PMCF (Post Market Clinical Follow-up) Evaluation of Clareon Vivity/Vivity Toric
Phase: NA
Conditions: Aphakia
Sponsor: Alcon Research

 
 
 
 
 
PMCF Evaluation of Clareon Vivity/Vivity Toric 
 
 
STUDY ID 
ILE632‐C002 
 
 
PROTOCOL  
Version 1 
13‐Mar‐2023 
 
 
NCT05852470 

Document ID: 
V-CLN-0035639 
Status: Approved, Version: 1.0 
Approved Date: 13 Mar 2023 
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Alcon – Business Use Only 
 
Device Protocol for ILE632-C002 
Title: PMCF Evaluation of Clareon Vivity/Vivity Toric 
Protocol Number: 
ILE632-C002 
Clinical Investigation 
Type:  
Post market Interventional 
Test Product: 
Clareon™ Vivity/Vivity Toric Extended Vision IOLs 
(CNWET0, CNWET3-T6, CCWET0, CCWET3-T6) 
Sponsor Name and 
Address: 
Alcon Research, LLC, and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
 
 
 
 
Property of Alcon 
Confidential 
May not be used, divulged, published, or otherwise disclosed without the consent of Alcon 

Document ID: 
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Investigator Agreement: 
• 
I have read the clinical study described herein, recognize its confidentiality, and 
agree to conduct the described study in compliance with Good Clinical Practices; 
applicable international and national regulations, laws, guidelines, and standards; the 
conditions of approval imposed by the reviewing IRB or regulatory authority; and in 
accordance with the ethical medical research principles outlined in the Declaration 
of Helsinki.  
• 
I will supervise all testing of the device involving human subjects and ensure that 
the requirements relating to obtaining informed consent and IRB review and 
approval are met in accordance with applicable local and governmental regulations. 
• 
I have read and understand the appropriate use of the investigational product(s) as 
described in the protocol, current investigator’s brochure, product information, or 
other sources provided by the sponsor. 
• 
I understand the potential risks and side effects of the investigational product(s). 
• 
I agree to maintain adequate and accurate records in accordance with government 
regulations and to make those records available for inspection. 
• 
I agree to comply with all other requirements regarding the obligations of clinical 
investigators and all other pertinent requirements of the sponsor and government 
agencies. 
• 
I agree to ensure that all associates, colleagues, and employees assisting in the 
conduct of the study are informed of their obligations in meeting the above 
commitments. 
Have you ever been disqualified as an investigator by any Regulatory Authority? 
 No        Yes 
Have you ever been involved in a study or other research that was terminated? 
 No        Yes 
If yes, please explain here: 
Principal investigator: 
 
Signature 
 
 
 
 
 
Date 
Name and professional 
position: 
 
Address: 
 
 
 
 

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Status: Approved, Version: 1.0 
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Table of Contents 
Device Protocol for ILE632-C002 ............................................................................................. 1 
Table of Contents ....................................................................................................................... 3 
List of Tables .............................................................................................................................. 6 
List of Figures ............................................................................................................................ 6 
1 
GLOSSARY OF TERMS .................................................................................................... 7 
2 
LIST OF ACRONYMS AND ABBREVIATIONS ........................................................... 12 
3 
PROTOCOL SUMMARY ................................................................................................. 13 
4 
PROTOCOL AMENDMENTS ......................................................................................... 21 
5 
INTRODUCTION ............................................................................................................. 22 
5.1 
Rationale and Background ................................................................................. 22 
5.2 
Purpose of the Study .......................................................................................... 22 
5.3 
Risks and Benefits ............................................................................................. 23 
6 
STUDY OBJECTIVES...................................................................................................... 23 
6.1 
Primary Objective(s) .......................................................................................... 23 
6.2 
Secondary Objective(s) ...................................................................................... 24 
6.4 
Safety Objective(s) ............................................................................................ 25 
7 
INVESTIGATIONAL PLAN ............................................................................................ 26 
7.1 
Study Design...................................................................................................... 26 
7.2 
Rationale for Study Design................................................................................ 27 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations ........................................................................................ 27 
7.3 
Rationale for Duration of Treatment/Follow-Up ............................................... 27 
7.4 
Rationale for Choice of Comparator Product .................................................... 28 
7.5 
Data Monitoring Committee .............................................................................. 28 
8 
STUDY POPULATION .................................................................................................... 28 
8.1 
Inclusion Criteria ............................................................................................... 29 
8.2 
Exclusion Criteria .............................................................................................. 29 
8.3 
Rescreening of Subjects ..................................................................................... 30 
9 
TREATMENTS ADMINISTERED................................................................................... 31 

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9.1 
Investigational Product(s) .................................................................................. 31 
9.2 
Other Medical Device or Medication Specified for Use During the Study ....... 34 
9.3 
Treatment Assignment / Randomization ........................................................... 34 
9.4 
Treatment masking ............................................................................................ 34 
9.5 
Accountability Procedures ................................................................................. 34 
9.6 
Changes to concomitant medications, treatments/ procedures .......................... 34 
10 STUDY PROCEDURES AND ASSESSMENTS ............................................................. 35 
10.1 Informed Consent and Screening ...................................................................... 35 
10.2 Description of Study Procedures and Assessments ........................................... 35 
10.2.1 
Demographics .................................................................................... 36 
10.2.2 
Medical History and Concomitant Medication ................................. 36 
10.2.3 
Urine Pregnancy: Entry Criteria ........................................................ 36 
10.2.4 
Preoperative/Operative Chart Review Information: Entry Criteria 
and Effectiveness Assessment ........................................................... 36 
10.2.5 
Photopic Pupil Size: Effectiveness Assessment ................................ 37 
10.2.6 
Slit Lamp Biomicroscopy: Safety Assessment .................................. 37 
10.2.7 
Tonometry: Safety Assessment .......................................................... 37 
10.2.8 
Dilated Fundus: Entry Criteria/Safety Assessment ........................... 37 
10.2.9 
IOLSAT Questionnaire: Effectiveness Assessment ........................... 37 
10.2.10 QUVID Questionnaire: Safety Assessment ....................................... 37 
 
 
10.2.13 Best Corrected Distance Visual Acuity: Effectiveness Assessment .. 38 
 
10.2.15 Distance Corrected Intermediate Visual Acuity: Effectiveness 
Assessment ........................................................................................ 38 
 
10.2.17 Distance Corrected Near Visual Acuity: Effectiveness Assessment.. 38 
 
10.2.19 Contrast Sensitivity: Safety Assessment ........................................... 39 
10.2.20 Adverse Event Collection: Safety Assessment .................................. 39 
10.2.21 Device Deficiencies: Safety Assessment ........................................... 39 
10.3 Unscheduled Visits ............................................................................................ 39 
10.4 Discontinued Subjects ....................................................................................... 40 
10.4.1 
Screen Failures .................................................................................. 40 
10.4.2 
Discontinuations ................................................................................ 40 

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10.4.3 
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product ....................................... 40 
10.5 Clinical Study Termination ................................................................................ 40 
10.5.1 
Follow-up of subjects after study participation has ended ................ 41 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 41 
11.1 General Information .......................................................................................... 41 
11.2 Monitoring for Adverse Events ......................................................................... 43 
11.3 Procedures for Recording and Reporting .......................................................... 44 
11.4 Return product analysis ..................................................................................... 46 
11.5 Unmasking of the Study Treatment ................................................................... 46 
11.6 Follow-Up of Subjects with Adverse Events ..................................................... 47 
12 ANALYSIS PLAN ............................................................................................................ 47 
12.1 Subject Evaluability ........................................................................................... 47 
12.2 Analysis Sets...................................................................................................... 48 
12.3 Demographic and Baseline Characteristics ....................................................... 48 
12.4 Effectiveness Analyses ...................................................................................... 48 
12.4.1 
Analysis of Primary Effectiveness Endpoints ................................... 48 
12.4.1.1 
Statistical Hypotheses ........................................................ 48 
12.4.1.2 
Analysis Methods............................................................... 49 
12.4.2 
Analysis of Secondary Effectiveness Endpoints ............................... 50 
12.4.2.1 
Statistical Hypotheses ........................................................ 50 
12.4.2.2 
Analysis Methods............................................................... 51 
12.5 Handling of Missing Data .................................................................................. 52 
12.6 Safety Analyses.................................................................................................. 52 
12.6.1 
Analysis of Safety Endpoints ............................................................ 52 
12.6.1.1 
Statistical Hypotheses ........................................................ 52 
12.6.1.2 
Analysis Methods............................................................... 53 
12.7 Interim Analyses and Reporting ........................................................................ 53 
12.8 Sample Size Justification ................................................................................... 53 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 53 
13.1 Subject Confidentiality ...................................................................................... 53 
13.2 Completion of Source Documents and Case Report Forms .............................. 54 

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13.3 Data Review and Clarifications ......................................................................... 54 
13.4 Sponsor and Monitoring Responsibilities.......................................................... 55 
13.5 Regulatory Documentation and Records Retention .......................................... 55 
13.6 Quality Assurance and Quality Control ............................................................. 56 
14 ETHICS ............................................................................................................................. 56 
15 REFERENCES .................................................................................................................. 58 
15.1 Regulations and Standards................................................................................. 58 
15.2 Scientific and Other References ........................................................................ 58 
16 APPENDIX A – Protocol Amendments ............................................................................ 58 
 
List of Tables 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol ........................... 12 
Table 3–1 
Schedule of Study Procedures and Assessments ............................................. 20 
Table 6–1 
Primary Objective(s) ........................................................................................ 23 
Table 6–2 
Secondary Objective(s) .................................................................................... 24 
 
 
Table 6–4 
Safety Objective(s)........................................................................................... 26 
Table 9–1 
Test Product ..................................................................................................... 31 
Table 9–2 
Comparator Product ......................................................................................... 32 
 
List of Figures 
Figure 11-1 
Categorization of All Adverse Events .............................................................. 42 
Figure 11-2 
Categorization of All Serious Adverse Events ................................................. 42 
 
 

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1 GLOSSARY OF TERMS 
Names of Test Product(s) 
Throughout this document, test product(s) will be referred to 
as Clareon Vivity/Vivity Toric IOL(s). 
Name of Comparator 
Product(s) 
Throughout this document, comparator product(s) will be 
referred to as Clareon/Clareon Toric Aspheric IOL(s) 
Adverse Device Effect 
(ADE) 
Adverse event related to the use of an investigational 
medical device or comparator. 
Note: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation; any malfunction; 
and use error or intentional misuse.  
Adverse Event (AE) 
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 or comparator 
and whether anticipated or unanticipated.  
Note: For subjects, this definition includes events related to 
the investigational medical device, comparator, or the 
procedures involved. For users or other persons, this 
definition is restricted to the use of the investigational 
medical device or comparator. 
Requirements for reporting Adverse Events in the study can 
be found in Section 11. 
Anticipated Serious 
Adverse Device Effect 
(ASADE) 
An effect which by its nature, incidence, severity, or 
outcome has been identified in the risk assessment. 
Clinical Investigation Plan 
(CIP) 
The document(s) stating the rationale, objectives, design, 
and prespecified analysis, methodology, organization, 
monitoring, conduct, and record-keeping of the clinical 
investigation.  

