A Prospective Randomized Controlled Multi-center Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus
Conditions: Aphakia, Cataract, Presbyopia
Sponsor: RxSight, Inc.

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PROTOCOL CSP-033 
 
A PROSPECTIVE RANDOMIZED CONTROLLED MULTI-CENTER CLINICAL 
STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE RXSIGHT 
LIGHT ADJUSTABLE LENS (LAL) IN SUBJECTS DESIRING AN EXTENDED 
DEPTH OF FOCUS 
 
 
RxSight, Inc. 
100 Columbia, Suite 120 
Aliso Viejo, CA 92656 
 
Version 17 
October 12, 2020 
 
 
 
 
 
 
 
I have read and agree to follow the procedures as outlined in this protocol. 
 
This protocol contains confidential proprietary information with respect to RxSight products 
and clinical trials.  I agree to hold this information in confidence and not to disclose it to any 
third parties for a period of five years from the date of this agreement, or until this 
information becomes a matter of public knowledge through no action or failure on my part to 
maintain its confidentiality. 
 
 
_________________________________ 
  Site Name 
 
 
_________________________________ 
__________________ 
  Signature 
  Date 
 
 

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7.4 
CONTROL LENS IMPLANTATION ....................................................................... 42 
7.5 
EXAMINATION SCHEDULE ................................................................................. 42 
7.6 
CLINICAL PARAMETERS .................................................................................... 43 
7.7 
DATA REPORTING ............................................................................................. 54 
7.8 
STUDY COMPLETION PROCEDURES .................................................................. 54 
 Subject Completion ............................................................................... 54 
 Subject Withdrawal Prior to Implantation ........................................ 54 
 Subject Withdrawal due to intraoperative complications 
prior to or during attempted Implantation ........................................ 55 
 Subject Discontinuation After Implantation ...................................... 55 
 Lost to Follow-Up .................................................................................. 55 
 Study Termination ................................................................................ 55 
8 
STATISTICAL METHODS ..................................................................................... 56 
8.1 
SAMPLE SIZE CALCULATION ............................................................................ 56 
 Sample Size for the Effectiveness Endpoints ...................................... 56 
 Sample Size for the Safety Endpoints .................................................. 59 
 Sample Size for the Study ..................................................................... 59 
8.2 
GENERAL CONSIDERATION ............................................................................... 59 
8.3 
POPULATIONS FOR ANALYSIS ........................................................................... 59 
 Pre-COVID-19 Population ................................................................... 59 
 Modified Safety Population .................................................................. 60 
 Intent-to-treat (ITT) Population and Full Analysis Set (FAS) .......... 60 
 Per-Protocol (PP) Population ............................................................... 60 
8.4 
BASELINE CHARACTERISTICS ........................................................................... 61 
8.5 
EFFECTIVENESS ANALYSES ............................................................................... 61 
 Primary Analyses for the Effectiveness Endpoints ............................ 61 
 Secondary/Sensitivity Analyses for the Primary Effectiveness 
Endpoints ............................................................................................... 64 
 Covariates and Subgroup Analyses ..................................................... 65 
 Additional Effectiveness Analyses ....................................................... 66 
8.6 
SAFETY PARAMETERS ........................................................................................ 71 
 Adverse Events (AE) ............................................................................. 71 
 Change in Monocular Photopic BCDVA ............................................ 71 
 
 Subjective Symptoms and Complaints ................................................ 72 
 Other Ocular Examinations ................................................................. 72 

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 Distance Corrected Contrast Sensitivity (Mesopic/Photopic w 
and w/o glare) ........................................................................................ 73 
 IOL Stability (Tilt/Decentration) ........................................................ 73 
 Wavefront Aberrometry ..................................................................... 73 
 Secondary Surgical Intervention (SSI) .............................................. 73 
8.7 
SEQUENCE OF PLANNED ANALYSES .................................................................. 74 
 Final Analysis ........................................................................................ 74 
9 
ADVERSE EVENTS ................................................................................................. 74 
9.1 
ADVERSE EVENT DEFINITIONS ......................................................................... 74 
9.2 
ADVERSE DEVICE EFFECT (ADE) DEFINITION ................................................ 77 
9.3 
DEVICE DEFICIENCY (DD) DEFINITION ........................................................... 77 
9.4 
SERIOUS ADVERSE EVENT DEFINITION ............................................................ 77 
9.5 
UNANTICIPATED PROBLEM DEFINITION .......................................................... 77 
9.6 
IDENTIFICATION AND COLLECTION .................................................................. 78 
 Evaluations ............................................................................................. 78 
9.7 
SAE REPORTING ............................................................................................... 79 
9.8 
UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) REPORTING ................. 79 
9.9 
DEVICE DEFICIENCY (DD) REPORTING ........................................................... 80 
9.10 UNANTICIPATED PROBLEM (UP) REPORTING .................................................. 80 
9.11 PREGNANCY ....................................................................................................... 80 
9.12 POTENTIAL ADVERSE EVENTS .......................................................................... 80 
9.13 POTENTIAL COVID-19 RISKS .......................................................................... 81 
9.14 POTENTIAL BENEFITS ....................................................................................... 82 
10 
STUDY MONITORING ........................................................................................... 82 
11 
ETHICAL AND REGULATORY CONSIDERATIONS ...................................... 83 
11.1 SUBJECT INFORMATION AND CONSENT ............................................................ 83 
11.2 DECLARATION OF HELSINKI ............................................................................. 84 
11.3 ISO 14155:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR 
HUMAN SUBJECTS- GOOD CLINICAL PRACTICE ............................................. 84 
11.4 ADDITIONAL REGULATORY CONSIDERATIONS ................................................ 84 
11.5 STUDY INITIATION/CONDUCT ........................................................................... 84 
11.6 COMPLIANCE WITH THE CLINICAL STUDY PROTOCOL ................................... 84 
11.7 PROTOCOL DEVIATIONS (PDS) ......................................................................... 84 
11.8 PROTOCOL AMENDMENTS ................................................................................ 85 
11.9 PUBLICATION POLICY ....................................................................................... 85 
11.10 INSURANCE AND INDEMNITY ............................................................................. 85 

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12 
REFERENCES .......................................................................................................... 85 
 
  
 
 
 

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RXSIGHT, INC. 
 
PROTOCOL NO. CSP-033 
 
A PROSPECTIVE RANDOMIZED CONTROLLED MULTI-CENTER CLINICAL 
STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE RXSIGHT 
LIGHT ADJUSTABLE LENS (LAL) IN SUBJECTS DESIRING AN EXTENDED 
DEPTH OF FOCUS 
 
1 
STUDY SYNOPSIS 
1.1 
STUDY OBJECTIVE 
 
The primary objective of this study is to evaluate, for the visual correction of aphakia and 
presbyopia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) to 
provide an extended depth of focus (improve intermediate and near visual acuity without 
compromising distance visual acuity) in subjects who have undergone bilateral implantation 
with the LAL and subsequent light treatments for refractive and presbyopia correction (LAL 
group). To assess for effectiveness, a control group consisting of subjects bilaterally 
implanted with commercially available IOLs (SofPort LI61AO monofocal IOL, Bausch + 
Lomb) (Control group) will be used. Primary effectiveness will be demonstrated by 
comparing monocular measurements of depth of focus (DOF), photopic distance corrected 
intermediate visual acuity (67 cm), and photopic best corrected distance visual acuity (4 
meters) between primary eyes in the LAL group and Control group at the Postop Month 6 
visit. Secondary effectiveness will be demonstrated by comparing monocular measurements 
of primary eyes of photopic uncorrected distance visual acuity (UCDVA) (4 
meters)/uncorrected intermediate visual acuity (UCIVA) (67 cm)/uncorrected near visual 
acuity (UCNVA) (40 cm) and monocular measurements of primary eyes of photopic 
uncorrected distance visual acuity (4 meters) and photopic distance corrected near visual 
acuity (40 cm) between the LAL group and Control group at the Postop Month 6 visit. 
 
 
1.2 
STUDY POPULATION   
The study population will consist of up to 350 subjects enrolled (informed consent form 
signed) to allow for up to 230 subjects with implantation of either the LAL IOL or Control 
IOL attempted in the Full Analysis Set (FAS). An additional 17 subjects were previously 
implanted in the pre-COVID-19 population. Each subject will desire to improve their depth 
of focus (improve intermediate and near visual acuity without compromising distance visual 
acuity), will be good candidates for bilateral IOL implantation, and will agree to participate 
in a randomized clinical study. Study subjects will be randomized 1:1 to either undergo 
bilateral LAL implantation and light treatments for refractive and presbyopia correction 
(LAL group) or to undergo bilateral implantation with commercially available IOLs (SofPort 
LI61AO monofocal IOL, Bausch + Lomb) (Control group). All study subjects must have 
preoperative keratometric astigmatism of <0.75 D in both eyes. Subject’s eyes must meet all 
other applicable inclusion criteria and none of the exclusion criteria.  
 

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lane at this visit. Eyes measured with a manifest cylinder of ≥0.50 D will receive a sphero-
cylindrical light treatment while eyes with <0.50 D of manifest cylinder will receive a non-
astigmatic light treatment. 
 
Three to 7 days after the Adjustment #2 light treatment, both eyes will be eligible to receive 
an adjustment #3 light treatment. If the eye’s |MRSE| is ≥0.25 D OR manifest cylinder is 
measured at ≥0.50 D, then the eye will receive an adjustment #3 light treatment; otherwise 
the eye will be eligible to proceed to lock-in #1.  
 
The lock-in #1 light treatment will be performed in the primary eye 3 to 7 days after the 
subject’s final adjustment light treatment followed 3 to 7 days later by the lock-in #2 
treatment, if needed. The lock-in #1 treatment will be performed in the fellow eye 3 to 7 days 
after the final lock-in in the primary eye and after confirmation that there has been no 
ultraviolet (UV) retinal damage per Sections 7.3.2.1 and 7.3.2.2 followed 3 to 7 days later by 
lock-in #2, if needed. Subjects in the LAL group will receive 
, up to 
three sphero-cylindrical/non-astigmatic light treatments, and one or two lock-in treatments in 
each eye. 
   
Examinations will occur at regular intervals over a 6 month period to evaluate the safety and 
effectiveness outcomes. For eyes in the LAL group, if an eye is diagnosed with ultraviolet 
(UV) retinal damage, an additional follow-up exam will be added at 12 months 
postoperatively to confirm resolution or document sequelae, if any. Masked examiners will 
be utilized at the Postop Month 6 visit.   
 
