Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix
Phase: NA
Conditions: Aphakia, Presbyopia
Sponsor: Alcon Research

 
 
 
 
 
Contralateral Study of Clareon PanOptix Pro vs. Clareon 
PanOptix 
 
 
STUDY ID 
ILQ137-C002 Study B 
 
 
PROTOCOL v2 
18-Mar-2025 
 
 
NCT06401551 

Document ID:
V-CLN-0187723
Status: Approved, Version: 2.0
Approved Date: 18 Mar 2025
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Device Protocol for ILQ137-C002
Title: Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix
Protocol Number:
ILQ137-C002
Clinical Investigation 
Type: 
Post Market Interventional / Confirmatory
Test Product:
Clareon™PanOptix™Pro Trifocal IOL, Model PXYWT0
Clareon™PanOptix™Pro Trifocal IOL, Model PAYWT0
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

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Investigator Agreement:
x
I have read the clinical study described herein, recognize its confidentiality, and 
agree to conduct the described trial 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. 
x
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.
x
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.
x
I understand the potential risks and side effects of the investigational product(s).
x
I agree to maintain adequate and accurate records in accordance with government 
regulations and to make those records available for inspection.
x
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.
x
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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Table of Contents
Device Protocol for ILQ137-C002 ............................................................................................1 
Table of Contents .......................................................................................................................3 
List of Tables..............................................................................................................................7 
List of Figures............................................................................................................................7 
1 
GLOSSARY OF TERMS ....................................................................................................8 
2 
LIST OF ACRONYMS AND ABBREVIATIONS ...........................................................14 
3 
PROTOCOL SUMMARY.................................................................................................16 
4 
PROTOCOL AMENDMENTS .........................................................................................22 
5 
INTRODUCTION.............................................................................................................23 
5.1 
Rationale and Background.................................................................................23 
5.2 
Purpose of the Study..........................................................................................23 
5.3 
Risks and Benefits .............................................................................................24 
6 
STUDY OBJECTIVES......................................................................................................26 
6.1 
Primary Objective(s)..........................................................................................26 
6.2 
Secondary Objective(s): ....................................................................................26 
 
 
 
 
6.5 
Safety Objective(s): Sub-Study A and Sub-Study B .........................................29 
7 
INVESTIGATIONAL PLAN ............................................................................................30 
7.1 
Study Design......................................................................................................30 
7.2 
Rationale for Study Design................................................................................31 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations........................................................................................32 
7.3 
Rationale for Duration of Treatment/Follow-Up...............................................32 
7.4 
Rationale for Choice of Comparator Product....................................................33 
7.5 
Data Monitoring Committee..............................................................................33 
8 
STUDY POPULATION ....................................................................................................33 
8.1 
Inclusion Criteria...............................................................................................34 
8.2 
Exclusion Criteria..............................................................................................34 
8.3 
Rescreening of Subjects.....................................................................................36 

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9 
TREATMENTS ADMINISTERED...................................................................................36 
9.1 
Investigational Product(s)..................................................................................36 
9.2 
Other Medical Device or Medication Specified for Use During the Study.......43 
9.3 
Treatment Assignment/Randomization .............................................................43 
9.4 
Lens Power ........................................................................................................43 
9.5 
Treatment Masking............................................................................................44 
9.5 
Accountability Procedures.................................................................................44 
9.6 
Changes to Concomitant Medications, Treatments/Procedures ........................45 
9.6.1 
Changes to Concomitant Medications...............................................45 
9.6.2 
Changes to Treatments/Procedures....................................................45 
10 STUDY PROCEDURES AND ASSESSMENTS.............................................................46 
10.1 Informed Consent and Screening ......................................................................47 
10.2 Description of Study Procedures and Assessments ...........................................47 
10.2.1 
Demographics: Entry Criteria............................................................48 
10.2.2 
Medical History and Concomitant Medications: Entry Criteria........48 
10.2.3 
Urine Pregnancy: Entry Criteria........................................................48 
10.2.4 
Inclusion/Exclusion Criteria: Entry Criteria......................................48 
10.2.5 
Keratometry, Axial Length, and Anterior Chamber Depth: Entry 
Criteria/Effectiveness Assessment.....................................................48 
10.2.6 
Target Residual Refractive Error: Entry Criteria/Effectiveness 
Assessment ........................................................................................48 
10.2.7 
Predicted Residual Astigmatism: Entry Criteria................................49 
10.2.8 
Slit Lamp Biomicroscopy: Safety Assessment..................................49 
10.2.9 
Intraocular Pressure: Safety Assessment...........................................49 
10.2.10 Dilated Fundus: Entry Criteria/Safety Assessment ...........................49 
10.2.11 Administration of Treatment (Cataract Surgery): Safety 
Assessment ........................................................................................49 
 
 
 
 
10.2.15 Monocular Photopic Best Corrected Distance Visual Acuity: 
Effectiveness Assessment at 4 m: Effectiveness Assessment............50 
 
 
 
 

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10.2.30 Adverse Event Collection: Safety Assessment..................................52 
10.2.31 Device Deficiencies: Safety Assessment...........................................52 
10.2.32 IOL Observations: Safety Assessment ..............................................53 
10.2.33 Subjective PCO: Safety Assessment .................................................53 
10.2.34 Nd:YAG Capsulotomy: Safety Assessment.......................................53 
10.2.35 SSI: Safety Assessment .....................................................................53 
10.3 Unscheduled Visits ............................................................................................53 
10.4 Discontinued Subjects .......................................................................................54 
10.4.1 
Screen Failures ..................................................................................54 
10.4.2 
Discontinuations................................................................................54 
10.4.3 
Subjects with Aborted Implantation and Explanted IOL(s) ..............54 
10.5 Clinical Study Termination................................................................................55 
10.5.1 
Follow-up of Subjects after Study Participation has Ended..............55 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................56 
11.1 General Information ..........................................................................................56 
11.2 Device Deficiencies...........................................................................................57 
11.3 Monitoring for Adverse Events .........................................................................58 
11.4 Procedures for Recording and Reporting ..........................................................58 
11.5 Intensity and Causality Assessments.................................................................59 

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11.6 Return Product Analysis ....................................................................................60 
11.7 Unmasking of the Study Treatment...................................................................60 
11.8 Follow-Up of Subjects with Adverse Events.....................................................61 
11.9 Pregnancy in the Clinical Study ........................................................................61 
12 ANALYSIS PLAN ............................................................................................................61 
12.1 Subject Evaluability...........................................................................................62 
12.2 Analysis Sets......................................................................................................62 
12.3 Demographic and Baseline Characteristics .......................................................63 
12.4 Effectiveness Analyses ......................................................................................63 
12.5 Handling of Missing Data..................................................................................63 
12.6 Safety Analyses..................................................................................................63 
12.7 Interim Analyses and Reporting ........................................................................64 
12.8 Sample Size Justification...................................................................................65 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................65 
13.1 Subject Confidentiality......................................................................................65 
13.2 Completion of Source Documents and Case Report Forms..............................66 
13.3 Data Review and Clarifications.........................................................................67 
13.4 Sponsor and Monitoring Responsibilities..........................................................67 
13.5 Regulatory Documentation and Records Retention ..........................................68 
13.6 Quality Assurance and Quality Control.............................................................68 
14 ETHICS .............................................................................................................................68 
15 REFERENCES ..................................................................................................................70 
15.1 Regulations and Standards.................................................................................70 
15.2 Scientific and Other References ........................................................................70 
 
17 APPENDIX B – Sub-Study A ...........................................................................................71 
17.1 Analysis of Primary Effectiveness Endpoint(s).................................................71 
17.1.1 
Statistical Hypotheses........................................................................71 
17.1.2 
Analysis Methods ..............................................................................72 
 
 
 
 
 
 

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18 APPENDIX C– Sub-Study B ............................................................................................75 
18.1 Analysis of Primary Effectiveness Endpoint(s).................................................75 
18.1.1 
Statistical Hypotheses........................................................................75 
18.1.2 
Analysis Methods ..............................................................................75 
 
 
 
 
 
 
List of Tables
Table 2-1 
List of Acronyms and Abbreviations Used in This Protocol ...........................14 
Table 3-1 
Schedule of Study Procedures and Assessments .............................................20 
Table 6-1 
Primary Objective(s): Sub-Study A and Sub-Study B.....................................26 
 
 
 
 
 
 
Table 6-5 
Safety Objective(s): Sub-Study A and Sub-Study B........................................29 
Table 9-1 
Test Products....................................................................................................36 
Table 9-2 
Comparator Product.........................................................................................41 
Table 9-3 
Procedural Complications................................................................................45 
List of Figures
Figure 7-1 
Study Design Flowchart...................................................................................31 
Figure 11-1 
Categorization of All Adverse Events..............................................................56 
Figure 11-2 
Categorization of All Serious Adverse Events.................................................56 

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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 PanOptix Pro, Model PXYWT0 and Clareon 
PanOptix Pro, Model PAYWT0 
When Clareon PanOptix Pro is used it refers to both models 
independently: Model PAYWT0 or Model PXYWT0
Name of Comparator 
Product(s)
Clareon PanOptix, Model CNWTT0
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.

