjects by utilizing the same control group for statistical comparisons. 
5. 
ACRONYMS 
The following acronyms are used throughout the document:   
• UCDVA:  uncorrected distance visual acuity 
• BCDVA:  best corrected distance visual acuity 
• UCIVA:  uncorrected intermediate visual acuity 
• DCIVA:  distance corrected intermediate visual acuity 
• UCNVA:  uncorrected near visual acuity 
• DCNVA:  distance corrected near visual acuity 
• D: diopters 

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6. 
STUDY OBJECTIVES AND ENDPOINTS 
The purpose of this study is to evaluate the safety and effectiveness of the next-
generation TECNIS Model ZFR00 and Model ZYR00 IOLs.  The key study timeframe for 
all endpoints will be the 1-month postoperative visit, although data will be reviewed at 
other time points as well. 
6.1 
PRIMARY EFFECTIVENESS ENDPOINTS 
FOR MODEL ZFR00:  MONOCULAR, PHOTOPIC DCIVA AT 66 CM  
Success criteria:  Statistically significant improvement in mean distance corrected 
intermediate visual acuity for the investigational Model ZFR00 eyes vs. control 
eyes.   
FOR MODEL ZYR00:  MONOCULAR, PHOTOPIC DCIVA AT 66 CM  
Success criteria:  Statistically significant improvement in mean distance corrected 
intermediate visual acuity for the investigational Model ZYR00 eyes vs. control 
eyes.   
6.2  
PRIMARY SAFETY ENDPOINTS  
For Model ZFR00: Rates of adverse events vs. ISO SPE rates 
For Model ZYR00: Rates of adverse events vs. ISO SPE rates 
6.3 
OTHER ENDPOINTS 
• Monocular and binocular, best corrected distance depth of focus  
• Monocular BCDVA percent 20/40 or better vs. ISO SPE rate 
• Binocular UCDVA, BCDVA, UCIVA, DCIVA, UCNVA and DCNVA 
• Monocular UCDVA, UCIVA, UCNVA and DCNVA 
• Monocular and binocular low-contrast BCDVA (10%) 
• Monocular and binocular best corrected distance contrast sensitivity vs 
control (mesopic with and without glare at 1.5, 3, 6, and 12 cpd, photopic 
without glare at 3, 6, 12, and 18 cpd)  
• Visual symptoms via PRO instrument  
• Ocular/visual symptoms (non-directed responses as obtained from the open-
ended question “Are you having any difficulties with your eyes or vision?”) 
• Subject spectacle independence and satisfaction questionnaire responses 
• Medical findings/complications 
• Lens findings/complications 
 

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7. 
STUDY PRODUCTS 
7.1 
INTRAOCULAR LENSES  
The three lens models used in this study include the investigational TECNIS Next-
Generation IOLs, Model ZFR00 and ZYR00, and the TECNIS Multifocal Model ZLB00 
control IOL.  The investigational IOLs are modifications of the Symfony and Multifocal 
IOLs, single-piece, SENSAR acrylic IOLs with a modified prolate (aspheric) design on 
the anterior optic surface to reduce spherical aberration and a diffractive posterior optic 
design.   
Investigational TECNIS Next-Generation IOLs, Models ZFR00 and ZYR00 
The TECNIS Next-Generation IOLs, Models ZFR00 and ZYR00, are posterior chamber, 
1-piece, aspheric, diffractive, acrylic, foldable IOLs designed for placement in the 
capsular bag (Figures 1 and 2).  The lenses are made of the same hydrophobic 
SENSAR acrylic material as the material/mechanical 1-piece parent, the JJV SENSAR 1 
Piece IOL, Model AAB00, and one of the optical parents, the TECNIS Symfony IOL, 
Model ZXR00 (Figure 3).  The lenses have the same overall geometry/dimensions  
(13 mm overall length and 6 mm optic diameter) as the material/mechanical 1-piece 
parent IOL, the JJV SENSAR IOL, Model AAB00,  and both optical parents, the TECNIS 
Symfony IOL, Model ZXR00, and the TECNIS Multifocal IOL, Model ZM900.  The 
investigational lenses also have the same TECNIS modified prolate (aspheric) design on 
the anterior optic surface as the optical parents, the Symfony and Multifocal IOLs, to 
reduce spherical aberration.   
The Model ZLB00 control IOL (Figure 5) is derived from the same predecessor lenses 
as those for the subject devices.  Model ZLB00 shares the same lens material, general 
dimensions, lens geometry, and one-piece soft acrylic lens platform as the SENSAR 1-
Piece IOL, Model AAB00, which is the material/mechanical parent of the subject 
devices.   Model ZLB00 also incorporates the same aspheric anterior optic feature and 
similar diffractive profile on its posterior optic as the TECNIS Multifocal IOL, Model 
ZM900, and the TECNIS Symfony IOL, Model ZXR00, which are both optical parents of 
the subject devices.   Therefore, the ZLB00 control IOL can be considered a multifocal 
analog of the subject devices.   
The posterior optic designs of the investigational lenses have been modified compared 
to the optical parent IOLs.  The Model ZFR00 has a diffractive profile consisting of 14 
concentric rings compared to the 9 concentric rings (10 zones) of the parent Symfony 
IOL and 32 concentric rings of the parent Multifocal IOL, Model ZM900 (Figure 4).  The 
Model ZYR00 has a diffractive profile consisting of 22 concentric rings.  The 
modifications to the posterior diffractive optics of both investigational IOLs are designed 

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to further extend the depth of focus compared to the Symfony IOL and provide improved 
intermediate visual acuity compared to the TECNIS Multifocal IOL. 
Figure 1:  Drawing and Photograph of a TECNIS Model ZFR00 IOL 
        
 
 
Figure 2:  Drawing and Photograph of a TECNIS Model ZYR00 IOL 
           
 
 
Figure 3:  Drawing and Photograph of a TECNIS Symfony IOL 
        
 

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Figure 4:  Drawing and Photograph of a TECNIS Multifocal IOL, Model ZM900 
 
 
Figure 5:  Drawing and Photograph of a TECNIS Multifocal IOL, Model ZLB00 
 
 
Like all of JJV’s 1-piece soft acrylic IOLs, Models ZFR00, ZYR00, Model ZXR00, and the 
Model ZLB00 control, have a surface treatment of Polyethylene Glycol (PEG) to reduce 
tackiness of the lens surface and include a ProTEC 360° barrier edge, the stability of 
Tri-Fix 3-point design, and a frosted-edge treatment.  
INDICATIONS FOR INVESTIGATIONAL IOLS 
The Model ZFR00 is currently indicated for primary implantation for the visual correction 
of aphakia, in adult patients with less than 1 diopter of preexisting corneal astigmatism, 
in whom a cataractous lens has been removed.  The lens mitigates the effects of 
presbyopia; compared to a standard multifocal IOL, the lens is intended to provide 
improved intermediate visual acuity, while maintaining comparable near and distance 
visual acuity.  The Model ZFR00 IOL is intended for placement in the capsular bag only. 
The Model ZYR00 is currently indicated for primary implantation for the visual correction 
of aphakia, in adult patients with less than 1 diopter of preexisting corneal astigmatism, 

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in whom a cataractous lens has been removed.  The lens mitigates the effects of 
presbyopia; compared to a standard multifocal IOL, the lens is intended to provide 
improved intermediate visual acuity, while maintaining comparable near and distance 
visual acuity.  The Model ZYR00 IOL is intended for placement in the capsular bag  only. 
INDICATIONS FOR CONTROL IOL 
The TECNIS Multifocal IOL, Model ZLB00, is indicated for primary implantation for the 
visual correction of aphakia, in adult patients with or without presbyopia in whom a 
cataractous lens has been removed by phacoemulsification and who desire near, 
intermediate, and distance vision with increased spectacle independence.  The Model 
ZLB00 IOL is intended for capsular bag placement only. 
STORAGE AND DISTRIBUTION 
Consignments of all three study lenses will be supplied to the sites.  All study lenses 
should be stored in the original packaging and kept in a dry place.  Lenses should not be 
stored in direct sunlight or at temperatures greater than 45° C (113°F).  Each lens is 
packaged in a lens tray and sealed in a peel-pouch.  The lens is sterile as long as the 
package has not been opened or damaged and the shelf-life expiration date has not 
been exceeded. The Principal Investigator is responsible for ensuring that the 
investigational lenses are used only for subjects enrolled in this study. 
COMPARISON CHART 
Table 1 describes the dimensional and optical similarities between the study lenses and 
other associated JJV lenses. 

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7.2 
IOL IMPLANTATION SYSTEMS  
The investigational TECNIS Models ZFR00 and ZYR00 and the control TECNIS Model 
ZLB00 lenses are to be implanted using the UNFOLDER Platinum 1 Series Implantation 
System (DK7796 handpiece with the UNFOLDER Platinum 1 Series cartridge, Model 
1MTEC30) or the ONE SERIES Ultra Implantation System (DK7786 or DK7791 
handpiece with the One Series Ultra cartridge, Model 1VIPR30). 
8. 
STUDY POPULATION 
All study subjects will be enrolled from the normal surgical cataract population at up to 
14 sites in the U.S.A.  Approximately 260 subjects will be enrolled (signed informed 
consent document) to achieve approximately 220 randomized and bilaterally-implanted 
subjects, resulting in approximately 195 evaluable subjects (65 in each test group and 
65 in the control group) at 1 and 6 months.  This allows a screen failure rate of 
approximately 15% and a drop-out rate of approximately 10% for implanted subjects.  
Each site should implant approximately 15 subjects, and no site may implant more than 
25% of the enrollment total.   
This study will include only subjects undergoing bilateral primary cataract extraction and 
IOL implantation and who meet all of the study inclusion and exclusion criteria in both 
eyes.  All subjects who meet the eligibility criteria will be offered enrollment in the study.  
Eligibility criteria may not be waived by the investigator.  Any questions regarding patient 
eligibility are to be discussed with JJV prior to subject enrollment.  Those subjects who 
meet the eligibility criteria and agree to participate will be randomized to receive lenses 
from the same lens group in both eyes, either Model ZFR00, Model ZYR00 or Model 
ZLB00 control.  Subjects will be enrolled at each site sequentially until the overall study 
recruitment goals are met or the site limit is reached.   
8.1 
INCLUSION CRITERIA  
Note: All criteria apply to each eye 
• Minimum 22 years of age 
• Bilateral cataracts for which posterior chamber IOL implantation has been planned  
• Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen with a 
glare source or 20/40 Snellen or worse without a glare source  
• Potential for postoperative BCDVA of 20/30 Snellen or better 
• Corneal astigmatism: 
o Normal corneal topography 
o Preoperative corneal astigmatism of 1.00 D or less in both eyes 
• Clear intraocular media other than cataract in each eye 
• Availability, willingness and sufficient cognitive awareness to comply with 
examination procedures 

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• Signed informed consent and HIPAA authorization or equivalent documentation 
necessary to comply with applicable privacy laws pertaining to medical treatment in 
the governing countries 
• Ability to understand and respond to a questionnaire in English  
8.2 
EXCLUSION CRITERIA  
Note: All criteria apply to each eye 
• Requiring an intraocular lens power outside the available range of +14.0 D  
to +26.0 D 
• Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or 
abnormally-shaped pupils)  
• Irregular corneal astigmatism 
• Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, 
nystagmus, etc.) 
• Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery. 
Note: Prophylactic peripheral iridotomies and peripheral laser retinal repairs that, in 
the opinion of the investigator will not confound study outcome or increase risk to the 
subject, are acceptable.  
• Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are 
predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the 
study 
• Inability to achieve keratometric stability for contact lens wearers (per procedure 
outlined in Section 10.3) 
• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect 
visual outcomes or increase risk to the subject 
• Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration 
or other retinal disorders) that are predicted to cause visual acuity losses to a level 
worse than 20/30 Snellen during the study 
• Subjects with conditions associated with increased risk of zonular rupture, including 
capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as 
pseudoexfoliation, trauma, or posterior capsule defects 
• Use of systemic or ocular medications that may affect vision 
• Prior, current, or anticipated use during the course of the 6-month study of 
tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of 
the investigator, confound the outcome or increase the risk to the subject (e.g., poor 
dilation or a lack of adequate iris structure to perform standard cataract surgery) 
• Poorly-controlled diabetes 
• Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the 
opinion of the investigator, would increase the operative risk or confound the 
outcome(s) of the study (e.g., immunocompromised, connective tissue disease, 
suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular 
inflammation, etc.).  Note: controlled ocular hypertension without glaucomatous 
changes (optic nerve cupping and visual field loss) is acceptable. 
• Known ocular disease or pathology that, in the opinion of the investigator,  
o may affect visual acuity 
o may require surgical intervention during the course of the study (macular 
degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled 
glaucoma, etc.) 