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Note: The protocol and other documents referenced in the 
protocol (for example, the Statistical Analysis Plan, the 
Manual of Procedures, the Deviations and Evaluability 
Plan, and the Protocol Monitoring Plan) comprise the CIP. 
Clinical Investigation 
Report (CIR) / Clinical 
Study Report 
The document describing the design, execution, statistical 
analysis, and results of a clinical investigation. The Clinical 
Investigation Report is synonymous with the Clinical Study 
Report. 
Device Deficiency 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, usability, safety, or 
performance.  
Note: This definition includes malfunctions, use errors, and 
inadequacy in the information supplied by the manufacturer 
including labelling related to the investigational medical 
device or the comparator. 
Requirements for reporting Device Deficiencies in the study 
can be found in Section 11. 
Enrolled Subject 
Any subject who signs an informed consent form for 
participation in the study. 
Point of Enrollment 
The time at which, following recruitment and before any 
clinical investigation-related procedures are undertaken, a 
subject signs and dates the informed consent form. 
Interventional Clinical 
Study 
A pre- or postmarket clinical investigation where the 
assignment of a subject to a particular medical device is 
decided in advance by a clinical investigation plan, or 
diagnostic or monitoring procedures requested in the CIP are 
in addition to those available as normal clinical practice and 
burden the subject. 
Investigational Product 
A preventative (vaccine), a therapeutic (drug or biologic), 
device, diagnostic, or palliative used as a test or comparator 
product in a clinical study, including a product with a 
marketing authorization when used or assembled 

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(formulated or packaged) in a way different from the 
authorized form, or when used for an unauthorized 
indication, or when used to gain further information about 
the authorized form. 
Malfunction 
Failure of an investigational medical device to perform in 
accordance with its intended purpose when used in 
accordance with the instructions for use or clinical 
investigation plan (CIP), or investigator’s brochure (IB). 
Nonserious Adverse Event 
Adverse event that does not meet the criteria for a serious 
adverse event. 
Postmarketing / 
Postauthorization study 
 
Any study conducted within the conditions laid down in 
product labelling and other conditions laid down for the 
marketing of the product or under normal conditions of use. 
A postmarketing study falls either within the definitions of 
an interventional or a noninterventional study and may also 
fall within the definition of a postapproval study. 
Product Complaint 
 
Any oral, electronic, or written communication that alleges 
deficiencies related to the identity (labeling), quality, 
durability, reliability, safety, effectiveness, or performance 
of a marketed product, including failure of the product, 
labeling, or packaging to meet specifications, whether or not 
the product is related to or caused the alleged deficiency. A 
complaint may allege that an adverse event or medical 
device malfunction has occurred. 
Serious Adverse Device 
Effect (SADE) 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
Serious Adverse Event 
(SAE) 
Adverse event that led to any of the following:  
• Death. 
• A serious deterioration in the health of the subject, users 
or other persons as defined by one or more of the 
following:  

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a) a life-threatening illness or injury   
Note: Life-threatening means that the individual was 
at immediate risk of death from the event as it 
occurred, i.e., it does not include an event which 
hypothetically might have caused death had it 
occurred in a more severe form. 
b) any potentially sight-threatening event or permanent 
impairment to a body structure or a body function 
including chronic diseases. 
c) inpatient hospitalization or prolonged 
hospitalization. 
d) a medical or surgical intervention to prevent a) or b). 
This includes any ocular secondary surgical 
intervention excluding posterior capsulotomy. 
e) any indirect harm as a consequence of incorrect 
diagnostic test results when used within 
manufacturer’s instructions for use. 
• Fetal distress, fetal death, congenital abnormality or 
birth defect including physical or mental impairment. 
Note: Planned hospitalization for a preexisting condition, or 
a procedure required by the CIP, without serious 
deterioration in health, is not considered a serious adverse 
event.  
Refer to Section 11 for additional SAEs. 
Serious Health Threat 
Signal from any adverse event or device deficiency that 
indicates an imminent risk of death or a serious deterioration 
in the health in subjects, users, or other persons, and that 
requires prompt remedial action for other subjects, users, or 
other persons. 
Note: This would include events that are of significant and 
unexpected nature such that they become alarming as a 

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potential serious health hazard or possibility of multiple 
deaths occurring at short intervals.  
Study Start 
The start of the study is considered to coincide with the 
enrollment of the first patient.  
Study Completion 
The completion of the study is considered to coincide with 
the study-level last subject last visit or the decision to 
terminate the study, whichever is later. 
Unanticipated Serious 
Adverse Device Effect 
(USADE) 
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the risk 
assessment.  
Use Error 
User action or lack of user action while using the medical 
device that leads to a different result than that intended by 
the manufacturer or expected by the user.  
Note: 
a) Use error includes the inability of the user to 
complete a task. 
b) Use errors can result from a mismatch between the 
characteristics of the user, user interface, task, or 
use environment. 
c) Users might be aware or unaware that a use error 
has occurred. 
d) An unexpected physiological response of the patient 
is not by itself considered a use error. 
e) A malfunction of a medical device that causes an 
unexpected result is not considered a use error.” 
Vulnerable Subject 
An individual who is unable to fully understand all aspects 
of the investigation that are relevant to the decision to 
participate, or who could be manipulated or unduly 
influenced as a result of a compromised position, 
expectation of benefits or fear of retaliatory response. 
 

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2 LIST OF ACRONYMS AND ABBREVIATIONS 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol 
Abbreviation 
Definition 
ADE 
Adverse device effect 
AE 
Adverse event 
ASADE 
Anticipated serious adverse device effect 
BCDVA 
Best corrected distance visual acuity 
cm 
Centimeter 
CFR 
Code of Federal Regulations 
CRF 
Case report form 
D 
Diopter 
DCIVA 
Distance corrected intermediate visual acuity 
DCNVA 
Distance corrected near visual acuity 
DFU 
Directions for use 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
ETDRS 
Early Treatment Diabetic Retinopathy Study 
FAS 
Full Analysis Set 
GCP 
Good Clinical Practice 
GPCMS 
Global Product Complaint System  
IB 
Investigator’s brochure 
IEC 
Independent ethics committee 
ICF 
Informed consent form 
IOL 
Intraocular lens 
IOLSAT 
Intraocular Lens Satisfaction 
IOP 
Intraocular pressure 
IP 
Investigational product 
IEC 
Independent Ethics Committee 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
LogMAR 
Logarithm of the minimum angle of resolution 
m 
Meter 
mm 
Millimeter 
MOP 
Manual of procedures 
N/A 
Not applicable 
OD 
Right eye 
OS 
Left eye 
PCO 
Posterior capsular opacification 
 
 
Q 
Question 
QUVID 
Questionnaire for Visual Disturbances 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 

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Abbreviation 
Definition 
SD 
Standard deviation 
US 
United States 
USADE 
Unanticipated serious adverse device effect 
VA 
Visual acuity 
 
3 PROTOCOL SUMMARY 
Investigational 
product type 
Device 
Study type 
Interventional 
Investigational 
products 
Test Product: Clareon Vivity/Vivity Toric Extended Vision IOLs 
(CNWET0, CNWET3-T6, CCWET0, CCWET3-T6) 
Comparator Product: Clareon/Clareon Toric Aspheric IOLs (SY60WF, 
CNW0T3-T6, CC60WF, CCW0T3-T6) and Clareon with AutonoMe 
(CCA0T0, CNA0T0) 
Note: Subjects enrolled in this study will be 3 to 6 months (90 to 180 
days) post implantation (after second eye implant) with the 
commercially available Test product or Control product at the time of 
Visit 1.  
No investigational products are being implanted during the study. 
Purpose and 
Scientific 
Rationale for 
the Study 
Registration of the Clareon Vivity and Clareon Vivity Toric IOLs has 
been achieved utilizing clinical safety and performance data from its 
parent IOL models: AcrySof IQ Vivity, AcrySof IQ Toric, and Clareon 
monofocal. This study seeks to generate clinical data from previously 
implanted subjects to augment parent model data and support the 
clinical benefits statements with model-specific data. 

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Brief 
Summary of 
the Protocol 
This study seeks to generate clinical data from subjects previously 
implanted with the Clareon Vivity/Clareon Vivity Toric IOLs or 
Clareon Monofocal/Clareon Toric IOLs. This study will assess key 
performance endpoints to support clinical benefits with model-specific 
data. 
Objective(s) 
Co-Primary Effectiveness: 
 
• 
To demonstrate that Clareon Vivity/Vivity Toric IOL is non‐
inferior to Clareon Monofocal/Clareon Toric IOL in mean 
binocular photopic best corrected distance visual acuity 
(BCDVA) at 3 to 6 months (90 to 180 days) postoperatively. 
• 
To demonstrate that Clareon Vivity/Vivity Toric IOL is superior 
to Clareon Monofocal/Clareon Toric IOL in mean binocular 
photopic distance corrected intermediate visual acuity (DCIVA) 
(66 cm from spectacle plane) at 3 to 6 months (90 to 180 days) 
postoperatively. 
 
Secondary Effectiveness: 
• 
To demonstrate that Clareon Vivity/Vivity Toric IOL is superior 
to Clareon Monofocal/Clareon Toric IOL in mean binocular 
photopic distance corrected near visual acuity (DCNVA) (40 cm 
from spectacle plane) at 3 to 6 months (90 to 180 days) 
postoperatively.  
• 
To demonstrate that Clareon Vivity/Vivity Toric IOL is superior 
to Clareon Monofocal/Clareon Toric IOL with respect to 
proportion of subjects who respond “Never” to Q1 of the 
IOLSAT questionnaire (Overall, in the past 7 days, how often did 
you need to wear eyeglasses to see?) at 3 to 6 months (90 to 180 
days) postoperatively. 
Safety:  
• 
To describe the adverse event rates of Clareon Vivity/Vivity Toric 
IOL and Clareon Monofocal/Clareon Toric IOL collected in this 
study.  