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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. 
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 Trial 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 

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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 trial, including a product with a 
marketing authorization when used or assembled 
(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).
Noninterventional Study
Clinical investigation that draws inferences about the 
possible effect of an intervention on subjects, but the 
investigator has not assigned subjects into intervention 
groups based on a protocol and has not made any attempts to 
collect data on variables beyond those available throughout 
the course of normal clinical practice and burden to the 
subject.
NOTE: The term “noninterventional” is synonymous with 
“observational.”
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 labeling 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.

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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.
Randomized Subject
Any subject who is assigned a randomized treatment.
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: 
x
Death.
x
A serious deterioration in the health of the subject, users 
or other persons as defined by one or more of the 
following: 
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.

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e) any indirect harm as a consequence of incorrect 
diagnostic test results when used within 
manufacturer’s instructions for use.
x
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 
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 trial, 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. 

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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
AAS
All-Implanted Analysis Set
ACD
Anterior chamber depth
ADE
Adverse device effect
AE
Adverse event
ASADE
Anticipated serious adverse device effect
BAS
Best Case Analysis Set
BCDVA
Best corrected distance visual acuity
CFR
Code of Federal Regulations
CIP
Clinical investigation plan
cm
Centimeter
Clareon 
PanOptix, Model 
CNWTT0
Clareon PanOptix Trifocal IOL, Model CNWTT0
Clareon 
PanOptix Pro
Clareon PanOptix Trifocal IOL, Model PAYWT0 and Clareon 
PanOptix Trifocal IOL, Model PXYWT0
Clareon 
PanOptix Pro, 
Model PAYWT0
Clareon PanOptix Pro Trifocal IOL, Model PAYWT0
Clareon 
PanOptix Pro, 
Model PXYWT0
Clareon PanOptix Pro Trifocal IOL, Model PXYWT0
CPO
Clareon PanOptix, Model CNWTT0
CPO Pro
Clareon PanOptix Pro Trifocal IOL, Model PAYWT0 or Clareon 
PanOptix Pro Trifocal IOL, Model PXYWT0
CRF
Case report form
D
Diopter
eCRF
Electronic case report form
EDC
Electronic data capture
EC
Ethic Committee
eIFU
Electronic instructions for use
EN
European standard
ETDRS
Early treatment diabetic retinopathy study
GCP
Good Clinical Practice
IB
Investigator’s brochure
ICF
Informed consent form
IFU
Instructions for use
IOL
Intraocular lens

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Abbreviation
Definition
IOP
Intraocular pressure
IP
Investigational product
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
MTF
Modulation Transfer Function
n
Number
Nd:YAG
Neodymium-doped yttrium aluminum garnet
NI
Noninferiority
nm
nanometer
N/A
Not applicable
OD
Right eye
OS
Left eye
OUS
Outside of the United States
PCO
Posterior capsular opacification
S
Superior
SADE
Serious adverse device effect
SAE
Serious adverse event
SAS
Safety Analysis Set
Std.
Standard
SSI
Secondary surgical intervention
USA
United States of America
USADE
Unanticipated serious adverse device effect
VA
Visual acuity

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3 PROTOCOL SUMMARY
Investigational 
product type
Device
Study type
Interventional
Investigational 
products
Test Products: Clareon PanOptix Pro Trifocal IOL, Model PXYWT0 
and Clareon PanOptix Pro Trifocal IOL, Model PAYWT0
Comparator Product: Clareon PanOptix Trifocal IOL, Model CNWTT0 
Purpose and 
Scientific 
Rationale for 
the Study
The studies under this protocol (sub-study A and sub-study B) will 
establish the safety and effectiveness of two Clareon PanOptix Pro 
models (Models PXYWT0 and PAYWT0). 
Brief Summary 
of the Protocol
The objective of the studies under this protocol is to evaluate the safety 
and effectiveness of the two Clareon PanOptix Pro models: Model 
PXYWT0 and Model PAYWT0 compared to Clareon PanOptix.
Subjects will be implanted contralaterally with Clareon PanOptix Pro 
(test) and Clareon PanOptix (comparator). Each of the Clareon 
PanOptix Pro models represents an incremental change to Clareon 
PanOptix, as such, the indications for use for each model is the same.
Subjects will be randomized to one of two sub-studies. Sub-study A 
will evaluate Model PXYWT0 and sub-study B will evaluate Model 
PAYWT0. Subjects randomized to sub-study A will be further 
randomized to receive Model PXYWT0 or Clareon PanOptix in the first 
surgical eye, and the second eye will receive the other lens. Similarly, 
subjects randomized to sub-study B will be further randomized to 
receive Model PAYWT0 or Clareon PanOptix in the first surgical eye 
and the second eye will receive the other lens. The 1st surgical eye will 
be the eye with the worse BCDVA at screening. When the BCDVA is
equal between the two eyes, the right eye (OD) will be the 1st surgical 
eye.

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Subjects in each study will be followed for a total of approximately 6
months postoperatively with key endpoints being assessed at the 2-
month postoperative follow-up visit (Visit 3A).
Objective(s)
Primary Effectiveness Objectives (Sub-Study A and Sub-Study B):
To demonstrate noninferiority of monocular photopic BCDVA of the 
Clareon PanOptix Pro models compared to Clareon PanOptix at 2 
months postoperative (Visit 3A).
Endpoint(s) 
Primary Effectiveness (Sub-Study A and Sub-Study B)
x
Mean monocular photopic BCDVA (logMAR) at 4 m at 2 
months postoperative (Visit 3A).
Safety (Sub-Study A and Sub-Study B)
x
AEs 
x
Device deficiencies
x
IOP
x
Slit lamp examination findings including:
•
Proportion of eyes with subjective posterior capsular 
opacification (PCO)
•
Proportion of eyes with posterior capsulotomy 
•
IOL observations
x
Dilated fundus examination findings, including fundus 
visualization
x
Intraoperative surgical problems
x
Other procedures at surgery (combined and/or additional)
x
SSIs
Assessment(s) 
Effectiveness
x
Monocular photopic BCDVA (logMAR) at 4 m
Safety
x
Slit lamp examination, including:

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x
Posterior capsule opacification evaluation
x
Posterior capsulotomy evaluation
x
IOL observations
x
Intraocular pressure 
x
Dilated fundus examination
x
Ocular and nonocular AEs
x
Device deficiencies
x
SSIs
Study Design
This is a prospective, multicenter, randomized, assessor and subject 
masked, contralateral, active controlled study. The study protocol 
contains two sub studies: Sub-study A and Sub-study B
x
Sub-study A (n = ~66 implanted subjects) – Subjects implanted 
contralaterally with Clareon PanOptix Pro, Model PXYWT0 in 1 
eye and Clareon PanOptix, Model CNWTT0 in the fellow eye
x
Sub-study B (n = ~66 implanted subjects) – Subjects implanted 
contralaterally with Clareon PanOptix Pro, Model PAYWT0 in 1 
eye and Clareon PanOptix, Model CNWTT0 in the fellow eye
Subjects at each site will be randomized to either sub-study A or sub-
study B.
The protocol will be executed simultaneously and identically for both 
sub-studies by the sites. Segregation by sub-study A and sub-study B 
will only be used for analysis and reporting. (See additional information 
in Appendix B and Appendix C).
Enrollment will commence at approximately 10 investigative sites. All
of the study sites will be located in one country, the United States.
The total duration of a subject’s participation in the study is 
approximately 7 months, attending 9 study visits (which includes the
Screening Visit). Subjects will be followed for a total of approximately 
6 months postoperatively 
 

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Subject 
population
Adult subjects with bilateral cataracts and less than 1.00 D of 
preoperative corneal astigmatism.
Planned number of subjects enrolled/consented: Approximately 158
Planned number of treated/implanted/randomized subjects: 
Approximately 132
Planned number of completed subjects: Approximately 120
Sites and 
Locations
Planned number of clinical sites: Approximately 10 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 (22 years or older at the time of participation in the study) with 
bilateral cataracts.
Preoperative corneal astigmatism less than 1.00 D in each eye.
Key exclusion 
criteria
(See Section 8.2
for a complete 
list of exclusion
criteria)
Subjects who desire monovision correction.
Predicted residual astigmatism of > 0.50 D between the two eyes.
Data analysis 
and sample size 
justification
A total of 132 subjects will be randomized (approximately 66 per sub-
study). Assuming a drop-out rate of 10%, approximately 60 subjects 
will be evaluable at the 2-month postoperative period (visit 3A) for 
each sub-study. The power estimates for each of the powered analyses 
are presented below:
Order
Endpoint
Comparison
Expected 
difference
Std. 
Dev^
Power
Sub-study A and Sub-Study B
Primary
Monocular BCDVA
NI
0
.08
>99.9%
A NI margin of 0.1 logMAR is used for the non-inferiority comparisons above.