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o may be expected to require retinal laser treatment or other surgical intervention 
during the course of the study (macular degeneration, cystoid macular edema, 
diabetic retinopathy, etc.) 
• Patient is pregnant, plans to become pregnant, is lactating or has another condition 
associated with the fluctuation of hormones that could lead to refractive changes 
• Concurrent participation or participation within 60 days prior to preoperative visit in 
any other clinical trial 
• Desire for monovision correction 
9. 
INVESTIGATOR SELECTION 
9.1 
INVESTIGATOR QUALIFICATIONS 
JJV will select ophthalmic surgeons who have completed a residency in ophthalmology 
(or its documented equivalent) and are licensed to practice medicine and perform 
surgery at his/her investigative site. Each site will have one designated principal 
investigator; some sites may have additional implanting sub-investigators/surgeons.   
Investigators will be selected from surgeons who are experienced in small-incision, 
surgery and have implanted TECNIS Multifocal ZLB00 IOLs in cataract patients.  
Investigators should have established their personalized A-constant for the TECNIS 
Multifocal ZLB00 IOL.  All sites are required to have adequate staff support for reporting 
and subject follow-up, as well as the necessary instrumentation to conduct study testing. 
9.2 
INVESTIGATOR OBLIGATIONS 
Investigators are required to fulfill the following obligations: 
• Conduct the study in accordance with the relevant and current protocol.  Investigator 
will make changes to a protocol only after notifying and obtaining approval from JJV, 
the FDA and the Investigational Review Board (IRB), except when necessary to 
protect the safety, rights or welfare of subjects 
• Personally conduct and supervise the study 
• Maintain a list of appropriately qualified persons to whom the investigator has 
delegated significant trial-related duties 
• Be responsible for protecting the rights, safety and welfare of subjects under the 
investigator’s care and be responsible for the control and documentation of the 
devices under investigation 
• Inform patients that the device(s) are being used for investigational purposes and 
that requirements relating to obtaining informed consent and IRB approval are met 
according to 21CFR50, 21CFR56, 21CFR812 and all other applicable laws and 
regulations 
• Maintain confidentiality as required by HIPAA or similar laws and regulations 
• Shall not obtain written informed consent from any subject to participate or allow any 
subject to participate before obtaining FDA and IRB approval 

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• Document in each subject’s case history that informed consent was obtained prior to 
participation in the study as required by 21CFR812 
• Report to JJV and the reviewing IRB any adverse experiences that occur during the 
course of the study in accordance with applicable laws and regulations 
• Maintain adequate and accurate records in accordance with applicable laws and 
regulations and make available all study documents and subject medical records for 
inspection by either JJV, duly authorized regulatory agencies (e.g., FDA, PMDA, 
Health Canada, MOH, etc.) and/or the IRB 
• Submit progress reports on the investigation to JJV and the reviewing IRB at regular 
intervals, but no less often than yearly as required by 21CFR812.150  
• Ensure the IRB that is responsible for initial and continuing review of the study 
complies with applicable laws and regulations 
• Report all changes in research activity and all unanticipated problems involving risks 
to patients to the IRB and JJV 
• Supervise and permit investigational device use and disposition in accordance with 
applicable regulations and protocol requirements.  Upon completion of enrollment or 
termination of the study or the investigator’s part of the study, or at JJV’s request, 
return to JJV any remaining supply of the investigational device 
• Provide sufficient accurate financial information to JJV to allow JJV to submit 
complete and accurate certification or disclosure statements as required by 
21CFR54.  Promptly update this information if any relevant changes occur during the 
course of the investigation or for up to one year following completion of the study 
• Comply with all other obligations of clinical investigators and requirements according 
to all applicable FDA regulations (e.g., 21CFR812), all other applicable laws and 
regulations, and all conditions of approval imposed by the reviewing IRB and the 
FDA 
• Ensure that all associates, colleagues and employees assisting in the conduct of the 
study are adequately informed about the protocol, the investigational device, their 
study-related duties and functions and agree to fulfill their obligations in meeting the 
above commitments. 
Investigators shall provide adequate time and resources to conduct and report on the 
study. The Investigator, or delegate, shall notify JJV of any change in the conduct of the 
study including changes in study personnel assigned to the study project, location of the 
investigational device(s), or maintenance of study records, etc.  
9.3 
INVESTIGATOR APPROVAL  
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Study Files/Notebook.  Copies of IRB submissions and 
approvals should be forwarded to JJV.  Study sites will obtain IRB approvals and fulfill 
any other site-specific regulatory requirements.  The investigator is required to report to 

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JJV within five working days any withdrawal of approval by the reviewing IRB for his/her 
participation in the investigation. 
Prior to the start of subject enrollment, the following documents must be signed and 
returned to JJV: 
• Confidentiality Agreement 
• Clinical Trial Agreement 
• Investigator Agreement/Protocol Signature page 
• Clinical Investigator Brochure Signature page 
• Financial Disclosure form 
• Signed and dated copy of investigator’s current curriculum vitae 
• Copy of the investigator’s current medical license  
• Hospital/Ambulatory Surgery Center Clinical Study Acknowledgement, if required 
By signing the study documents, the investigator agrees to conduct this study according 
to the obligations above and all other applicable regulatory and legal requirements. 
10. EXPERIMENTAL PLAN 
10.1 OVERVIEW 
This study will be conducted in accordance with U.S. Code of Federal Regulations, the 
Declaration of Helsinki, ISO 14155:2011 and all other applicable laws and regulations.  
The study will not begin until regulatory and IRB approvals have been obtained. 
This study will be a prospective, multicenter, bilateral, randomized, comparative 
subject/evaluator-masked clinical investigation conducted at up to 14 sites.  Up to 
260 subjects will be enrolled to achieve approximately 220 randomized and bilaterally 
implanted subjects, resulting in approximately 195 evaluable subjects (65 in each 
test group and 65 in the control group) at 1 and 6 months.  After informed consent is 
obtained and confirmation that all eligibility criteria are met, the eye(s) may be treated.  
After signing the informed consent form, subjects meeting all eligibility criteria will be 
randomized to receive lenses from the same lens group in both eyes, either the 
investigational Model ZFR00 or Model ZYR00 IOLs, or the Model ZLB00 control IOL.  
For each subject, the investigator will choose which eye to operate on first at his/her 
discretion based on his/her standard clinical practice (e.g., the eye with the worse 
cataract, poorer best corrected distance vision and/or more severe optical/visual 
complaints).  All subjects are intended to have bilateral cataract surgery with the 
second-eye surgery occurring after the 1-week postoperative exam for the first eye, but 
no more than 30 days after the first-eye surgery.  All subjects will be examined through 
6 months postoperatively according to the visit schedule described in Section 10.2, Visit 
Schedule. 

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Although the investigators implanting the lenses cannot be masked, subjects and study 
evaluators responsible for conducting all vision testing will remain masked to which 
lenses were implanted through the 6-month study visit.  Because differences between 
the investigative and control lenses may be discernible upon slit-lamp examination, 
special care must be taken to maintain masking of study technicians.  As such, it is 
recommended that only the investigator, sub-investigator or other designated and 
trained clinician perform all biomicroscopic slit-lamp exams.  To maintain consistency, as 
well as masking, it is recommended that a single individual (study technician or 
coordinator designated by the investigator) conduct all postoperative study-related vision 
testing, although a back-up person should also be designated and trained. 
Key preoperative data include ocular health and history, visual acuities, manifest 
refraction, keratometry, topography, biomicroscopic slit-lamp findings, ocular symptoms 
and biometry.  The operative visit will include standard procedures for cataract surgery 
and IOL implantation.  Key postoperative data collection includes monocular and 
binocular uncorrected and distance corrected visual acuities, contrast sensitivity, 
defocus curve, slit-lamp findings, non-directed visual symptoms, questionnaires and 
adverse events.  A chart summary of all examination procedures required at each study 
visit is provided in Appendix A.  If needed, specific equipment necessary to perform the 
required procedures will be supplied for the duration of the study (Appendix B). 
10.2 VISIT SCHEDULE 
The study visit schedule for all study subjects is outlined in Table 2.   
All subjects are intended to have bilateral cataract surgery with the second-eye 
surgery occurring after the 1-week exam for the first eye but no more than 30 days 
after the first-eye surgery.  After each surgery, each eye will be examined 1 day 
postoperatively (1-2 days) and again at 1 week (7-14 days).  Following the second-eye 
surgery, both eyes will be evaluated at 1 month (30-60 days) and 6 months 
(120-180 days).  Unscheduled visits may be conducted as necessary at the discretion 
of the investigator for medically-indicated follow-up.   

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participate further in the study, or if they decide not to proceed with surgery.  These 
subjects will be exited from the study.   
Preoperative testing to be performed for each eye includes the following: 
POTENTIAL DISTANCE VISUAL ACUITY   
The subject must be capable of achieving Snellen 20/30 or better best corrected 
distance vision in each eye after cataract extraction and IOL implantation.  The surgeon 
may use his/her judgment, the Potential Acuity Meter (PAM), or other methods 
(e.g., pinhole, laser interferometer, etc.) to estimate the subject’s potential postoperative 
acuity. 
UNCORRECTED DISTANCE VISUAL ACUITY   
Monocular uncorrected distance visual acuity (UCDVA) is to be measured using a 
standard Snellen chart or equivalent. 
BEST CORRECTED DISTANCE VISUAL ACUITY AND MANIFEST REFRACTION  
Preoperative manifest refraction is required.  Monocular, best corrected distance visual 
acuity (BCDVA) is to be measured using a standard Snellen chart or equivalent and 
must be Snellen 20/40 or worse, with or without a glare source. 
KERATOMETRY AND TOPOGRAPHY   
Preoperative corneal astigmatism, as measured by keratometry or topography, should 
be 1.00 D or less.  No irregular astigmatism should be present preoperatively, and 
topography should be normal.  
CONTACT LENS WEAR AND CORNEAL STABILITY 
For contact lens wearers, keratometric corneal stability following cessation of contact 
lens wear must be verified before surgery.  PMMA contact lenses are not to be worn for 
at least 6 months; rigid gas-permeable contact lenses are not to be worn for at least 
1 month; and extended-wear or daily-wear soft contact lenses are not to be worn for at 
least 1 week prior to the preoperative visit.  Corneal stability must be verified for any 
subject who has worn PMMA lenses within 5 years or any other type of contact lenses 
within 6 months prior to the preoperative visit.  To verify stability, repeat the keratometric 
measurements at least 1 week after the initial preoperative baseline keratometric 
measurement.  Corneal curvature is considered to be stable if the difference in 
keratometric cylinder (vertical vs. horizontal keratometric readings) between the two time 
points does not exceed 0.50 D.  Additionally, the difference between the two horizontal 
readings as well as the difference between the two vertical readings must be no more 
than 0.50 D.  Changes in keratometric axis must be no more than ±15
○.  If a change 
exceeding these criteria is noted, surgery is to be postponed until keratometric stability is 