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• 
To describe monocular (first eye implanted) and binocular 
mesopic contrast sensitivity test (with and without glare) 
outcomes at 3 to 6 months (90 to 180 days) postoperatively. 
• 
To estimate rates of severe and most bothersome (separately) 
visual disturbances as reported by subjects using a questionnaire 
(QUVID) at 3 to 6 months (90 to 180 days) postoperatively. 
Endpoint(s)  
 
Primary Effectiveness 
• 
Mean Binocular photopic BCDVA (logMAR) at 4 m. 
• 
Mean Binocular photopic DCIVA (logMAR) at 66 cm. 
Secondary Effectiveness 
• 
Mean Binocular photopic DCNVA (logMAR) at 40 cm. 
• 
Proportion of subjects who respond “Never” to Q1 of the 
spectacle use questionnaire (IOLSAT) 
Safety 
• 
 Adverse events (ocular and non-ocular, serious and non-serious) 
• 
Device deficiencies 
• 
Proportion of subjects with severe and most bothersome 
(separately) visual disturbances using the QUVID Questionnaire 
• 
Binocular and monocular (first eye implanted) mesopic contrast 
sensitivity test (with and without glare) 
• 
Mean IOP 
• 
Slit lamp examination findings including: 
o IOL observations  
o Absolute IOL position change (tilt and decentration) 
o Subjective posterior capsular opacification (PCO) 
o Presence of posterior capsulotomy  
• 
Dilated fundus examination findings 
Assessment(s)  
Primary and Secondary Effectiveness: 
• 
Manifest refraction 

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• 
Binocular photopic BCDVA (logMAR) at 4 m. 
• 
Binocular photopic DCIVA (logMAR) at 66 cm. 
• 
Binocular photopic DCNVA (logMAR) at 40 cm 
• 
IOLSAT questionnaire 
Safety: 
• 
Adverse events (ocular and non-ocular, serious and non-serious) 
• 
Device deficiencies 
• 
Binocular and monocular (first eye implanted) mesopic contrast 
sensitivity test (with and without glare) 
• 
QUVID Questionnaire (binocular) to assess visual disturbances  
• 
Slit Lamp Exam 
• 
Dilated Fundus Exam 
• 
Tonometry  
Study Design 
This is a prospective/retrospective, multicenter, nonrandomized, parallel 
group, controlled, assessor masked interventional study. Both eyes of a 
subject must qualify for enrollment into this study. To reduce bias, 
manifest refraction, VA
 and contrast sensitivity 
assessors will be masked to the IOLs that have been previously 
implanted in the subject until the end of the study. To minimize bias, 
Alcon personnel (including biostatistics, masked data manager, and 
clinical project lead) will also be masked to the IOLs that have been 
previously implanted in the subject, to the extent possible. 
A total of 2 scheduled visits are planned and subject participation is 
expected to last approximately 2 weeks. The visits include a Screening 
visit (Visit 0) and 1 visit after screening (Visit 1). 
Subject 
population 
The study population consists of male and female subjects 18 years of 
age and older that were previously implanted bilaterally with the 
Clareon Vivity/Clareon Vivity Toric IOL or Clareon Monofocal/Clareon 
Toric IOL. 

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It is aimed to enroll approximately 210 subjects at up to 12 US 
investigative sites. Site specific targets will be adjusted based on 
individual site capabilities. Enrollment projections are as follows: 
210 subjects to be enrolled/sign consent (approximately 9.5% screen 
failure rate is expected) 
190 subjects to successfully complete final study visit (Visit 1) 
95 subjects in the Clareon Vivity/Clareon Vivity Toric arm 
95 subjects in the Clareon Monofocal/Clareon Toric arm 
Sites and 
Locations 
Planned number of clinical sites: up to 12 sites  
Planned locations (initial list of locations, which may change during 
start up or conduct according to study needs): United States 
Key inclusion 
criteria 
(See Section 8.1 
for a complete 
list of inclusion 
criteria) 
Adults (18 years or older at the time of participation in the study) with 
previous bilateral implantation of Clareon Vivity/Clareon Vivity Toric 
or Clareon Monofocal/Clareon Toric IOLs for at least 3 months and up 
to 6 months (90 to 180 days) after second eye implant. 
Key exclusion 
criteria 
(See Section 8.2 
for a complete 
list of exclusion 
criteria) 
History of clinically significant ocular co-morbidities that would affect 
surgical outcomes based on investigator expert medical opinion. 
Subjects who were targeted to monovision defined as ≥ 1.50 D of 
anisometropia. 
Clinically significant PCO affecting vision. 
Data analysis 
and sample 
size 
justification 
The Full Analysis Set (FAS) will be the primary analysis set for 
effectiveness and will be used for all safety analyses. 
 
 
 
 
The null and alternative hypotheses to be evaluated in support of the 
primary endpoints are: 

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• Clareon Vivity/Vivity Toric IOL is non-inferior compared to 
Clareon/Clareon Toric IOL with respect to mean binocular best-
corrected distance visual acuity at the postoperative visit. The non-
inferiority margin will be 0.1 logMAR.  
• Clareon Vivity/Vivity Toric IOL is superior to Clareon/Clareon 
Toric IOL with respect to mean binocular distance-corrected 
intermediate visual acuity (66 cm) at the postoperative visit.  
Analysis of the first primary endpoint (non-inferiority for binocular 
BCDVA) will be based on a two-sample t‐test assuming equal variances 
with testing based on a one-sided lower tailed test conducted at the 0.05 
significance level. A corresponding two-sided 90% confidence interval 
for the difference in means (Clareon Vivity/Vivity Toric IOL minus 
Clareon/Clareon Toric IOL) will be presented. Non-inferiority is 
demonstrated if the one-sided p-value for the t-test is less than 0.05 or, 
equivalently, the upper limit of the two-sided 90% confidence interval is 
less than the non-inferiority margin. A two-sided 95% confidence 
intervals will also be provided for descriptive purposes. 
Analysis of the second primary endpoint (superiority test for binocular 
DCIVA) will be based on a two-sample t‐test assuming equal variances 
with testing based on a one-sided lower tailed test conducted at the 0.05 
significance level. A two-sided 95% confidence interval for the 
difference in means (Clareon Vivity/Vivity Toric IOL minus 
Clareon/Clareon Toric IOL) will be presented. 
The null and alternative hypotheses to be evaluated in support of the 
secondary endpoints are: 
• Clareon Vivity/Vivity Toric IOL is superior to Clareon/Clareon 
Toric IOL with respect to mean binocular distance-corrected near 
visual acuity (40 cm) at the postoperative visit.  
• Clareon Vivity/Vivity Toric IOL is superior to Clareon/Clareon 
Toric IOL with respect to the proportion of subjects who respond 
“Never” to Q1 of the spectacle use questionnaire (IOLSAT) at the 
postoperative visit.  
Analysis of the first secondary endpoint (binocular DCNVA) will be 
based on a two-sample t‐test assuming equal variances with testing 
based on a one-sided lower tailed test conducted at the 0.05 significance 
level. A two-sided 95% confidence interval for the difference in means 

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(Clareon Vivity/Vivity Toric IOL minus Clareon/Clareon Toric IOL) will 
also be presented. 
Analysis of the second secondary endpoint (Q1 for IOLSAT) will be 
based on a Chi-squared test of two proportions with testing based on a 
one-sided upper tailed test carried out at the 0.05 significant level. The 
proportion of subjects who respond “Never” to Q1 of the spectacle use 
questionnaire (IOLSAT) in each group will be presented. 
In general, descriptive statistics generated for an endpoint will be based 
upon the type of parameter (i.e., whether the data is categorical or 
continuous) being analyzed. For categorical parameters, the statistics 
used to summarize the data descriptively include sample size, number in 
the category, and percent in the category. For continuous parameters, 
sample size, mean, median, standard deviation, minimum, and 
maximum will be presented. Summaries of logMAR visual acuity may 
include two-sides 95% confidence intervals for the difference between 
treatment groups.  
A total of 210 subjects will be enrolled (approximately 105 per arm). 
Assuming a screen failure rate of 9.5%, approximately 190 subjects will 
be evaluable at Visit 1 (95 per arm). The power estimates for the 
planned analyses are presented below: 
 
Order 
Endpoint 
Comparison 
Noninferiority 
Margin 
Expected 
difference 
SD
^ 
Power 
Co 
Primary 
Binocular 
BCDVA 
Noninferiority 
0.10 
0.04 
0.14 
90% 
Co 
Primary 
Binocular 
DCIVA at 
66 cm 
Superiority 
NA 
0.085 
0.14 
> 98% 
1st 
Secondary 
Binocular 
DCNVA 
at 40 cm 
Superiority 
NA 
0.14 
0.14 
> 99% 
2nd 
Secondary 
Q1 of 
IOLSAT 
= NEVER 
Superiority 
NA 
0.14 
NA 
> 96% 

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Overall power is estimated based on the assumption that each hypothesis test is independent. 
Associated 
materials 
None 
 
Table 3–1 
Schedule of Study Procedures and Assessments 
 
Visit 0 
(Screening 
Visit) 
Visit 1 
 
 
Study Day 0 
Study Day  
1 to 14 e 
Procedure/ Assessment 
 
3 to 6 months  
(90-180 days) 
post 2nd eye 
implant e 
Informed Consent 
X 
 
Demographics 
X 
 
Medical History c   
X 
 
Concomitant Medications c  
X 
X 
Inclusion/Exclusion 
X 
 
Urine pregnancy test d 
X 
 
Photopic Pupil Size 
X 
 
Slit Lamp Examination 
X 
 
Tonometry 
X 
 
Dilated Fundus Examination 
X 
 
Subjective PCO 
X 
 
Presence of Posterior Capsulotomy 
X 
 
IOL Observations 
X 
 
Absolute IOL Position Change (Tilt/Decentration) 
X 
 
Pre-Operative/Operative Information from Chart: 
• 
Lens model & power 
• 
IOL calculation method 
• 
Corneal topography and/or aberrometry (if 
available) 
• 
Biometry & keratometry 
X 
(retrospective) 
 
 
 
 

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Visit 0 
(Screening 
Visit) 
Visit 1 
 
• 
Predicted residual refractive error 
• 
Operating surgeon (first eye) 
• 
1st eye implanted (OD or OS) 
• 
Date of Surgery for second eye 
 
QUVID questionnaire 
 
X 
IOLSAT questionnaire 
 
X 
Manifest refraction 
 
X 
• 
Binocular BCDVA 
 
  
 
 
 
X 
 
 
• 
Binocular DCIVA 
• 
  
 
 
 
X 
 
 
• 
Binocular DCNVA 
 
  
 
 
 
X 
 
 
 
  
 
 
 
Binocular Mesopic Contrast Sensitivity (with and 
without glare) 
Monocular Mesopic Contrast Sensitivity (with and 
without glare) b 
 
X 
 
X 
Adverse Events 
X 
X 
Device Deficiencies 
X 
X 
   a  First and Second Eye Implanted, b First Eye Implanted only, c Medical History and Concomitant Meds will be 
reviewed in source only, d in women of childbearing potential only, e Visit 1 must occur at least one day after 
the Screening visit and it is recommended that is occur a max of 14 days after screening. The subject must be 
90-180 days post 2nd eye implant at the time of Visit 1. 
 
4 PROTOCOL AMENDMENTS 
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments must be created by the study sponsor and must be 
approved by the IRB/IEC and global and regional health authorities, as applicable, prior to 
implementation except when required to mitigate immediate safety risks or when the changes 
involve only logistical or administrative revisions.  