Safety for all study eyes will be evaluated per ISO 11979-7. 
 
1.4 
INCLUSION CRITERIA 
• Must sign a written Informed Consent Document and be willing to undergo cataract 
surgery for bilateral implantation of either the LAL or SofPort LI61AO IOL (Bausch 
+ Lomb). 
• Must be willing to be randomized to either the LAL group (bilaterally implanted with 
the LAL and receive light treatments for refractive and presbyopia correction) or the 
Control group (bilateral implantation with the SofPort LI61AO monofocal IOL).   
• 
Between the ages of 40 and 80 inclusive on the day the first cataract surgery is 
performed. 
• 
Preoperative keratometric cylinder <0.75 D in both eyes.   
• 
Cataractous lens changes as demonstrated by best corrected distance visual acuity 
(BCDVA) of 20/40 or worse with or without a glare source in both eyes. 
• 
Best corrected distance visual acuity projected to be 20/20 or better after cataract 
removal and intraocular lens (IOL) implantation in both eyes as estimated by 
potential acuity meter (PAM) or surgeon estimation.   
• 
Clear intraocular media other than cataract in both eyes. 
• 
Willing and able to comply with the requirements for study specific procedures and 
visits.  

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• 
 
  
• 
Able to complete a written questionnaire in English. 
• 
Requires an IOL power within the range available for both the LAL and SofPort 
LI61AO IOLs. 
 
1.5 
EXCLUSION CRITERIA 
• 
Pseudoexfoliation in either eye. 
• 
Pre-existing macular disease in either eye. 
• 
Patient with sufficiently dense cataract that precludes examination of the macula in 
either eye. 
• 
Retinal degenerative disorder that is expected to cause future vision loss in 
either eye. 
• 
Diabetes with any evidence of retinopathy in either eye.   
• 
Evidence of glaucomatous optic neuropathy in either eye.    
• 
History of uveitis in either eye.    
• 
Significant anterior segment pathology, such as rubeosis iridis, aniridia, or iris 
coloboma in either eye. 
• 
Pupil that is deformed including ectopic pupil condition in either eye. 
• 
Corneal pathology that is either progressive or sufficient to reduce BCDVA to 
worse than 20/20 in either eye. 
• 
Any corneal dystrophy including basement membrane dystrophy in either eye 
that in the opinion of the investigator may confound the outcome. 
• 
Keratoconus or suspected of having keratoconus in either eye. 
• 
Has undergone previous corneal or intraocular surgery in either eye, except 
eyes with previous pterygium excision are permitted as long as the pterygium 
did not extend more than 2mm onto the cornea from the limbus.  
• 
Subjects with serious co-morbid conditions that in the judgment of the investigator 
makes inclusion in the study not in the best interest of the subject. 
• 
Subjects taking systemic medication that may increase sensitivity to UV light such as 
tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, 
hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and 
methoxsalen. LDD treatment in patients taking such medications may lead to 
irreversible phototoxic damage to the eye. This is only a partial list of 
photosensitizing medications. Please evaluate all medications that the patient is taking 
for this effect prior to consideration for implantation.  
• 
Subjects taking a systemic medication that is considered toxic to the retina such as 
tamoxifen. 
• 
Subjects who the doctor believes will be unable to maintain steady fixation that is 
necessary for centration of the LDD light treatment in either eye. 
• 
Irregular astigmatism in either eye. 

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ABBREVIATIONS  
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariate 
ANOVA 
Analysis of Variance 
ANSI 
American National Standards Institute 
BCDVA 
Best Corrected Distance Visual Acuity 
CCC 
Continuous Circular Capsulorhexis 
CDRH 
Center for Devices and Radiological Health 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
D 
Diopter 
DCIVA 
Distance corrected intermediate visual acuity 
DCNVA 
Distance corrected near visual acuity 
DD 
Device Deficiency 
DES 
Dry Eye Syndrome 
DEQ 
Defocus Equivalent 
 
 
DOF 
Depth of Focus 
EC 
Ethics Committee 
EDC 
Electronic Data Capture 
EDF 
Extended Depth of Focus 
ETDRS 
Early Treatment Diabetic Retinopathy Study 
FA 
Fluorescein Angiography 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
ICD 
Informed Consent Document 
IDE 
Investigational Device Exemption 
IOL 
Intraocular Lens 
IOP 
Intraocular Pressure 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
ITT 
Intent To Treat 
KCYL 
Keratometric Cylinder 
LAL 
RxSight Light Adjustable Lens 

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LDD 
Light Delivery Device 
MR 
Manifest Refraction 
MRCYL 
Manifest Refraction Cylinder 
MRSE 
Manifest Refraction Spherical Equivalent 
NEI 
National Eye Institute 
OCT 
Optical Coherence Tomography 
PCO 
Posterior Capsular Opacity 
PD 
Protocol Deviation 
PHI 
Protected Health Information 
PMA 
Premarket Application 
PP 
Per Protocol Population 
PPC 
Precision Pulse Capsulotomy 
 
 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SDT 
Source Document Template 
SE 
Spherical Equivalent 
SPE 
Safety and Performance Endpoints 
SPK 
Superficial Punctate Keratitis 
SSI 
Secondary Surgical Intervention 
 
 
UADE 
Unanticipated Adverse Device Effect 
UCDVA 
Uncorrected Distance Visual Acuity 
UCIVA 
Uncorrected Intermediate Visual Acuity 
UCNVA 
Uncorrected Near Visual Acuity 
UV 
Ultraviolet 
VA 
Visual acuity 
 
 
 

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2.1 
CLINICAL STUDIES PERFORMED WITH PRIOR VERSION OF THE LIGHT ADJUSTABLE LENS 
AND LIGHT DELIVERY DEVICE 
Phase III Study Conducted Under IDE G100240 
A 600 eye prospective, randomized, controlled, multi-center clinical trial of the LAL and LDD 
designed to evaluate safety and effectiveness over a 12-month period was conducted at 17 sites. In 
addition to the visual correction of aphakia, reduction in residual spherocylindrical refractive error 
and improvement in uncorrected visual acuity were evaluated following LAL implantation and 
subsequent refractive adjustment of the LAL by the LDD.  
 
Eyes with ≥0.75 and ≤2.5 diopters (D) of keratometric cylinder were randomly assigned to receive 
either the LAL or a commercially available, posterior chamber, non-accommodating, control 
monofocal IOL. Six hundred eyes were implanted with 403 eyes randomized to the LAL group 
and 197 eyes to the Control group. 
 
Co-primary effectiveness endpoints included percent reduction in manifest cylinder, percent mean 
absolute reduction in manifest refraction spherical equivalent (MRSE), and rotation of the LAL. 
All primary effectiveness endpoints compared pre-adjustment (LAL) or 17-21 days (Control) to 6 
months postoperatively and the first two endpoints compared results between the LAL and Control 
groups. All three co-primary effectiveness endpoints were met with a p-value <0.0001. The 
difference in means for percent reduction in manifest cylinder was 54.7%, with a p-value <0.0001. 
The difference in means for percent reduction in absolute MRSE was 41.1% with a p-value 
<0.0001. Rotation of the LAL of ≤5 degrees was observed in 96.1% of LAL implanted eyes with 
both the upper and lower bound of the 95% confidence interval exceeding the requirement of 90%.  
 
100% of eyes in both the LAL and Control groups had BSCVA of 20/40 or better, exceeding the 
historic grid rate of 92.5% (ISO 11979-7). The incidence of sight-threatening complications and 
adverse events for the LAL and Control groups were also below the threshold rates calculated 
from the 1-year historical grid for intraocular lenses (ISO 11979-7, Ophthalmic implants- 
Intraocular lenses- Part 7: Clinical investigations) except for the category of Secondary Surgical 
Interventions (SSI), which was significantly higher than the historical rate (p<.05). 
 
In November 2017, the Center for Devices and Radiological Health (CDRH) of the Food and 
Drug Administration (FDA) approved RxSight’s premarket approval application (PMA) for the 
Light Adjustable Lens (LAL) and Light Delivery Device (LDD) system. This system is indicated 
for the reduction of residual astigmatism to improve uncorrected visual acuity after removal of the 
cataractous natural lens by phacoemulsification and implantation of the intraocular lens in the 
capsular bag; in adult patients: 
• With pre-existing corneal astigmatism of ≥ 0.75 diopters 
• Without pre-existing macular disease 
 
The system also reduces the likelihood of clinically significant residual spherical refractive errors. 
 

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3 
STUDY OBJECTIVE 
The primary objective of this study is to evaluate, for the visual correction of aphakia and 
presbyopia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) to provide an 
extended depth of focus (improve intermediate and near visual acuity without compromising 
distance visual acuity) in subjects who have undergone bilateral implantation with the LAL and 
subsequent light treatments for refractive and presbyopia correction (LAL group). To assess for 
effectiveness, a control group consisting of subjects bilaterally implanted with commercially 
available IOLs (SofPort LI61AO monofocal IOL, Bausch + Lomb) (Control group) will be used. 
Primary effectiveness will be demonstrated by comparing monocular measurements of depth of 
focus (DOF), photopic distance corrected intermediate visual acuity (67 cm), and photopic best 
corrected distance visual acuity (4 meters) between primary eyes in the LAL group and Control 
group at the Postop Month 6 visit. Secondary effectiveness will be demonstrated by comparing 
monocular measurements of primary eyes of photopic uncorrected distance visual acuity 
(UCDVA) (4 meters)/uncorrected intermediate visual acuity (UCIVA) (67 cm)/uncorrected near 
visual acuity (UCNVA) (40 cm) and monocular measurements of primary eyes of photopic 
uncorrected distance visual acuity (4 meters) and photopic distance corrected near visual acuity 
(40 cm) between the LAL group and Control group at the Postop Month 6 visit. 
 
4 
STUDY DESIGN 
A prospective, randomized, controlled, multi-center, clinical study will be conducted at a 
maximum of 11 sites located in the United States. Subjects will be followed for a 6 month period. 
A minimum of 20 subjects will undergo study implantation at each participating site, with less 
than 25% of the total study population implanted at one clinical site.  
 