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demonstrated.  Final biometry measurements and surgery should not take place until 
keratometric stability is achieved.  Note: if this method of determining corneal stability is 
not a standard procedure in your practice, the subject must sign the informed consent 
form prior to starting the stability procedure.  
IOL POWER AND TARGETED REFRACTION  
Axial length and anterior chamber depth (ACD) must be measured to determine the 
appropriate lens power to implant using an A-Constant.  IOLMaster, Lenstar or 
immersion biometry methods are preferred; however, surgeons should use the biometry 
method with which they have the most experience and which was used in the 
determination of the personalized A-Constant for the TECNIS Multifocal Model ZLB00 
lens.  The investigator’s personalized A-Constant for the TECNIS Multifocal Model 
ZLB00 lens will also be used for the investigational TECNIS Models ZFR00 and ZYR00 
lenses.  The lens power should be calculated to achieve emmetropia at distance.  
Intentional over- or under-correction (outside ± 0.50 D) should NOT be planned for either 
eye; however, surgeons may adjust the targeted refraction as necessary to achieve 
emmetropia based on surgeon factors, study subject experience and/or subject first-eye 
outcomes.  
ADDITIONAL PREOPERATIVE INFORMATION TO BE COLLECTED: 
• Informed consent documentation  
• Subject demographic information  
• Planned surgery dates for each eye 
• Ocular history, including presence of ocular pathology for each eye  
• Intraocular pressure for each eye 
• Cataract type and density for each eye 
• Dilated fundus exam results for each eye 
• Medical findings from a biomicroscopic slit-lamp exam for each eye 
• Ocular symptoms for each eye 
• Ocular and systemic medications 
• Questionnaire to collect preoperative patient expectations  
10.4 RANDOMIZATION AND MASKING 
A randomization list will be created by the JJV biostatistician for each investigative site 
and the randomization code will be uploaded into the electronic data capture system 
(EDC).  Subjects will be randomized to the investigational Model ZFR00 IOL, the 
investigational Model ZYR00 IOL or the Model ZLB00 control IOL.  Unmasked study 
personnel at the site will be trained to the randomization process through the EDC 
system and will randomize subjects after the subject has signed the informed consent 
form, has met all eligibility criteria and the investigator has documented which eye will be 
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As part of the informed consent process, the investigator or delegate will explain to the 
subject the requirements of a randomized study and the differences expected between 
the three lens models: the Models ZFR00 and ZYR00 investigational lenses and the 
Model ZLB00 control lens.  The surgeon and the operative staff will know which lens 
type is implanted.  There may also be site coordinators and other site study staff, such 
as those performing slit-lamp exams, who will be unmasked.  Unmasked study site staff 
will be instructed not to disclose the lens type the subject received or to talk about the 
lens to any masked evaluators or to the study subjects.   
The subjects and the study technicians performing the postoperative vision tests are to 
be masked through study completion.  To maintain subject/technician-masking through 
the 6-month study exams, a masking plan will be tailored for each site to detail how lens 
assignment information will be concealed from masked technicians.  Recommended 
steps to maintain masking include ensuring that all items pertaining to lens group 
assignment and lens implantation records are kept separately from all other study 
documents and subject medical records until after completion of the final study visit.  For 
example, lens stickers (indicating the lens model implanted) may be kept in the 
operating room study notebook until completion of the final study visit, at which time they 
may be placed in the subject medical charts.  In the meantime, temporary lens stickers 
(without lens model designations) may be used in the subject’s medical chart.   
To maintain subject masking, a temporary IOL implant identification card will be issued 
to the subject at the time of surgery.  Following completion of the final study exam, each 
subject will be given the permanent IOL implant identification card. 
10.5 STUDY LENS SUPPLY 
The investigational Model ZFR00 or ZYR00 lenses and the Model ZLB00 control lenses 
will be obtained from site consignments, supplied by JJV following IRB approval.  Two 
lenses should be available for each case, a primary lens and a back-up lens.  Unused 
back-up lenses are to be returned to the site consignment.  At the completion of study 
enrollment, any remaining consignment lenses will be shipped back to JJV following 
reconciliation of investigational lens inventory by an JJV CRA.  Any remaining control 
lenses will also be returned to JJV.  At all times, the storage, access and use of all 
investigational lenses must be controlled and complete lens accountability maintained 
(See Section 15.2.1 Lens Accountability).   
10.6 OPERATIVE PROCEDURES  
The investigator should use his or her standard, small-incision, cataract extraction 
surgical technique.  Lenses should be folded for implantation and inserted into the 
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Investigators should manage surgical outcomes to ensure that the total postoperative 
refractive astigmatism is as minimal as possible.  The total postoperative astigmatism, 
including surgically-induced astigmatism, should be targeted to be no greater than 1.0 D.  
Astigmatism may be managed by incision type and placement only.  No additional 
refractive procedures are to be performed during the operative procedure or 
throughout the postoperative study period (e.g., LRI, OCCI, CRI, AK, PRK, LASIK 
or LASEK). 
Operative case report forms will include the following information: 
INCISION TYPE AND SIZE   
Lenses should be inserted through an incision ranging in size from approximately 
2.2-3.0 mm, per the investigator’s standard technique when using the UNFOLDER 
Platinum 1 Series Implantation System or the ONE SERIES Ultra Implantation System.  
The incision may be clear corneal, limbal or scleral tunnel at the discretion of the 
investigator. 
CAPSULORHEXIS SIZE AND METHOD  
The anterior capsulotomy should be a continuous, curvilinear capsulorhexis 
approximately 5.0 to 5.5 mm in diameter to allow slight overlap of the lens optic edge.  
The anterior capsulotomy method may be manual (rhexis) or laser-assisted.  
LENS REMOVAL 
Lens removal may occur using laser fragmentation combined with 
phacoemulsification/aspiration or using only phacoemulsification/aspiration.  
VISCOELASTIC   
Viscoelastic materials should be used as is customary for each investigator and 
recorded on the case report form (CRF). 
IMPLANT INSTRUMENTATION USED   
Lenses should be folded for implantation and inserted into the capsular bag using either 
the UNFOLDER Platinum 1 Series Implantation System (DK7796 handpiece with the 
Platinum 1 Series cartridge, Model 1MTEC30) or the ONE SERIES Ultra Implantation 
System (DK7786 [plunger] or the DK7791 [twist] handpieces with the ONE SERIES Ultra 
cartridge, Model 1VIPR30).   
SURGICAL COMPLICATIONS   
Should a surgical complication occur, implantation of a study lens will be at the 
investigator’s discretion.  In the event of capsular bag or zonular rupture, the lens should 
not be implanted if the complication may result in lens instability.  Additionally, the lens is 

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not to be implanted in the sulcus.  In this case, the investigator may implant his/her 
choice of a back-up, non-investigational IOL.  The subject should be exited from the 
study if a non-study lens is implanted as a result of a surgical complication during the 
first-eye implantation; however, the eye will be followed until resolution of the 
complication prior to exiting the subject.  Should a surgical complication occur during the 
second-eye surgery and result in implantation of a non-study lens, the subject will not be 
exited from the study; the first eye will continue to be followed per-protocol, although 
data may be analyzed separately, and the second eye will be followed for safety until 
resolution of the complication. 
MEDICATIONS   
Preoperative, operative and intraoperative medications should be used as is customary 
for each investigator and will be recorded on the CRF.   
TYPE OF CLOSURE   
Wound closure is left to the surgeon’s discretion and will be recorded on the CRF. 
ADDITIONAL OPERATIVE INFORMATION COLLECTED INCLUDES: 
• Date of surgery 
• Operative eye 
• Lens power and serial number 
• Lens placement 
• Other surgical procedures 
• Surgical technique according to protocol 
• Product complaints 
• Serious and/or device-related adverse events 
10.7 POSTOPERATIVE PROCEDURES  
Postoperatively, subjects will be examined according to the schedule in Section 10.2, 
Visit Schedule.  Only the most recently operated eye will be evaluated at the 1-day and 
1-week visits.  Both eyes will be evaluated at the 1-month and 6-month visits.   
Study technicians responsible for conducting all vision testing will be masked.  
Therefore, it is recommended that only the investigator/sub-investigator or other 
designated and trained clinician perform the biomicroscopic slit-lamp exams.  To 
maintain consistency and masking throughout the study, it is recommended that a single 
individual (study technician or coordinator designated by the investigator) conduct all 
postoperative study-related vision testing, although a back-up person should also be 
designated and trained.  

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Note:  Subjects are not to wear contact lenses postoperatively until after completion of 
this study.  Wearing contact lenses may potentially cause corneal edema or topography 
changes that may influence the visual acuity results.  During the study, if correction is 
required, spectacles should be prescribed.  
A postoperative CRF will collect the following information, although not all data are 
required at every visit (see Appendix A): 
MANIFEST REFRACTION AND REFRACTION ADJUSTMENTS (MASKED 
PROCEDURE) 
Postoperative study manifest refractions are to be performed using the M&S System at a 
distance of 4.0 meters.  Manifest refraction (MR) is to be performed using the Maximum 
Plus refraction method as detailed in Appendix C.   
Because 4.0 meters is not optical infinity, refraction adjustments are necessary to ensure 
proper vision testing taking into account test distance and refraction distance.  
Appendix D lists the refraction adjustments required for the various vision tests using 
the BCDVA refraction. 
DISTANCE VISUAL ACUITY TESTING (MASKED PROCEDURE) 
Distance visual acuity will be measured postoperatively under photopic lighting 
conditions (85 cd/m2, 80–110 cd/m2 acceptable) using the M&S System at a test 
distance of 4.0 meters.  For eyes unable to achieve a postoperative BCDVA of Snellen 
20/40 (i.e., LogMAR 0.3, number of letters correct 70), a reason must be specified.  
Instructions for using the M&S System are detailed in Appendix E, and for distance 
visual acuity in Appendix F.  
LOW CONTRAST DISTANCE VISUAL ACUITY (10%) (MASKED PROCEDURE) 
Low contrast (10% contrast) distance visual acuity will be measured under photopic 
conditions (85 cd/m2, 80-110 cd/m2 acceptable) using the M&S System at a test distance 
of 4.0 m.  Instructions for low contrast distance testing are detailed in Appendix F.   
 
 
 

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The following distance visual acuity measurements are to be performed per the visit 
schedule in Appendix A:  
Test 
Test 
Distance Illumination 
Type of Testing 
Refraction 
Adjustment 
UCDVA 
4 m 
Photopic  
(85 cd/m
2) 
Monocular 
Binocular 
+0.25 D 
adjustment only 
BCDVA 
4 m 
Photopic  
(85 cd/m
2) 
Monocular 
Binocular 
No adjustment; 
ETDRS Rx only 
BCDVA 
Low 
Contrast 
4 m 
Photopic  
(85 cd/m
2) 
Monocular 
Binocular 
No adjustment; 
ETDRS Rx only 
INTERMEDIATE VISUAL ACUITY (MASKED PROCEDURE) 
Intermediate visual acuity will be measured under photopic conditions (85 cd/m2, 
80-110 cd/m2 acceptable) using the M&S System at a test distance of 66 cm.  
Instructions for using the M&S System are detailed in Appendix E and for intermediate 
testing in Appendix G.   
The following intermediate visual acuity measurements are to be performed per the visit 
schedule in Appendix A: 
Test 
Test 
Distance Illumination 
Type of Testing 
Refraction 
Adjustment 
UCIVA 
66 cm 
Photopic  
(85 cd/m
2) 
Monocular 
Binocular  
No adjustment 
DCIVA 
66 cm 
Photopic  
(85 cd/m
2) 
Monocular 
Binocular 
-0.25 D added to 
ETDRS sphere Rx 
NEAR VISUAL ACUITY (MASKED PROCEDURE) 
Near visual acuity will be measured under photopic conditions (85 cd/m2, 80-110 cd/m2 
acceptable) using the Good-Lite self-calibrating, retro-illuminated box with 100% contrast 
ETDRS near charts at a test distance of 40 cm.   
Instructions for using the ETDRS near chart, including setting appropriate lighting 
conditions, and the visual acuity conversion chart between the number of ETDRS letters 
read and Snellen equivalents are provided in Appendix H.   

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The following near visual acuity measurements are to be performed per the visit 
schedule in Appendix A: 
Test 
Test 
Distance Illumination 
Type of Testing 
Refraction 
Adjustment 
UCNVA 
40 cm 
Photopic  
(85 cd/m
2) 
Monocular 
Binocular  
No adjustment 
DCNVA 
40 cm 
Photopic  
(85 cd/m
2) 
Monocular 
Binocular  
-0.25 D added to 
ETDRS sphere Rx 
DEPTH OF FOCUS TESTING (MASKED PROCEDURE) 
Monocular, best corrected distance depth of focus testing will be performed at the 
1-month visit on the first eye only for all subjects, and binocular best corrected distance 
depth of focus testing will be performed at the 6-month visit on all subjects.   
Depth of focus testing will be performed under photopic conditions (85 cd/m2, 
80-110 cd/m2 acceptable) using the M&S System at 4.0 meters with the ETDRS 
refraction in place (no adjustment necessary for test distance).  The subject is to be 
defocused in -0.50 D increments with spherical minus lenses; at each defocus 
increment, a LogMAR measurement is obtained.  Testing is to be conducted from 
+2.00 D through -4.00 D of defocus.  Further instructions for defocus testing are detailed 
in Appendix I. 
The following defocus curve measurements are to be performed per the visit schedule in 
Appendix A:  
Test 
Test 
Distance Illumination 
Type of 
Testing 
Refraction 
Adjustment 
Monocular Depth 
of Focus 
4 m 
Photopic  
(85 cd/m
2) Monocular  
No adjustment; 
ETDRS Rx only 
Binocular Depth of 
Focus 
4 m 
Photopic  
(85 cd/m
2) Binocular  
No adjustment; 
ETDRS Rx only 
PUPIL SIZE  
Photopic (without glare), and mesopic with and without glare pupil sizes will be 
measured postoperatively during the study.  For consistency, the same method of 
measurement should be used throughout the study. 
Photopic pupil size measurements are to be performed under the same lighting 
conditions at which photopic distance visual acuity is tested.  Pupil sizes under the other 
lighting conditions will be measured during the contrast sensitivity testing procedures.  
Instructions for measuring pupil size are detailed in Appendix J.  

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DISTANCE CONTRAST SENSITIVITY TESTING (MASKED PROCEDURE) 
Best corrected distance contrast sensitivity will be tested under mesopic with and without 
glare and photopic without glare conditions using the M&S System for sine-wave 
gratings at 1.5, 3.0, 6.0, 12.0 cycles per degree (cpd) (mesopic and mesopic with glare) 
and 3.0, 6.0, 12.0 and 18.0 cpd (photopic without glare).  The test distance is 8 feet 
(2.5 meters).  Best corrected distance contrast sensitivity is to be performed with a 
+0.12 D refractive adjustment to the sphere of the manifest refraction.  Detailed 
instructions for contrast sensitivity testing are provided in Appendix K.  
The following contrast sensitivity measurements are to be performed per the visit 
schedule in Appendix A: 
Contrast 
Sensitivity 
Test 
Test 
Distance 
Spatial 
Frequency 
Type of 
Testing 
Refraction 
Adjustment 
Photopic  
(85 cd/m
2) 
without glare 
2.5 m 
3, 6, 12 and 
18 cpd 
Monocular  
Binocular 
+0.12 D added to 
ETDRS sphere Rx 
Mesopic  
(3 cd/m
2) 
without glare 
2.5 m 
1.5, 3, 6 and 
12 cpd 
Monocular  
Binocular 
+0.12 D added to 
ETDRS sphere Rx 
Mesopic  
(3 cd/m
2) 
with glare 
2.5 m 
1.5, 3, 6 and 
12 cpd 
Monocular  
Binocular 
+0.12 D added to 
ETDRS sphere Rx 
BIOMICROSCOPIC SLIT-LAMP EXAM   
A biomicroscopic slit-lamp exam must be performed at each postoperative visit to 
determine the presence or absence of any medical or lens findings, complications or 
adverse events.  IOL decentration and tilt are to be determined subjectively.  The center 
of the lens relative to the pupil can be used to determine IOL decentration, with the 
diffractive rings used as a guide to locate the center of the IOL.  Note that the pupil 
center may not always be aligned with the visual axis of the eye; therefore, the 
investigator should consider deviations in pupil center from visual axis when reporting 
IOL decentration.   
Findings of aqueous cells and flare, corneal edema, posterior capsule striae (wrinkles), 
posterior capsular opacification and IOL glistenings are to be rated using standardized 
grading scales of 0 to +4 (0 = none, +4 = severe) during the slit-lamp biomicroscopy.  
The specific grading scales are provided in Appendix L.   
ND:YAG CAPSULOTOMY 
If an Nd:YAG capsulotomy is necessary, it is recommended that the procedure be 
performed at least 1 week prior to a study exam; this is particularly important for the 