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Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study must sign 
the approved, revised informed consent (re-consent), as required by the IRB/IEC. 
Refer to Appendix A for detailed description of amendments.  
5 INTRODUCTION 
5.1 Rationale and Background 
The Clareon Vivity and Vivity Toric Extended Vision IOLs employ the non-diffractive, wave-
front shaping X-WAVE™ technology which, compared to a monofocal IOL, provides an 
extended range of vision from distance to near while maintaining a low incidence of visual 
disturbances. The Clareon Vivity Toric Extended Vision IOL models also compensate for 
corneal astigmatism.  
The Clareon Vivity and Vivity Toric Extended Vision IOLs mitigate the effects of presbyopia 
by providing an extended depth of focus. Compared to an aspheric monofocal IOL, these 
lenses seek to provide improved intermediate and near visual acuity while maintaining 
comparable distance visual acuity.  
The clinical benefits of the Vivity Extended Vision optical design have been supported by 
previous studies of the AcrySof IQ Vivity IOLs. This study seeks to generate data to support 
these benefit statements with model-specific data from Clareon Vivity and Vivity Toric IOLs. 
The inclusion of Clareon Monofocal as a control (comparator) will allow for comparative 
analyses to support the benefits of this technology. 
5.2 Purpose of the Study 
Registration of the Clareon Vivity and Clareon Vivity Toric IOLs has been achieved utilizing 
clinical safety and performance data from its parent IOL models: AcrySof IQ Vivity, 
AcrySof IQ Toric, and Clareon monofocal. This study seeks to generate clinical data from 
previously implanted subjects to augment parent model data and support the clinical benefits 
statements with model-specific data. 
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards. 
There are no immediate plans to submit the results of this study for publication; however, the 
results may be offered for publication if they are of scientific interest.  

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5.3 Risks and Benefits 
Risk management principles have been applied to both the planning and the intended conduct 
of the clinical investigation, to ensure the reliability of the clinical data generated and the 
safety of the subjects. The clinical investigation process risks are managed through 
appropriate training and monitoring according to the protocol-specific monitoring plan. 
Investigational device risks, including risks associated with use of device and methods and 
procedures for application of device, are defined in the investigator’s brochure and/or product 
labeling and are managed through review of safety assessments outlined in this protocol.  
This is an interventional study where subjects enrolled into this study will have existing 
bilateral IOLs implanted with test and control IOL between 3 to 6 months post 2nd eye 
implant. 
Risks of the study are considered to be no greater than a typical eye examination since 
procedures (e.g., VA testing, IOP, and slit lamp exam) are commonly performed by eye care 
practitioners. Further, risks are minimized by compliance with the eligibility criteria, study 
procedures, and clinical monitoring. 
Device deficiencies observed during this study for both test and control IOL will be 
documented and reported as described in Section 11.1. 
There is no intended clinical benefit to the subject. This clinical study may benefit the 
medical community by contributing to the knowledge of IOL development. 
Subjects in this study may come away with a sense of wellbeing gained by contributing to the 
understanding of new or improved IOLs. 
Subjects will receive nominal compensation for their time and inconvenience. 
6 STUDY OBJECTIVES 
6.1 Primary Objective(s) 
Table 6–1 
Primary Objective(s) 
Objective(s) 
Endpoint(s) 
Co-Primary Effectiveness: 
 
To demonstrate that Clareon Vivity/Vivity 
Toric IOL is noninferior to Clareon 
Mean binocular photopic best corrected 
distance visual acuity (BCDVA) at 3 to 6 

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Objective(s) 
Endpoint(s) 
Monofocal/Clareon Toric IOL in mean 
binocular photopic best corrected distance 
visual acuity (BCDVA) at 3 to 6 months (90 
to 180 days) postoperatively. 
months (90 to 180 days) postoperatively 
after second eye implant. 
To demonstrate that Clareon Vivity/Vivity 
Toric IOL is superior to Clareon 
Monofocal/Clareon Toric IOL in mean 
binocular photopic distance corrected 
intermediate visual acuity (DCIVA) (66 cm 
from spectacle plane) at 3 to 6 months (90 
to 180 days) postoperatively.  
Mean binocular photopic distance corrected 
intermediate visual acuity (DCIVA) (66 cm 
from spectacle plane) at 3 to 6 months (90 
to 180 days) postoperatively after second 
eye implant. 
 
6.2 Secondary Objective(s) 
Table 6–2 
Secondary Objective(s) 
Objective(s) 
Endpoint(s) 
To demonstrate that Clareon Vivity/Vivity Toric 
IOL is superior to Clareon Monofocal/Clareon 
Toric IOL in mean binocular photopic distance 
corrected near visual acuity (DCNVA) (40 cm 
from spectacle plane) at 3 to 6 months (90 to 
180 days) postoperatively.  
Mean binocular photopic distance corrected 
near visual acuity (DCNVA) (40 cm from 
spectacle plane) at 3 to 6 months (90 to 180 
days) postoperatively.  
 
To demonstrate that Clareon Vivity/Vivity Toric 
IOL is superior to Clareon Monofocal/Clareon 
Toric IOL with respect to proportion of subjects 
who respond “Never” to Q1 of the IOLSAT 
questionnaire (Overall, in the past 7 days, how 
often did you need to wear eyeglasses to see?) at 
3 to 6 months (90 to 180 days) postoperatively.  
Proportion of subjects who respond “Never” to 
Q1 of the IOLSAT questionnaire (Overall, in 
the past 7 days, how often did you need to wear 
eyeglasses to see?) at 3 to 6 months (90 to 180 
days) postoperatively. 

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Table 6–4 
Safety Objective(s) 
Objective(s) 
Endpoint(s) 
To describe the adverse event rates of 
Clareon Vivity/Vivity Toric IOL and 
Clareon Monofocal/Clareon Toric IOL 
collected in this study 
 Adverse events (ocular and non-ocular, 
serious and non-serious) 
To describe monocular (first eye implanted) 
and binocular mesopic contrast sensitivity 
test (with and without glare) outcomes at 3 
to 6 months (90 to 180 days) 
postoperatively.  
 
Binocular and monocular (first eye 
implanted) mesopic contrast sensitivity test 
(with and without glare) 
To estimate rates of severe and most 
bothersome (separately) visual disturbances 
as reported by subjects using a questionnaire 
(QUVID) at 3 to 6 months (90 to 180 days) 
postoperatively 
Proportion of subjects with severe and most 
bothersome (separately) visual disturbances 
using the QUVID Questionnaire 
7 INVESTIGATIONAL PLAN 
7.1 Study Design 
This is a prospective/retrospective, multicenter, nonrandomized, parallel group, controlled, 
assessor masked interventional study. Both eyes of a subject must qualify for enrollment into 
this study. To reduce bias, manifest refraction, VA 
 and contrast sensitivity 
assessors will be masked to IOLs that have been previously implanted in the subject until the 
end of the study. To minimize bias, Alcon personnel (including biostatistics, masked data 
manager, and clinical project lead) will also be masked to the IOLs that have been previously 
implanted in the subject, to the extent possible. 
A total of 2 scheduled visits are planned and subject participation is expected to last 
approximately 2 weeks. The visits include a Screening visit (Visit 0) and 1 visit after 
screening (Visit 1) that should occur 1 to 14 days after Visit 0. The subject must be 90-180 
days post 2nd eye implant at the time of Visit 1. Visit 1 must occur at least one day after the 
Screening visit and it is recommended that is occur a max of 14 days after screening. The 
study is expected to be completed in approximately 5 months.  
The study population consists of male and female subjects 18 years of age and older that 
were previously implanted bilaterally with the Clareon Vivity/Clareon Vivity Toric IOLs or 
Clareon Monofocal/Clareon Toric IOLs. Visit 1 must occur at least 3 months and up to 6 
months (90 to 180 days) after second eye implant.  

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The first operative eye is defined as the eye that was implanted first. The second operative 
eye is defined as the eye that was implanted second. (Note: Eyes that are implanted on the 
same day are acceptable in this study.)  
It is aimed to enroll approximately 210 subjects to complete approximately 190 subjects at 
the final study visit (approximately 95 in each arm). This assumes approximately a 9.5% 
screen failure rate. Up to 12 US investigative sites are planned for this study. Site specific 
targets will be adjusted based on individual site capabilities.  
7.2 Rationale for Study Design  
Registration of the Clareon Vivity and Clareon Vivity Toric IOLs has been achieved utilizing 
clinical safety and performance data from its parent IOL models: AcrySof IQ Vivity, 
AcrySof IQ Toric, and Clareon monofocal. This study seeks to generate clinical data from 
previously implanted subjects to augment parent model data and support clinical benefit 
statements with model specific data.  
Subjects in this study, in both test and control groups, have prior bilateral IOL implants with 
no new surgical interventions under the current protocol. The assessments are similar to a 
typical eye examination since procedures (e.g., VA/performance testing, slit lamp exam) are 
commonly performed by eye care practitioners. Other assessments such as contrast sensitivity 
may not be commonly used but are established techniques for ocular assessments that have 
been well studied in the literature.  
To reduce bias, manifest refraction, VA
 and contrast sensitivity assessors 
will be masked to IOLs that have been previously implanted in the subject until the end of the 
study and testing methods have predefined procedures. 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations 
Not applicable 
7.3 Rationale for Duration of Treatment/Follow-Up 
No treatment will be undertaken during the course of the study as the subject population has 
been previously implanted. Subjects will attend one visit (Visit 1) after screening to collect 
assessment data.  