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Associated 
materials
None
Table 3-1
Schedule of Study Procedures and Assessments
Visit
0
Visit
00b
Visit
1
Visit
2
Visit
00Ac
Visit
1A
Visit
2A
Visit
3Ad
Visit
4A
USVe
Procedure/Assessment
Screening
Preoperative
Day 0
1st Eye Surgery
Day 1-2 Post Visit 00
Day 7-14 Post
Visit 00
Day 0 for
2nd Eye Surgery
Day 1-2 Post Visit
00A
Day 7–14
Post visit 00A
Day 45-70
(2 Months) Post 
Visit 00A 
Day 180-210 
(6 Months) Post 
Visit 00A
Unscheduled Visit
Informed Consent
X
Demographics
X
Medical History
X
Concomitant Medications
X
X
X
X
X
X
X
X
X
X
Urine Pregnancy Testa*
X
Inclusion/Exclusion criteria
X
X
X
Slit lamp Exam
Xh
X
X
X
X
X
X
(X)
Dilated fundus examination
Xh
X
(X)
Keratometry
Xh
Axial length
Xh
Anterior Chamber Depth 
Xh
Target Residual Refractive Error
Xh
Predicted Residual Astigmatism
Xh
Intraocular pressure
X
X
X
X
X
X
X
(X)

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Visit
0
Visit
00b
Visit
1
Visit
2
Visit
00Ac
Visit
1A
Visit
2A
Visit
3Ad
Visit
4A
USVe
Procedure/Assessment
Screening
Preoperative
Day 0
1st Eye Surgery
Day 1-2 Post Visit 00
Day 7-14 Post
Visit 00
Day 0 for
2nd Eye Surgery
Day 1-2 Post Visit
00A
Day 7–14
Post visit 00A
Day 45-70
(2 Months) Post 
Visit 00A 
Day 180-210 
(6 Months) Post 
Visit 00A
Unscheduled Visit
Subjective Posterior Capsule
Opacification
X
X
X
X
X
X
(X)
Nd:YAG capsulotomyi
(X)
(X)
(X)
(X)
(X)
(X)
(X)
IOL observations
X
X
X
X
X
X
(X)
Secondary Surgical Interventions
X
X
X
X
X
X
X
X
(X)
Randomization
Xj
Device Deficiencies
X
X
X
X
X
X
X
X
X
Adverse Events (including SSI), 
both volunteered and elicited
X
X
X
X
X
X
X
X
X
X
a. In women of child-bearing potential only
b. It is recommended that Visit 00 (1st eye surgery) occur within 14 days of the Screening Visit (Visit 0).
c. It is recommended that Visit 00A (2nd eye surgery) occur a minimum of 7 days and a maximum of 14 days 
after Visit 00 (1st eye surgery).
d. If necessary, Visit 3A may be completed over 2 days within a two week period. Visit 3A must be completed 
within the specified window.
e. Unscheduled Visit: Assessments marked as (X) are optional as per the investigator’s discretion. 
f. In the surgical eye that is applicable to the visit.
g. Unscheduled Visit: 
monocular photopic BCDVA 
done using the standard of care method (e.g., Snellen, LogMAR).
h. Historical data collected prior to informed consent and within 60 days of Screening (Visit 0), may be used if 
collected per study requirements.
i. (X): Procedure performed as necessary. 
j. Randomization must occur after confirmation of eligibility and prior to 1st eye surgery.
*Documented in source document only. No entry into database
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.
. 
5 INTRODUCTION
5.1
Rationale and Background
The studies under this protocol seek to understand the safety and effectiveness of the two 
Clareon PanOptix Pro models (PXYWT0 and PAYWT0). Subjects will be implanted 
contralaterally with one of the Clareon PanOptix Pro models (test) and Clareon PanOptix 
(comparator).
5.2
Purpose of the Study
The objective of the studies under this protocol is to:
Evaluate the safety and effectiveness of the two Clareon PanOptix Pro models (Model 
PXYWT0 and Model PAYWT0) compared to Clareon PanOptix 

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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 these sub-studies for publication; 
however, the results may be offered for publication if they are of scientific interest. 
5.3
Risks and Benefits
Risk management principles have been applied to both the planning and the intended conduct 
of the clinical investigation, in order 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 product labeling/IFUs and are 
managed through review of safety assessments outlined in this protocol. 
Participation in the clinical study will require the subject to undergo cataract surgery and 
implantation with one of the Clareon PanOptix Pro models (test) in one eye and Clareon 
PanOptix (comparator) in the fellow eye. Complications may occur on the surgery day or 
throughout the postoperative period. As with any type of intraocular surgery, there is a 
possibility of complications due to anesthesia, drug reactions, and surgical problems. The 
surgical procedure can exacerbate a preexisting ocular condition. Possible problems during 
surgery include corneal endothelial touch, detached Descemet’s membrane, iris damage, iris 
prolapse, iris trauma, iris incarceration, zonular rupture, vitreous loss, capsulorhexis tear, 
capsular rupture, uncontrollable intraocular pressure, hyphema, and retinal damage. An IOP 
increase may occur from the surgical procedure, residual viscoelastic in the eye, or a steroid 
response to postoperative medications. Additionally, potential postoperative AEs include but 
are not limited to corneal stromal edema, cystoid macular edema, endophthalmitis, hypopyon, 
iritis, lens dislocation, membrane formation on the IOL, pupillary block, retinal detachment, 
cyclitic membrane, transient or persistent glaucoma, retinal tear, vitritis, iris touch, pupil 
ovalization, posterior synechiae, ocular inflammation, ocular discomfort or pain, 
inflammation, decreased vision, decreased contrast sensitivity, decreased color perception, 
visual disturbances, and corneal endothelial cell loss. An IOL replacement or explantation 
may be appropriate in some cases of residual refractive error, ocular infection, subject 
dissatisfaction, or visual disturbances (e.g., glare, halos, starbursts, hazy vision, blurred 
vision, double vision, visual distortions, and color distortions). An SSI (e.g., IOL 

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repositioning, replacement, or explantation) may be appropriate if the IOL position 
significantly differs from the intended placement. Alternatively, spectacles or contact lenses 
may be prescribed to resolve residual refractive error. Other SSIs include, but are not limited 
to: IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy 
or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair.
There may also be unknown risks to use of the Clareon PanOptix Pro and Clareon PanOptix 
IOLs. Any risk to subjects in this clinical study will be minimized by compliance with the 
eligibility criteria and study procedures, clinical oversight, and monitoring. 
Refer to the IFUs for additional information. 
Clinical evidence from published peer-reviewed clinical literature, clinical experience, and 
clinical investigations with parent IOLs establishes an acceptable safety and effectiveness 
profile for the Clareon PanOptix IOL. The Clareon PanOptix IOL is indicated for visual 
correction of aphakia and treatment of the effects of presbyopia in adult patients. The Clareon 
PanOptix IOL treats the effects of aphakia and presbyopia by providing near, intermediate, 
and distance vision following crystalline lens removal and IOL implantation and provides 
increased spectacle independence. Based on the formal risk assessment, it was concluded that 
the benefits of increased near and intermediate vision while maintaining good vision at 
distance significantly outweigh the risks of suboptimal surgical outcomes and increased 
likelihood of visual disturbances when the Clareon PanOptix IOLs are used in cataract 
surgery.
The risk/benefit profile for Clareon PanOptix Pro models is expected to be the same as 
Clareon PanOptix as these newer models represent an incremental change to Clareon 
PanOptix. Clareon PanOptix Pro has the same indications as Clareon PanOptix and is also 
indicated for visual correction of aphakia and treatment of the effects of presbyopia in adult 
patients. This study is designed to assess if the Clareon PanOptix Pro models may provide 
additional clinical benefits.  
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.