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6-month study visit, as this is the key study exam for evaluation of safety and 
effectiveness.  
DILATED FUNDUS EXAM 
A dilated fundus exam is to be performed at the 6-month visit to evaluate retinal status 
and fundus visualization.  
INTRAOCULAR PRESSURE  
Intraocular pressure (IOP) is to be measured using the investigator’s usual method.  It is 
recommended that the same method be used for all study subjects at the site for the 
duration of the study. 
OCULAR SYMPTOMS (NON-DIRECTED; SPONTANEOUS) 
Subjective ocular symptoms are to be assessed at each postoperative visit by asking 
“Are you having any difficulties with your eyes/vision?”  Subjects should not be prompted 
for specific responses; however, if a subject reports halos, night glare or starbursts, the 
level of severity should be determined (mild, moderate or severe). 
MEDICATIONS   
Postoperative ocular medications should be used as is customary for each investigator 
and recorded in the source document for each subject.  Medications will be recorded on 
a medication log CRF as applicable. 
ADVERSE EVENTS 
Subjects should be assessed at each visit for occurrence of and/or change in status of 
any adverse events, particularly serious and/or device-related adverse events.  See 
Section 11.0, Adverse Events, for further information. 
QUESTIONNAIRES  
Questionnaires will be administered at the 1-month and 6-month visits to collect 
information regarding spectacle usage, visual symptoms, visual quality and subject 
satisfaction.  In order to minimize any effect the doctor-patient relationship may have on 
a subject’s responses on the questionnaire, the study questionnaires will be 
self-administered by the subjects.  The questionnaires are to be administered at the start 
of the 1-month and 6-month study visits, prior to any visual acuity testing. 
In addition, if a subject is seen after the 1-month postoperative visit for an unscheduled 
visit due to an optical/visual symptom complaint, the PRO Visual Symptoms 
Questionnaire (PRVSQ) will be administered at that visit, as well as prior to any 
secondary surgical intervention for an optical/visual symptom complaint.  If additional 
unscheduled visits and/or a secondary surgical intervention due to the same 

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optical/visual symptom complaint occur within 2 weeks of each other, it is not necessary 
to complete the PRO Visual Symptoms Questionnaire a second time. 
The optical visual symptom complaints that trigger the PRO Visual Symptoms 
Questionnaire include any of the seven symptoms from the PRVSQ: halos, glare, 
starbursts, sensitivity to light, streaks of light, occlusions, or poor light vision. 
If the subject indicates in the PRO Visual Symptoms Questionnaire that s/he has visual 
symptoms or other problems with their vision that are bothersome enough to want the 
lenses removed and replaced, the investigator will document a determination for whether 
or not, in their opinion, the problem is related to the optical properties of the lens. 
10.8 EXIT OF SUBJECTS  
An Exit CRF will be completed for all subjects, either when they complete the study or if 
they exit early.   
It is the responsibility of the investigator to provide complete follow-up data to JJV for 
each subject, and every attempt should be made to gather that complete follow-up data 
for all subjects enrolled, as missing data can have a negative effect on the study results. 
Patients who would be traveling, relocating or otherwise unavailable for postoperative 
follow-up visits should not be enrolled in this clinical study. 
A subject will be considered a "screen failure" if he/she does not meet the eligibility 
criteria or if consent is withdrawn prior to randomization.   
A subject will be considered "discontinued prior to treatment" if the subject is randomized 
but does not undergo surgery or receive a study lens for various reasons including: the 
planned implant being aborted due to surgical complications, the subject withdrawing 
consent prior to treatment or the subject died prior to treatment.   
Subjects will be "discontinued" from the study if one study lens (if implanted unilaterally) 
or both study lenses (if implanted bilaterally) are removed or if the subject dies. 
If a subject receives at least one study lens, he/she is to be followed according to the 
schedule in Table 2 (Section 10.2) for visit windows.   
Subjects will be considered “lost-to-follow-up” from the study only if irretrievably lost for 
unavoidable reasons such as: subject moved/unable to locate, subject ill/unable to 
travel, subject uncooperative/refuses further study participation.  In the event of subject 
relocation, effort must be made by the investigator to secure follow-up information 
(i.e., slit-lamp findings and general visual acuity, etc.) from the subject’s new physician.   

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If a subject is exited early from the study, the investigator must indicate the reason for 
study exit on the CRF.  In the event of a lens removal or other serious adverse event, 
the subject may be exited from the study; however, effort must be made by the 
investigator to follow the subject until resolution of the adverse event before exiting the 
subject from the study. 
Following study completion or early exit, subjects will be informed about which lens 
model they received.  Additionally, all study subjects are to be instructed to undergo 
regular eye examinations at least yearly and also to return to their doctor if any eye 
complications are experienced.   
10.9 UNSCHEDULED VISITS  
During the study period, if a non-protocol-required visit is done for the purpose of 
medically-indicated follow-up for a study eye, data from this visit should be reported 
using the Unscheduled Visit CRF.  The need for unscheduled visits is at the 
investigator’s discretion.  Specific examinations to be performed at unscheduled visits 
are also at the discretion of the investigator (based on the reason for the unscheduled 
visit) and data are to be recorded in the appropriate section of the CRF. 
Data to be collected may include: 
• Snellen manifest refraction 
• Uncorrected and best corrected distance visual acuity using a Snellen chart 
• Intraocular pressure 
• Slit-lamp examination for medical and/or lens findings  
• Dilated fundus exam 
• Ocular symptoms 
• Adverse events 
• Medications 
If, prior to the second-eye surgery, the fellow eye is re-examined (e.g., at a first-eye,  
1-day visit) and there are clinically significant changes from the preoperative exam, data 
is to reported using the Unscheduled Visit CRF.  If there are no changes or non-clinically 
significant changes from the original preoperative exam, an Unscheduled Visit CRF is 
not required. 
If the first eye is examined at a second-eye visit (e.g., 1 day or 1 week) and there are 
medical and/or lens findings, and/or a subject has an optical/visual symptom complaint, 
data are to be reported using the Unscheduled Visit CRF. 
Conditions found postoperatively, but previously documented at the preoperative visit, 
do not trigger an unscheduled visit report.  However, if the severity of the condition 
increases from the preoperative visit, an Unscheduled Visit CRF is needed. 

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In addition, if a subject is seen after the 1-month postoperative visit for an unscheduled 
visit due to an optical/visual symptom complaint, the PRO Visual Symptoms 
Questionnaire must be administered at that visit, as well as prior to any secondary 
surgical intervention for an optical/visual symptom complaint.  If additional unscheduled 
visits and/or a secondary surgical intervention due to the same optical/visual symptom 
complaint occur within 2 weeks of each other, it is not necessary to complete the PRO 
Visual Symptoms Questionnaire a second time. 
The optical visual symptom complaints that trigger the PRO Visual Symptoms 
Questionnaire include any of the seven symptoms from the PRVSQ: halos, glare, 
starbursts, sensitivity to light, streaks of light, occlusions, or poor light vision. 
10.10 PROTOCOL DEVIATIONS  
Any departure from the protocol procedures represents a protocol deviation.  Protocol 
deviations may be subject-based (e.g., inclusion/exclusion criteria, informed consent 
deviation, etc.) or procedural-based (e.g., out-of-interval visits, non-compliance with 
testing procedures, etc.).  All protocol deviations will be documented using the protocol 
deviation CRF.  Any deviation made to protect the life or physical well-being of a subject 
in an emergency as well as any use of the investigational device without obtaining 
informed consent must be reported to JJV within 5 working days.  Protocol deviations 
will be monitored by JJV, and if the non-compliance is persistent or egregious, JJV may 
take action, including but not limited to termination of the investigator’s participation in 
the study.  The investigator is also responsible for informing the reviewing IRB of 
instances of protocol non-compliance in accordance with the IRB requirements. 
11. ADVERSE EVENTS AND PRODUCT COMPLAINTS  
11.1 ADVERSE EVENT DEFINITIONS 
Adverse Event (AE) 
An adverse event is defined (following ISO 14155) as any untoward medical occurrence, 
unintended disease or injury, or untoward clinical signs (including abnormal laboratory 
findings) in subjects, users or other persons, whether or not related to the study device.   
Serious Adverse Event (SAE) 
An adverse event is considered serious (following ISO 14155) if it is an untoward 
occurrence which may or may not be related to use of the study device that 
• is sight- or life-threatening,  
• results in death,  
• requires inpatient hospitalization or prolongation of hospitalization (a planned 
hospitalization for a pre-existing condition without a serious deterioration in 
health is not considered a serious adverse event), 

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• results in permanent impairment of a body structure or body function,  
• necessitates medical or surgical intervention to prevent permanent impairment to 
a body structure or function, or 
• results in fetal distress, fetal death or a congenital abnormality or birth defect 
Device-Related Adverse Event/Adverse Device Effect (ADE) 
A device-related adverse event is defined as any adverse event that is believed to be 
definitely, probably or possibly related to the study device (following the guidelines in 
Section 11.4, Causal Relationship).  A device-related event is also considered an 
adverse device effect (ADE; following ISO 14155) resulting from the use of the study 
device that may result from user error, insufficiencies or inadequacies in the instructions 
for use, deployment, implantation, installation, operation of any malfunction of the 
device.   
Study-Specific Serious Anticipated Adverse Events 
The following is a list including, but not limited to, ocular serious adverse events (SAE) 
that are anticipated and must be reported to JJV for this study.  Any events that are 
unlikely but anticipated (i.e., endophthalmitis) will be reported to the FDA and other 
appropriate regulatory agencies. 
• Endophthalmitis/Intraocular infection 
• Hypopyon 
• Hyphema 
• IOL dislocation 
• Cystoid macular edema 
• Pupillary block 
• Retinal detachment/tear 
• Persistent corneal edema 
• Persistent iritis 
• Persistent uveitis 
• Persistent raised IOP requiring treatment 
• Toxic anterior segment syndrome 
• Visual symptoms requiring secondary surgical intervention (e.g., lens removal) 
• Tilt and decentration requiring secondary surgical intervention (e.g., 
repositioning) 
• Residual refractive error resulting in a secondary surgical intervention 
• Retained lens material resulting in secondary surgical intervention 
NOTE 1:  Wound burps during the first week postoperatively, suture removal, planned 
blepharoplasty and Nd:YAG capsulotomy (for PCO) are not considered adverse events 
for this study. 

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NOTE 2: Raised IOP requiring treatment, corneal edema, and iritis will only be 
considered serious if persistent at the final study visit (120-180 days postoperative) or 
sight-threatening at the time of occurrence.  Treatment merely to hasten the resolution of 
such conditions (and not intended to prevent permanent damage to the eye) will not be 
reported as serious adverse events.   
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) 
Any UADE (USA 21CFR 812.3(s)) or USADE (ISO 14155) is defined as 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 was not previously identified in 
nature, severity, or degree of incidence in the investigational plan (i.e., this protocol), 
application (including a supplementary plan or application), or risk assessment, or any 
other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects.   
11.2 PRODUCT COMPLAINT/DEVICE DEFICIENCY DEFINITION 
A product complaint/device deficiency is defined (21 CFR 820.3(b) and ISO 14155) as 
any alleged deficiency related to the identity, quality, durability, reliability, safety, 
effectiveness, or performance of a device. This may include malfunctions, use error and 
inadequacies in labeling.  Product complaints can pertain to any marketed JJV device 
being used in the study as well as the investigational device.  The investigator is to 
assess whether the deficiency could have led to a serious adverse event without suitable 
action or intervention or under less fortunate circumstances. 
11.3 ADVERSE EVENT AND COMPLAINT REPORTING REQUIREMENTS 
All adverse events and any complaint encountered using any JJV product, regardless of 
severity and whether or not attributed to the study device(s), are to be reported to JJV 
and recorded on the case report form corresponding to the visit during which awareness 
of the event occurred.  Adverse events are also to be reported to the reviewing IRB as 
per the IRB’s reporting requirements.  If required, adverse events will be reported to the 
appropriate regulatory agencies (e.g., FDA) according to all applicable laws and 
regulations.   
Reporting of adverse events shall follow the USA Code of Federal Regulations 
(21CFR812) for sites in the USA.  General guidelines are provided below: 
Adverse Event Reporting 
An adverse event that is not serious or device-related is to be reported to JJV in a timely 
manner.  Notification of non-serious and non-device related adverse events will occur by 

