Post-Market Clinical Investigation of the Clareon® IOL
Phase: NA
Conditions: Cataract, Aphakia
Sponsor: Alcon Research



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1
PROTOCOL SYNOPSIS
Financial 
Disclosure for US 
FDA Submission 
Required?
Yes
X
No
Test Article(s) / 
Product(s):
Clareon aspheric hydrophobic acrylic monofocal intraocular lens 
(IOL) Model SY60WF
Hereto referred to as Clareon IOL
Objective(s):
Primary Objective: To evaluate the long-term (3 years) 
favorable visual acuity and adverse event outcomes for the 
Clareon IOL. A comparison to historical safety and performance 
endpoint (SPE) rates as reported in EN ISO 11979-7:2014 will be 
conducted for Visual Acuity and Adverse Events at one year.
Secondary Objective: To evaluate the visual acuity outcomes 
with the Clareon IOL.
Clinical Trial 
Design:
A prospective, multicenter, single group safety and performance 
clinical trial.
No. of Subjects:
a) Required for statistical analysis: 125 subjects (evaluable) 
completed
b) Planned (enrolled): Approximately 200 subjects implanted 
bilaterally (n = 400 eyes)
c) Each site should target approximately 10 subjects. 
Region(s):
EU and Australia (approximately 10-20 sites)
Clinical Trial 
Duration:
a) Total expected duration of the clinical investigation: 
Approximately 43 months
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b) Expected duration of each subject's participation: 
Approximately 36 months
c) Planned follow-up duration: 36 months post-bilateral 
implantation
d) Estimated time needed to select the number of subjects (ie,
enrollment period): Approximately 6 months
Clinical Trial 
Population:
Adult subjects, 22 years of age or older, with no ocular pathology 
(other than cataract) that could confound study outcomes, who 
require cataract extraction in both eyes will be considered for
enrollment in this study. Full details are found in Section 10
SUBJECT POPULATION.
Treatments:
Test Article:
Clareon IOL (Model SY60WF).
Administration:
Routine small incision cataract surgery 
with unilateral IOL implantation.
General Description:
A range of commonly used spherical 
powers (diopters) will be available, from 
15 to 25D in 0.50D steps.
Duration of 
Treatment:
Intraocular lenses are implantable 
medical devices and are intended for 
long term use over the lifetime of the 
cataract subject. 
Control Article:
N/A
Note: Historical safety and performance 
endpoints rates will serve as a 
comparator (EN ISO 11979-7:2014).
Administration:
N/A
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General Description:
N/A
Duration of 
Treatment:
N/A
Inclusion & 
Exclusion Criteria:
Details can be found in Section 10: SUBJECT POPULATION
Performance

Monocular best corrected distance visual acuity (BCDVA)

Monocular uncorrected distance visual acuity (UCDVA)
Safety

Adverse events (AEs), including Secondary Surgical 
Interventions (SSIs)

Device deficiencies

Surgical problems

Other procedures during surgery

Intraocular pressure (IOP)

Slit-lamp examination

IOL observations

IOL position change

Subjective posterior capsule opacification (PCO)

Posterior capsulotomy 

Dilated fundus examination (DFE)
Other

Manifest refraction

Keratometry

Axial length (AL)

Anterior chamber depth (ACD)
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Planned Analyses
The primary analysis set for effectiveness analyses will be the All-Implanted Analysis 
Set (AAS). AAS includes all eyes with successful test article implantation.
 
 
 
 
The Safety Analysis Set will include all eyes with attempted implantation with the test 
article (successful or aborted after contact with the eye) and will be used for the safety 
analyses.
The performance target in support of the primary effectiveness objective is to 
demonstrate that the one-sided exact 95% upper confidence limit for the percentage of 
subjects with monocular best corrected distance visual acuity (BCDVA) of 0.3 logMAR 
or better at 1 year (Visit 5A) is not worse than SPE rate of 92.5% for AAS (as reported 
in EN ISO 11979-7:2014). 
Descriptive statistics (mean, median, standard deviation, number of subjects/eyes, 
minimum, maximum, and the two-sided 95% confidence interval) will be provided for 
effectiveness endpoints, separately for first implanted eyes and second implanted eyes.
The primary safety objective is to evaluate the safety of the Clareon IOL for first and 
second operative eyes separately up to 3 Years (Visit 7A). Adverse Events rates at 1 year 
(Visit 5A) will be compared to historical safety and performance endpoint (SPE) rates as 
reported in EN ISO 11979-7:2014.
Descriptive statistics for adverse events (including SSIs) will be presented separately for 
first and second eyes. The one-sided exact 95% lower confidence limits for incidence 
rates observed up to one year of study follow-up (ie, after all subjects have completed 
Visit 5A) will be compared to the cumulative and persistent adverse event SPE rates (as 
reported in EN ISO 11979-7:2014), separately for first implanted eyes and second 
implanted eyes.
For the remaining study endpoints, descriptive statistics generated for effectiveness and 
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safety parameters will be based upon the type of parameter (ie, whether the data were 
categorical or continuous) being analyzed. For categorical parameters, the statistics used 
to summarize the data descriptively included sample size, number in the category, and 
percent in the category. For continuous parameters, sample size, mean, median, standard 
deviation, minimum, and maximum will be presented.
 