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6 STUDY OBJECTIVES
6.1
Primary Objective(s)
Table 6-1
Primary Objective(s): Sub-Study A and Sub-Study B
Objective(s)
Endpoint(s)
To demonstrate noninferiority of monocular 
photopic BCDVA of the Clareon PanOptix 
Pro models compared to Clareon PanOptix 
at 2 months postoperative (Visit 3A).
Mean monocular photopic BCDVA 
(logMAR) at 4 m at 2 months postoperative 
(Visit 3A).
6.2
Secondary Objective(s):
N/A

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6.5
Safety Objective(s): Sub-Study A and Sub-Study B 
Table 6-5
Safety Objective(s): Sub-Study A and Sub-Study B
Objective(s)
Endpoint(s)
To describe the incidence of ocular AEs
including SSIs at all visits
x
AEs
x
Device deficiencies
x
IOP
x
Slit lamp examination findings 
including:

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Objective(s)
Endpoint(s)
o
Proportion of eyes with subjective 
posterior capsular opacification 
(PCO)
o
Proportion of eyes with posterior 
capsulotomy 
o
IOL observations
x
Dilated fundus examination findings, 
including fundus visualization
x
Intraoperative surgical problems
x
Other procedures at surgery (combined 
and/or additional)
x
SSIs
7 INVESTIGATIONAL PLAN
7.1
Study Design
This is a prospective, multicenter, randomized, assessor and subject masked, contralateral, 
active controlled study. 
The study protocol contains two sub-studies: sub-study A and sub-study B
x
Sub-study A (n = ~66 implanted subjects) – Subjects implanted contralaterally with 
Clareon PanOptix Pro, Model PXYWT0 in one eye and Clareon PanOptix, Model 
CNWTT0 in the fellow eye
x
Sub-study B (n = ~66 implanted subjects) – Subjects implanted contralaterally with 
Clareon PanOptix Pro, Model PAYWT0 in one eye and Clareon PanOptix, Model 
CNWTT0 in the fellow eye
After subjects have been screened and met inclusion/exclusion criteria, subjects will be 
randomized to one of the two sub-studies. Sub-study A will evaluate PXYWT0 and sub-study 
B will evaluate PAYWT0. Subjects randomized to sub-study A will be further randomized to 
receive Model PXYWT0 or Clareon PanOptix in the first surgical eye, and the second eye 
will receive the other lens. Similarly, subjects randomized to sub-study B will be further 
randomized to receive Model PAYWT0 or Clareon PanOptix in the first surgical eye and the 
second eye will receive the other lens. 
For both groups, the 1st operative eye is defined as the eye with the worse BCDVA at 
Screening (Visit 0). If the BCDVA is the same in both eyes, the right eye (OD) will be 
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protocol will be executed simultaneously and identically for both sub-studies by the 
sites.
x
Subjects will be implanted contralaterally with Clareon PanOptix Pro (test) and 
Clareon PanOptix (comparator). The contralateral study design allows for assessment 
of subject response and will confirm noninferiority of the Clareon PanOptix Pro 
 
x
To reduce bias, testing methods have predefined procedures. Also, this study is 
assessor and subject-masked. 
 
Masked assessors will be masked to IOLs 
implanted in the subject until the time of the final database lock. Subjects will be 
masked to the IOLs implanted until the end of their study exit visit.
7.2.1 Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations
Two interim analyses are planned for this study. The first interim analysis will occur when 
approximately 40 subjects (20 subjects in each sub-study; minimum of 30 subjects total) have 
completed the 2-month visit (Visit 3A). This analysis is designed to review preliminary safety 
and effectiveness results for strategic business decisions.
The second interim analysis will be conducted after all treated subjects have completed the 2-
month visit (Visit 3A) and all inferential analysis will be conducted. 
No changes will be made to the design or conduct of the ongoing study as a result of the 
interim analyses.
7.3
Rationale for Duration of Treatment/Follow-Up
All subjects will be followed for approximately 6 months postoperatively. This period will 
allow sufficient subject recovery from surgery and stability of visual outcomes. Additionally, 
this postoperative period will ensure adequate evaluation of the primary 
 
endpoints being assessed at the 2-month (Visit 3A) postoperative visit, and to adequately 
assess device safety. 

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7.4
Rationale for Choice of Comparator Product
The comparator used in this study, Clareon PanOptix IOL, Model CNWTT0 is a well-
established trifocal IOL with proven benefits and safety profile. It was chosen to allow 
confirmation of noninferiority of the Clareon PanOptix Pro models 
 
 
7.5
Data Monitoring Committee
Not applicable
8 STUDY POPULATION
The study population consists of male and female subjects (age 22 or older at the time of 
participation in the study) with a diagnosis of bilateral cataracts. It is aimed to enroll 
(consent) approximately 158 in approximately 10 sites in the United States, with a target of 
132 contralaterally implanted subjects, with approximately 13 to 22 subjects per site. Site-
specific targets may vary based upon individual site capabilities. Estimated time needed to 
recruit subjects for the study is approximately 6 months; however, unanticipated 
circumstances may shorten or lengthen this time and would not require amendment of this 
protocol. 
This protocol allows enrollment of the following vulnerable population(s), with associated 
justification for each population: 
Elderly – It is appropriate to include elderly subjects in this clinical trial, as cataract 
formation is a known age-related occurrence and is common to this population. The 
investigational IOL under study is intended for implantation upon the removal of a 
cataractous crystalline lens to alleviate this age-related condition common to the elderly 
population. It is necessary to include elderly subjects in this clinical trial to gain data 
regarding the safety and effectiveness of the investigational IOL in this population.
The elderly population 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 trial prior to enrollment of elderly subjects. Any 
specific requirements imposed by the IRB/IEC regarding participation of elderly subjects will 
be implemented and documented, as appropriate. Upon conclusion of the clinical trial, all 

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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. 
Both eyes of a subject must qualify for enrollment into this 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 (22 years or older at the time of participation in the study) with bilateral 
cataracts
4. 
Planned bilateral cataract extraction by routine phacoemulsification 
5.
Calculated IOL power between +15 D and +25 D in each eye when targeting 
emmetropia, defined as IOL power with amount of targeted postoperative refractive 
error closest to 0 D based on power calculation
6.
Preoperative corneal astigmatism less than 1.00 D in each eye
7.
Potential postoperative BCDVA of 0.2 logMAR or better in each eye in the expert 
medical opinion of the investigator
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,
b. have a positive urine pregnancy test result at Screening,
c.
intend to become pregnant during the study period,
d. are breastfeeding

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Subjects who become pregnant during the study will not be discontinued; however, 
data will be excluded from selected analyses (described in Section 12.2) because 
pregnancy can alter refraction and VA results
2.
History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment 
(uveal, vitreoretinal) pathologic change including retinal vascular occlusive disease, 
retinal detachment or peripheral retinal laser photocoagulation, ARMD, glaucoma, 
diabetic retinopathy, retinitis pigmentosa, and any pathologic changes associated 
with the optic nerve
3.
History of recurrent anterior segment/posterior segment inflammation
4.
Clinically significant corneal diseases (epithelium, stromal, and/or endothelium) that
may, according to the investigator's medical opinion, adversely affect visual 
outcomes. 
These ocular pathologies include but are not limited to old significant corneal scars 
(including Salzman’s nodular degeneration), active or inactive keratitis with 
compromise of the refractive capability of the cornea, keratoconjunctivitis sicca with 
compromise of visual function, active keratouveitis, endothelial dystrophy (Fuch’s 
and non-guttate), keratoconus, etc. 
Note: Patients with any pathological manifestations that may potentially affect 
postoperative VA should not be included in this study
5.
Clinically significant/severe dry eye that would affect study measurements based on
the investigator’s expert medical opinion
6.
History of previous intraocular or corneal (refraction or trauma related) surgery
7.
Current or past history of amblyopia or monofixation syndrome with poor 
stereoscopic vision
8.
Subjects currently participating in another investigational drug or device study that 
may confound the results of this investigation
9.
Any other ocular or systemic comorbidity that, in the investigator’s medical opinion, 
may confound the results of this study or prohibit the completion of the study 
assessments or increase the risk for the subject
10.
Subjects with conditions that increase the risk of zonular rupture during cataract 
extraction procedure that may affect the postoperative centration or tilt of the IOL 
(e.g., patients of exfoliation syndrome, Marfan syndrome)
11.
Subjects who desire monovision correction
12.
Predicted residual astigmatism of > 0.50 D between the two eyes