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7.4 Rationale for Choice of Comparator Product 
The test group includes subjects previously implanted bilaterally with Clareon Vivity/Clareon 
Vivity Toric IOLs. The control (comparator) group includes subjects previously implanted 
bilaterally with Clareon Monofocal/Clareon Toric IOLs. Both groups were chosen to 
generate clinical data to augment parent model data and support the clinical benefits with 
model-specific data. Clareon Monofocal was chosen as the control (comparator) to support 
clinical benefit statements in which the performance of Clareon Vivity/Vivity Toric is 
compared to a monofocal IOL. 
7.5 Data Monitoring Committee 
Not applicable 
8 STUDY POPULATION 
The study population consists of male and female subjects (18 years or older at the time of 
participation in the study) with previous bilateral implantation of Clareon Vivity/Clareon 
Vivity Toric or Clareon Monofocal/Clareon Toric IOLs for at least 3 months and up to 6 
months (90 to 180 days) after second eye implant. It is aimed to enroll (consent) 
approximately 210 subjects at up to 12 sites in the United States, with a target of 190 subjects 
completing the study. The investigators and sites should also target equal numbers of subject 
in each group: Clareon Vivity/Clareon Vivity Toric or Clareon Monofocal/Clareon Toric, if 
possible. This is recommended but not required. Site-specific targets will vary based upon 
individual site capabilities. Estimated time needed to recruit subjects for the study is 
approximately 4 months; however, unanticipated circumstances may shorten or lengthen this 
time and would not require amendment of this protocol. Because a 9.5% screening failure 
rate is expected, approximately 210 subjects are expected to be enrolled.  
This protocol allows enrollment of the following vulnerable population(s), with associated 
justification for each population:  
Elderly – It is appropriate to include the elderly in this clinical study, as IOL implantation is 
intended to treat age-related cataract formation and is common to this population.   
The elderly will be protected through the informed consent process, which will include any 
risks specific to the elderly subjects, as well as any specific responsibilities associated with 
their participation. In addition, an IRB/IEC will review and approve the inclusion of elderly 
subjects in this clinical study prior to enrollment of elderly subjects. Any specific 
requirements imposed by the IRB/IEC regarding participation of elderly subjects will be 

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implemented and documented, as appropriate. Upon conclusion of the clinical study, all 
subjects, including elderly subjects, will return to standard medical care for ongoing 
conditions.  
8.1 Inclusion Criteria 
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject is considered enrolled in the study. 
Subjects eligible for inclusion in this study must fulfill all of the following criteria: 
1. 
Subject must be able to understand and sign an IRB/IEC approved Informed 
Consent form.  
2. 
Willing and able to attend all scheduled study visits as required per protocol. 
3. 
Adults (18 years or older at the time of participation in the study) with previous 
bilateral implantation of Clareon Vivity/Clareon Vivity Toric or Clareon 
Monofocal/Clareon Toric IOLs for at least 3 months and up to 6 months after 
second eye implant.  
The IOL spherical power must be within the 10.0 to 30.0 D range in both eyes and 
for both lens types. If a Toric lens was used, the cylinder power at the IOL plane 
must be in the range +1.50 to +3.75 Diopters in 0.75 D increments for each eye.  
A subject may have a Toric lens in one eye and a non-Toric in the fellow eye as 
long as the IOL type is matched (e.g., Clareon Vivity/Vivity Toric or Clareon 
Monofocal/Monofocal Toric). 
4. 
Documented medical history and required preoperative baseline information 
available for retrospective data collection. 
8.2 Exclusion Criteria 
Subjects fulfilling any of the following criteria are not eligible for participation in this study. 
1. 
Women of childbearing potential, defined as all women who are physiologically 
capable of becoming pregnant and who are not postmenopausal for at least 1 year or 
are less than 6 weeks since sterilization, are excluded from participation if any of the 
following apply: 
a. they are currently pregnant, 

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b. have a positive urine pregnancy test result at Screening, 
c. intend to become pregnant during the study period, 
d. are breastfeeding. 
Subjects who become pregnant during the study will not be discontinued;  
2. 
Subjects currently participating in another investigational drug or device study. 
3. 
History of clinically significant ocular co-morbidities that would affect surgical 
outcomes based on investigator expert medical opinion.  
4. 
History of corneal refractive surgery. 
5. 
Subjects who were targeted to monovision defined as ≥ 1.50 D of anisometropia. 
6. 
Clinically significant PCO affecting vision.  
7. 
History of Amblyopia or Monofixation syndrome with poor stereoscopic vision.  
8.3 Rescreening of Subjects 
Rescreening of subjects is not allowed in this study. 
 
 

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9 TREATMENTS ADMINISTERED 
9.1 Investigational Product(s) 
Test Product(s): 
Clareon Vivity/Vivity Toric Extended Vision IOLs 
(CNWET0, CNWET3-T6, CCWET0, CCWET3-T6) 
Comparator Product(s) (If 
applicable): 
Clareon/Clareon Toric Aspheric (SY60WF, 
CNW0T3-T6, CC60WF, CCW0T3-T6) and Clareon 
with AutonoMe (CCA0T0, CNA0T0) 
 
Table 9–1 
Test Product 
Test Product 
Clareon Vivity/Vivity Toric Extended Vision IOLs (CNWET0, 
CNWET3-T6, CCWET0, CCWET3-T6) 
Manufacturer 
Alcon Laboratories, Inc. 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
USA 
Indication for use 
and intended 
purpose in the 
current study  
The Clareon Vivity™ Extended Vision Hydrophobic IOLs are 
indicated for primary implantation for the visual correction of 
aphakia in adult patients with < 1.00 D of preoperative corneal 
astigmatism, in whom a cataractous lens has been removed by 
extracapsular cataract extraction.  
The Clareon Vivity™ Toric Extended Vision IOLs are indicated for 
primary implantation for the visual correction of aphakia and for 
reduction of residual refractive astigmatism in adult patients with 
pre-existing corneal astigmatism, in whom a cataractous lens has 
been removed by extracapsular cataract extraction.  
Both the Clareon Vivity and Clareon Vivity Toric lenses mitigate 
the effects of presbyopia by providing an extended depth of focus. 
Compared to an aspheric monofocal IOL, the lens provides 
improved intermediate and near visual acuity, while maintaining 
comparable distance visual acuity and intended for capsular bag 
placement only. 

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Product description 
and parameters 
available for this 
study 
No investigational products are being implanted during the study. 
Information on Clareon Vivity/Vivity Toric Extended Vision IOLs 
may be found in the DFU. 
Formulation 
N/A 
Usage 
N/A 
Packaging 
description 
N/A 
Labeling description N/A 
Training and/or 
experience 
requirements for 
device 
No additional training or experience is required to administer the 
test product as no test product is being implanted. 
Storage conditions 
N/A 
Additional 
information 
N/A 
Supply 
N/A 
 
Table 9–2 
Comparator Product 
Comparator Product(s) 
Clareon/Clareon Toric Aspheric (SY60WF, 
CNW0T3-T6, CC60WF, CCW0T3-T6) and 
Clareon with AutonoMe (CCA0T0, 
CNA0T0) 
Manufacturer 
Alcon Laboratories, Inc. 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
USA 
Indication for Use 
The Clareon™ Aspheric Hydrophobic 
Acrylic IOLs are indicated for primary 

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implantation in the capsular bag in the 
posterior chamber of the eye for the visual 
correction of aphakia in adult patients in 
whom a cataractous lens has been removed. 
The Clareon™ Toric Aspheric Hydrophobic 
Acrylic IOLs are indicated for primary 
implantation in the capsular bag in the 
posterior chamber of the eye for visual 
correction of aphakia and preexisting 
corneal astigmatism to reduce residual 
refractive cylinder and improve uncorrected 
distance vision in adult patients in whom a 
cataractous lens has been removed. 
Product description and parameters 
available for this study 
No investigational products are being 
implanted during the study. 
Information on Clareon Vivity/Vivity Toric 
Extended Vision IOLs may be found in the 
DFU. 
Formulation 
N/A  
Usage 
N/A 
Packaging description 
N/A 
Labeling description 
N/A 
Training and/or experience requirements for 
device 
No additional training or experience is 
required to administer the test product as no 
test product is being implanted. 
Storage conditions 
N/A 
Additional identifying information 
N/A 
 

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Supply 
N/A 
 
9.2 Other Medical Device or Medication Specified for Use During the 
Study 
No other medical devices or medications are required to be used in conjunction with the 
treatments during the clinical study.  
9.3 Treatment Assignment / Randomization 
Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system. This study is not randomized. 
9.4 Treatment masking 
This study is ONLY assessor-masked for manifest refraction, VA, 
 and contrast 
sensitivity. To minimize bias, Alcon personnel (including biostatistics, masked data manager, 
and clinical project lead) will also be masked to the IOLs that have been previously 
implanted in the subject, to the extent possible. All other members associated with the study 
(at the site and the study sponsor) are unmasked.  
This level of masking will be maintained throughout the conduct of the study. Unmasking 
will occur only after all planned study data have been validated, and the database locked.  
Masked study personnel must avoid seeking information that may compromise masking. 
Unmasked study personnel must not disseminate information that is potentially unmasking to 
any masked personnel. The masked and unmasked site personnel must coordinate all study 
activities as necessary to protect masking and minimize bias during the study. Any 
unmasking of assessor or subject must be reported to Alcon. 
9.5 Accountability Procedures 
Not applicable 
9.6 Changes to concomitant medications, treatments/ procedures 
After the subject is enrolled into the study, the investigator must instruct the subject to notify 
the study site about: 
• 
Any new medications  

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• 
Alterations in dose or dose schedules for current medications 
• 
Any medical procedure or hospitalization that occurred or is planned 
• 
Any nondrug therapies (including physical therapy and blood transfusions).  
The investigator must document this information in the subject’s case history source 
documents. 
10 STUDY PROCEDURES AND ASSESSMENTS 
This section describes the procedures and assessments for this clinical study. There are two 
study Visits in this study.  
Visit 0 is the screening visit. Informed consent procedures as well as eligibility are performed 
at this visit. 
Visit 1 will occur 3 to 6 months (90 to 180 days) after the second eye implant of the subject 
being enrolled. Visit 1 must occur at least one day after the screening visit and it is 
recommended that is occur a maximum of 14 days after screening. Endpoint assessments and 
study exit are performed at this visit. 
10.1 Informed Consent and Screening 
The investigator or delegate must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IRB/IEC-approved informed consent document. The subject 
must sign the ICF BEFORE any study-specific procedures or assessments can be performed, 
including study-specific screening procedures. Additionally, have the individual obtaining 
consent from the subject and a witness, if applicable, sign and date the informed consent 
document.  
The investigator or delegate must provide a copy of the signed document to the subject and 
place the original signed document in the subject’s chart, or provide documentation as 
required by local regulations. 
10.2 Description of Study Procedures and Assessments 
Study-specific procedures and assessments described here may include standard of care; 
other standard of care procedures performed in the clinical management of the subject are not 
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Detailed descriptions of assessments and procedures are provided in the MOP. The 
investigator is responsible for ensuring responsibilities for all procedures and assessments are 
delegated to appropriately qualified site personnel. 
10.2.1 Demographics 
Obtain demographic information including age, race, ethnicity, and sex. 
10.2.2 Medical History and Concomitant Medication 
Medical History and Concomitant Medications will be documented in the subject’s source 
but will not be collected in the eCRF for this study.  
10.2.3 Urine Pregnancy: Entry Criteria 
Perform urine pregnancy test according to the manufacturer's procedure on female subjects of 
child-bearing potential.   
10.2.4 Preoperative/Operative Chart Review Information: Entry Criteria 
and Effectiveness Assessment 
From preoperative/operative chart review, collect and record the lens model implanted, the 
IOL power, biometry, keratometry, the predicted target residual refractive error for each eye, 
operating surgeon (first eye), 1st operative eye (OD/OS), date of surgery for second eye. Also 
collect the IOL calculation method used (e.g., Barrett) in each eye. If a separate Toric 
calculator was used in addition to the IOL power calculation, document the Toric calculator 
used in each eye. 
Note: To qualify for study participation the subject must have the Clareon Vivity/Vivity Toric 
bilaterally or Clareon Monofocal/Toric bilaterally and an IOL spherical power must be within 
the 10.0 to 30.0 D range in both eyes and for both lens types. If a Toric lens was used, the 
cylinder power at the IOL plane must be in the range +1.50 to +3.75 Diopters in 0.75 D 
increments for each eye. A subject may have a Toric lens in one eye and a non-Toric in the 
fellow eye as long as the IOL type is matched (e.g., Clareon Vivity/Vivity Toric or Clareon 
Monofocal/Monofocal Toric). 
Subjects who were targeted to monovision defined as ≥ 1.50 D of anisometropia do not 
qualify for the study and should be excluded.  
Review for exclusion criteria.  