Patients who require bilateral cataract extraction and intraocular lens implantation and who wish 
to improve their depth of focus will be pre-screened for eligibility as part of pre-entry activity. If it 
is determined that the patient may be eligible to participate, delegated and trained study staff will 
explain the study purpose, procedures, risks/benefits and subject responsibilities to the potential 
participant. Written informed consent must be obtained prior to initiation of any clinical 
procedures that are performed solely for the purpose of determining eligibility for. The patient is 
enrolled upon signing the informed consent. Both eyes of all subjects must be screened for 
eligibility at the same preoperative visit. If at any time during the preoperative screening, either 
eye does not meet inclusion or exclusion criteria, screening for that subject should be discontinued 
and the subject will be exited from the study. Subjects that meet all inclusion/exclusion criteria 
will be randomly assigned in a 1:1 ratio to either the LAL group or Control group. In addition, 
each eye of the subject will be assigned as either the primary eye or fellow eye. Pre-determined 
randomization schemes will be utilized. The primary eye of each subject will be scheduled for 
surgery first with implantation of the fellow eye separated by 7 to 14 days.    
 
All study eyes will be targeted for post cataract surgery emmetropia as measured on a 4 meter 
exam lane. If surgical complications (either prior to attempting to implant the study IOL or after 
study IOL implantation has been attempted) occur with the primary eye and no IOL is implanted, 

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DURATION OF STUDY 
Each subject will participate in the study for approximately 6 months. The recruitment phase is 
expected to last approximately 14 months. The complete study period is expected to be 
approximately 20 months.  
 
STUDY SITE 
The study will be performed in ophthalmology clinics. The investigators will be ophthalmic 
surgeons trained in cataract surgery with implantation of intraocular lenses. Study responsibilities 
will be registered in a delegation log that will be kept at the investigational site. The overall 
responsibility at the study clinic remains with the investigator. 
 
5 
OUTCOME PARAMETERS 
5.1 
EFFECTIVENESS PARAMETERS 
Primary Endpoints 
• Monocular Depth of Focus (DOF) measured at the logMAR 0.20 level at Postop  
Month 6 
 
At Postop Month 6, the LAL group (primary eyes) demonstrates at least 0.5 D greater 
monocular photopic negative lens induced distance-corrected depth of focus compared 
to the Control group (primary eyes) at 0.20 logMAR visual acuity threshold. 
 
• Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm at 
Postop Month 6 
 
At Postop Month 6, the LAL group (primary eyes) demonstrates statistical superiority 
over the Control group (primary eyes) on mean photopic monocular distance corrected 
intermediate visual acuity (DCIVA) at 67 cm. [one-sided test using level of 
significance of 0.025]. 
  
• Outcome of Monocular DCIVA at 67 cm better than or equal to 0.20 logMAR for the 
LAL group at Postop Month 6 
 
At Postop Month 6, the proportion of the LAL primary eyes reaching this outcome is at 
least 50%. In other words, the median of photopic monocular DCIVA at 67 cm for the 
LAL group (primary eyes) is at least 0.20 logMAR. 
 
• Monocular Best Corrected Distance Visual Acuity (BCDVA) at Postop Month 6 
 
At Postop Month 6, the LAL group (primary eye) is statistically non-inferior to the 
Control group (primary eyes) on mean, monocular photopic BCDVA using a non-
inferiority margin of 0.10 logMAR.  
 

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6.2 
EXCLUSION CRITERIA 
• 
Pseudoexfoliation in either eye. 
• 
Pre-existing macular disease in either eye. 
• 
Patient with sufficiently dense cataract that precludes examination of the macula in either 
eye. 
• 
Retinal degenerative disorder that is expected to cause future vision loss in either 
eye. 
• 
Diabetes with any evidence of retinopathy in either eye.   
• 
Evidence of glaucomatous optic neuropathy in either eye.    
• 
History of uveitis in either eye.    
• 
Significant anterior segment pathology, such as rubeosis iridis, aniridia, or iris coloboma in 
either eye. 
• 
Pupil that is deformed including ectopic pupil condition in either eye. 
• 
Corneal pathology that is either progressive or sufficient to reduce BCDVA to 
worse than 20/20 in either eye. 
• 
Any corneal dystrophy including basement membrane dystrophy in either eye that 
in the opinion of the investigator may confound the outcome. 
• 
Keratoconus or suspected of having keratoconus in either eye. 
• 
Has undergone previous corneal or intraocular surgery in either eye, except eyes 
with previous pterygium excision are permitted as long as the pterygium did not 
extend more than 2mm onto the cornea from the limbus.  
• 
Subjects with serious co-morbid conditions that in the judgment of the investigator makes 
inclusion in the study not in the best interest of the subject. 
• 
Subjects taking systemic medication that may increase sensitivity to UV light such as 
tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, 
hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and methoxsalen. 
LDD treatment in patients taking such medications may lead to irreversible phototoxic 
damage to the eye. This is only a partial list of photosensitizing medications. Please 
evaluate all medications that the patient is taking for this effect prior to consideration for 
implantation.  
• 
Subjects taking a systemic medication that is considered toxic to the retina such as 
tamoxifen. 
• 
Subjects who the doctor believes will be unable to maintain steady fixation that is 
necessary for centration of the LDD light treatment in either eye. 
• 
Irregular astigmatism in either eye. 
• History of ocular herpes simplex virus in either eye.  

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A summary of the LAL design characteristics is presented below: 
Lens Optic 
• Material:  Photo-reactive, UV absorbing Silicone 
• Light transmission:  UV cut-off at 10% T ≥ 392 nm for all lens power 
• Index of refraction:  1.43 
• Diopter power:  +10 to +15.0 diopters and +25.0 to +30.0 D in 1.0 diopter increments; 
+16.0 to +24.0 diopters in 0.5 diopter increments 
• Optic type:  Biconvex  
• Optic edge:  Square on posterior surface and round on anterior surface 
• Overall diameter:  13.0 mm 
• Optic diameter:  6.0 mm 
 
Haptics 
 
o Configuration:  Modified C 
o Material:  Blue polymethylmethacrylate 
o Haptic angle:  10° 
 
The LAL silicone material is designed to respond to a narrowband UV light by incorporating 
photoreactive components in the cross-linked silicone lens matrix.  Post implantation, the LAL 
shape may be altered non-invasively (refractive power may be increased or decreased) by 
photoinitiation of a select spatial intensity profile. The silicone material contains photoreactive 
additive, which is selectively photo-polymerized in targeted areas upon exposure to the near UV 
light to alter the lens shape thus modifying spherical and spherocylindrical power of the LAL. The 
change in the shape becomes permanent when the remaining photoreactive additive is consumed 
following application of a non-profiled beam of the same ultraviolet light. 
 
 LIGHT DELIVERY DEVICE (LDD) 
RxSight’s Light Delivery Device (LDD) is a UV light projection system (Figure 2) used to induce 
a predictable change in LAL power after implantation. RxSight’s LDD consists of an anterior 
segment biomicroscope with the addition of an optical projection system, electronic control 
circuitry, and a UV source. The LDD delivers light profiles with adequate intensity and duration to 
induce polymerization of photoreactive additive leading to a refractive power change of the LAL. 
Because this procedure is performed after implantation, residual refractive errors can be 
minimized, reducing the need for spectacles, corneal refractive procedures, or additional IOL 
procedures to optimize a patient’s vision. 

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FIGURE 2:  RXSIGHT LIGHT DELIVERY DEVICE (LDD) 
 
 DEVICE MANUFACTURER 
The LAL and LDD are manufactured by RxSight, Inc. located in Aliso Viejo, California (FDA 
Establishment Registration No. 3012712027). RxSight, Inc. has an established Quality 
Management System that is in conformance with the following standards: 
• 21 C.F.R. Part 820 (Quality System Regulation) 
• EN ISO 13485:2016 (Quality Management System with scope: design, manufacture, 
distribution and service of therapeutic, surgical and diagnostic devices and instruments 
especially for ophthalmology), and the Medical Device Directive 93/42/EEC.  
 
The Sponsor will keep records to document the physical location of all investigational devices 
from shipment to the investigational sites until use, return or disposal. Traceability for both the 
LAL and LDD will be achieved by use of device serial numbers.  
 
The principal investigator or an authorized designee shall keep records documenting the receipt, 
use, return, and disposal of the investigational devices, which shall include: 
• The date of receipt 
• Identification of each investigational device (batch number/serial number or unique code) 
• The expiry date, if applicable 
• The date or dates of use 
• Subject identification 

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The lock-in #1 light treatment will be performed in the primary eye 3 to 7 days after the subject’s 
final adjustment light treatment followed 3 to 7 days later by the lock-in #2 treatment, if needed. 
The lock-in #1 treatment will be performed in the fellow eye 3 to 7 days after the final lock-in in 
the primary eye and after confirmation that there has been no ultraviolet (UV) retinal damage per 
Sections 7.3.2.1 and 7.3.2.2 followed 3 to 7 days later by lock-in #2, if needed. Subjects in the 
LAL group will receive 
, up to three sphero-cylindrical/non-astigmatic light 
treatments, and one or two lock-in treatments in each eye. 
 
Examinations will occur at regular intervals over a 6 month period to evaluate the safety and 
effectiveness outcomes. For eyes in the LAL group, if an eye is diagnosed with ultraviolet (UV) 
retinal damage, an additional follow-up exam will be added at 12 months postoperatively to 
confirm resolution or document sequelae, if any. Masked examiners will be utilized at the Postop 
Month 6 visit.  
 
Safety for all study eyes will be evaluated per ISO 11979-7. 
 
7.3 
LAL IMPLANTATION AND REFRACTIVE ADJUSTMENT 
Each investigative site will follow a standard regimen of pre-, intra-, and postoperative 
medications to be used in the study that has been reviewed and approved by the study medical 
monitor. This standard regimen will also specify the ophthalmic viscoelastic device to be used 
during surgery. 
 
 SURGICAL PROCEDURE 
The LAL will be implanted using standard microsurgical techniques.  
 
No additional corneal refractive procedures are allowed until after the subject has been exited from 
the study.   
 
The surgical procedure for the LAL will be performed as follows: 
1. Prepare and drape the eye for surgery in accordance with standard surgical procedures. 
2. A clear corneal incision will be made using the surgeon’s standard instrumentation and 
techniques.  
3. Use viscoelastic as agreed upon within the standard regimen to fill the anterior chamber 
through the incision opening.   
4. Perform an anterior circular capsulorhexis of a maximum of 5.2 mm in diameter using 
standard technique. The capsulorhexis should be well-centered with a 360° overlapping 
capsular edge to minimize IOL tilt and decentration and longitudinal IOL shift. The 
capsulorhexis and/or nuclear fragmentation can be performed with a femtosecond laser. 
Precision pulse capsulotomy (PPC) can also be used to perform the capsulorhexis.  
5. The surgeon will extract the cataract by phacoemulsification. 