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recording events on the CRF when noted.  Such adverse events are also to be reported 
to the reviewing IRB per their reporting requirements.  
Complaints/Device Deficiency Reporting  
A general product complaint or device deficiency is to be reported to JJV in a timely 
manner.  Notification of complaints/device deficiencies will occur by recording complaints 
on the CRF at the visit the complaint occurs (e.g., operative visit) and/or by a phone call 
to JJV.   
Any device deficiency that could have led to a serious adverse event without suitable 
action or intervention, or under less fortunate circumstances, must be reported to the 
sponsor immediately (no later than 24 hours after detection). Device deficiencies that 
could have led to a serious adverse event should also be reported to the investigator’s 
IRB per their reporting requirements. 
Serious and/or Device-Related Adverse Event Reporting 
SAEs and/or ADEs are to be documented using the Serious Adverse Event/Adverse 
Device Effect (SAE/ADE) CRF.  In the event of an SAE, JJV must be notified 
immediately (no later than 24 hours after detection).  Any SAE/ADE is to be reported to 
JJV by phone, email and/or by submitting the completed SAE/ADE CRF.  Any SAE or 
device-related AE should also be reported to the investigator’s IRB per their reporting 
requirements. 
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) Reporting 
If during the study, a serious adverse event occurs that may reasonably be regarded as 
device-related and was not previously expected in nature, severity, or degree of 
incidence, the investigator is to report the UADE/USADE to JJV within 24 hours, and to 
the investigator’s IRB as soon as possible (and no later than 10 working days after 
learning of the event for sites in the USA as required by 21CFR812). 
11.4 CAUSAL RELATIONSHIP  
The investigator should always be alert to adverse events that may be related to the 
study device or the use of the study device (i.e., the procedure specific to the initial 
application of the device).  An attempt should be made in every case to determine the 
causality of the event.  The following definitions are to be used as guidelines in 
determining the relationship between the event and the study device and/or use of the 
device.   
Definitely related: 
If the event is associated with the device and/or the use of the 
device beyond a reasonable doubt, a causal relationship exists 

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between the adverse event and the device and/or the use of the 
study device. 
Probably related:   
There is a reasonable possibility of a causal relationship 
between the adverse event and the device and/or the use of the 
study device and/or the adverse event cannot be reasonably 
explained by another cause. 
Possibly related:   
The adverse event has not been determined to be related to the 
device or the use of the device, but no other cause has been 
identified and the device and/or the use of the study device 
cannot be ruled out as a possible cause. 
Unlikely to be related: The possibility of a potential causal relationship between 
adverse event and the device and/or the use of the device could 
exist, but the adverse event can be reasonably explained by 
another cause. 
Not related: 
There is no possibility of a causal relationship between the 
adverse event and the device and/or the use of the study device 
and/or the adverse event can be attributed to another cause. 
If an adverse event is believed to be definitely, probably or possibly related to the study 
device and/or the use of the device, the event will be considered related to the study 
device and/or the use of the device.   
11.5 ADVERSE EVENT FOLLOW-UP 
For every adverse event, appropriate measures should be undertaken to treat and/or 
monitor the subject until resolution occurs.  The subject
's files are to include all pertinent 
medical data relating to the event including the subject’s medical records, medical 
reports and/or judgments from colleagues or outside specialists who assisted in the 
treatment and follow-up of the subject.  The investigator should keep JJV closely 
informed as to the outcome of serious and/or device-related adverse events, thereby 
allowing JJV to comply with the appropriate regulatory reporting requirements.  An 
SAE/ADE CRF should be completed each time the subject returns to the investigator or 
other specialist(s) for follow-up of a serious and/or device-related adverse event until 
resolution of the event.  Any subject who is to be exited from the study due to a serious 
and/or device-related adverse event should be followed until the outcome is determined 
prior to being exited from the study. 
12. PROTOCOL CHANGES/AMENDMENTS  
If the investigator wishes to modify any procedure and/or the design of the study, he or 
she must contact and obtain consent from JJV regarding the proposed changes prior to 
implementation.  Any modifications (including additional data collection) require approval 

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by the FDA and all other appropriate regulatory agencies, as well as approval of the 
governing IRBs prior to implementation.   
13. ETHICS REVIEW AND PATIENT WELFARE 
13.1 INSTITUTIONAL REVIEW BOARD (IRB) 
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Notebook.  Copies of IRB submissions and approvals 
should be forwarded to JJV. 
The investigator is responsible for notifying the IRB of reportable adverse events as well 
as any other circumstance in which additional procedures outside the protocol were 
conducted to eliminate apparent hazards to subjects. 
13.2 INFORMED CONSENT 
The current version of the IRB-approved study informed consent form must be signed by 
each study subject prior to any study-specific examinations being performed.  The 
IRB-approved informed consent form is to be signed and dated by the subject as well as 
by the person who conducted the informed consent discussion.  The signed informed 
consent form will be maintained by the investigator as a permanent part of the subject’s 
medical records.  A copy of the signed and dated form is to be provided to the subject.  
The investigator will provide JJV written acknowledgement on the preoperative case 
report form that a signed agreement of informed consent has been obtained and is in the 
investigator’s possession for each subject.  As required by 21CFR812 Part G, the site 
shall document in the source documents that informed consent was obtained prior to 
participation in the study for each subject enrolled. 
NOTE:  The informed consent process also includes obtaining the subject’s signature on 
an Authorization for Use/Disclosure of Health Information for Research Form or 
equivalent documentation necessary to comply with applicable privacy laws pertaining to 
medical treatment in the governing countries.   
NOTE:  The sponsor will secure appropriate insurance for study subjects prior to study 
start. 
14. DOCUMENTATION 
14.1 SOURCE DOCUMENTS 
Source documents must be kept for all study subjects.  Source documents may include 
a subject’s medical records, hospital charts, clinic charts, the investigator’s subject study 

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files, as well as results of any diagnostic tests or procedures such as topographies or 
laboratory tests with photographs or instrument printouts. 
Each site is expected to adhere to the clinic’s own standard documentation requirements 
for medical charts/clinic notes.  For the purposes of this clinical study, the medical 
charts/clinic notes must also include, at a minimum, the following data that will be 
considered source data and will be reviewed by JJV: 
• Subject’s name and study identification number 
• Subject’s contact information 
• Study protocol number and the Sponsor name (JJV) 
• A statement that informed consent was obtained prior to participation in the study 
(including the date)  
• Evidence of subject eligibility 
• Dates of all subject visits and surgeries throughout the duration of the study 
• Implant serial number identification (NOTE: This is masked information, and may 
only be reviewed by unmasked study staff) 
• Concurrent medications 
• Corrected and uncorrected distance visual acuity (NOTE: M&S electronic data and 
near visual acuity score sheets are considered source documentation and are to be 
retained by the site.  A paper copy of the M&S results will be printed and validated by 
the site) 
• Manifest refraction 
• Occurrence and status of any operative complications, postoperative medical or lens 
findings and adverse events 
• Occurrence and status of any subject complaints, e.g., ocular/visual symptoms 
• The date the subject exited the study, and a notation as to whether the subject 
completed the study or reason for early exit. 
14.2 SUBJECT CONFIDENTIALITY 
Subjects will be assigned a site/subject number to maintain subject confidentiality.  
Subject names may possibly be disclosed to JJV or regulatory agencies during 
inspection of medical records related to the study, but reasonable precautions will be 
taken to maintain confidentiality of personal information to the extent permitted by 
applicable laws and regulations. 
14.3 CASE REPORT FORM COMPLETION 
This study will use an electronic data capture system.  All study staff responsible for 
entering data into the system must complete certification prior to using the system.  The 
investigator is responsible for ensuring that data are properly recorded on each subject’s 
case report forms and related documents.  Prior to database lock, the investigator will 
verify completeness and accuracy of data submitted to JJV.  

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14.4 STUDY SUMMARY 
A final investigator’s summary (study close-out) will be provided to JJV and the 
reviewing IRB after termination or the completion of the study or the investigator’s part of 
the investigation, as directed by JJV.  
15. MONITORING  
JJV will perform three types of monitoring to ensure compliance with regulations: data 
monitoring, administrative monitoring, and safety monitoring. 
15.1 DATA MONITORING 
In order to ensure a well-controlled clinical trial, JJV will follow specific data monitoring 
procedures, routinely generate reports and periodically review safety and effectiveness 
data.  To avoid bias, any analyses generated prior to site closures will not be 
disseminated to any of the investigative sites. 
An electronic data capture system (EDC) will be used to transmit case report forms from 
the investigative site to JJV.  Requests for data clarification will be handled through this 
same system.   
To minimize data omissions and inconsistencies on clinical reports and to ensure that 
data are accurately transcribed to computer data files, JJV will follow internal data 
processing procedures that include automated and manual quality control checks to 
identify any data discrepancies.  Any such items will be resolved and documented as 
needed in EDC. 
Prevention of Missing Data 
Methods used to safeguard against missing data that can have deleterious effects on the 
study integrity and reliability of its outcomes will include training study staff with WebEx, 
centralized and/or on-site programs.  In addition, subjects will be encouraged at the time 
of informed consent to avoid missing study visits, as missing data may affect the study 
reliability and diminish the scientific value of their contribution to the study. 
15.2 ADMINISTRATIVE MONITORING 
Administrative monitoring procedures will ensure that study devices, subjects, and forms 
can be traced and will allow monitoring of investigator progress and compliance.  
Accountability and traceability of study devices will be monitored by trained JJV 
personnel. 
Device Accountability 
Complete lens accountability will be maintained at the investigative site by maintaining 
records of all investigational lenses (Models ZFR00 and ZYR00 lenses) received from 

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and returned to JJV.  A site log will be used to track all lenses for date of receipt, eye 
implanted, serial number, lens power, use and disposition/return to JJV.  This site log 
and any other investigational lens information will be maintained in the operative room 
study binder.  During periodic investigative site monitoring visits, JJV personnel will 
review investigative site lens inventory records and logs to ensure IOL accountability 
compliance and complete investigational lens traceability.   
Site Monitoring Plan 
Prior to performing any study implants, the requirements of the study and reporting 
mechanisms will be explained to each investigator either personally at the investigative 
site or at a formal study investigator meeting.  When necessary, a pre-study site 
qualification visit may be performed to assess the adequacy of the site to perform the 
study for sites that have not previously worked with JJV or have undergone significant 
changes, or have not been visited in the past year.  A study initiation visit will be 
conducted for all sites prior to the first implant.  
Throughout the duration of the study, site visits to monitor compliance to this protocol will 
be made at each investigative site.  During interim site monitoring visits, JJV will review 
informed consent documents and subject eligibility, and the data on study case report 
forms will be verified against subject charts and other source documents to ensure 
complete and accurate reporting.  The subject files will also be reviewed to assure that 
all adverse events and any issues encountered with JJV products have been reported in 
a timely fashion.  
JJV will also review source documents to verify that all required items have been 
documented in the subject medical charts.  Refer to Section 14.1, Source Documents, 
for a list of items that are required for source documentation.  In addition to subject files, 
study logs will be checked and conformance to lighting levels for visual acuity tests will 
be verified.   
Training on study-specific procedures may also be conducted during monitoring visits.  
For this study in particular, a training/monitoring visit is likely to occur just prior to or 
during the first of the 1-month and 6-month visits, wherein the most extensive vision 
testing occurs.  
Upon study completion, a final close-out site visit to each site will be made to monitor the 
last of the subject data records and finalize any outstanding study issues.  
A separate Study Monitoring Plan will be established prior to study start that will define 
the type and frequency of monitoring visits and frequency of record monitoring.  

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15.3 SAFETY MONITORING 
The medical monitor will review results throughout the clinical trial as necessary to 
ensure the continued safety of the device and to ensure that no subjects are exposed to 
unreasonable risk.  The medical monitor will be available to answer all questions from 
investigators.  The medical monitor will review and assess any reports of serious and/or 
device-related adverse events as well as device deficiencies that could have led to a 
serious adverse event, and discuss these with the reporting investigator(s) as 
necessary.  The medical monitor, as well as any other qualified personnel designated by 
JJV, shall also review any interim progress reports, as applicable.   
16. PUBLICATIONS 
Refer to the Clinical Trial Agreement for information regarding JJV publication policies. 
17. RISK ANALYSIS 
POTENTIAL RISKS AND RISK MANAGEMENT 
RISKS OF THE TECNIS NEXT-GENERATION IOLS, MODELS ZFR00 AND ZYR00 
The TECNIS Models ZFR00 and ZYR00 IOLs are designed to provide far, intermediate 
and near vision; however, glasses may still be needed to improve distance vision and/or 
to have useful vision for intermediate or near tasks.  Visual symptoms, particularly 
dysphotopsias such as halos, night glare, starbursts, etc., are expected to be 
comparable to or less than with a standard multifocal IOL.  Dysphotopsias may become 
less noticeable over time; however, the IOL may be removed if necessary.  There may 
be a reduction in contrast sensitivity under certain conditions compared to a monofocal 
lens although contrast sensitivity is expected to be in between that of the TECNIS 
Symfony IOL and TECNIS Multifocal IOLs.  Due to the diffractive optic design, the ability 
to perform some eye treatments (e.g., retinal photocoagulation) may be affected, and 
caution should be used when interpreting results of autorefractors or wavefront 
aberrometers that utilize infrared light, or when performing a duochrome test.  These 
risks are not unlike other diffractive technology IOLs.   
GENERAL RISKS OF CATARACT SURGERY AND IOL IMPLANTATION 
There are risks and complications associated with cataract surgery and IOL implantation 
in general.  These can include worsening of vision, hemorrhage, loss of corneal clarity, 
inflammation, infections, retinal detachment, pupil changes, glaucoma, etc.  
Complications can result in poor vision, loss of vision or loss of the eye.   
RISK MANAGEMENT 
Subjects will be closely monitored thought the trial duration.  The occurrence of adverse 
events and complaints will be assessed at each study visit and reported to JJV 