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purpose in the 
current study 
less than 1 D of preexisting corneal astigmatism, in whom a 
cataractous lens has been removed. The lens mitigates the effects of 
presbyopia by providing improved intermediate and near VA, while 
maintaining comparable distance VA with a reduced need for 
eyeglasses, compared to a monofocal IOL.
Intended purpose: The Clareon PanOptix Pro IOL is intended for 
use by a trained ophthalmic surgeon. The IOL is intended to be 
placed in the capsular bag in the posterior chamber of the eye, 
replacing the natural crystalline lens. This position allows the IOL 
to function as a refractive medium in the correction of aphakia. This 
IOL has a biconvex optic containing an aspheric design and a 
diffractive structure on the anterior surface. The diffractive structure 
divides incoming light to provide a range of vision from distance to 
intermediate to near. This IOL provides an option for clinicians to 
provide patients an intermediate add power of +2.17 D and a near 
add power of +3.25 D at the IOL plane (representing +1.65 D and 
+2.35 D at the corneal plane after implantation, respectively, for an 
average human eye). The aspheric biconvex optic compensates for 
the positive spherical aberration of the cornea as compared to a 
standard spherical optic.
Product description 
and parameters 
available for this 
study
Compared to Clareon PanOptix IOL Model CNWTT0, this Clareon 
PanOptix Pro IOL improves the fidelity of the diffractive structure 
to enhance the overall light utilization and image quality between 
the distance and intermediate peaks.
x
Optic type: Single-piece IOL with diffractive aspheric 
biconvex optic
x
Optics material: Blue light filtering acrylate/methacrylate 
copolymer
x
Optic powers (spherical equivalent diopters): +15.0 through
+25.0 D in 0.5 D increments
x
Index of refraction: 1.55
x
Haptic configuration: STABLEFORCE™ Modified-L
Haptics
x
Haptic material: Blue light filtering acrylate/methacrylate 
copolymer

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x
Optic diameter (mm): 6.0
x
Overall length (mm): 13.0
x
Haptic angle: 0°
Formulation
N/A
Usage
IOLs are implantable medical devices and are intended for long
term use over the lifetime of the pseudophakic subject.
Packaging 
description
Alcon standard package contains below items:
x
The IOL
x
A subject registration card in case it is needed for the Alcon 
market (lens implant reply card)
x
A subject identification card, for the patient (implant card)
x
Adhesive labels containing the IOL information and unique 
serial number
x
eIFU reference card 
Labeling description
Packaged in a standard Alcon IOL carton. The carton is labeled 
with the following information: name of the lens, model number, 
overall diameter, optic diameter, diopter power, serial number, 
name of the manufacture, storage condition, expiration date, sterile, 
and single use.
Training and/or 
experience 
requirements for 
device
In order to implant IOLs in study subjects, the surgeons 
participating in the study must be licensed ophthalmologists with 
cataract surgery experience and trained on the protocol.
Storage conditions
N/A
Additional 
information
More information on the test article can be found in the test article 
IFU
Supply
Alcon will supply a consignment of this test article in the diopter 
range +15.0 D and +25.0 D
Test Product
Clareon PanOptix Pro Trifocal IOL, Model PAYWT0  
Manufacturer
Alcon Laboratories, Inc.
6201 South Freeway

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Fort Worth, Texas 76134-2099
USA
Indication for use 
and intended 
purpose in the 
current study 
Indication: The Clareon PanOptix Pro Trifocal IOL is indicated for 
primary implantation in the capsular bag in the posterior chamber of 
the eye for the visual correction of aphakia in adult patients, with 
less than 1 D of preexisting corneal astigmatism, in whom a 
cataractous lens has been removed. The lens mitigates the effects of 
presbyopia by providing improved intermediate and near VA, while 
maintaining comparable distance VA with a reduced need for 
eyeglasses, compared to a monofocal IOL.
Intended purpose: The Clareon PanOptix Pro IOL is intended for 
use by a trained ophthalmic surgeon. The IOL is intended to be 
placed in the capsular bag in the posterior chamber of the eye, 
replacing the natural crystalline lens. This position allows the IOL 
to function as a refractive medium in the correction of aphakia. 
This IOL has a biconvex optic containing an aspheric chromatic 
aberration correcting design and a diffractive structure on the 
anterior surface. The diffractive structure divides incoming light to 
provide a range of vision from distance to intermediate to near. This 
IOL provides an option for clinicians to provide patients an 
intermediate add power of +2.17 D and a near add power of +3.25 
D at the IOL plane (representing +1.65 D and +2.35 D at the 
corneal plane after implantation, respectively, for an average human 
eye). The aspheric biconvex optic compensates for the positive 
spherical aberration of the cornea as compared to a standard 
spherical optic.
Product description 
and parameters 
available for this 
study

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Formulation
N/A
Usage
IOLs are implantable medical devices and are intended for long
term use over the lifetime of the pseudophakic subject.
Packaging 
description
Alcon standard package contains below items:
x
The IOL
x
A subject registration card in case it is needed for the Alcon 
market (lens implant reply card)
x
A subject identification card, for the patient (implant card)
x
Adhesive labels containing the IOL information and unique 
serial number
x
eIFU reference card 
Labeling description
Packaged in a standard Alcon IOL carton. The carton is labeled 
with the following information: name of the lens, model number, 
overall diameter, optic diameter, diopter power, serial number, 
name of the manufacture, storage condition, expiration date, sterile, 
and single use.
Training and/or 
experience 
requirements for 
device
In order to implant IOLs in study subjects, the surgeons 
participating in the study must be licensed ophthalmologists with 
cataract surgery experience and trained on the protocol.
Storage conditions
N/A
Additional 
information
More information on the test article can be found in the test article 
IFU

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Supply
Alcon will supply a consignment of this test article in the diopter 
range +15.0 D and +25.0 D
Table 9-2
Comparator Product
Comparator Product
Clareon PanOptix Trifocal IOL, Model CNWTT0
Manufacturer
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134-2099
USA
Indication for use 
and intended 
purpose in the 
current study 
Indication: The Clareon PanOptix Pro Trifocal IOL is indicated for 
primary implantation in the capsular bag in the posterior chamber of 
the eye for the visual correction of aphakia in adult patients, with 
less than 1 D of preexisting corneal astigmatism, in whom a 
cataractous lens has been removed. The lens mitigates the effects of 
presbyopia by providing improved intermediate and near VA, while 
maintaining comparable distance VA with a reduced need for 
eyeglasses, compared to a monofocal IOL.
Intended purpose: The Clareon PanOptix Pro IOL is intended for 
use by a trained ophthalmic surgeon. The IOL is intended to be 
placed in the capsular bag in the posterior chamber of the eye, 
replacing the natural crystalline lens. This position allows the IOL 
to function as a refractive medium in the correction of aphakia. The 
optic portion is biconvex and includes an aspheric surface. The 
optic diffractive structure is in the central 4.5 mm portion of the 
optic and divides the incoming light to create a +2.17 D 
intermediate and a +3.25 D near add power at the IOL plane 
(representing +1.65 D and +2.35 D at the corneal plane after 
implantation, respectively, for an average human eye). The anterior 
aspheric surface of the Clareon PanOptix IOL is designed with 
negative spherical aberration to compensate for the positive
spherical aberration of an average cornea.
Product description 
and parameters 
x
Optic type: Single-piece IOL with diffractive aspheric 
biconvex optic

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available for this 
study
x
Optics material: Blue light filtering acrylate/methacrylate 
copolymer
x
Optic powers (spherical equivalent diopters): +15.0 through
+25.0 D in 0.5 D increments
x
Index of refraction: 1.55
x
Haptic configuration: STABLEFORCE™ Modified-L
Haptics
x
Haptic material: Blue light filtering acrylate/methacrylate
copolymer
x
Optic diameter (mm): 6.0
x
Overall length (mm): 13.0
x
Haptic angle: 0°
Formulation
N/A
Usage
IOLs are implantable medical devices and are intended for long
term use over the lifetime of the pseudophakic subject.
Packaging 
description
Alcon standard package contains below items:
x
The IOL
x
A subject registration card in case it is needed for the Alcon 
market (lens implant reply card)
x
A subject identification card, for the patient (implant card)
x
Adhesive labels containing the IOL information and unique
serial number
x
eIFU reference card 
Labeling description
Packaged in a standard Alcon IOL carton. The carton is labeled 
with the following information: name of the lens, model number, 
overall diameter, optic diameter, diopter power, serial number, 
name of the manufacture, storage condition, expiration date, sterile, 
and single use.
Training and/or 
experience 
requirements for 
device
In order to implant IOLs in study subjects, the surgeons 
participating in the study must be licensed ophthalmologists with 
cataract surgery experience and trained on the protocol.
Storage conditions
N/A