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treatment while eyes with <0.50 D of manifest cylinder will receive a non-astigmatic light 
treatment.  
 
Three to 7 days after the Adjustment #2 light treatment, both eyes will be eligible to receive an 
adjustment #3 light treatment. If the eye’s |MRSE| is ≥0.25 D OR manifest cylinder is measured at 
≥0.50 D, then the eye will receive an adjustment #3 light treatment; otherwise the eye will be 
eligible to proceed to lock-in #1.  
 
The lock-in #1 light treatment will be performed in the primary eye 3 to 7 days after the subject’s 
final adjustment light treatment followed 3 to 7 days later by the lock-in #2 treatment, if needed. 
The lock-in #1 treatment will be performed in the fellow eye 3 to 7 days after the final lock-in in 
the primary eye and after confirmation that there has been no ultraviolet (UV) retinal damage per 
Sections 7.3.2.1 and 7.3.2.2 followed 3 to 7 days later by lock-in #2, if needed. Subjects in the 
LAL group will receive 
, up to three sphero-cylindrical/non-astigmatic 
light treatments, and one or two lock-in treatments in each eye. 
 
7.3.2.1 Postponement of Light Treatment Procedure(s) 
LDD treatments should be delayed in both eyes if any of the following new symptoms or changes 
in performance are noted in either study eye; 
• Color Vision Testing: Treatment should be delayed if the subject scores worse on Part 2 of 
the City University Color Test than the Postop Week 3 visit for Tritan evaluation. 
• Erythropsia Evaluation: With any score of 2 (red), the treatment should be delayed. 
• Best Corrected Distance Visual Acuity: With any loss of BCDVA (unless the cause is known 
to be non-retinal) of 10 letters or more on an ETDRS (logMAR) chart compared to the Postop 
Week 3 visit BCDVA, treatment should be delayed. 
 
The subject should return for follow-up visits until the subject’s visual assessment of erythropsia 
is a score of 0 or 1 (indicates the paper looks white or pink), the BCDVA is within 10 letters of 
the Postop Week 3 visit BCDVA and an equivalent or better score than the Postop Week 3 visit 
test is measured in the Tritan section of the City University Color Test, at which time the next 
LDD treatment may be delivered.  
 
• If sutures were utilized at the time of surgery to close the incision wound, light treatments 
should not commence on the eye until a minimum of 4 weeks after suture removal.7 
• An eye with an ocular adverse event that could be negatively impacted by light treatment or 
negatively impact the effectiveness or safety of a light treatment should have light treatments 
delayed until after the adverse event has subsided.  This includes corneal edema and 
superficial punctate keratitis (SPK) (Grade 3 (moderate) or more severe)), retinal conditions 
including diabetic retinopathy and cystoid macular edema, epithelial defect, endophthalmitis 
 
7 Azar D, Stark W, Dodick J, et al. Prospective, randomized vector analysis of astigmatism after three-, one-, and no-
suture phacoemulsification. J Cataract Refract Surg 1997; 23:1164-1173. 

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or any other safety concern that the investigator believes may be negatively impacted by light 
treatment.   
• If an eye is discovered with evidence of premature photopolymerization as evidenced as a 
zone on the lens surface, the investigator should contact the Sponsor for further instructions. 
(see Appendix 1 for additional details regarding premature photopolymerization).   
• Any eye possessing clinically significant posterior capsular (PC) haze should undergo a YAG 
capsulotomy procedure prior to the adjustment. A minimum of 48 hours should separate the 
YAG treatment from the corresponding refraction and LDD adjustment. 
 
7.3.2.2 Requirements for Additional Testing 
Additional testing should be performed as soon as possible to evaluate whether UV-related retinal 
damage has occurred if any of the following is observed. When additional testing is required, all 
light treatments on either eye should be delayed until after OCT images are obtained and no 
phototoxic damage is seen. Testing should always include spectral domain OCT and if indicated 
. 
 
Spectral Domain OCT Testing Only 
Any visit after the Postop Week 3 visit: 
• BCDVA is reduced by 10 letters or more when compared with BCDVA at the Postop 
Week 3 visit unless the cause of the BCDVA loss is known to be non-retinal. 
 
OR 
• An increase in score of more than 1 on Part 2 of the Tritan evaluation (City University 
Color Test) when compared to the Postop Week 3 visit score. 
 
Spectral Domain OCT 
 
At the Postop Month 3 visit or later (includes all unscheduled visits after the Postop Month 3 
visit): 
• BCDVA is reduced by 10 letters or more when compared with the BCDVA at the Postop 
Week 3 visit unless the cause of BCDVA loss is known to be non-retinal. 
 
OR 
• An increase in score of 1 or greater on Part 2 of the Tritan evaluation (City University 
Color Test) when compared to the Postop Week 3 visit score except in cases where the 
Part 2 score changes to a 1 from a Postop Week 3 visit score of 0 as this change is 
considered normal.8 
 
OR 
• Any score of 1 (pink) or 2 (red) on the in-office erythropsia assessment. 
 
OR 
• Any report of moderate or severe amounts of added pink or reddish color 
 
 
 
 
8 The City University Colour Vision Test, 3rd Edition, 1998, Keeler Ltd., Windsor.   

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2. Within the Confirmation screen, review all information and press the “Confirm” button. 
3. Verify that the LDD ring lights and reticle target are activated. 
4. Apply topical anesthetic.   
5. Position the RxSight supplied contact lens (M = 0.766x, black contact lens) on the cornea 
using hydroxypropyl methylcellulose or hypromellose as the coupling medium.   
Note: The RxSight contact lens is similar to those used in other ophthalmic procedures in 
which customized magnification is required. To ensure correct magnification for treatment, 
use only the RxSight designated contact lens. 
6. Instruct the subject to focus straight ahead on the LDD fixation light with the eye to be 
treated. 
7. Using the microscope, focus on the cornea and verify that there are no trapped bubbles 
present. Confirm alignment of the contact lens by approximately aligning the Purkinje images 
to the inner circle of the reticle target. 
8. Using the microscope, focus on the LAL haptics and align the reticle target with the periphery 
of the LAL. 
9. Press the “Ready” button 
10. Initiate the irradiation delivery as prompted by the LDD display using the joystick or foot 
pedal to keep the LAL centered in the alignment reticle. 
11. Perform micro adjustments to keep the reticle target centered to the LAL and to keep the LAL 
in focus. In the case of subject movement, loss of alignment, or loss of focus, pause the 
treatment, quickly refocus, realign the lens with respect to the reticle beam, and immediately 
resume treatment to limit the duration of any pauses once the light treatment has been 
initiated.  
Note: Always maintain the LAL in focus by focusing at the haptics. Never focus onto the 
CCC (capsulotomy) or Purkinje images. 
12. If the lock-in treatment is aborted before completion, do not initiate a new lock-in sequence; 
instead; contact the Sponsor for further instructions.   
13. Upon completion of the lock-in #1 treatment, a notification may appear that informs the user 
that all required treatments are complete. If this notification appears, proceed to step #15. If 
no notification appears, then the subject will require a lock-in #2 treatment and proceed to 
step #14.  
14. The subject will return for the second lock-in treatment 3 to 7 days after the first lock-in 
treatment.   
15. The subject will be permitted to discontinue wear of the UV protective eyewear exactly 24 
hours after the final lock-in treatment for the fellow eye has been completed. 
 
 

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1 Tests indicated with an “X” must be performed at each unscheduled visit. Other tests may be conducted based on the investigator’s assessment of the 
subject. 
M Measurements will be conducted by a masked observer who will not be aware of which lens has been implanted. The masked observer should not 
have access to the subject’s medical and/or study records. The masked observer should not conduct any study examinations at follow-ups with 
masked examinations beyond the visual measurements indicated with the “M”. 

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7.7 
DATA REPORTING 
Electronic data capture (EDC) will be utilized for this study.  Case report forms (CRFs) will 
be developed by the sponsor.  In order to facilitate data entry, the CRFs coincide with the 
data entry pages in the EDC system. Research sites will be provided with source document 
templates (SDTs) that correlate with the CRFs. The appropriate SDTs will be completed and 
initialed or signed where indicated at each examination.  All SDTs will be completed in a 
legible manner in black/blue ink.  
 
Any corrections to the SDTs will be made by drawing a single line through the incorrect 
entry, recording the correct information, and initialing and dating the change.  The study 
SDTs and data entered in the EDC system will be reviewed by the Study Monitor.  
All clinical data generated in the study will be submitted to the RxSight Clinical Affairs 
Department or designated CRO for quality assurance review and statistical analysis.  All 
SDTs and data entered into the EDC system will be reviewed for completeness and evident 
recording errors will be rectified by contact with the appropriate clinical site.  Computerized 
data checks will be used to identify unusual data entries for verification prior to statistical 
analysis. 
 
To minimize the amount of missing data, investigators will be trained on the deleterious 
effect that missing data have on trial integrity and credibility and that missing data could 
diminish the scientific value of all subjects' altruistic contributions. 
 
7.8 
STUDY COMPLETION PROCEDURES 
An End of Study Form must be completed for all subjects enrolled in the study upon subject 
completion, withdrawal or discontinuation. 
 
 SUBJECT COMPLETION 
For subjects with both eyes successfully implanted with a study IOL, study completion is 
when both the primary and fellow study eyes have completed the Postop Month 6 
examination. For subjects with only the primary eye successfully implanted with a study 
IOL, study completion is when the primary study eye has completed the Postop Month 6 
examination.   
 
Subjects with ocular serious adverse events or adverse device effects that are unresolved at 
study exit should continue to be followed until resolution of the event or until they are stable 
per the investigator’s evaluation. 
  
 SUBJECT WITHDRAWAL PRIOR TO IMPLANTATION 
Subjects may be withdrawn from the study prior to implantation if they do not meet all 
inclusion/exclusion criteria (screen failures) or decide not to participate in the study.   
 

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 SUBJECT WITHDRAWAL DUE TO INTRAOPERATIVE COMPLICATIONS PRIOR TO OR 
DURING ATTEMPTED IMPLANTATION 
Subjects that meet all inclusion/exclusion criteria but do not undergo implantation of the 
primary eye due to intraoperative complications prior to or during introduction of the IOL 
will be followed to stability or resolution of any adverse events and then exited from the 
study.  
 