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according to Section 11.0, Adverse Events and Product Complaints.  Additionally, JJV 
will monitor incoming data following the procedures outlined in Section 15.0, Monitoring.  
The Medical Monitor will ensure subjects are not exposed to additional risks by 
monitoring serious adverse events, device-related adverse events, and device-
deficiencies that could have led to serious adverse events (Section 15.3, Safety 
Monitoring).  
POTENTIAL BENEFITS 
The general clinical performance of the TECNIS Next-Generation IOLs, Models ZFR00 
and ZYR00, are expected to be similar to the TECNIS Model ZLB00 control IOL 
regarding distance and near visual acuities and safety outcomes.  Improved intermediate 
visual acuity and functionality may be achieved with the TECNIS Next-Generation IOLs, 
Models ZFR00 and ZYR00 with comparable or less levels of dysphotopsia as compared 
to the control IOL. 
CONCLUSION 
The hazards/risks associated with the TECNIS Next-Generation IOLs, Models ZFR00 
and ZYR00, are acceptable and within those of JJV’s other advanced optic IOLs.  The 
potential clinical benefits of the TECNIS Next-Generation IOLs, Models ZFR00 and 
ZYR00, outweigh the residual risks when the device is used as intended.  
18. RECORDS RETENTION 
All study-related correspondence, subject records, consent forms, Authorization for 
Use/Disclosure of Health Information Forms or similar medical treatment privacy law 
documentation, records of the distribution and use of all study products, and original 
case report forms should be maintained by the investigator.   
The investigator must maintain and have access to the following essential documents 
until notified by the Sponsor.  Note:  This may be for a minimum of 25 years after 
completion of the study.  JJV requires notification if the investigator wishes to relinquish 
ownership of the data so that mutually agreed-upon arrangements can be made for 
transfer of ownership to a suitably-qualified, responsible person. 
• 
All case report forms  
• 
All adverse event information (i.e., medical records, medical reports and/or 
judgments from colleagues or outside specialists who assisted in the treatment and 
follow-up of the subject) 
• 
Investigational supply records/inventory 
• 
IRB approval documentation 
• 
Study correspondence  
• 
Study agreements 

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• 
Site visit documentation 
• 
Protocol(s) 
• 
Subject log(s) 
• 
Clinical Investigator’s Brochure 
• 
Completed subject informed consent forms and medical privacy forms (e.g., 
Authorization for Use/Disclosure of Health information) 
• 
Subject medical chart/clinic notes (Not applicable for transfer of ownership to JJV) 
19. TERMINATION OF THE INVESTIGATION 
The clinical investigation will be suspended in the event of high levels of complications 
and/or adverse events that are unexpected in nature and/or severity and evaluated as to 
causality relative to the study device.  The clinical investigation may be suspended if the 
Medical Monitor or the IRB, upon review and evaluation of the clinical data, finds 
unacceptable clinical performance or the level of single or total complications and/or 
adverse events unacceptable for continuation of the investigation. 
If causality is shown not to be related to the study device, the study may be resumed in 
accordance with the IRB and regulations of the FDA.  The study will be terminated if 
causality is shown to be related to the study device. 
Additionally, the investigator or JJV may stop a subject’s participation at any time.  JJV 
may also stop the study at any time for reasons it determines appropriate.  However, no 
suspension of the study would be made to disadvantage the study subjects.  Following 
suspension of the study for any reason, all study subjects who have already received 
treatment would continue to be followed through completion of the study visit schedule. 
20. STATISTICAL METHODS 
This section highlights the analyses to be performed for key study endpoints.  The key 
study timeframe for all endpoints will be the 1-month postoperative visit, although data 
will be reviewed at other time points as well.  TECNIS Models ZFR00 and ZYR00 will 
both be compared to the TECNIS Model ZLB00 control separately for all analyses.  All 
data will be reported by IOL group.   
20.1 ANALYSIS POPULATION 
The safety population (SP) of all subjects implanted who have available data will be 
used for all analysis.  No data imputation will be performed for missing data.  For the 
monocular endpoints, the safety population will consist of first eyes implanted with a 
study IOL; for binocular endpoints, the safety population will consist of subjects 
implanted with the same IOL in both eyes. The primary analysis population will be the 

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safety population (SP) for all endpoints.  Second eye data will only be reported for 
monocular safety endpoints as supportive data. 
20.2 PRIMARY STUDY ENDPOINTS 
Primary Effectiveness Endpoints 
MODEL ZFR00: MONOCULAR DISTANCE CORRECTED INTERMEDIATE VISUAL 
ACUITY (DCIVA) AT 66 CM 
The primary effectiveness endpoint for the Model ZFR00 IOL is mean (LogMAR), 
photopic, monocular, first-eye, distance corrected intermediate visual acuity (66 cm) at 1 
month postoperative.  The mean, SD, median, minimum, maximum and 95% C.I. will be 
reported by IOL group.  Results will be reported by lens group for first eyes using 
one-sided, two-sample t-tests with an alpha level of 0.025.  Note that a lower LogMAR 
value is a better acuity and a higher LogMAR value is a poorer acuity.  The null 
hypothesis is that the mean monocular DCIVA LogMAR value for the Model ZFR00 eyes 
is worse than or equal to that for control eyes.  The alternate hypothesis is that the mean 
monocular DCIVA LogMAR value for Model ZFR00 eyes is better than that for control 
eyes. 
Ho: μ
c - μ
t ≤ 0 (Model ZFR00 lens is worse than (higher LogMAR) or equal to control) 
H1: μc - μ
t > 0 (Model ZFR00 lens is better (lower LogMAR) than control) 
 
where 
μt = mean LogMAR DCIVA for the Model ZFR00 lens 
μc = mean LogMAR DCIVA for control lens  
 
Reject the null hypothesis if one-sided p-value ≤ 0.025. 
The success criterion is a statistically significantly lower mean LogMAR value for the 
Model ZFR00 investigational lens compared to the control lens (p ≤ 0.025).   
MODEL ZYR00: MONOCULAR DISTANCE CORRECTED INTERMEDIATE VISUAL 
ACUITY (DCIVA) AT 66 CM 
The primary effectiveness endpoint for the Model ZYR00 IOL is mean (LogMAR), 
photopic, monocular, first-eye, distance corrected intermediate visual acuity (66 cm) at 1 
month postoperative.  Analysis for the Model ZYR00 will be similar to the Model ZHR00 
described above.  Results will be reported by lens group for first eyes using one-sided, 
two-sample t-tests with an alpha level of 0.025.  Note that a lower LogMAR value is a 
better acuity and a higher LogMAR value is a poorer acuity.  The null hypothesis is that 
the mean monocular DCIVA LogMAR value for the Model ZYR00 eyes is worse than or 
equal to that for control eyes.  The alternate hypothesis is that the mean monocular 
DCIVA LogMAR value for Model ZYR00 eyes is better than that for control eyes. 

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Ho: μ
c - μ
t ≤ 0 (Model ZYR00 lens is worse than (higher LogMAR) or equal to control) 
H1: μc - μ
t > 0 (Model ZYR00 lens is better (lower LogMAR) than control) 
 
where 
μt = mean LogMAR DCIVA for the Model ZYR00 lens 
μc = mean LogMAR DCIVA for control lens  
 
Reject the null hypothesis if one-sided p-value ≤ 0.025. 
The success criterion is a statistically significantly lower mean LogMAR value for the 
Model ZYR00 compared to the control lens (p ≤ 0.025).   
Primary Safety Endpoints 
MODEL ZFR00: RATES OF ADVERSE EVENTS VS. ISO SPE RATES 
The primary Model ZFR00 safety endpoint for this study is the rate of adverse events vs. 
ISO SPE rates at 1 month postoperative.  The frequency and proportion of first eyes and 
second eyes with these events will be reported over time by IOL group.  Statistical 
comparisons to ISO SPE rates will be based on first-eye data; adverse event rates for 
the Model ZFR00 investigational lens first eyes will be compared to the ISO SPE rates 
using a one-sided, exact test based on the binomial distribution.  The null hypothesis is 
that the AE rate for the Model ZFR00 investigational lens eyes is lower than or equal to 
the ISO SPE values, and the alternative hypothesis is that the AE rate for study eyes is 
higher than the ISO SPE values.  
Ho: p
t ≤  pi  
H1: p
t  > pi 
 
where 
pt = proportion of Model ZFR00 investigational lens eyes with the AE  
pi = proportion of eyes reported in ISO SPE rates with the AE  
Reject the null hypothesis if one-sided p-value < 0.05. 
MODEL ZYR00: RATES OF ADVERSE EVENTS VS. ISO SPE RATES 
The primary Model ZYR00 safety endpoint for this study is the rate of adverse events vs. 
ISO SPE rates at 1 month postoperative.  The frequency and proportion of first and 
second eyes with these events will be reported over time by IOL group.  Statistical 
comparisons to ISO SPE rates will be based on first-eye data; adverse event rates for 
Model ZYR00 investigational lens first eyes will be compared to the ISO SPE rates using 
a one-sided, exact test based on the binomial distribution.  The null hypothesis is that 
the AE rate for Model ZYR00 investigational lens eyes is lower than or equal to the ISO 
SPE values, and the alternative hypothesis is that the AE rate for study eyes is higher 
than the ISO SPE values.  
 

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Ho: p
t ≤  pi  
H1: p
t  > pi 
 
where 
pt = proportion of Model ZYR00 investigational lens eyes with the AE  
pi = proportion of eyes reported in ISO SPE rates with the AE  
Reject the null hypothesis if one-sided p-value < 0.05. 
20.3 ADDITIONAL ENDPOINTS 
Intermediate Visual Acuity endpoints 
Other intermediate endpoints include binocular UCIVA and DCIVA, and monocular 
UCIVA.  For binocular UCIVA and DCIVA and monocular UCIVA, superiority approach 
similar to DCIVA described above will be used.   
In addition, the frequency and proportion achieving each line for all other intermediate 
endpoints will be reported over time by IOL group. 
Near and Distance Visual Acuity endpoints 
For monocular photopic BCDVA, the frequency and proportion of eyes achieving each 
acuity line will be reported over time by IOL group.  The proportion of investigational lens 
eyes achieving 20/40 or better at 1 month will be compared to the ISO SPE rate for 
posterior chamber IOLs (all first eyes) using a one-sided, exact test based on binomial 
distribution.  The null hypothesis (based on the ISO guidance document) is that the 
proportion of investigational lens eyes achieving 20/40 or better BCDVA is greater than 
or equal to the ISO SPE values, and the alternative hypothesis is that the proportion of 
investigational lens eyes achieving 20/40 or better BCDVA is less than the ISO SPE 
values. 
In addition, the mean logMAR photopic BCDVA will be compared between lens groups 
for first eyes using a non-inferiority method.  The null hypothesis is that the mean 
difference (control minus investigational lens) between the control and investigational 
IOLs is ≤-0.1 LogMAR (1 line) with the alternative hypothesis that the mean difference is 
>-0.1 LogMAR.  A 90% confidence interval (CI) of a two-sample, two-sided, t-test will be 
used for evaluation.  The success criteria is achieved if the lower limit of the 90% CI of 
the difference is greater than -0.1 LogMAR.   
For monocular and binocular UCDVA, BCDVA with low contrast (10%) and binocular 
photopic BCDVA, similar statistics using a non-inferior method will be used.  Frequency 
and proportion of eyes achieving each line will also be reported over time by IOL group. 

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For all near endpoints, a non-inferior approach similar to photopic BCDVA described 
above will be used.  In addition, the frequency and proportion of eyes achieving each 
line will be reported over time by IOL group. 
Defocus Endpoints 
For defocus results, the defocus curve will be produced by IOL group.  The diopters of 
defocus where the mean visual acuity 20/32 or better is achieved will be derived by 
visual inspection of the defocus curve. 
Manifest refraction endpoint 
Descriptive analysis of refractive sphere, cylinder and spherical equivalent (MRSE) will 
be reported by IOL groups for both eyes.  Since refraction was performed at 4M, 0.25D 
will be subtracted from the sphere value.  Refractive data will then be converted to plus 
cylinder notation.   
MRSE is then calculated by the following formula:   MRSE = sphere + ½ cylinder.    
Questionnaire Endpoints 
For questionnaire data, including visual symptoms, the frequency and proportion of 
subjects with a given response will be reported by IOL group.  For comparisons between 
IOL groups, Wilcoxon Rank-Sum test will be used for ordinal data, and Fisher’s exact 
test will be used for categorical data.  The null hypothesis is that there is no difference 
between responses, and the alternative hypothesis is that there is a difference between 
responses.  Two-sided testing and alpha of 0.05 will be used to evaluate questionnaire 
data.  
Safety endpoints 
For contrast sensitivity data, descriptive analyses including mean, standard deviation, 
median, minimum, maximum and 90% confidence intervals will be presented by IOL 
group. 
The frequency and percentage of medical findings, lens findings and non-directed 
ocular/visual symptoms will be reported over time by IOL group for both eyes. 
20.4 VISUAL  ACUITY CONVENTIONS AND GENERAL STATISTICS  
Visual acuity data will be converted to LogMAR values prior to analysis and adjusted for 
the test distance used if it is not the standard distance for the chart.  Descriptive 
statistics will typically include sample size (N), mean, standard deviation (SD), median, 
minimum (Min) and maximum (Max) as appropriate for continuous variables.  For 
continuous variables, statistical tests (e.g., t-test) assuming normality will generally be 
used.  For categorical data, the frequency and proportion will be reported and Fisher’s 

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exact test or Chi-square test will generally be applied.  For ordinal categorical data, the 
frequency and proportion will be reported with the Wilcoxon Rank-Sum test generally 
used.   
20.5 INTERIM REPORTS 
Although interim study progress reports will be conducted for this study, all masking of 
study subjects and masked study technicians will be maintained and interim reports will 
not be disseminated to investigators/site personnel. 
20.6 SAMPLE SIZE CALCULATIONS 
For the primary endpoint of distance corrected intermediate visual acuity, there is 90% 
power to detect a 1-line or greater difference in mean visual acuity between the 
investigational lens groups and the control group (assume one-sided testing with an 
alpha of 0.025 and standard deviation of 1.6 lines) with 65 subjects in each lens group. 
For contrast sensitivity there is 80% power to detect a non-inferiority margin of 0.15 log 
units between the investigational lens groups and the control group (assume one-sided 
alpha=0.05 and standard deviation of 0.34) with 65 subjects in each lens group. 
If the dropout rate is assumed at 10%, approximately 73 subjects will be implanted in 
each lens group to achieve a minimum of 65 subjects in each lens group at 1 and 6 
months. 
 