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Additional 
information
More information on the test article can be found in the test article 
IFU
Supply
Alcon will supply a consignment of this test article in the diopter 
range +15.0 D and +25.0 D
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. Treatment will be assigned by randomization via the EDC system on the day 
of or after the Screening visit, if the subject meets all entry criteria. 
Subjects will be randomized to one of two sub-studies and to contralateral treatment in a 1:1 
ratio. Subjects will be block randomized by investigational site. Subjects at each site will be 
randomized to one of two sub-studies in a 1:1 ratio. Sub-study A will evaluate Model 
PXYWT0 and sub-study B will evaluate Model PAYWT0. Subjects randomized to sub-study 
A will be further randomized to receive Model PXYWT0 or Model CNWTT0 in the first 
surgical eye, and the second eye will receive the other lens. Similarly, subjects randomized to 
sub-study B will be further randomized to receive Model PAYWT0 or Model CNWTT0 in 
the first surgical eye and the second eye will receive the other lens. The 1st surgical eye will 
be the eye with the worse BCDVA at screening. When the BCDVA is equal between the two 
eyes, the right eye (OD) will be the 1st surgical eye. 
Reminder: The subjects and the study staff members responsible for performing 
masked assessments must NOT be told of the treatment assignment.
9.4
Lens Power
Lens dioptric power will be determined by each surgeon’s standard of care. The subject must 
be targeted with the IOL power with the amount of targeted postoperative refractive error 
closest to 0 D based on power calculation. 
Note: Preoperative corneal astigmatism must be less than 1.00 D in each eye and the 
predicated residual astigmatism must NOT be > 0.50 D between the two eyes.

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9.5
Treatment Masking
This study is assessor-masked and subject-masked. 
 
 
 Alcon personnel (including biostatistics, masked data 
manager, and clinical project lead) will also be masked. All other members associated with 
the study (at the site and the study sponsor) are unmasked.
Alcon personnel will be masked to IOLs implanted in the eye until the 2nd interim study 
database lock. At the 1st interim analysis, unmasking of Alcon personnel will be limited to the 
subset of subjects included in the 1st interim lock as needed. Masked assessors will be 
masked to the IOLs implanted until the final database lock.
Subjects will be provided with implant cards by unmasked personnel upon exiting the study 
and will become unmasked at that time.
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. 
9.5
Accountability Procedures
Upon receipt of IPs, the investigator or delegate must conduct an inventory of all lenses by 
serial number, complete study-specific confirmation of receipt procedures as described in the 
MOP and retain any required documentation in the investigator’s clinical study records. 
Throughout the study, the investigator or delegate must maintain records of IP use for each 
subject. This record must be made available to the study monitor for the purposes of 
verifying the accounting of IP supplies. Any discrepancies and/or deficiencies between the 
observed disposition and the written account must be recorded along with an explanation. All 
IPs sent to the investigator must be accounted for by study sponsor personnel, and in no case 
be used in an unauthorized manner.
Refer to Section 11 of this protocol for additional information on the reporting of device 
deficiencies and to the MOP for information on return of investigational products associated 
with these events.

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x
Visit 1 (1 Day) is Day 1 to Day 2 post 1st eye surgery,
x
Visit 1A (1 Day) is Day 1 to Day 2 post 2nd eye surgery,
x
Visit 2 (1 Week) is Day 7 to Day 14 post 1st eye surgery,
x
Visit 2A (1 Week) is Day 7 to Day 14 post 2nd eye surgery,
x
Visit 3A (2 month) is Day 45 to Day 70 post 2nd eye surgery,
x
Visit 4A (6 month) is Day 180 to Day 210 post 2nd eye surgery.
If necessary, Visit 3A (2 months) may be completed over 2 days within a two week period, 
and must be completed within the specified window.
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 
excluded.
NOTE: Historical data collected prior to informed consent and within 60 days of Screening, 
may be used if collected per study requirements.
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. 
 
 
 
 

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. 
10.2.1 Demographics: Entry Criteria
Obtain demographic information including age, race, ethnicity, and sex.
10.2.2 Medical History and Concomitant Medications: Entry Criteria
Medical history and concomitant medications will be collected in the eCRF as outlined in the 
MOP. 
10.2.3 Urine Pregnancy: Entry Criteria
Perform urine pregnancy test according to the manufacturer's procedure on female subjects of 
childbearing potential.
10.2.4 Inclusion/Exclusion Criteria: Entry Criteria
Determine if subject meets entry criteria as outlined in Section 8. Subjects not meeting entry 
criteria are screen failures and should not continue in the study. 
NOTE: Determinations related to entry criteria must be made by medically qualified study 
staff. 
For subjects meeting entry criteria, refer to Section 9.3 for details on treatment assignment.
10.2.5 Keratometry, Axial Length, and Anterior Chamber Depth: Entry 
Criteria/
Measure keratometry, ACD, and AL according to the investigator’s standard of care for each 
eye. 
10.2.6 Target Residual Refractive Error: Entry Criteria/
 
Record target residual refractive error for each eye.
The targeted postoperative residual refractive error for lens selection must be closest to 
0 D based on power calculation. 

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10.2.7 Predicted Residual Astigmatism: Entry Criteria
Record predicted residual astigmatism for each eye. The use of a IOL Toric calculator is 
required.
Incisions to reduce astigmatism during surgery are allowed in this study and must also be 
taken into account when calculating predicted residual astigmatism.
A subject with predicted residual astigmatism of > 0.50 D between the two eyes should 
not be enrolled in the study.
10.2.8 Slit Lamp Biomicroscopy: Safety Assessment
Slit lamp examination must be performed in both eyes. Record any slit lamp findings, any 
IOL observations, any subjective PCO. This assessment must be performed by medically 
qualified study staff.
10.2.9 Intraocular Pressure: Safety Assessment
Perform tonometry assessment in each eye according to the to the investigator’s standard of 
care. Record IOP results.
10.2.10 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.
10.2.11 Administration of Treatment (Cataract Surgery): Safety 
Assessment
Perform cataract surgery in alignment with each subject’s assigned treatment  from 
randomization. In both sub-studies, the 1st operative eye is defined as the eye with the worse 
BCDVA at Screening (Visit 0). If the BCDVA is the same in both eyes, the right eye (OD) 
will be identified as the 1st operative eye.

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10.2.15 Monocular Photopic Best Corrected Distance Visual Acuity: 
Effectiveness Assessment at 4 m: Effectiveness Assessment
Measure monocular photopic ETDRS BCDVA at 4 m in each eye. This assessment must be 
performed by delegated trained masked assessor only.

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10.2.30Adverse Event Collection: Safety Assessment
Assess and record any AEs that are observed or reported since the previous visit, including 
those associated with changes in concomitant medication dosing.
Note: AEs must be recorded for all enrolled subjects from the time of signature of informed 
consent form, regardless of subject enrollment status (screen failure or randomized).
10.2.31 Device Deficiencies: Safety Assessment
Assess and record any device deficiencies that are reported or observed since the previous 
visit. Requirements for reporting device deficiencies in the study can be found in Section 11.

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Note: Device deficiencies must be recorded for all enrolled subjects from the time of 
signature of informed consent form, regardless of subject enrollment status (screen failure or 
randomized).
10.2.32 IOL Observations: Safety Assessment
Document any observations related to the IOL (e.g., haze, discoloration).
10.2.33 Subjective PCO: Safety Assessment
Assess and document presence of posterior capsule opacification (PCO).
10.2.34 Nd:YAG Capsulotomy: Safety Assessment
If a posterior capsulotomy (i.e., YAG laser treatment) has been performed since last visit, 
document the treatment including treatment date, eye, and size of the capsulotomy.
10.2.35 SSI: Safety Assessment
Document and report any SSIs (e.g., IOL repositioning) as an SAE.
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 nonstudy personnel, the investigator is to capture AE-related information on the AE 
form upon becoming aware.
During all unscheduled visits, the investigator must conduct the following procedures: 
x
Collect AE information
x
Record changes in medical condition or concomitant medication
The investigator may perform optional study assessment as outlined in Table 3-1, if clinically 
indicated.
The investigator may perform additional non-study procedures for proper diagnosis and 
treatment of the subject. 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 form and prior 
to randomization are considered screen failures. Subjects who are deemed no longer eligible 
to be implanted with a study lens after randomization (due to intraoperative exclusions or 
other noted issues) will be withdrawn from the study.
The investigator must document the reason for screen failure or withdrawal in the subject’s 
case history source documents.
Subject numbers must not be re-used.
10.4.2 Discontinuations
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the investigator after exposure to investigational product. 
NOTE: Subjects not implanted at the time of surgery (1st operative eye) and the study IOL 
did not touch the eye must be captured as withdrawn. 
Subject numbers of discontinued subjects must not be re-used for another subject (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 Subjects with Aborted Implantation and Explanted IOL(s)
Implantation may be attempted twice. After two aborted attempts to implant, meaning the 
investigational product touched the eye, the eye must be implanted with a nonstudy provided 
IOL. Refer to Section 9.6.2 for additional information.