 SUBJECT DISCONTINUATION AFTER IMPLANTATION 
After successful IOL implantation bilaterally or only in the primary eye, the subject will be 
withdrawn from the study if both IOLs are explanted or the IOL is explanted from the 
primary eye respectively or the subject has deceased. 
  
The reason for discontinuation will be recorded on the appropriate study worksheet.  Subjects 
who are discontinued from the study will still be a part of the study analyses up until the 
point they are exited.  In the case of an explant, the investigator should continue follow-up 
for a period that ensures no adverse consequences have resulted.  When possible, all 
necessary clinical assessments will be performed prior to the Subject exiting the study even if 
the assessment was not scheduled at that particular visit. 
 
 LOST TO FOLLOW-UP 
Subjects for which the final post-operative case report form is overdue and who refuse to be 
followed, or have difficulty being followed, or cannot be contacted despite extensive written 
and telephone follow-ups to determine the final clinical outcome, will be considered lost to 
follow-up. Sites must make a minimum of three documented attempts via telephone, email, 
or regular mail to contact the subject.  If the subject does not reply to any of these attempts, 
the site must send a letter by certified mail (with a request for notification of receipt of 
delivery) to the subject.  If a subject is non-responsive to these follow-up attempts, the 
subject will be considered to be lost to follow-up. 
 
 STUDY TERMINATION 
The study may be stopped at any time by the Sponsor for reasonable cause with appropriate 
notification. Conditions that may warrant study termination include, but are not limited to the 
following: 
• Safety concerns. Clinical data from the study will be monitored to assure the safety of 
enrolled subjects. 
 
If the clinical study is prematurely terminated, the Sponsor will inform the Investigator, the 
IRB, and other appropriate regulatory bodies. If the Sponsor terminates the study for safety 
reasons, it will immediately notify the Investigator, the IRB, and other appropriate regulatory 
bodies and provide an explanation of the reasons for termination. The Investigator will be 
provided with instructions for study termination and applicable subject follow-up. The 
Sponsor will continue to provide resources to fulfill the Clinical Study Plan obligations for 
follow-up of the subjects enrolled in the study. 
 

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Sample Size for the Effectiveness Endpoints 
Based on the sample sizes discussed above for the primary and secondary effectiveness 
endpoints, a sample size of at least 180 (90 ´ 2) enrolled, randomized, and bilaterally treated 
subjects are needed for the effectiveness evaluation. 
 
 SAMPLE SIZE FOR THE SAFETY ENDPOINTS 
Primary Safety Endpoint 
The sample size for the incidence of ocular serious adverse events, including persistent and 
cumulative events defined per ISO 11979-7, is based on the recommendation from American 
Academy of Ophthalmology Task Force Consensus Statement for Extended Depth of Focus 
Intraocular Lenses, “The EDF IOL group should consist of a minimum of 100 patients.”  
With 100 LAL subjects, the study has 95% confidence to observe at least one incidence of 
safety events with a rate of at least 2.7%. With a drop-out rate of 10%, at least 112 LAL 
subjects with implantation attempted are needed. For comparison, at least 112 Control 
subjects with implantation attempted are needed. 
 
 SAMPLE SIZE FOR THE STUDY 
Based on Sections 8.1.1 and 8.1.2, the planned study sample size of up to 230 (~ 112 ´ 2) 
enrolled and randomized subjects who have had LAL implantation (LAL group) or Control 
IOL implantation (Control group) attempted is sufficient. 
 
8.2 
GENERAL CONSIDERATION 
The statistical analysis of the data will be performed using SAS version 9.3 or higher or 
another industry standard statistical software package.  Continuous variables will be 
summarized using descriptive statistics, specifically the mean, median, standard deviation, 
minimum and maximum. Categorical variables will be summarized by frequencies and 
percentages. For monocular measurements such as refraction or monocular visual acuity, the 
summaries will be provided for the primary eyes and fellow eyes of the LAL subjects and 
those of the Control subjects separately.  For binocular measurements such as binocular 
visual acuity or the patient reported outcomes, the summaries will be provided for the LAL 
subjects and Control subjects separately.  The 95% confidence interval for mean or for 
percentage may be provided. 
Unless otherwise specified, all p-values will be two-sided for a two-sided significance level 
of 0.05 or one-sided for a one-sided significance level of 0.025.  In general, the confidence 
intervals will be two-sided at 95% confidence level.  For the ISO-specified cumulative or 
persistent adverse event rate, one-sided lower 95% confidence limit will be provided. 
 
8.3 
POPULATIONS FOR ANALYSIS 
 PRE-COVID-19 POPULATION 
The Pre-COVID-19 population consists of any subject (or eye) who has signed the informed 
consent and has had the LAL or Control lens implantation attempted, which is defined as the 
point at which the lens makes contact with the eye, prior to the March, 2020 suspension of 
cataract surgeries. Safety and effectiveness analyses for subjects in this population will be 

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performed separately. Seventeen subjects (10 LAL and 7 Control) met this definition. Due to 
the COVID-19 pandemic, study visits for these 17 subjects may have been delayed outside 
protocol specified windows or missed completely. Therefore these subjects will be excluded 
from the modified safety and Full Analysis Set populations. 
 
 MODIFIED SAFETY POPULATION 
The modified safety population consists of any subject (or eye) who has signed the informed 
consent and has had the LAL or Control lens implantation attempted, which is defined as the 
point at which the lens makes contact with the eye. The Pre-COVID-19 study subjects will be 
excluded from this population. This population will be used for the safety summaries. The 
lens groups of this population will be based on the actual received lens.  No imputation will 
be performed. 
 
For subjects encountering intraoperative complications before study lens implantation, their 
intraoperative complications will be listed separately.  
 
 
 INTENT-TO-TREAT (ITT) POPULATION AND FULL ANALYSIS SET (FAS) 
The intent-to-treat (ITT) population contains all of the randomized subjects regardless of 
having the study lens implantation attempted.  Since randomized subjects may not have 
implantation attempted due to intraoperative complications during cataract extraction or for 
other reasons such as delays due to the COVID-19 pandemic, the ITT population will not be 
used for the primary effectiveness analyses. Instead, the Full Analysis Set (FAS) which is 
defined as the ITT subjects with study lens implantation attempted (regardless of successful 
implantation) after cataract extraction will be used for the primary effectiveness analyses. 
The Pre-COVID-19 study subjects will be excluded from this population. The primary 
analyses of the primary effectiveness endpoints and the monocular outcomes of the 
secondary effectiveness endpoints will be based on the primary eyes of the FAS; the primary 
analyses of the binocular outcomes of the secondary effectiveness endpoints will be based on 
the subjects in the FAS.  The analysis group will be based on the randomized group (LAL 
versus Control), not based on the actual lens received. 
For the subjects that do not have the available data of the primary or secondary effectiveness 
endpoints or have lens exchange or explants before Postop Month-6, the imputation 
described in Section 8.5.1 will be used for the primary analysis of the primary and secondary 
effectiveness endpoints.  Different imputations will be included in the sensitivity analyses 
described in Section 8.5.2 below. 
 
 PER-PROTOCOL (PP) POPULATION 
The per-protocol population is a subset of the FAS and is comprised of the FAS subjects that 
do not have any major protocol deviations.  Major protocol deviations will include those 
deviations that may impact subject safety, affect the integrity of study data and/or affect 
subject willingness to participate in the study, such as implantation, adjustment and lock-in 
procedures that are not performed as specified in the protocol and/or Operator’s manual.  The 
PP population will be used for supportive effectiveness analyses. 

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8.4 
BASELINE CHARACTERISTICS 
Demographics (such as age, gender, and race) and baseline characteristics will be 
summarized for the safety population and FAS subjects by the lens group (LAL versus 
Control lens).  For the monocular measurements, the summary will be prepared for the 
primary eyes and the fellow eyes separately.  The data of the fellow eyes that do not have the 
LAL or the control lens implanted will be excluded from the fellow-eye summaries and, if 
needed, may be listed separately.   
 
The analyses will also be stratified by the study site in order to assess the similarity of these 
baseline characteristics among the study sites. 
 
8.5 
EFFECTIVENESS ANALYSES 
The primary analyses for the primary effectiveness endpoints will be based on the FAS 
population described in Section 8.3.3.  For each type of visual acuity for eyes with study lens 
exchange or explants before Postop Month-6, the worst observed Month-6 visual acuity of 
the corresponding lens group will be used to impute the Month-6 visual acuity whether or not 
the Month-6 data is available. 
 
 PRIMARY ANALYSES FOR THE EFFECTIVENESS ENDPOINTS 
For the primary analyses of the primary and secondary effectiveness endpoints, the missing 
Postop Month-6 visual acuity will be imputed by the worst observed Month-6 visual acuity 
of the corresponding lens group. 
First Co-Primary Effectiveness Endpoint 
From the depth of focus test, the mean logMAR visual acuity of the primary eyes will be 
calculated and plotted against the corresponding lens diopter of the defocusing lens (defocus 
curve) at Postop Month 6 for the LAL and Control groups, separately.  In case of missing 
visual acuity values from the depth of focus test, the worst observed visual acuity value of 
the corresponding defocusing lens diopter at Postop Month 6 of the same lens group will be 
used to impute the missing visual acuity values at Postop Month 6.  A horizontal line at a Y-
axis value of logMAR 0.20 will be included in the defocus curves. The lens diopter values 
corresponding to the intercepted point of the 0.20 logMAR horizontal line and the defocus 
curve for the negative diopter value will be estimated.  The DOF at Postop Month 6 is the 
absolute difference between the negative lens diopter values corresponding to the 0.20 
logMAR visual acuity and 0 diopter.  The DOF at Postop Month 6 will be calculated for the 
two lens groups separately and numerically compared to the target difference value of 0.5 D.  
No formal statistical comparison will be performed. 
 
Second Co-Primary Effectiveness Endpoint 
The analysis will be based on the primary eyes of the FAS. The mean, standard deviation 
(SD), 95% confidence interval of the mean based on one-sample t-distribution, median, 
minimum, and maximum will be derived for logMAR monocular photopic DCIVA at Postop 
Month 6.  
 

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Dichotomous Outcomes: 3rd primary effectiveness endpoint and 2nd, 3rd, and 4th 
secondary effectiveness endpoint 
For each endpoint, the analysis will assume all missing responses for the LAL group are non-
responders, then one is responder and all other are non-responders, and gradually proceed to 
all missing responses for the LAL group are responders; similarly, the assumptions will be 
made for the missing response for the Control group.  For the third secondary effectiveness 
endpoint, the p-value based on an approximate z-test will be calculated for each combination.  
For the third primary effectiveness endpoint and the second and fourth secondary 
effectiveness endpoint, the 95% confidence interval of the proportion will be calculated for 
each of the LAL-group assumption and these confidence intervals will be plotted. 
 