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If corneal topography and/or aberrometry are/is available in the chart, collect this information 
for each eye.  
Refer to MOP for details. 
10.2.5 Photopic Pupil Size: Effectiveness Assessment 
During manifest refraction/VA assessment, perform and record photopic pupil size in both 
eyes at 4 m and record to the nearest 0.5 mm.  
10.2.6 Slit Lamp Biomicroscopy: Safety Assessment 
Slit lamp examination must be performed in both eyes. Record any slit lamp findings, 
absolute IOL position change (tilt and decentration), any IOL observations, any subjective 
PCO and the subject has the presence of a posterior capsulotomy. Refer to MOP for details. 
This assessment must be performed by medically qualified study staff. 
10.2.7 Tonometry: Safety Assessment 
Perform tonometry assessment in both eyes according to the to the investigator’s standard of 
care. Record IOP. 
10.2.8 Dilated Fundus: Entry Criteria/Safety Assessment 
Dilated fundus examination includes ophthalmoscopic assessments of the vitreous, retina, 
macula, choroid, and optic nerve of both eyes. This assessment must be performed by 
medically qualified study staff. 
10.2.9 IOLSAT Questionnaire: Effectiveness Assessment 
Provide the IOLSAT questionnaires to the subject for completion. It is recommended that the 
questionnaire be completed (after the QUVID questionnaire) by the subject prior to 
performance of manifest refraction, VA, 
 and contrast sensitivity assessments. 
10.2.10 QUVID Questionnaire: Safety Assessment 
Provide the QUVID questionnaire to the subject for completion. It is recommended that the 
QUVID be completed before IOLSAT questionnaire. The questionnaire should be completed 
by the subject prior to administration of manifest refraction VA, 
 and contrast 
sensitivity assessments. 

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10.2.11 Manifest Refraction: Effectiveness Assessment 
Perform and record manifest refraction using technique detailed in the MOP at 4 m. This 
assessment must be performed by delegated trained masked assessor only. 
10.2.13 Best Corrected Distance Visual Acuity: Effectiveness Assessment 
Measure and record binocular 
 ETDRS BCDVA at 4 
m. This assessment must be performed by delegated trained masked assessor only. 
10.2.15 Distance Corrected Intermediate Visual Acuity: Effectiveness 
Assessment 
Measure and record binocular 
 ETDRS DCIVA at 66 cm. This 
assessment must be performed by delegated trained masked assessor only. 
10.2.17 Distance Corrected Near Visual Acuity: Effectiveness Assessment 
Measure and record binocular 
 ETDRS DCNVA at 40 cm. This 
assessment must be performed by delegated trained masked assessor only. 

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10.2.19 Contrast Sensitivity: Safety Assessment 
Measure and record both binocular and first eye monocular contrast sensitivity under 
mesopic lighting conditions with and without glare. This assessment must be performed by 
delegated trained masked assessor only. Refer to MOP for details. 
10.2.20 Adverse Event Collection: Safety Assessment 
Assess and record any adverse events that are observed or reported since the time of consent. 
AEs must be recorded for all enrolled subjects from the time of signature of informed 
consent, regardless of subject enrollment status (screen failure). 
10.2.21 Device Deficiencies: Safety Assessment 
Assess and record any device deficiencies that are reported or observed since the time of 
consent. Requirements for reporting device deficiencies in the study can be found in Section 
11.  
Device deficiencies must be recorded for all enrolled subjects from the time of signature of 
informed consent, regardless of subject enrollment status (screen failure). 
10.3 Unscheduled Visits 
If a subject visit occurs between any regularly scheduled visit and the visit is conducted by 
study personnel, this visit must be documented as an Unscheduled Visit. If the subject seeks 
medical attention outside the clinic (for example, at an emergency room) or at the clinic but is 
seen by non-study personnel, the investigator is to capture adverse event-related information 
on the adverse event form upon becoming aware. 
During all unscheduled visits, the investigator must conduct the following procedures:  
• 
Collect adverse event information 
• 
Record changes in medical condition or concomitant medication 
The investigator may perform additional procedures for proper diagnosis and treatment of the 
subject (e.g., subjective VA, slit lamp exam, tonometry, and dilated fundus exam). The 
investigator must document this information in the subject’s case history source documents. 

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10.4 Discontinued Subjects 
10.4.1 Screen Failures 
Subjects who were excluded from the study after signing the informed consent, excluded 
based on inclusion/exclusion criteria at the Screening Visit, and prior to Visit 1 testing.  
The investigator must document the reason for screen failure in the subject’s case history 
source documents. 
Subject numbers must not be reused. 
10.4.2 Discontinuations 
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the investigator after inclusion/exclusion criteria has been met at Screening Visit. 
Subject numbers of discontinued subjects must not be reused (i.e., subject replacement is not 
allowed). 
Subjects may discontinue from study or study treatment at any time for any reason. Subjects 
may also be discontinued from study treatment at any time if, in the opinion of the 
investigator, continued treatment poses a risk to their health. 
The investigator must document the reason for study or treatment discontinuation in the 
subject’s case history source documents. 
To ensure the safety of all subjects who discontinue early, investigators must assess each 
subject and, if necessary, advise them of any therapies and/or medical procedures that may be 
needed to maintain their health. 
10.4.3 Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product  
Not applicable 
10.5 Clinical Study Termination 
The study sponsor reserves the right to suspend or close the investigational site or suspend or 
terminate the study in its entirety at any time. 
If the clinical study is prematurely terminated or suspended by the study sponsor:  

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• 
The study sponsor must: 
o Immediately notify the investigator(s) and subsequently provide 
instructions for study termination. 
o Inform the investigator and the regulatory authorities of the 
termination/suspension and the reason(s) for the termination/suspension.  
• 
The investigator must: 
o Promptly notify the IRB/IEC of the termination or suspension and of the 
reasons.  
o Provide subjects with recommendations for poststudy treatment options as 
needed. 
The investigator may terminate the site’s participation in the study for reasonable cause. 
10.5.1 Follow-up of subjects after study participation has ended  
Following this study, the subject will return to their eye care professional for their routine eye 
care. 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
11.1 General Information  
An 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. Refer to the Glossary of Terms 
and figures below for categories of AEs and SAEs. 
 

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Figure 11-1 
Categorization of All Adverse Events 
ADE
Device /
procedure-
related?
Meets 
seriousness 
criteria?
SAE
All AEs
AE
No
No
Yes
Yes
 
 
Figure 11-2 
Categorization of All Serious Adverse Events 
All SAEs
Device /
procedure 
related?
SAE
SADE
No
Yes
 
 
 

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Specific Events Relevant to this Protocol 
In addition to reporting all AEs (serious and nonserious) meeting the definitions, the 
investigator must report any occurrence of the following as an SAE: 
• 
Cystoid macular edema 
• 
Hypopyon 
• 
Endophthalmitis 
• 
Lens dislocation from posterior chamber 
• 
Pupillary block 
• 
Retinal detachment 
Any other potentially sight-threatening event may also be considered serious based on the 
judgment of the investigator and should be reported appropriately as delineated in Section 
11.3 (Procedures for Recording and Reporting). 
Device Deficiencies  
A device deficiency may or may not be associated with subject harm (i.e., ADE or SADE); 
however, not all ADEs or SADEs are due to a device deficiency. The investigator should 
determine the applicable category for the identified or suspect device deficiency and report 
any subject harm separately. Examples of device deficiencies include the following: 
• 
Failure to meet product specifications (e.g., incorrect IOL power) 
• 
IOL defect 
• 
Scratched IOL  
• 
Lack of performance 
 
11.2 Monitoring for Adverse Events 
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the investigator should inquire about AEs by asking the standard questions shown 
below and report as applicable: 
• 
“Have you had any health problems since your last study visit?” 

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• 
“Have there been any changes in the medications you take because of a new health 
issue or worsening of an existing health issue since your last study visit?” 
In addition, changes in any protocol-specific parameters and/or questionnaires evaluated 
during the study are to be reviewed by the investigator. Any untoward (unfavorable and 
unintended) change in a protocol-specific parameter or questionnaire response that is 
clinically relevant, in the opinion of the investigator, is to be reported as an AE. These 
clinically relevant changes will be reported regardless of causality.  
11.3 Procedures for Recording and Reporting 
AEs are collected from the time of informed consent. Any preexisting medical conditions or 
signs/symptoms present in a subject prior to the start of the study (i.e., before informed 
consent is signed) are not considered AEs in the study and should be recorded in the Medical 
History section of the eCRF.  
For each recorded event, the ADEs and SAEs documentation must include date of 
occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness 
and causality. In addition, the investigator must document all device deficiencies reported or 
observed with test and comparator products on the Device Deficiency eCRF. The site must 
submit all available information on ADEs, SAEs, and device deficiencies to the study sponsor 
as follows: 
• 
All SAEs must be reported immediately (within 24 hours) of the investigator’s or 
site’s awareness.  
• 
ADEs that do not meet seriousness criteria and device deficiencies must be reported 
within 10 calendar days of the investigator’s or site’s awareness.  
• 
A printed copy of the completed Serious Adverse Event and Adverse Device Effect 
and/or Device Deficiency eCRF must be included with product returns.  
• 
Additional relevant information after initial reporting must be entered into the eCRF as 
soon as the data become available. 
• 
Document any changes to concomitant medications on the appropriate eCRFs. 
• 
Document all relevant information from Discharge Summary, Autopsy Report, 
Certificate of Death etc., if applicable, in narrative section of the Serious Adverse 
Event and Adverse Device Effect eCRF. 
Note: Should the EDC system become nonoperational, the site must complete the appropriate 
paper Serious Adverse Event and Adverse Device Effect and/or Device Deficiency Form. The 

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completed form is emailed to the study sponsor at msus.safety@alcon.com according to the 
timelines outlined above; however, the reported information must be entered into the EDC 
system once it becomes operational. 
In addition to recording all AEs into the EDC system, any AEs and device deficiencies for 
non-study marketed devices/products will be considered and processed as spontaneous 
following the postmarket vigilance procedures and should be communicated to the 
device’s/product’s manufacturer as per local requirements. 
Study sponsor representatives may be contacted for any protocol related question and 
their contact information is provided in the Manual of Procedures that accompanies 
this protocol. 
Further, depending upon the nature of the AE or device deficiency being reported, the study 
sponsor may request copies of applicable portions of the subject’s medical records. The 
investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC. 
Intensity and Causality Assessments 
Where appropriate, the investigator must assess the intensity (severity) of the AE based on 
medical judgment with consideration of any subjective symptom(s), as defined below: 
Intensity (Severity) 
Mild  
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom. 
Moderate  
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities. 
Severe  
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 
 