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APPENDIX B EQUIPMENT LIST 
The following equipment will be supplied to an investigative site for the duration of the 
study provided that the site does not already have such equipment available for use.  
This equipment loan will be documented in the Clinical Trial Agreement, which indicates 
that the equipment is to be returned to JJV at the completion of the study. 
• M&S Technologies CTS-1000 Smart System© Computerized Vision Testing 
System, including laptop computer, tablet, and glare bracket (“M&S System”) 
• Good-Lite EVS-1500 retro-illuminated visual acuity light box and stand 
• Four Good-Lite ETDRS near visual acuity charts (100% contrast) on two cards, 
for a test distance of 40 cm  
• Neutral density trial frame lenses for mesopic testing 
• +0.12 D trial frame lenses 
• Gossen Light Meter 
• Tape measure (meters) 
• Colvard Pupillometer (if site does not use a NeurOptics pupillometer) 
• JJV insertion systems: 
o ONE SERIES Ultra Implantation System with cartridges, or 
o UNFOLDER Platinum 1 Series Implantation System with cartridges 
 
 
 

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APPENDIX C MAXIMUM PLUS MANIFEST REFRACTION TECHNIQUE WITH 
CYLINDER REFINEMENT  
Manifest refraction testing will be performed using the M&S System at 4.0 meters with 
the room lighting set to that required for photopic distance visual acuity testing (85 
cd/m2).  NOTE: Objective refraction by either retinoscopy or autorefraction can be used 
as a starting point for the Manifest Refraction.  Always ensure that the endpoint of 
refraction is maximum plus (or minimum minus) power that yields maximum visual 
acuity. 
1) Occlude the fellow eye. 
2) SPHERE: Starting with the objective refraction, refine the sphere to yield best visual 
acuity.  Important: Add plus power (or reduce minus) until subject demonstrates at 
least a 1-line loss from best visual acuity (fogging).  Then step down to the most plus 
(or least minus) sphere power until visual acuity and clarity show no improvement. 
3) CYLINDER AXIS: Refine cylinder with a cross-cylinder and the objective cylinder 
refraction as the starting point.  Refine axis first and power second, since the correct 
axis can be found with an incorrect power, but the correct power cannot be found 
with an incorrect axis.  
a. Direct the subject’s attention to 1 line above (larger letters) the best visual acuity.  
With the trial cylinder (axis and power) in the phoropter, introduce cross-cylinder 
for axis refinement.  When asking the subject which cross-cylinder axis position 
is better, “one or two?”, remind the subject to look at different letters on the line 
and report preference based on the overall clarity of the letters.  
b. Refine the axis based on the subject’s responses, using small steps (less than 
five degrees), until the subject reports no difference in the two choices. 
c. Cylinder axis may be further confirmed by bracketing:  Slowly rotate the trial 
cylinder in one direction until the subject reports blurring and note the axis.  
Rotate the trial cylinder in the opposite direction past the presumed axis until the 
subject reports blurring, again noting the axis. The average of the two noted axes 
can be taken as the final astigmatism axis. 
4) CYLINDER POWER:  Set the cross cylinder to refine cylinder power and present 
choices to the subject, reminding the subject to look at different letters on the line 
and report preference based on overall clarity of the letters.  Reduce or increase trial 
cylinder power accordingly.  
a. Maintain the spherical equivalent throughout cylinder power refinement by 
adjusting the sphere once for every two clicks of cylinder power change. 
5) SPHERE CHECK: Introduce plus sphere in 0.25 D increments until the subject 
reports and demonstrates a reduction in visual acuity.  Then reduce sphere power in 
0.25 D steps until visual acuity and clarity show no improvement. 
 
 

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APPENDIX D REFRACTION ADJUSTMENTS 
Postoperative study manifest refractions are to be performed using the M&S System at a 
distance of 4.0 meters.  Because 4.0 meters is not optical infinity, refraction adjustments 
are necessary to ensure proper vision testing taking into account test distance and 
refraction distance.  The adjustment required (in diopters) is 1/test distance (in meters).  
To adjust a 4.0-meter refraction to optical infinity, -0.25 D is to be added to the sphere of 
the refraction to obtain a true distance (infinity) correction.  On the other hand, to adjust 
optical infinity to a 4.0-meter test distance, +0.25 D is to be given.  In the case where the 
refraction distance (4.0 meters) and the vision test distance (4.0 meters) are the same, 
no adjustment is necessary.  The following table lists the refraction adjustments required 
for the various vision tests in this study: 
Refraction Adjustments for Vision Testing 
 
Vision Test 
Test 
Distance 
Correction/Adjustment 
Uncorrected distance visual acuity (UCDVA) 
4.0 m 
+0.25 D adjustment only 
Best corrected distance visual acuity 
(BCDVA) 
4.0 m 
No adjustment; ETDRS Rx only 
Best corrected distance visual acuity 
(BCDVA),10% contrast 
4.0 m  
No adjustment; ETDRS Rx only 
Best corrected distance defocus curve testing 
4.0 m 
No adjustment; ETDRS Rx only 
Uncorrected intermediate visual acuity 
(UCIVA) 
66 cm 
No adjustment 
Distance corrected intermediate visual acuity 
(DCIVA) 
66 cm 
-0.25 D added to ETDRS sphere Rx 
Uncorrected near visual acuity  
(UCNVA) 
40 cm 
No adjustment 
Distance corrected near visual acuity 
(DCNVA) 
40 cm 
-0.25 D added to ETDRS sphere Rx 
Best corrected distance contrast sensitivity 
2.5 m 
+0.12 D added to ETDRS sphere Rx 
 
 
 

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APPENDIX E INSTRUCTIONS FOR USING THE M&S SYSTEM 
Distance and intermediate visual acuity, low-contrast distance visual acuity, defocus, 
and contrast sensitivity testing will be performed using theM&S System.  This system 
provides descending LogMAR charts with proportionally spaced SLOAN letters at 100% 
contrast for high contrast visual acuity and defocus testing, 10% contrast for low-contrast 
distance visual acuity and appropriate contrast levels for contrast sensitivity testing.  
Each presentation is randomized and is consistent and repeatable.  The system is 
calibrated for both distance to subject and pixels/inch so that optotypes precisely follow 
ANSI Z80.21-2010 and ISO 8596:2000 in regard to size, spacing between optotypes and 
spacing between lines.    
Figure 4:  Example of LogMAR 4.0 meter chart screen 
 
The M&S System background luminance is automatically set to 85 cd/m2 (range of 
80-110 cd/m2 is acceptable) for photopic testing and, with a neutral density filter placed 
in front of the laptop, lighting is reduced to 3 ± 0.5 cd/m2 for mesopic testing.  Room 
lighting is to be set to a level lower than the illumination from the laptop screen.  Ambient 
lighting should be dim to dark (less than 50 lux) to maximize pupil size.  No surface 
(including reflective surfaces) within the subject’s field of vision should be brighter than 
the chart background in luminance.  The room lighting and screen luminance will be 
verified each time the computer is turned on using the JJV-provided, auto-adjusting, 
monitor-calibration system to ensure light levels are appropriate.  
The M&S System will be set up to perform required visual tests in a specific order, with 
prompts on the screen to allow the technician to set up the subject for monocular or 
binocular testing, refraction adjustments as needed and uncorrected or best corrected 
testing.  Letters on all charts will appear randomly, with the technician controlling 
movement through charts based on subject responses.  
As a subject completes a visual acuity line, the technician will select the total number of 
letters correctly read for that line on the handheld controller, press “Enter” and then 

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confirm the number of letters correct at the next prompt.  The M&S System will then 
advance to the next line of testing and the process will repeat.  The system will end the 
test when the subject no longer has any correct responses.  The number of letters 
correctly read will be displayed on the laptop screen, along with the LogMAR value and 
Snellen acuity.  Record the total number of letters read.  A similar process will be done 
for contrast sensitivity grating responses.  Once a test is completed, follow the prompts 
on the computer screen to start the next test. 
Test results are stored in the M&S computer and a hard copy will be printed and 
validated as a back-up. 
 
 

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APPENDIX F INSTRUCTIONS FOR DISTANCE VISUAL ACUITY TESTING 
For distance visual acuities, the M&S System laptop should be placed at a test distance 
of 4.0 meters from the subject for testing distance visual acuities.  A laptop setting may 
be used to reverse charts for rooms that require “folding” via a mirror to reach a distance 
of 4.0 meters.  Whether standard or “folded”, measure and record the test distance 
accurately.  If the room set-up does not allow the computer to be placed at precisely 
4.0 meters, the M&S System can be adjusted to account for the actual test distance 
used. 
The M&S System will be set up to perform the required distance visual acuity tests in a 
specific order, with prompts on the screen to allow the technician to set up the subject 
for monocular or binocular testing, refraction adjustment as needed and uncorrected or 
best corrected testing.   
Subjects should be reminded prior to testing that squinting is not allowed.  The 
technician is to observe the subject to ensure the subject is not squinting during visual 
acuity testing.  If squinting is observed, the subject is to be reminded by the testing 
technician not to squint.   
Distance visual acuity measurements are to be performed per the visit schedule in 
Appendix A.  Monocular testing is required on the first eye implanted only; to test 
subjects monocularly, occlude the second eye in the phoropter or with an occluder if trial 
lenses are used.   
Visual acuity measurements are based on the total number of correctly read letters.  
Subjects should be persuaded to read the smallest letters possible even if they have to 
guess.  Follow the testing process listed in Appendix E.  At the end of the test, the 
number of letters correctly read will be displayed on the laptop screen, along with the 
LogMAR value and Snellen acuity.  Record the total number of letters read in the EDC 
system.   
BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) LOW CONTRAST (10%) 
Monocular testing is required on the first eye implanted only; to test subjects 
monocularly, occlude the second eye in the phoropter or with an occluder if trial lenses 
are used.   
Visual acuity measurements are based on the total number of correctly read letters.  
Subjects should be persuaded to read the smallest letters possible even if they have to 
guess.  Follow the testing process listed in Appendix E.  At the end of the test, the 
number of letters correctly read will be displayed on the laptop screen, along with the 

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LogMAR value and Snellen acuity.  Record the total number of letters read in the EDC 
system.   
 
 

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APPENDIX G INSTRUCTIONS FOR INTERMEDIATE VISUAL ACUITY 
TESTING  
Intermediate visual acuity will be measured using the M&S System at a test distance of 
66 cm.  Subjects should be reminded prior to testing that squinting is not allowed and the 
testing technician should carefully observe to ensure the subject is not squinting.  If 
squinting is observed, the subject is to be reminded by the testing technician not to 
squint.   
The M&S System will be set up to perform the required intermediate visual acuity tests in 
a specific order, with prompts on the screen to allow the technician to set up the subject 
for monocular or binocular testing, refraction adjustment as needed, and uncorrected or 
distance corrected testing.   
Intermediate visual acuity measurements are to be performed per the visit schedule in 
Appendix A.  Monocular testing is required on the first eye implanted only; to test 
subjects monocularly, occlude the second eye in the phoropter or with an occluder if trial 
lenses are used.   
Visual acuity measurements are based on the total number of correctly read letters.  
Subjects should be persuaded to read the smallest letters possible even if they have to 
guess.  Follow the testing process listed in Appendix E.  At the end of the test, the 
number of letters correctly read will be displayed on the laptop screen, along with the 
LogMAR value and Snellen acuity.  Record the total number of letters read in the EDC 
system.   

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APPENDIX H INSTRUCTIONS FOR NEAR VISUAL ACUITY TESTING 
Near visual acuity will be measured using a using Good-Lite 100% ETDRS near charts 
designed for 40 cm and the Good-Lite self-illuminated and self-calibrated illumination 
box.  The Good-Lite illumination box is self-illuminated and self-calibrates to a light level 
of approximately 85 cd/m2 (range of 80–110 cd/m2 is acceptable).  Room lighting is to be 
set at a level lower than the illumination from the light box, per manufacturer instructions.  
Ambient luminance should be from dim to dark to maximize pupil size.  No surface 
(including reflective surfaces) within the subject’s field of vision should exceed the chart 
background in luminance. 
The light box should be placed at a test distance of 40 cm from the subject for testing 
near visual acuities.  Subjects should be reminded prior to testing that squinting is not 
allowed and the testing technician should carefully observe.  If squinting is observed, the 
subject is to be reminded by the testing technician not to squint.   
To avoid chart memorization, charts will be changed between every visual acuity 
measurement.  Monocular testing will be required on the first eye implanted only, with 
the second eye occluded.  Monocular and binocular uncorrected testing will be 
completed before monocular and binocular distance corrected testing are done.   
Near visual acuity testing is to be performed per Appendix A.  Visual acuity 
measurements are based on the total number of correctly read letters.  Subjects should 
be persuaded to read the smallest letters possible even if they have to guess.  Record 
the total number of letters read correctly for each near test on the case report form.  
Near score grids are to be used and must be retained as source documentation.  A 
reference chart for the conversion of the number of correctly-read ETDRS letters to a 
Snellen line equivalent is provided later in this section. 
PROCEDURE:  Begin with monocular uncorrected near visual acuity testing for the first 
eye implanted with the second eye occluded, and instruct subjects to read each line from 
left to right until they cannot read any additional letters.  Subjects should be persuaded 
to read the smallest letters possible even if they have to guess.  Alternate the near chart 
per the score sheet and perform binocular uncorrected near visual testing.  Change the 
near chart per the score sheet and ensure the refractive adjustment of -0.25 D has been 
added for corrected near acuities.  Begin testing with monocular distance corrected 
visual acuity (in the first eye) followed by binocular distance corrected visual acuity.  
Record the total number of letters read for each test condition on the score grid and in 
the EDC system. 
 