 COVARIATES AND SUBGROUP ANALYSES 
The purpose of performing the covariates and subgroup analyses are to evaluate the possible 
effects of these covariates on the primary effectiveness endpoints.  The intention of these 
analyses is not for claiming treatment effect on any subgroups.  The following covariates will 
be evaluated based on the imputation for the missing data used for the primary analyses: 
• Age group (based on observed quartiles) 
• Gender (male and female) 
• Race (White and non-White) 
• Ethnicity (Hispanic-Latino and not Hispanic-Latino) 
• Study site 
• MRSE at Postop Week 3 (£-3.00 D, >-3.00 D to -2.00D, >-2.00 D to -1.00 D, >-
1.00 D to <1.00 D, ³1.00 to <2.00 D, ³2.00 to <3.00 D, and ³3.00D) 
• MRCYL at Postop Week 3 (< 0.50 D, ³0.50 D to <1.00 D, ³1.00 to <2.00 D, 
³2.00 to <3.00 D, and ³3.00 D) 
• DEQ at Postop Week 3 (0.00 D to <1.00 D, ³1.00 to <2.00 D, ³2.00 to <3.00 D, 
and ³3.00 D) 
For the first co-primary effectiveness endpoint, the difference in monocular DOF at Postop 
Month 6 between the two lens groups will be derived for each level of each covariate.  
Additionally, DOF and the difference in DOF between the two lens groups will be stratified 
by the photopic pupil size (<3.0 mm, ³3.0 to £4.0 mm, and >4.0 mm) measured at Postop 
Month 6.  Meanwhile, the analysis will be performed by the axial length measured 
preoperatively (<21.0 mm, 21.0 mm to £26.0 mm, and >26.0 mm). 
 
For the continuous effectiveness endpoints (the second and fourth co-primary effectiveness 
endpoints and the first and fifth secondary effectiveness endpoints), the mean, SD, 95% 
confidence interval of the mean, median, maximum, and maximum will be calculated by lens 
group for each level of each covariate.  For each covariate, the mean differences among 
different levels of the covariate will be compared based on two-way analysis of variance 
(ANOVA) with lens group, covariate, and interaction of lens group and covariate as the 

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factors.  A p-value of 0.15 will be used for evaluating the possible covariate and interaction 
effects. 
 
For the third secondary effectiveness endpoints, the responder rate along with the exact 95% 
confidence intervals based on binomial distribution will be provided for each level of each 
covariate by the lens group.  For each covariate, the difference in the responder rate between 
the two lens groups among the different levels of the covariate will be compared based on the 
Gail-Simon test.  A p-value of 0.15 will be used for evaluating the possible covariate effects. 
 
For the third co-primary effectiveness endpoint and the second and four secondary 
effectiveness endpoint, the responder rate along with the exact 95% confidence intervals 
based on binomial distribution will be provided for each level of each covariate based on the 
primary eyes of the FAS LAL subjects.  For each covariate, the responder rate differences 
among different levels of the covariate will be compared based on Fisher’s exact test.  A p-
value of 0.15 will be used for evaluating the possible covariate effects. 
 
It should be noted that the subgroups of these covariates will be re-examined and may be re-
categorized or eliminated due to small sample size (if there are < 10 subjects within each 
subgroup). 
 
 ADDITIONAL EFFECTIVENESS ANALYSES 
The following effectiveness outcomes will be summarized descriptively based on the 
observed data of the implanted eyes or subjects in the FAS.  No imputation for missing 
values will be performed.  The 95% confidence interval of the mean, if required, will be 
calculated based on the t-distribution; the 95% confidence interval of the proportion, if 
required, will be derived by the binomial distribution.  It should also be noted that, for the 
MRCYL data analyses, the absolute MRCYL value will be used to present the summaries for 
simplicity. 
 
8.5.4.1 Manifest Cylinder (MRCYL) 
The MRCYL will be summarized by implanted eyes (primary versus fellow eyes) and lens 
group (LAL versus Control) beginning at the Postop Week 3 visit using descriptive statistics 
for continuous outcomes (such as mean and standard deviation).  The number and percent of 
eyes with a MRCYL of £0.25 D, 0.50, 0.75 D, 1.0 D, 1.25 D, 1.5 D, 1.75, and ³2.0 D at each 
visit will be reported.  The descriptive statistics and percent of eyes with different MRCYL 
outcomes described previously will be stratified by MRCYL of < 0.50 D, ³ 0.50 to <1.00 D, 
³1.00 to <2.00 D, ³2.00 D to <3.00 D, and ³3.00 D at Postop Week 3 in order to compare 
the findings between the two lens groups.  
In addition, the mean manifest cylinder at Postop Month 6 for each lens group and the 
number and percent of eyes by lens group with increases in cylinder ≥1.00 D between Postop 
Week 3 and Postop Month 6 will be reported. 
 

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8.5.4.2 Cylinder Correction Accuracy  
For eyes measured with MRCYL < 0.50 D at the Postop Week 3 visit, two analyses will be 
performed. In the primary analysis, the intended cylinder correction will be assumed to be 0 
and in a supportive analysis, the intended cylinder correction will be the highest MRCYL at 
any of the adjustment visits.  For other eyes, the intended cylinder correction will be the 
MRCYL measured at the Postop Week 3 visit.  The count and percent of eyes with accuracy 
of cylinder correction to intended target within 0.50 D and 1.00 D will be reported at Postop 
Month 3 and Postop Month 6 by eye (primary versus fellow) and lens group (LAL versus 
Control) for the implanted eyes/subjects in the FAS.  Additionally, the deviation of the 
achieved adjustment from the attempted adjustment will be summarized by the descriptive 
statistics for continuous outcomes.  In addition, the descriptive statistics for the LAL eyes 
with ≥0.50 D of cylinder at the Postop Week 3 visit will be further stratified into bins 
approximately 1.0 D in width. 
 
8.5.4.3 Vector Difference 
Vector differences between the intended cylinder change and the achieved cylinder change 
will be calculated and summarized descriptively by eye (primary versus fellow) and lens 
group (LAL versus Control). In eyes for which no cylinder adjustment is attempted, the 
intended change will be considered zero and the entire change from Postop Week 3 will be 
treated as an error. 
 
The analyses will be performed based on the MRCYL and the cylinder of the aberrometry 
readings separately.  
 
8.5.4.4 Refractive Cylinder Stability  
Refractive cylinder stability will be presented for consistent cohort and eyes with two 
consecutive visits.  The following statistics will be calculated by eye and lens group. 
• 
Percentage of eyes that achieve change of ≤1.00 D of refractive cylinder; 
• 
Percentage of eyes that achieve change of ≤0.50 D of refractive cylinder; 
• 
Mean MRCYL change between two visits and the corresponding 95% confidence 
interval, mean change per month, and mean change per year 
 
8.5.4.5 MRSE 
The measured MRSE, adjusted MRSE (to account for the measured distance of 4 meters) and 
change in MRSE from Postop Week 3 will be summarized by the descriptive statistics for 
continuous outcomes (such as mean and standard deviation) and the 95% confidence interval 
of the mean at each visit for implanted primary eyes and implanted fellow eyes of the LAL 
group and of the Control group.  The descriptive statistics will also be stratified by the MRSE 
at Postop Week 3 with bins of £-3.00 D, >-3.00 D to -2.00D, >-2.00 D to -1.00 D, >-1.00 D 
to <1.00 D, ³1.00 to <2.00 D, ³2.00 to <3.00 D, and ³3.00D for the two lens groups 
separately. 
 
 

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8.5.4.6 Accuracy of MRSE 
The number and percent of eyes with a MRSE correction compared to the intended target 
within 0.25 D, 0.50 D, 0.75 D, 1.0 D, 1.25 D, 1.5 D, 1.75 D, and ≥2.0 D at each visit will be 
reported by eyes and lens group, at Postop Month 3 and Postop Month 6. For LAL eyes, the 
targeted post-adjustment MRSE is 0.00 D in all cases. The attempted MRSE adjustment is 
the Postop Week 3 MRSE in the primary analysis and will be the highest absolute MRSE at 
any of the adjustment visits in a supportive analysis. For Control eyes, the targeted post-
adjustment MRSE is the Postop Week 3 MRSE and the attempted MRSE adjustment is 0.   
Additionally, the deviation of the achieved adjustment from the attempted adjustment will be 
summarized by the descriptive statistics for continuous outcomes.  For the LAL group, the 
descriptive statistics will also be stratified by the MRSE at Postop Week 3 with bins of 
approximately 1.00 D wide. 
 
The 95% confidence interval of the mean deviation and the 95% confidence interval of the 
proportion of eyes within 0.50 D and 1.00 D will be provided. 
 
To evaluate any potential bias introduced by poor IOL power selection in the control arm, 
descriptive statistics of the difference in magnitude of MRSE measured at the Postop Week 3 
visit will be calculated. 95% confidence intervals on the mean difference will be calculated. 
 
8.5.4.7 Absolute MRSE 
The analyses methods described for the MRSE will be used for analyzing the absolute 
MRSE. 
 
8.5.4.8 Refractive MRSE stability 
The refractive stable point will be determined based on the criteria described in Section F.3 
of ANSI Z80.11-2012 document as follows: 
• At least 95% of the treated eyes have a change ≤1.00 D of MRSE between the two 
refractions; 
• The mean rate of change in MRSE, as determined by a paired analysis, is ≤0.5 D per 
year (0.04 D/month) over the same time period; 
• The mean rate of change of MRSE decreases monotonically over time, with a 
projected asymptote of zero or a rate of change attributable to normal aging; 
• The 95% confidence interval for mean rate of change includes zero or a rate of 
change attributable to normal aging. 
 
The MRSE change between Postop Month 3 and Postop Month 6 will also be presented by 
eye and lens group. 
 
8.5.4.9 Defocus Equivalent (DEQ) 
The DEQ, as defined as the absolute value of the MRSE error to target plus half the absolute 
value of the MRCYL, will be summarized descriptively by eye and lens group at Postop 

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Week 3, Postop Month 3, and Postop Month 6 visits.  The number and percent of eyes with 
DEQ ≤0.5 D and 1.0 D will also be summarized at the corresponding visit.  
 