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If the IOL implantation is attempted and aborted due to device deficiency, then a device 
deficiency form must be completed and the IOL must be returned to the study sponsor in 
appropriate safe packaging.
In case an explant is performed: the explanted eye will be followed for safety as routine 
standard of care for explants of approved IOLs.
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: 
x
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. 
x
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.
Breaking of the masked treatment codes will be done after locking the database.
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.

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11 ADVERSE EVENTS AND DEVICE DEFICIENCIES
11.1 General Information
An AE is any untoward medical occurrence, unintended disease or injury, or untoward
clinical sign (including abnormal laboratory findings) in subjects, users, or other persons,
whether or not related to the investigational medical device (test product). Refer to the
Glossary of Terms for categories of AEs and SAEs.
Figure 11-1
Categorization of All Adverse Events
Figure 11-2
Categorization of All Serious Adverse Events
Specific Events Relevant to this Protocol

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In addition to reporting all AEs (serious and non-serious) meeting the definitions, the 
Investigator must report any occurrence of the following as an SAE:
Cumulative (at any visit during the study) Serious Adverse Events:
x
Cystoid macular edema
x
Hypopyon
x
Endophthalmitis
x
Lens dislocation
x
Pupillary block
x
Retinal detachment
x
SSI (excluding posterior capsulotomy)
Persistent (still present at conclusion of study) Serious Adverse Events:
x
Corneal stromal edema
x
Cystoid macular edema
x
Iritis
x
Elevated IOP requiring treatment
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 
11.4.
11.2 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:
x
Failure to meet product specifications (e.g., incorrect IOL power)
x
IOL and delivery system defect
x
Broken IOL optic
x
Broken IOL haptic

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x
Scratched IOL optic
x
Unsealed device packaging
x
Suspect product contamination (IOL)
11.3 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:
x
“Have you had any health problems since your last study visit?”
x
“Have there been any changes in the medicines you take since your last study visit?”
In addition, changes in any protocol-specific parameters 
 evaluated 
during the study are to be reviewed by the investigator. Any untoward (unfavorable and 
unintended) change in a protocol-specific parameter or questions 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.
11.4 Procedures for Recording and Reporting
AEs are collected from the time of signing 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.
In addition, aqueous cells and flare, corneal edema, raised IOP, and superficial punctate 
keratitis are examples of early postoperative findings that are typically observed following 
ocular surgery. These are not considered AEs if they can be reasonably expected to resolve 
within 2 weeks and not result in any untoward long term visual outcome impact.
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 study 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 immediately as follows:

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x
All SAEs must be reported immediately (within 24 hours) of the investigator’s or site’s 
awareness.
x
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.
x
A printed copy of the completed Serious Adverse Event and Adverse Device Effect 
and/or Device Deficiency eCRF must be included with product returns. 
x
Additional relevant information after initial reporting must be entered into the eCRF as 
soon as the data become available.
x
Document any changes to concomitant medications on the appropriate eCRFs.
x
Document all relevant information from discharge summary, autopsy report, certificate 
of death, etc., if applicable, in narrative section of the Adverse Device Effect (for 
related AEs) and Serious Adverse Event eCRF.
Note: Should the EDC system become non-operational, the site must complete the
appropriate paper SAE and ADE and/or device deficiency form. The 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.
Any AEs and device deficiencies for any non-study marketed devices/products will be 
considered and processed as spontaneous (following the post-market vigilance procedures) 
and should be communicated to the device’s/product’s manufacturer as per local 
requirements. Any AEs and device deficiencies with the test or comparator IP should still be 
reported in EDC and can enter in the comment the other manufactures product if applicable.
Study sponsor representatives may be contacted for any protocol related questions and 
their contact information is provided in the MOP 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 study IP device deficiencies that could have led to a 
SADE according to the requirements of regulatory authorities or IRB/IEC.
11.5 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:

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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
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 non-serious to serious or from unrelated to related.
11.6 Return Product Analysis
Study sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol.
Alcon study products associated with device deficiencies and/or product related AEs should 
be returned under conditions described in the MOP.
11.7 Unmasking of the Study Treatment
Masked information on the identity of the assigned medical device should not be disclosed to 
the masked assessor or to the subject during the study. Refer to Section 9.5 of the protocol. If 
the treatment code needs to be broken in the interest of subject safety, the investigator is 
encouraged to contact an appropriate study sponsor representative prior to unmasking the 

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information if there is sufficient time. Dependent upon the individual circumstances (i.e., 
medical emergency), the code may be broken prior to contact with the study sponsor. The 
study sponsor must be informed of all cases in which the code was broken and of the 
circumstances involved. Additionally, the study sponsor may be required to unmask the 
information in order to fulfill expedited regulatory reporting requirements.
11.8 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). Any additional data received up to 6 months after 
subject has completed the study should be documented and available upon the study 
sponsor’s request. 
All complaints received after this time period will be considered and processed as 
spontaneous (following the post-market 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. 
11.9 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
All study conduct, effectiveness, and safety data will be reported for each sub-study (A and 
B) separately.
The primary time point of interest is 2 Months (Visit 3A) postoperative. After all subjects 
complete the 2-Month Visit (Visit 3A), the study database will be locked to conduct final 
inferential analyses. The study will be continued until all subjects complete the 6-Month 
Visit (Visit 4A), at which time the study database will be considered final and locked to 
report longer term effectiveness and safety results. 

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12.1 Subject Evaluability
Subject evaluability must be determined prior to breaking the code for masked treatment 
assignment and locking the database, based upon the deviations and evaluability plan. 
Subjects will be randomized to sub-study (A or B) and contralateral treatment in a 1:1 ratio to 
receive the investigational products. 
12.2 Analysis Sets
There will be three analysis datasets for each sub-study: the all-implanted analysis set, the 
best-case analysis set, and the safety analysis set.
The all-implanted analysis set (AAS) will include all subjects with successful test and 
comparator article contralateral implantation, with at least one postoperative visit.
The best-case analysis set (BAS) will include all subjects with successful contralateral 
implantation with the test and comparator article that had: 
x
At least one postoperative visit,
x
No preoperative ocular pathology or macular degeneration at any time in either eye 
and
x
No major protocol deviations 
Subjects who become pregnant at any time during the study will also be excluded from the 
BAS.
All eyes with attempted test or comparator article implantation (successful or aborted after 
contact with the eye) will be considered evaluable for the Safety Set (SAS).
The primary analysis set for effectiveness analyses will be the AAS, 
 
 
 
 
All effectiveness analyses will be conducted on an as-treated basis. Eyes will be categorized 
under the actual study IOL implanted.