For every AE in the study, the investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by study sponsor utilizing the same definitions, as shown below: 
Causality 

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Related 
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study procedure has 
not been demonstrated, but there is a reasonable possibility that the AE was caused by the 
medical device or study procedure. 
Not Related  An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (i.e., there are other more likely causes for the AE). 
The study sponsor will assess the AEs and may upgrade the investigator’s assessment of 
seriousness and/or causality. The study sponsor will notify the investigator of any AEs that is 
upgraded from nonserious to serious or from unrelated to related. 
11.4 Return product analysis  
Study sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol.  
Should a product need to be returned, include the Complaint # which will be provided by 
study sponsor after the case is entered in the study sponsor’s Global Product Complaint 
Management System (GPCMS). 
Return any recoverable Alcon Product associated with a product related AE (ADE, SADE) or 
device deficiency to the sponsor. Procedures vary by country, so investigators must contact 
their assigned monitor for detailed guidance. Follow biohazard regulations if the product has 
touched the eye (i.e., place the product in a biohazard labeled bag). Include the SAE/ADE or 
device deficiency electronic case report form (eCRF) in the return package. Maintain a copy 
of shipment tracking information and all documents submitted with the product. 
11.5 Unmasking of the Study Treatment 
 This study is assessor-masked for manifest refraction, VA, 
 and contrast sensitivity. 
To minimize bias, Alcon personnel (including biostatistics, masked data manager, and clinical 
project lead) will also be masked to the IOLs that have been previously implanted in the 
subject, to the extent possible. All other members associated with the study (at the site and 
the study sponsor) are unmasked.  
This level of masking will be maintained throughout the conduct of the study. Unmasking 
will occur only after all planned study data have been validated, and the database locked. 

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11.6 Follow-Up of Subjects with Adverse Events  
The investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study.  
The investigator should provide the study sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (i.e., database lock).  
All complaints received after study completion will be considered and processed as 
spontaneous (following the postmarket vigilance procedures) and should be communicated to 
the medical device’s manufacturer as per local requirements. 
The investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements.  
Pregnancy in the Clinical Study: Pregnancy is not reportable as an AE; however, 
complications may be reportable and will be decided on a case-by-case basis.  
12 ANALYSIS PLAN 
In general, descriptive statistics generated for an endpoint will be based upon the type of 
parameter (i.e., whether the data is categorical or continuous) being analyzed. For categorical 
parameters, the statistics used to summarize the data descriptively include sample size, 
number in the category, and percent in the category. For continuous parameters, sample size, 
mean, median, standard deviation, minimum, and maximum will be presented. 
Analysis assumptions will be periodically reviewed during study conduct for deviations from 
analysis assumptions or the presence of outliers. The statistical methods should only be 
modified if there is a significant risk that the validity of the results can be substantively 
impacted. Because the study is open label, any discussion of analysis assumptions should not 
be based on review of any results by treatment group. 
12.1 Subject Evaluability 
Final subject evaluability must be determined prior to locking the database, based upon the 
Deviations and Evaluability Plan. 

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12.2 Analysis Sets 
The Full Analysis Set (FAS) will include all eyes for enrolled subjects who are bilaterally 
implanted with the test or comparator IOL. The FAS will be the primary analysis set for 
effectiveness and will be used for all safety analyses. 
12.3 Demographic and Baseline Characteristics 
Demographic and baseline characteristics will be summarized by treatment group and 
overall. Counts and percentages will be presented for categorical variables such as sex, 
categorized age group (< 65 years; ≥ 65 years), race, and ethnicity. The number of values, 
mean, standard deviation, median, and minimum, and maximum values will be presented for 
continuous baseline variables. 
12.4 Effectiveness Analyses 
12.4.1 Analysis of Primary Effectiveness Endpoints 
The co-primary effectiveness objectives are: 
1. To demonstrate that Clareon Vivity/Vivity Toric IOL is non‐inferior to Clareon 
Monofocal/Clareon Toric IOL in mean binocular photopic best corrected distance 
visual acuity (BCDVA) at 3 to 6 months (90 to 180 days) postoperatively. 
2. To demonstrate that Clareon Vivity/Vivity Toric IOL is superior to Clareon 
Monofocal/Clareon Toric IOL in mean binocular photopic distance corrected 
intermediate visual acuity (DCIVA) (66 cm from spectacle plane) at 3 to 6 months (90 
to 180 days) postoperatively. 
The corresponding primary effectiveness endpoints are 
• 
Binocular photopic BCDVA (logMAR) at 4 m. 
• 
Binocular photopic DCIVA (logMAR) at 66 cm. 
12.4.1.1 Statistical Hypotheses 
The null and alternative hypotheses for the first primary effectiveness endpoint are:  

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𝐻0: 𝜇𝑇𝑒𝑠𝑡−𝜇𝐶𝑜𝑚𝑝𝑎𝑟𝑎𝑡𝑜𝑟≥∆ 
𝐻1: 𝜇𝑇𝑒𝑠𝑡−𝜇𝐶𝑜𝑚𝑝𝑎𝑟𝑎𝑡𝑜𝑟< ∆ 
where μTest and μComparator are the means for binocular BCDVA for test (Clareon Vivity/Vivity 
Toric IOL) and comparator (Clareon Monofocal/Clareon Toric IOL), respectively, at 3 to 6 
months (90 to 180 days) postoperatively, and ∆ is the noninferiority margin set at 0.1 
logMAR. 
The null and alternative hypotheses for the second primary effectiveness endpoint are:  
𝐻0: 𝜇𝑇𝑒𝑠𝑡≥𝜇𝐶𝑜𝑚𝑝𝑎𝑟𝑎𝑡𝑜𝑟 
𝐻1: 𝜇𝑇𝑒𝑠𝑡< 𝜇𝐶𝑜𝑚𝑝𝑎𝑟𝑎𝑡𝑜𝑟 
where μTest and μComparator are the means for binocular DCIVA for test (Clareon Vivity/Vivity 
Toric IOL) and comparator (Clareon Monofocal/Clareon Toric IOL), respectively, at 3 to 6 
months (90 to 180 days) postoperatively. 
12.4.1.2 Analysis Methods 
The FAS will be used for the primary statistical analyses for both endpoints. 
 
 
Analysis of the first primary endpoint (noninferiority for binocular BCDVA) will be based on 
a two-sample t‐test assuming equal variances with testing based on a one-sided lower tailed 
test conducted at the 0.05 significance level. A corresponding two-sided 90% confidence 
interval for the difference in means (Clareon Vivity/Vivity Toric IOL minus Clareon/Clareon 
Toric IOL) will be presented. Noninferiority is demonstrated if the one-sided p-value for the 
t-test is less than 0.05 or, equivalently, the upper limit of the two-sided 90% confidence 
interval is less than the noninferiority margin. A two-sided 95% confidence intervals will also 
be provided for descriptive purposes. 
Analysis of the second primary endpoint (superiority test for binocular DCIVA) will be based 
on a two-sample t‐test assuming equal variances with testing based on a one-sided lower 
tailed test conducted at the 0.05 significance level. A two-sided 95% confidence interval for 

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the difference in means (Clareon Vivity/Vivity Toric IOL minus Clareon/Clareon Toric IOL) 
will be presented. 
12.4.2 Analysis of Secondary Effectiveness Endpoints 
The secondary effectiveness objectives are: 
1. To demonstrate that Clareon Vivity/Vivity Toric IOL is superior to Clareon 
Monofocal/Clareon Toric IOL in mean binocular photopic distance corrected near 
visual acuity (DCNVA) (40 cm from spectacle plane) at 3 to 6 months (90 to 180 days) 
postoperatively. 
2. To demonstrate that Clareon Vivity/Vivity Toric IOL is superior to Clareon 
Monofocal/Clareon Toric IOL with respect to proportion of subjects who respond 
“Never” to Q1 of the IOLSAT questionnaire (Overall, in the past 7 days, how often did 
you need to wear eyeglasses to see?) at 3 to 6 months (90 to 180 days) postoperatively. 
The corresponding secondary effectiveness endpoints are: 
• 
Mean binocular photopic DCNVA (logMAR) at 40 cm. 
• 
Proportion of subjects who respond “Never” to Q1 of the spectacle use questionnaire 
(IOLSAT) 
12.4.2.1 Statistical Hypotheses 
The null and alternative hypotheses for the first secondary endpoint are:  
𝐻0: 𝜇𝑇𝑒𝑠𝑡≥𝜇𝐶𝑜𝑚𝑝𝑎𝑟𝑎𝑡𝑜𝑟 
𝐻1: 𝜇𝑇𝑒𝑠𝑡< 𝜇𝐶𝑜𝑚𝑝𝑎𝑟𝑎𝑡𝑜𝑟 
where μTest and μComparator are the means for binocular DCNVA for test (Clareon Vivity/Vivity 
Toric IOL) and comparator (Clareon Monofocal/Clareon Toric IOL), respectively, at 3 to 6 
months (90 to 180 days) postoperatively. 
The null and alternative hypotheses for the second secondary endpoint are:  
𝐻0: 𝑝𝑇𝑒𝑠𝑡≤𝑝𝐶𝑜𝑚𝑝𝑎𝑟𝑎𝑡𝑜𝑟 
𝐻1: 𝑝𝑇𝑒𝑠𝑡> 𝑝𝐶𝑜𝑚𝑝𝑎𝑟𝑎𝑡𝑜𝑟 

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where pTest and pComparator are the proportion of subjects who respond “Never” to Q1 of the 
IOLSAT, for test (Clareon Vivity/Vivity Toric IOL) and comparator (Clareon 
Monofocal/Clareon Toric IOL), respectively, at 3 to 6 months (90 to 180 days) 
postoperatively. 
12.4.2.2 Analysis Methods 
The FAS will be used for the primary statistical analyses for both endpoints. 
 
 
Analysis of the first secondary endpoint (binocular DCNVA) will be based on a two sample t‐
test assuming equal variances with testing based on a one-sided lower tailed test conducted at 
the 0.05 significance level. A two sided 95% confidence interval for the difference in means 
(Clareon Vivity/Vivity Toric IOL minus Clareon/Clareon Toric IOL) will also be presented. 
Analysis of the second secondary endpoint (Q1 for IOLSAT) will be based on a Chi-squared 
test of two proportions with testing based on a one-sided upper tailed test carried out at the 
0.05 significant level. The proportion of subjects who respond “Never” to Q1 of the spectacle 
use questionnaire (IOLSAT) in each group will be presented. 