8.5.4.10 Autorefraction 
Autorefraction sphere, cylinder, and spherical equivalent will be summarized descriptively at 
each visit by eye and lens group. Additionally, the vector analysis based on an IRC of 
MRCYL at Postop Week 3 and SIRC based on autorefraction cylinder (ARCYL) at Postop 
Month 6 will be performed by eye and lens group. 
 
8.5.4.11 Monocular Visual Acuity 
The study includes the following monocular visual acuities: 
• Distance Visual Acuity 
o Monocular photopic uncorrected distance visual acuity (no trial lens in front 
of eye) 
o Monocular photopic uncorrected distance visual acuity  
(monocular photopic UCDVA) using a +0.25 D lens to compensate for 4 
meter test distance 
o Monocular photopic best distance corrected visual acuity  
(monocular photopic BCVDA) 
• Intermediate Visual Acuity 
o Monocular photopic uncorrected intermediate visual acuity (monocular 
photopic UCIVA) 
o Monocular mesopic distance corrected intermediate visual acuity (monocular 
mesopic DCIVA) 
o Monocular photopic distance corrected intermediate visual acuity (monocular 
photopic DCIVA) 
o Monocular mesopic best corrected intermediate visual acuity  
(monocular mesopic BCIVA) 
• Near Visual Acuity 
o Monocular photopic uncorrected near visual acuity (monocular photopic 
UCNVA) 
o Monocular mesopic distance corrected near visual acuity  
(monocular mesopic DCNVA) 
o Monocular photopic distance corrected near visual acuity  
(monocular photopic DCNVA) 
o Monocular mesopic best corrected near visual acuity  
(monocular mesopic BCNVA) 
 
For each of the above monocular visual acuities, the outcomes will be presented with the 
number and percent of eyes that fall into each VA category at each visit (e.g. 0.00 logMAR 
or better, 0.10 logMAR or better, 0.20 logMAR or better, etc.) by eye (primary eyes and 
fellow eyes) and lens group (LAL versus Control).  The logMAR values will be summarized 
by descriptive statistics for continuous outcomes for each visit by eye and lens group.  Odd 
ratios, comparing LAL versus Control primary eyes and their confidence intervals will be 
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0.20, and 0.30. Change in visual acuity from the Postop Week 3 visit will be presented at 
each visit as categorical outcomes of “increase of 15 letters or more”, “Increase of 10-14 
letters”, “Increase of 5-9 letters”, “No change”, “Decrease of 5-9 letters”, “Decrease of 10-14 
letters”, and “Decrease of 15 letters or more” by eye and lens group.  The change in logMAR 
values from the Postop Week 3 visit will also be presented by eye and lens group. A 
subgroup analysis will be performed based on the amount of refractive error present at the 
Postop Week 3 visit. A comparison of the mean difference between the LAL and Control for 
these subgroups will be presented. 
 
For the postoperative 6-Month DCIVA (both mesopic and photopic) and DCNVA (both 
mesopic and photopic), the mean logMAR values will be stratified by the MRSE at Postop 
Week 3 with bins of £-3.00 D, >-3.00 D to -2.00D, >-2.00 D to -1.00 D, >-1.00 D to <1.00 
D, ³1.00 to <2.00 D, ³2.00 to <3.00 D, and ³3.00D for the LAL eyes. 
 
In order to address the effect of pupil size, the analyses for the mesopic visual acuity 
described above will be stratified by the mesopic pupil size (<3.0 mm, ³3.0 to £4.0 mm, and 
>4.0 mm). In order to assess the effect of the distance refractive error on the uncorrected 
acuity, a scatter plot with Postop Month 6 logMAR UCDVA using a +0.25 D lens as the Y-
axis and Postop Month 6 MRSE as the X-axis will be prepared.  The Regression Analysis 
with a regression model using logMAR UCDVA using a +0.25 D lens at Postoperative 
Month 6 as the dependent variable and the corresponding MRSE as the independent variable 
will be performed.  The effect of the MRCYL and that of DEQ on the logMAR UCDVA 
using a +0.25 D lens will also be analyzed based on the same regression analysis.  The scatter 
plot and the regression analysis will also be performed for the Postop Month 6 logMAR 
UCIVA and UCNVA. 
 
It should be noted that the change in monocular photopic BCDVA are treated as key safety 
outcomes and the associated analyses are described in Section 8.6.2 below. 
 
8.5.4.12 Binocular Visual Acuity 
The study includes the following binocular visual acuities: 
• Binocular photopic uncorrected distance visual acuity  
(binocular photopic UCDVA) using a +0.25 D lens over each eye to compensate for 4 
meter test distance 
• Binocular photopic uncorrected intermediate visual acuity  
(binocular photopic UCIVA) 
• Binocular photopic uncorrected near visual acuity  
(binocular photopic UCNVA) 
 
The analyses methods described for the monocular uncorrected visual acuity will be 
performed for binocular visual acuity based on implanted subjects by lens group. 
 
8.5.4.13 Depth of Focus 
Descriptive statistics of the logMAR visual acuity measured at each lens diopter will be 
calculated for the depth of focus test performed at  Postop Month 6 by eye and lens group.  

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determining if it is “related” or “not related” to the IOL optical properties.  
 
8.7 
SEQUENCE OF PLANNED ANALYSES 
 FINAL ANALYSIS 
When all enrolled subjects have completed or exited the study, the final statistical analyses 
based on the SAP will be performed. 
9 
ADVERSE EVENTS 
If an adverse event (AE) occurs, the first concern will be the safety and welfare of the 
subject; treatment should be provided as appropriate for the event. During the study, the 
Investigator should appropriately treat and follow each AE until it resolves, stabilizes, or it is 
determined that further improvement is not expected. 
 
9.1 
ADVERSE EVENT DEFINITIONS 
 
 
An adverse event (AE) is 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 investigational medical device. 
 
Note 1 to entry: This definition includes events related to the investigational medical device 
or the comparator. 
 
Note 2 to entry: This definition includes events related to the procedures involved. 
 
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
 
Unanticipated Adverse Device Effects (UADE) are 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 or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that relates 
to the rights, safety, or welfare of subjects. 
 
An investigator will submit to the Sponsor and to the reviewing IRB a report of any UADE 
occurring during an investigation as soon as possible, but in no event later than 10 working 
days after the investigator first learns of the effect. The Sponsor will immediately conduct an 
evaluation of any unanticipated adverse device effect. The results of the evaluation will be 
reported to FDA and to all reviewing IRB’s and participating investigators within 10 working 
days of the Sponsor becoming aware of the event. Thereafter the Sponsor shall submit 
additional reports concerning the effect as FDA requests. If a UADE is determined by the 
Sponsor to present an unreasonable risk to study subjects, all investigations or parts of the 
investigation presenting that risk will be terminated as soon as possible. Termination will 
occur not later than 5 working days after this determination is made, and not later than 15 

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• Related or possibly related to the participation in the research (possibly related means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the drugs, devices, or procedures involved in the research); and 
• Suggests that the research places participants or others at a greater risk of harm [new 
or increased risk (including physical, psychological, economic, or social)] than was 
previously known or recognized. 
 
9.6 
IDENTIFICATION AND COLLECTION 
Identification and collection of an AE begins after informed consent has been obtained and 
documented. Standard sources of identifying AEs include:  
• direct observation by the Investigator or study team member 
• asking the study participant a specific question (e.g., “Since your last visit, have you 
experienced any problems with your eyes or vision?”)  
• unsolicited volunteering of information by the study participant (e.g., “Doctor, I have 
had numerous headaches since I started using this lens.”)  
 
Ocular AEs, ocular SAEs, and systemic SAEs observed or elicited by the Investigator, 
reported by the subject, or resulting from a test result, etc., occurring during the clinical 
investigation must be documented. During the study, the Investigator should treat the study 
subject as appropriate to ensure his/her safety and welfare. Refer to Section 7.8.1 for 
additional information pertaining to ongoing AEs at subject exit.  
 
Pre-existing conditions will not be considered AE/SAEs but will be collected at the 
Preoperative Visit as medical history. A worsening of a pre-existing condition during the 
study should be documented as an AE and evaluated accordingly.  
 
Hospitalization is a criterion for assessment of seriousness. Hospitalization in the absence of 
a medical AE is not in itself an AE. For example, the following reports of hospitalization 
without a medical AE should not be considered either an SAE or an AE: 
• Planned hospitalization for a pre-existing condition without serious deterioration in 
health (e.g., planned knee replacement surgery)  
• Social admission (e.g., subject has no place to sleep)  
• Administrative admission (e.g., for yearly physical exam or elective procedures not 
related to the study)  
• Optional admission not associated with a precipitation medical AE (e.g., for elective 
cosmetic surgery)  
 
 EVALUATIONS 
When evaluating AEs, the Principal Investigator or delegated MD sub-Investigator must 
determine if the event is serious, assess the severity of symptoms, the relationship of the event 
to the device or study protocol, using the following guidelines:  
 
 

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must be terminated within 5 working days following the decision, and no later than 15 
working days after first learning of the UADE. 
 
 
9.9 
DEVICE DEFICIENCY (DD) REPORTING 
All device deficiencies (DDs) should be reported to the Sponsor without unjustified delay. 
The Sponsor will assess the DD to determine whether it led to an adverse event (AE). AEs 
resulting from DDs will be documented, assessed, and reported in accordance with adverse 
event guidelines. DDs that did not lead to an adverse event but could have led to a Serious 
Adverse Device Effect (SADE) will be reported in the future PMA as required in ISO 14155. 
 
9.10 
UNANTICIPATED PROBLEM (UP) REPORTING 
If an incident, experience, or outcome meets all 3 criteria of the unanticipated problem 
definition described in section 9.5, then a UP should be reported to the Sponsor without 
unjustified delay. Furthermore, reporting of an unanticipated problem to the IRB should 
occur within 10 business days of discovery by the Investigator or Sponsor Representative 
reporting the event. The IRB will report unanticipated problems to the appropriate regulatory 
agencies and to the institutional official/sponsor, as appropriate. 
  
9.11 
PREGNANCY 
During the study, all female subjects of childbearing potential should be instructed to contact 
the investigator immediately if they suspect they might be pregnant (e.g., missed or late 
menstrual period).  Female subjects who become pregnant during the study will be followed 
until completion of pregnancy. Every effort will be made to obtain the health status of the 
mother and infant or fetus (in cases of miscarriage or therapeutic abortion) at term.  
Pregnancy itself is not considered an AE. 
 