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Conversion Reference Chart for GOOD-LITE Near (40 cm) Chart (ETDRS) 
Standard Snellen 
Line Equivalent 
Number of 
ETDRS Letters 
Read at 40 cm 
 Standard Snellen 
Line Equivalent 
Number of 
ETDRS Letters 
Read at 40 cm 
 
20/10 
85 
 
20/50 
49 
84 
 
48 
83 
 
20/60 
47 
20/13 
82 
 
46 
81 
 
45 
80 
 
44 
79 
 
43 
78 
 
20/80 
42 
20/16 
77 
 
41 
76 
 
40 
75 
 
39 
74 
 
38 
73 
 
20/100 
37 
20/20 
72 
 
36 
71 
 
35 
70 
 
34 
69 
 
33 
68 
 
20/126 
32 
20/25 
67 
 
31 
66 
 
30 
65 
 
29 
64 
 
28 
63 
 
20/160 
27 
20/32 
62 
 
26 
61 
 
25 
60 
 
24 
59 
 
23 
58 
 
20/200 
22 
20/40 
57 
 
21 
56 
 
20 
55 
 
19 
54 
 
18 
53 
 
>20/200 
17 
20/50 
52 
 
16 
51 
 
15 
50 
 
 
 
 
 
 

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APPENDIX I INSTRUCTIONS FOR DEPTH OF FOCUS TESTING 
All depth of focus testing is to be performed under photopic conditions using the M&S 
System at a test distance of 4.0 meters.  Subjects should be reminded prior to testing 
that squinting is not allowed and the testing technician should carefully observe to 
ensure the subject is not squinting.  If squinting is observed, the subject is to be 
reminded by the testing technician not to squint.   
This test is to be done monocularly at the 1-month visit for all subjects and binocularly at 
the 6-month visit for all subjects.  Only the first eye implanted will be tested at the 
1-month visit.    
Monocular Depth of Focus Testing (1-month visit):  With the subject’s distance correction 
in place for the first eye and the second eye occluded, defocus the image by +2.00 D 
over the manifest distance correction in the first eye.  Start the test by instructing the 
subject to read as many letters as possible on the M&S system, even if they have to 
guess.  The technician will control movement through charts based on subject 
responses and the system will end the testing when a threshold is reached.  The number 
of letters correctly read and the LogMAR score will be displayed on the laptop screen; 
record the total number of letters correct in EDC.  Continue to change the defocus 
in -0.50 D increments, repeating the test and recording the total number of letters correct 
at each level of defocus.  Continue to change the defocus to -4.00 D over the subject’s 
distance correction. 
Binocular Depth of Focus Testing (6-month visit):  Begin binocular testing by defocusing 
the image by +2.00 D over the manifest distance correction in both eyes.  Start the test 
by instructing the subject to read as many letters as they can on the M&S system, even 
if they have to guess.  The technician will control movement through charts based on 
subject responses and the system will end the testing when a threshold is reached.  The 
number of letters correctly read and the LogMAR score will be displayed on the laptop 
screen; record the total number of letters correct in EDC.  Continue to change the 
defocus in -0.50 D increments in both eyes, repeating the test and recording the total 
number of letters correct at each level of defocus.  Continue to change the defocus 
to -4.00 D over the subject’s distance correction. 
 
 

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APPENDIX J INSTRUCTIONS FOR PUPIL SIZE MEASUREMENTS 
Pupil size should be measured by a Colvard pupillometer (Oasis Medical) or a 
NeurOptics pupillometer (NeurOptics, Inc.).  For consistency, the same method should 
be used throughout the study.  Pupil size should be recorded to the nearest one-half 
millimeter (one-tenth millimeter for NeurOptics). 
PHOTOPIC PUPIL SIZE: 
Photopic pupil size for each eye should be measured under the same lighting conditions 
as the photopic distance visual acuity testing.  To measure photopic pupil size, have the 
subject look at a spot in the distance (without glasses) and allow one eye to be exposed 
to the ambient room lighting while measuring the pupil of the other eye.  Repeat the 
measurement on the second eye, and record the photopic pupil size for both eyes.   
MESOPIC PUPIL SIZE: 
Mesopic pupil size for each eye should be measured under mesopic conditions.  Room 
lights should be off and the 1.5 ND filter placed in front of the M&S System to reduce the 
lighting to 3 cd/m2.  Place a 1.5 ND filter lens for each eye in the trial frames/phoropter.  
After 10 minutes of dark adaptation, have the subject (without glasses and/or trial 
frames) look at a spot on the mesopic contrast sensitivity chart and allow one eye to 
continuously be exposed to the lighting condition while measuring the pupil of the other 
eye.  Repeat the measurement on the second eye, and record the mesopic pupil size for 
both eyes.   
MESOPIC WITH GLARE PUPIL SIZE: 
Mesopic with glare pupil size for each eye should be measured under mesopic with glare 
contrast sensitivity conditions.  Room lights should be off, the 1.5 ND filter placed in front 
of the M&S System to reduce the lighting to 3 cd/m2, and the glare lights from the M&S 
System on.  Have the subject (without glasses and/or trial frames) look at a spot on the 
mesopic with glare contrast sensitivity chart and allow one eye to continuously be 
exposed to the lighting condition while measuring the pupil of the other eye.  Repeat the 
measurement on the second eye, and record the mesopic with glare pupil size for both 
eyes.   

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APPENDIX K INSTRUCTIONS FOR CONTRAST SENSITIVITY TESTING 
Contrast sensitivity testing will be measured using the M&S system for sine-wave 
gratings (1.5, 3, 6, 12 and/or 18 cycles per degree).  Testing will be done under mesopic 
and mesopic with glare and photopic lighting conditions.  The test distance for the 
M&S system is 8 feet (2.5 meters).  Mesopic testing without glare will be performed 
before contrast sensitivity with glare testing.   
This test is to be done monocularly at the 1-month and binocularly at the 6-month visit 
for all subjects.  Only the first eye implanted will be tested at the 1-month visit.   All 
subjects will be tested with best corrected manifest refraction in place, and a refraction 
adjustment of +0.12 D over manifest refraction in place.  Subjects should be shown the 
contrast sensitivity target samples before dark adaptation for mesopic testing is started.  
Contrast sensitivity measurements are based on subject identification of the orientation 
of a low contrast grating (vertical, horizontal, tilted left or tilted right).  For each grating 
presented, the subject will have to identify or guess the orientation of the grating.  After 
an automated protocol, contrast sensitivity values will be displayed on the laptop screen 
for 1.5, 3, 6, 12 and/or 18 cpd.   
Monocular Testing (1-month visit):  The test will begin with the photopic lighting condition 
and then proceed to the mesopic without glare lighting condition.  Dim to dark room 
lighting will be used along with a 1.5 ND filter in front of the M&S system laptop 
computer screen.  Dark adapt the subject for 10 minutes and measure mesopic pupil 
size per Appendix J prior to beginning the test.  Place the subject’s distance correction 
with the +0.12 D refraction adjustment in place for the first eye implanted and occlude 
the second eye implanted.  Ensure the 1.5 ND filter lenses have been removed from the 
trial frames/phoropter before testing begins.  The 1.5 ND filter is only to be in front of the 
M&S system laptop computer screen.  Begin testing and instruct the subject to report the 
orientation of the contrast grating out loud as they view the grating, documenting the 
subject responses on the M&S tablet.  Encourage the subject to continue through all 
gratings, even if they have to guess.  The M&S System will advance to the next set of 
gratings based on the technician input of the subject’s responses.  Record the contrast 
sensitivity percentages displayed on the laptop computer for all the spatial frequencies in 
EDC. 
Binocular Testing (6-month visit):  The test will begin with the photopic lighting condition.  
Proceed to mesopic without glare lighting condition.  Dim to dark room lighting will be 
used along with a 1.5 ND filter in front of the M&S system laptop computer screen.  Dark 
adapt the subject for 10 minutes and measure mesopic pupil size per Appendix J prior 
to beginning the test.  Place the subject’s distance correction with the +0.12 D refraction 
adjustment in place for both eyes.  Ensure the 1.5 ND filter lenses have been removed 

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from the trial frames/phoropter before testing begins.  The 1.5 ND filter is only to be in 
front of the M&S system laptop computer screen.  Begin testing and instruct the subjects 
to report the orientation of the contrast grating out loud as they view the grating, 
documenting the subject responses on the M&S tablet.  Encourage the subject to 
continue through all gratings, even if they have to guess.  The M&S System will advance 
to the next set of gratings based on the technician input of the subject’s responses.  
Record the contrast sensitivity percentages displayed on the laptop computer for all the 
spatial frequencies in EDC. 
 
 

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APPENDIX L SLIT-LAMP EXAM RATINGS 
A.  Ratings of Aqueous Cells and Flare 
For consistency across study sites, the SUN (Standardization of Uveitis Nomenclature) 
Working Group Grading Scheme is to be used for grading of anterior chamber cells and 
flare as reported in: Standardization of uveitis nomenclature for reporting clinical data.  
Results of The First International Workshop; The standardization of uveitis nomenclature 
(SUN) working group.  Am J Ophthalmol 2005;140:509-516. 
CELLS 
Grade 
Cells in Field (Field is a 1x1 mm slit beam) 
0 
<1 
0.5+ 
1 - 5 
1+ 
6 - 15 
2+ 
16 - 25 
3+ 
26 - 50 
4+ 
>50 
 
FLARE 
Grade 
Description 
0 
None 
1+ 
Faint 
2+ 
Moderate (iris and lens details clear) 
3+ 
Marked (iris and lens details hazy) 
4+ 
Intense (fibrin or plastic aqueous) 
B.  Ratings of Corneal Edema 
Corneal edema should be classified according to the haziness of the epithelium, the 
number of microcysts observed, and the clouding of the stroma. 
Amount 
Grade 
Description 
None 
0 
Normal transparency: 
a. No epithelial or sub-epithelial haziness 
b. No microcysts 
c. No stromal cloudiness 
Trace 
+1 
a. Barely discernible localized epithelial or sub-epithelial haziness, and/or 
b. 1 to 20 microcysts, and/or 
c. Barely discernible localized stromal cloudiness 
Mild 
+2 
a. Faint but definite localized or generalized epithelial, sub-epithelial or 
stromal haziness/cloudiness, and/or 
b. 21-50 microcysts 
Moderate 
+3 
a. Significant localized or generalized epithelial, sub-epithelial or stromal 
haziness/cloudiness and/or 
b. 51-100 microcysts 
Severe 
+4 
a. Definite widespread epithelial or stromal cloudiness, giving dull glass 
appearance to cornea or numerous coalescent bullae (please note the 
number and location of bullae), and/or 
b. >100 microcysts or bullae, and/or 
c. Numerous striae (please note the number and location of striae or folds) 

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C.  Posterior Capsule Striae Grading Scale 
The following five-point grading scale is to be used for rating striae in the posterior 
capsule: 
Amount 
Grade Description 
None 
0 
None 
Trace 
+1 
One detectable, barely noticeable striae 
Mild 
+2 
One or two prominent striae 
Moderate 
+3 
Three or more prominent striae, but visibility of retina is 
not impacted 
Severe 
+4 
Three or more prominent striae affecting visualization of 
retina 
 
D.  Posterior Capsule Opacification Grading Scale 
Below is the five-point grading scale to be used for PCO determination: 
Amount 
Grade Description 
None 
0 
Normal posterior capsule with no area of opacity.  Red reflex 
bright. 
Trace 
+1 
Some loss of transparency involving the posterior capsule.  
Red reflex fairly bright 
Mild 
+2 
Mild loss of transparency with cloudiness extending through 
most of the posterior capsule.  There may be a few Elschnig’s 
pearls in the posterior capsule.  Red reflex mildly diminished. 
Moderate 
+3 
Moderate loss of transparency with difficulty visualizing the 
retina.  There may be multiple Elschnig’s pearls in the 
posterior capsule.  Red reflex markedly diminished. 
Severe 
+4 
Posterior capsule very opaque with inability to view the retina.  
The posterior capsule may have confluent Elschnig’s pearls 
and fibrous scarring.  Red reflex barely visible. 
 
E.  IOL Glistenings  
Use the following scale to grade IOL glistenings, using a slit beam 2.0 mm wide and 
10.0 mm long: 
Amount 
Grade 
Description 
None 
0 
No glistenings visible 
Rare 
+0.5 
<10 glistenings visible 
Trace 
+1 
10-19 glistenings visible 
Mild 
+2 
20-29 glistenings visible 
Moderate 
+3 
30-39 glistenings visible 
Severe 
+4 
≥40 glistenings visible