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12.3 Demographic and Baseline Characteristics
Demographic and baseline characteristics will be summarized for each sub-study on the 
subject and eye level (by treatment) as applicable. Counts and percentages will be presented 
for categorical variables such as sex, age group, race, and ethnicity. N, mean, standard 
deviation, median, minimum, and maximum will be presented for continuous variables that 
are collected at baseline such as age, eye biometry, monocular VA, and refractive errors.
12.4 Effectiveness Analyses
In general, descriptive statistics will be generated using mean, standard deviation, median, 
minimum, and maximum, for continuous variables. The number in each category and 
percentage will be reported for categorical variables. Summaries of logMAR VA may include 
two-sided 95% confidence intervals for the mean difference between treatment groups. 
For statistical inference testing, the overall Type I error will be maintained, within each sub-
study, at the alpha 0.05 level (one-sided) using a sequential testing approach that will be 
detailed in the statistical analysis plan.
See Appendix B for specific effectiveness analyses related to sub-study A and see Appendix 
C for specific effectiveness analyses related to sub-study B.
12.5 Handling of Missing Data
There will be no imputation of missing data.
12.6 Safety Analyses
The safety objective for this study is to describe the incidence of ocular AEs including SSIs. 
The safety endpoints are as follows for sub-study A and B: 
x
AEs 
x
Device deficiencies
x
IOP
x
Slit lamp examination findings including:
o
Proportion of eyes with subjective posterior capsular opacification (PCO)
o
Proportion of eyes with posterior capsulotomy 
o
IOL observations

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x
Dilated fundus examination findings, including fundus visualization
x
Intraoperative surgical problems
x
Other procedures at surgery (combined and/or additional)
x
SSIs
There are no safety hypotheses for either sub-study. The focus of the safety analysis will be a 
comprehensive descriptive assessment, of occurrence of ocular AEs and SSIs, as well as the 
other listed parameters. For all safety measures, descriptive statistics generated will be based 
upon the type of variable. For categorical variables summary statistics will include sample 
size, number in each category, and percentage in each category. For continuous variables, 
number of subjects/eyes, mean, median, standard deviation, minimum, and maximum will be 
reported. Safety measures may be presented in listings as appropriate. 
All AEs occurring from the time a subject signs the informed consent form to study exit will 
be accounted for in the reporting. Safety analyses will be conducted using the safety analysis 
set on a treatment-emergent basis. Descriptive summaries (counts and percentages) and 
listings will be presented. Individual subject listings will be provided for AEs that occur after 
signing the informed consent form but prior to exposure to IP.
12.7 Interim Analyses and Reporting
The first interim analysis will be conducted when approximately 40 subjects (approximately 
20 in each sub-study, minimum 30 subjects total) complete the 2-Month postoperative visit. 
This interim analysis is designed to review preliminary safety and effectiveness results for 
strategic business decision making purposes. There is no intention of stopping the study early. 
A second interim analysis will be conducted when all subjects complete the 2-Month 
postoperative visit, at this point treatment arms will be unmasked and all inferential analysis 
will be conducted. To control the overall type I error rate (at alpha = 0.05) the Lan-DeMets 
method with an O’Brien-Fleming alpha spending function will be utilized to distribute the 
type I error rate between the first and second interim analyses. The first interim analysis will 
be conducted when approximately 1/3 of the information fraction (in this case 1/3 of the 
target sample size) is available, therefore the alpha spend will be approximately 0.001 at the 
first interim analysis and accordingly the significance level at the second interim analysis 
(which is the primary inferential analysis point) will be 0.049 for all effectiveness endpoints. 
The power estimates provided below are based on a 0.049 significance level. 

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12.8 Sample Size Justification
A total of 132 subjects will be randomized (approximately 66 per sub-study). Assuming a 
drop-out rate of 10%, approximately 60 subjects will be evaluable at 2 months postoperative 
period (visit 3A) for each sub-study. The power estimates for each of the planned analyses are 
presented below:
Order
Endpoint
Comparison
Expected 
difference
Std. Dev^
Power
Sub-study A
Primary
Monocular BCDVA
NI
0
.08
>99.9%
Sub-study B
Primary
Monocular BCDVA
NI
0
.08
>99.9%
^Estimate of std. dev is based on two recent Alcon studies (ILH297-C001 and ILI875-C002). * Estimated based of 
simulated results from VirtIOL. **Difference would indicate clinically meaningful effect.  A NI margin of 0.1 logMAR
is used for all non-inferiority comparisons above.
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 trial 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:
x
Subject identification (name, sex, race/ethnicity)
x
Documentation of subject eligibility
x
Date of informed consent
x
Dates of visits
x
Documentation that protocol-specific procedures were performed
x
Results of study parameters, as required by the protocol
x
IP accountability records
x
Documentation of AEs and other safety parameters (if applicable)
x
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study
x
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. 

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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 
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 trial. For this 
study, the principal investigator and implanting sub-investigators must be healthcare 
professionals appropriately trained/licensed/certified to perform surgery/treat subjects with 
the condition under study.
The study sponsor is financially funding this clinical trial and will compensate the 
investigator and/or the institution(s) at which the study is conducted in accordance with a 
signed clinical trial 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.

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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, 
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 GCP; 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. 
x
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. 
x
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 wellbeing of human subjects under emergency 

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circumstances. Emergency deviations may proceed without prior approval of the sponsor and 
the IRB/EC, but shall be documented and reported to the sponsor and the IRB/EC 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.
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 a copy of the IFUs, 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 subject. 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 

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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 investigator should document subject withdrawal of consent. The investigator is the 
designated contact point for any such withdrawals.
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. 
15 REFERENCES
15.1 Regulations and Standards
The following references may be applicable in whole or in part for this clinical trial.
x
EN ISO 11979-7 Ophthalmic implants – Intraocular lenses – Part 7: Clinical 
Investigations of Intraocular Lenses for the Correction of Aphakia 
x
EN ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects - Good 
Clinical Practice
x
21 CFR Part 11 - Electronic Records; Electronic Signatures
x
21 CFR Part 50 - Protection of Human Subjects
x
21 CFR Part 56 - Institutional Review Boards
x
21 CFR Part 812 - Investigational Device Exemptions
x
21 CFR Part 54 - Financial Disclosure by Clinical Investigators
x
The California Bill of Rights, if applicable
15.2 Scientific and Other References
Not applicable. There are no references.

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17 APPENDIX B – Sub-Study A
17.1 Analysis of Primary Effectiveness Endpoint(s)
The primary objective of this study is to demonstrate noninferiority of monocular photopic 
BCDVA of the Clareon PanOptix Pro PXYWT0 model compared to Clareon PanOptix at 2 
months postoperative (Visit 3A). The primary endpoint is mean monocular photopic BCDVA 
(logMAR) at 4 m at 2 months postoperative (Visit 3A).
17.1.1 Statistical Hypotheses
The null and alternative hypotheses to be evaluated in support of the primary non-inferiority 
objective are as stated below:
ܪ଴ǣ ߤ஽൒ο
ܪୟǣ ߤ஽൏ο
where, ο refers to the non-inferiority margin, set at 0.1 logMAR, and ߤ஽ refers to the mean of 
the difference between paired observations of each subject’s eyes (test minus comparator) for 
monocular photopic BCDVA at 2 months post implantation.

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17.1.2 Analysis Methods
The primary effectiveness endpoint, associated with the above hypotheses, will be tested by 
generating a one-sided 95.1% upper confidence limit based on the mean paired difference 
(Clareon PanOptix Pro - Clareon PanOptix) using a one-sample t-test. The upper bound of 
the one-sided 95.1% confidence limit will be compared to the margin, 0.10 logMAR. If the 
upper bound is less than the margin, the null hypothesis will be rejected and it will be 
concluded that Clareon PanOptix Pro is noninferior to Clareon PanOptix for monocular 
photopic BCVDA at 4 m. The difference in means (Clareon PanOptix Pro minus Clareon 
PanOptix) and the associated one-sided upper confidence limit will be presented.

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18 APPENDIX C– Sub-Study B
18.1 Analysis of Primary Effectiveness Endpoint(s)
The primary objective of this study is to demonstrate noninferiority of monocular photopic 
BCDVA of the Clareon PanOptix Pro PAYWT0 model compared to Clareon PanOptix at 2 
months postoperative (Visit 3A). The primary endpoint is mean monocular photopic BCDVA 
(logMAR) at 4 m at 2 months postoperative (Visit 3A).
18.1.1 Statistical Hypotheses
The null and alternative hypotheses to be evaluated in support of the primary noninferiority 
objective are as stated below:
ܪ଴ǣ ߤ஽൒ο
ܪୟǣ ߤ஽൏ο
where, ο refers to the noninferiority margin, set at 0.1 logMAR, and ߤ஽ refers to the mean of 
the difference between paired observations of each subject’s eyes (test minus comparator) for 
monocular photopic BCDVA at 2 months post implantation.
18.1.2 Analysis Methods
The primary effectiveness endpoint, associated with the above hypotheses, will be tested by 
generating a one-sided 95.1% upper confidence limit based on the mean paired difference 
(Clareon PanOptix Pro - Clareon PanOptix) using a one-sample t-test. The upper bound of 
the one-sided 95.1% confidence limit will be compared to the margin, 0.10 logMAR. If the 
upper bound is less than the margin, the null hypothesis will be rejected and it will be 
concluded that Clareon PanOptix Pro is noninferior to Clareon PanOptix for monocular 
photopic BCVDA at 4 m. The difference in means (Clareon PanOptix Pro - Clareon 
PanOptix) and the associated one-sided upper confidence limit will be presented.

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Approved Date: 18 Mar 2025
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