All confirmed pregnancies must be immediately reported to the Sponsor within 48 hours of 
the investigator’s awareness of the pregnancy.  
 
9.12 
POTENTIAL ADVERSE EVENTS 
The following have been identified as potential adverse events for all cataract surgeries 
including the LAL. Please notify the Sponsor regarding any events that may be occurring 
more frequently than your customary rates, or more frequently than expected at your site.  
 
Infection, inflammation, hypopyon, endophthalmitis, infectious keratitis, hyphema, retinal 
detachment or other retinal problems including cystoid macular edema and epiretinal 
membranes, toxic anterior segment syndrome, glaucoma, corneal endothelial damage, vitritis, 
corneal edema which may require correction with a corneal transplant, lens dislocation out of 
the posterior chamber, pupillary block, striation on the lens with or without visual sequelae, 
iritis, synechiae, ptosis, wound leak, flat anterior chamber, increased astigmatism, rupture of 
the capsule, iris prolapse, vitreous in the anterior chamber, and retained pieces of the lens in 
the eye. These adverse events may result in total loss of vision or the loss of an eye. 
Secondary surgery may be required after the cataract surgery to treat surgical complications. 
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the cataract surgery. Visual problems after cataract surgery may include halos, glare, ghost 
images, and/or double vision which may be worse after implantation of an EDF type lens. 
Additionally reduced contrast sensitivity is also possible after implantation of an EDF type 
lens. These and other complications may result in permanent poor vision.    
 
Additional specific risks of the LAL include: 
The LAL must be implanted following specific surgical procedures. If these procedures are 
not followed by the surgeon, the lens may become scratched or improperly placed in the eye 
and may need to be explanted prior to light treatments. In order to perform the lens 
adjustment or the lens lock-in procedures, the subject’s pupil needs to be adequately dilated. 
If this cannot be accomplished for any reason, additional eye drops, injections into the eye, or 
surgery may need to be utilized to adequately dilate the pupil. If the pupil cannot be 
adequately dilated after these types of treatments, the LAL may need to be explanted. An 
unpredicted change in vision can occur resulting from ocular exposure to daylight or any 
other UV source before the LAL is locked-in. The light treatments may not improve vision 
and/or manifest refraction, and the adjustment/lock-in procedure may make vision worse, 
such that it may be necessary to remove and replace the LAL. Vision loss may be permanent 
and may not be improved by replacing the LAL. There is a potential risk for UV-induced 
damage to the eye, including the cornea and retina, which may be permanent. UV light can 
sometimes cause a reactivation of previous herpes virus infection in the eye. A reactivation 
of herpes virus can cause scarring of the cornea, blurred vision, eye pain, extreme light 
sensitivity, permanent loss of vision, and possible need for corneal transplant. Temporary or 
persistent erythropsia and/or temporary or persistent color vision deficiency may occur. 
Corneal dryness and corneal abrasions from the lens used for adjustment and lock-in can 
occur. After the lens adjustment(s) or after the lens lock-in procedures, discomfort, itching 
and light sensitivity may occur. In cases where a spherocylinder adjustment is performed, it 
is possible that visual disturbances may occur if the IOL rotates or if the correction is not 
performed on the correct axis of astigmatism. 
 
 
9.13 
POTENTIAL COVID-19 RISKS 
If a COVID-related public health emergency declaration is in place at the time of the study, 
the study site should take appropriate measures in a clinic setting to minimize spread of the 
virus in conformance to professional society guidelines and applicable guidance from the 
states and counties in which the sites are located. 
 
In addition, the study informed consent has been updated to outline additional subject risks 
that are related to trial participation during an ongoing COVID-19 pandemic. They are as 
follows: 
 
• The subject will be exposing themselves to added risks due to the COVID-19 
pandemic (including possible transmission of Coronavirus infection, and possible 
further complications including but not limited to hospitalization and/or death) 
beyond the risk of adverse events due to the investigational device and/or 
procedure(s). 

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• The subject will be at higher risk in an ophthalmic clinical study because of the close 
contact they will have with health care professionals during their procedure and 
assessment (since the examiner must make measurements close to their face), in 
addition to the need for multiple follow-up visits/exams which will expose them to 
other patients and/or healthcare professionals who could be transmitting the virus 
even if they do not have symptoms. 
• Subjects may still be at risk even if appropriate measures are taken to minimize risks 
in conformance to FDA guidance, American Academy of Ophthalmology guidelines, 
and guidance from the states and counties in which the study clinics are located. 
• Subjects should be aware that potential disruptions to the IDE study may be necessary 
due to current or future pandemic-related emergency restrictions, such as possible 
disruption of the study as a result of COVID-19 control measures that may lead to 
delays in scheduled follow-up visits. 
• Subjects who experience an adverse safety event (i.e. a safety complication) may 
experience a delay in seeing their doctor either due to COVID restrictions and/or due 
to their own concerns or fears about COVID risk, that could potentially lead to a 
dangerous situation with serious permanent visual side effects including loss of 
vision. Adverse outcomes typically require subjects to return for additional and 
possibly frequent follow-up office visits and examinations; thus increasing their 
COVID-related risks. 
• Subjects who have contracted COVID-19  or feel ill with flu-like symptoms during 
their participation in the study will not likely be permitted to continue routine 
scheduled study follow-up, thereby increasing the risk that diagnosis and treatment of 
potential adverse safety outcomes could be missed or delayed. 
  
RxSight will interact with study sites based on geographic location to determine which sites 
may be more impacted by COVID-19 during a particular period of enrollment and potentially 
subject to study disruptions. Sites may be restricted from enrolling in the study for a period 
of time based on local disease conditions. RxSight will work with sites to ensure that light 
treatments are continued when possible during any period of study disruptions, while 
maintaining subject safety.  
 
9.14 
POTENTIAL BENEFITS 
The subject’s benefit from taking part in this study is the correction of residual postoperative 
spherical and/or astigmatic refractive error and extended depth of focus resulting in potential 
improvements in uncorrected distance, intermediate and near vision. 
 
10 
STUDY MONITORING 
RxSight clinical personnel or designated CRO will monitor all clinical studies in a manner 
consistent with any applicable health authority regulations and the clinical research standards 
adopted by RxSight's Clinical Affairs Department. Study monitoring will involve the 
following elements:  

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11.2 
DECLARATION OF HELSINKI 
The study will be performed in accordance with the relevant recommendations guiding 
physicians in biomedical research involving human subjects adopted by the 18th World 
Medical Assembly, Helsinki, Finland, 1964 and later revisions, as well as applicable U.S. 
Food and Drug Administration regulations (21 CFR Parts 50, 56, and 812).  
It is the responsibility of the Principal Investigator to obtain Institutional Review Board 
approval of the Study Protocol and related study documents and to keep the IRB informed of 
any unanticipated problems and any amendments to the protocol. 
 
11.3 
ISO 14155:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN 
SUBJECTS- GOOD CLINICAL PRACTICE 
This study should be performed in compliance with ISO 14155:2011. 
 
11.4 
ADDITIONAL REGULATORY CONSIDERATIONS 
The proposed study is subject to all applicable governmental rules and regulations 
concerning the conduct of clinical trials on human subjects.  This includes, but is not 
necessarily limited to, the approval of an Institutional Review Board (where applicable); 
obtaining prospective informed consent; monitoring of the conduct of the study, the 
completeness of the study worksheets, and accuracy of data entered into the EDC system, as 
may be employed, by the Sponsor or its designee(s); and record retention by the Sponsor in 
accordance with 21 CFR Subpart G-Records and Reports.  
 
11.5 
STUDY INITIATION/CONDUCT 
The study will not commence until (1) approval is obtained from the IRB and appropriate 
regulatory authorities and  (2) written permission is given by the Sponsor. Any additional 
requirements imposed by the IRB or other appropriate regulatory authorities shall be 
followed. 
 
11.6 
COMPLIANCE WITH THE CLINICAL STUDY PROTOCOL 
The Investigator shall conduct this clinical investigation in accordance with the signed 
agreement with the Sponsor, the investigational plan, and the applicable regulations. The 
Investigator shall avoid improper influence on or inducement of the subject, Sponsor, 
Monitor, other Investigator(s) or other parties participating in or contributing to the clinical 
investigation.  
 
11.7 
PROTOCOL DEVIATIONS (PDS) 
Protocol deviations should be avoided.  Any deviation from the protocol will be recorded on 
a Case Report Form together with an explanation for the deviation.  Deviations should be 
reported to the Sponsor, who is responsible for analyzing them and assessing their 
significance. 
 
Deviations should be reviewed to determine the need to amend the protocol or to terminate 
the investigation. 

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Protocol deviations from the Pre-COVID-19 population will be reported separately with a 
description of those protocol deviations specifically related to COVID-19.  
 
NOTE:  The IRB and Competent Authorities or the appropriate regulatory bodies will be 
informed of protocol deviations per applicable reporting requirements.  
 
11.8 
PROTOCOL AMENDMENTS 
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments will be created by the Sponsor and must be approved 
by the IRB or other regulatory bodies as needed prior to implementation except when 
required to mitigate immediate safety risks or when the changes involve only logistical or 
administrative revisions. All protocol amendments must be clearly summarized to outline the 
changes that were made. 
 
11.9 
PUBLICATION POLICY 
The final report of the study will be available to the IRB and appropriate regulatory 
authorities.  
 
11.10 INSURANCE AND INDEMNITY 
The Sponsor shall ensure that acceptable insurance and indemnification is in place prior to 
enrollment of the first study subject.  
 
 
12 
REFERENCES 
1. Labiris G, Giarmoukakis A, Patsiamanidi M, et al. Mini-monovision versus 
multifocal intraocular lens implantation. J Cataract Refract Surg 2015; 41:53-57. 
2. De Vries NE, Webers CA, Touwslager WR, et al. Dissatisfaction after 
implantation of multifocal intraocular lenses. J Cataract Refract Surg 2011; 
37:859-865. 
3. Woodward MA, Randleman JB, Stulting RD. Dissatisfaction after multifocal 
intraocular lens implantation. J Cataract Refract Surg 2009; 35:992-997. 
4. Hayashi K, Manabe S-I, Yoshida M, Hayashi H. Effect of astigmatism on visual 
acuity in eyes with a diffractive multifocal intraocular lens. J Cataract Refract 
Surg 2010; 36:1323-1329. 
5. Braga-Mele R, Chang D, Dewey S, et al. Multifocal intraocular lenses: Relative 
indications and contraindications for implantation. J Cataract Refract Surg 2014; 
40:313-322.