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12.5 Handling of Missing Data 
Missing data will not be imputed. Subjects will be included in each respective analysis if 
there is an observed result for that subject at the specified time point. 
12.6 Safety Analyses 
12.6.1 Analysis of Safety Endpoints 
The safety endpoints are: 
• 
Adverse events  
• 
Device deficiencies 
• 
QUVID subject survey 
• 
Binocular and monocular (first eye implanted) mesopic contrast sensitivity test (with 
and without glare) 
• 
IOP 
• 
Slit lamp examination findings including: 
o IOL observations  
o Absolute IOL position change (tilt and decentration) 
o Subjective posterior capsular opacification (PCO) 
o Posterior capsulotomy rates 
• 
Dilated fundus examination, including fundus visualization 
12.6.1.1 Statistical Hypotheses 
No hypothesis testing of the safety endpoints are planned. 

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12.6.1.2 Analysis Methods 
The focus of the safety analysis will be a comprehensive descriptive assessment of 
occurrence of adverse events and other safety parameters. Descriptive summaries (counts and 
percentages) and listings will be presented. Individual subject listings will be provided for 
AEs that occur after signing informed consent. 
12.7 Interim Analyses and Reporting 
No interim analyses are planned. 
12.8 Sample Size Justification 
A total of 210 subjects will be enrolled (approximately 105 per arm). Assuming a screen 
failure rate of 9.5%, approximately 190 subjects will be evaluable at Visit 1 (95 per arm). The 
power estimates for the planned analyses are presented below: 
Order 
Endpoint 
Comparison 
Noninferiority 
Margin 
Expected 
difference 
SD^ 
Power 
Co Primary 
Binocular BCDVA 
Noninferiority 
0.10 
0.04 
0.14 
90% 
Co Primary 
Binocular DCIVA at 66 cm 
Superiority 
NA 
0.085 
0.14 
> 98% 
1st Secondary 
Binocular DCNVA at 40 cm 
Superiority 
NA 
0.14 
0.14 
> 99% 
2nd Secondary 
Q1 of IOLSAT = NEVER 
Superiority 
NA 
0.14 
NA 
> 96% 
 
 
Overall power is estimated based on the assumption that each hypothesis test is independent. 
 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS 
13.1 Subject Confidentiality 
The investigator must ensure that the subject’s identity is kept confidential throughout the 
course of the study. In particular, the investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. The study sponsor may collect a copy of the enrollment log without 
any directly identifying subject information.  
The study sponsor may share patient-level data collected in this study with qualified 
researchers to help facilitate product development or enhancements in research that is not 
directly related to the study objectives. The informed consent explains this to the study 
subject.  

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13.2 Completion of Source Documents and Case Report Forms 
The nature and location of all source documents will be identified to ensure that original data 
required to complete the CRFs exist and are accessible for verification by the site monitor, 
and all discrepancies shall be appropriately documented via the query resolution process. Site 
monitors are appointed by the study sponsor and are independent of study site staff. 
If electronic records are maintained, the method of verification must be determined in 
advance of starting the study.  
At a minimum, source documents include the following information for each subject: 
• 
Subject identification (name, sex, race/ethnicity) 
• 
Documentation of subject eligibility 
• 
Date of informed consent 
• 
Dates of visits 
• 
Documentation that protocol specific procedures were performed 
• 
Results of study parameters, as required by the protocol 
• 
Documentation of AEs and other safety parameters (if applicable) 
• 
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study 
• 
Date of study completion and reason for early discontinuation, if applicable 
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the CRF are consistent with the original source data. 
Only designated individuals at the site will complete the CRFs. The CRFs must be completed 
at regular intervals following the clinical study visit schedule. It is expected that all data 
reported have corresponding entries in the source documents. The principal investigator is 
responsible for reviewing and certifying that the CRFs are accurate and complete. The only 
subject identifiers recorded on the CRFs will be subject number, and subject demographic 
information.  
13.3 Data Review and Clarifications 
A review of CRF data to the subject’s source data will be completed by the site monitor to 
ensure completeness and accuracy. After the CRFs have been completed, additional data 

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clarifications and/or additions may be needed as a result of the data cleaning process. Data 
clarifications are documented and are part of each subject’s CRF. 
13.4 Sponsor and Monitoring Responsibilities 
The study sponsor will select principal investigators that are qualified by education, training, 
and experience to assume responsibility for the proper conduct of this clinical study.  
The study sponsor is financially funding this clinical study and will compensate the 
investigator and/or the institution(s) at which the study is conducted in accordance with a 
signed clinical study agreement. 
The study sponsor will designate a monitor to conduct the appropriate site visits at the 
appropriate intervals according to the study monitoring plan. The clinical investigation will 
be monitored to ensure that the rights and wellbeing of the subjects are protected, the 
reported data are accurate, complete, and verifiable from the source documents, and the study 
is conducted in compliance with the current approved protocol (and amendments[s], if 
applicable), with current GCP, and with applicable regulatory requirements. 
The site may not screen subjects or perform the informed consent process on any subject until 
it receives a notification from an appropriate study sponsor representative that the site may 
commence conducting study activities. Monitoring will be conducted periodically while the 
clinical study is ongoing. Monitoring methods may include site visits, telephone, written and 
fax correspondence. Close-out visits will take place after the last visit of the last subject at the 
site. 
A coordinating investigator may be identified by the study sponsor to review and endorse the 
final study report. In cases where a coordinating investigator is engaged, the study sponsor 
will select the coordinating investigator based upon their experience, qualifications, active 
study participation, and their willingness and availability to take on this role. 
13.5 Regulatory Documentation and Records Retention 
The investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the study sponsor and the investigator’s files will be reviewed as part of the 
ongoing study monitoring. Financial information is to be kept separately.  
Additionally, the investigator must keep study records and source documents consistent with 
the terms of the clinical study agreement with the study sponsor. If the investigator retires, 
relocates, or for any other reason withdraws from responsibility of keeping the study records, 

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then the study sponsor must be notified, and suitable arrangements made for retention of 
study records and source documents needed to comply with national and international 
regulations. 
13.6 Quality Assurance and Quality Control 
The study sponsor will secure agreement from all involved parties to ensure direct access to 
all study related sites, source data and documents, and reports for the purpose of monitoring 
and auditing by the study sponsor, and inspection by domestic and foreign regulatory 
authorities. Quality control will be applied to each stage of data handling to ensure that all 
data are reliable and have been processed correctly. Agreements made by the study sponsor 
with the investigator/institution and any other parties involved in the clinical study will be 
provided in writing as part of the protocol or as a separate agreement. 
14 ETHICS 
Investigations are conducted in compliance with Good Clinical Practices; international and 
national regulations, laws and guidelines; ISO 14155; the conditions of approval imposed by 
reviewing IRBs/IECs or regulatory authorities; and in accordance with the ethical medical 
research principles outlined in the Declaration of Helsinki  
• 
The SOPs of the study sponsor and contract research organizations participating in the 
conduct of the clinical study and all other applicable regulations shall apply.  
• 
Notifications and timelines for reporting protocol deviations should be based upon 
applicable Ethics Committee requirements. 
The investigator must ensure that all personnel involved in the conduct of the study are 
qualified to perform their assigned responsibilities through relevant education, training, and 
experience. The investigator and all clinical study staff must conduct the clinical study in 
compliance with the protocol. The investigator is not allowed to deviate from the protocol 
except to protect the rights, safety, and well-being of human subjects under emergency 
circumstances. Emergency deviations may proceed without prior approval of the sponsor and 
the IRB/IEC, but shall be documented and reported to the sponsor and the IRB/IEC as soon 
as possible. Deviations from this protocol, regulatory requirements, and/or GCP must be 
recorded and reported to the Sponsor prior to database lock. If needed, corrective and 
preventive action should be identified, implemented, and documented within the study 
records. Failure to implement identified corrective and preventative actions may result in site 
closure by the sponsor. Use of waivers to deviate from the clinical protocol is prohibited. 

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Before clinical study initiation, this protocol, the informed consent form, any other written 
information given to subjects, and any advertisements planned for subject recruitment must 
be approved by an IRB/IEC. The investigator must provide documentation of the IRB/IEC 
approval to the study sponsor. The approval must be dated and must identify the applicable 
protocol, amendments (if any), informed consent form, assent form (if any), all applicable 
recruiting materials, written information for subject, and subject compensation programs. The 
IRB/IEC must be provided with any periodic safety updates, and all other information as 
required by local regulation and/or the IRB/IEC. Any additional requirements imposed by the 
EC or regulatory authority shall be followed. At the end of the study, the investigator must 
notify the IRB/IEC about the study’s completion. The IRB/IEC also must be notified if the 
study is terminated prematurely. Finally, the investigator must report to the IRB/IEC on the 
progress of the study at intervals stipulated by the IRB/IEC. 
Voluntary informed consent must be obtained in writing from every. The obtaining of consent 
shall be documented before any procedure specific to the clinical investigation is applied to 
the subject.  
The investigator must have a defined process for obtaining the required consent. Specifically, 
the investigator, or their delegate, must explain the clinical study to each potential subject and 
the subject must indicate voluntary consent by signing and dating the approved informed 
consent form. The subject must be provided an opportunity to ask questions of the 
investigator, and if required by local regulation, other qualified personnel. The investigator 
must provide the subject with a copy of the consent form written in a language the subject 
understands. The consent document must meet all applicable local laws and provide subjects 
with information regarding the purpose, procedures, requirements, and restrictions of the 
study, along with any known risks and potential benefits associated with the IP and the study, 
the available compensation, and the established provisions for maintaining confidentiality of 
personal, protected health information. Subjects will be told about the voluntary nature of 
participation in the study and must be provided with contact information for the appropriate 
individuals should questions or concerns arise during the study. The subject also must be told 
that their records may be accessed by appropriate authorities and sponsor-designated 
personnel. The investigator must keep the original, signed copy of the consent (file in 
subject’s medical records) and must provide a duplicate copy to each subject according to 
local regulations.  
The study sponsor assures that the key designs of this protocol will be registered on public 
databases where required by current regulations, and, as applicable, results will be posted.   

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15 REFERENCES 
Not applicable 
15.1 Regulations and Standards 
The following references may be applicable in whole or in part for this clinical study. 
• 
ISO 14155:2020 - Clinical Investigation of Medical Devices for Human Subjects - 
Good Clinical Practice 
• 
21 CFR Part 11 - Electronic Records; Electronic Signatures 
• 
21 CFR Part 50 - Protection of Human Subjects 
• 
21 CFR Part 56 - Institutional Review Boards 
• 
21 CFR Part 54 - Financial Disclosure by Clinical Investigators 
15.2 Scientific and Other References 
Not applicable 
16 APPENDIX A – Protocol Amendments 
There are no amendments. This is the first version of the protocol.