 
Sample Size Justifications
If more than 110 of 125 eyes show monocular best corrected distance visual acuity 
(BCDVA) of 0.3 logMAR or better at 1 year (Visit 5A), the one-sided exact 95% upper 
confidence limit for the rate is not worse than SPE rate of 92.5%. Assuming that the 
mean and the standard deviation of monocular BCDVA are 0.0 and 0.18 logMAR 
respectively, the study has greater than 99% chance to meet this performance target. 
For any event where zero incidence is observed in 125 first-operative eyes with Clareon 
IOL, the one-sided exact 95% upper confidence limit for the adverse event rate is less 
than 2.4%. Thus, with 95% confidence, the true adverse event rate is less than 2.4%.
Approximately 200 subjects will be bilaterally implanted with the Clareon IOL in order 
to ensure at least 125 evaluable subjects complete the study.
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2
TABLE OF CONTENTS
Table of Contents
Post-Market Clinical Investigation of the Clareon® IOL...........................................................1
1
PROTOCOL SYNOPSIS........................................................................................2
2
TABLE OF CONTENTS........................................................................................7
Table of Contents .......................................................................................................................7
List of Tables............................................................................................................................10
List of Figures..........................................................................................................................10
3
ABBREVIATIONS...............................................................................................11
4
GLOSSARY OF TERMS .....................................................................................13
5
AMENDMENTS ..................................................................................................16
5.1
Amendment 1 ...................................................................................................16
6
SCHEDULE OF VISITS......................................................................................18
7
INTRODUCTION................................................................................................20
7.1
Background.......................................................................................................20
7.2
Clinical Trial Design.........................................................................................20
8
CLINICAL TRIAL OBJECTIVES.......................................................................22
8.1
Primary Objective.............................................................................................22
8.2
Secondary Objectives .......................................................................................22
8.4
Study Endpoints................................................................................................22
8.4.1
Primary Effectiveness Endpoint ...................................................................22
8.4.2
Secondary Effectiveness Endpoints..............................................................22
8.5
Safety Endpoints...............................................................................................23
9
INVESTIGATIONAL PLAN ...............................................................................24
9.1
Outline of Clinical Trial....................................................................................24
9.2
Study Design ....................................................................................................24
9.3
Rational for Study Design ................................................................................25
9.4
Procedures Per Study Visit ...............................................................................25
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9.5
Risk Benefit Assessment ..................................................................................25
9.6
Known and Potential Risks ..............................................................................26
9.7
Potential Benefits..............................................................................................27
10
SUBJECT POPULATION....................................................................................28
10.1
Inclusion Criteria..............................................................................................28
10.2
Exclusion Criteria (Prior to Surgery)................................................................29
10.3
Reasons for Discontinuation During Surgery...................................................30
11
TREATMENT.......................................................................................................32
11.1
Investigational Products ...................................................................................32
11.2
Usage ................................................................................................................35
11.2.1
Procurement..................................................................................................37
11.2.2
Labeling........................................................................................................37
11.2.3
Handling .......................................................................................................37
11.2.4
Dispensing and Accountability Procedures..................................................37
12
CLINICAL TRIAL PROCEDURES ....................................................................39
12.1
Clinical Trial Assessments................................................................................39
12.2
Identification of Potential Subjects ..................................................................39
12.3
Prohibited Procedures.......................................................................................39
12.4
Preoperative Screening Visit (Visit 0) ..............................................................39
12.5
Operative Visit (Visit 00 and Visit 00A)...........................................................41
12.6
1-2 Days Post-implantation Visit (Visit 1 and Visit 1A) ..................................42
12.7
1-2 Week Post-implantation Visit (Visit 2 and Visit 2A)..................................43
12.8
1-Month Post-implantation Visit (Visit 3A).....................................................43
12.9
4-6 Month Post-implantation Visit (Visit 4A)..................................................45
12.10
1-Year Post-implantation Visit (Visit 5A) ........................................................46
12.11
2-Year Post-implantation Visit (Visit 6A) ........................................................47
12.12
3-Year Post-implantation Visit (Visit 7A/ Early Exit)......................................48
12.13
Unscheduled Visits ...........................................................................................49
12.14
Aborted Implantation........................................................................................50
12.15
Discontinued Subjects ......................................................................................50
12.16
Subject Lost to Follow-up ................................................................................51
12.17
Clinical Trial Termination ................................................................................51
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13
DEVICE DEFICIENCIES AND ADVERSE EVENTS.......................................52
13.1
General Information .........................................................................................52
13.2
Serious Adverse Events (SAEs) .......................................................................53
13.2.1
Cumulative Serious Adverse Events.............................................................54
13.2.2
Persistent Serious Adverse Events................................................................54
13.3
Device Deficiencies..........................................................................................55
13.4
Supportive Characterization of Ocular Adverse Events...................................55
13.5
Secondary Surgical Interventions (SSI) ...........................................................55
13.6
Monitoring for Adverse Events ........................................................................56
13.7
Procedures for Recording and Reporting .........................................................56
13.8
Unmasking of the Study Information...............................................................58
13.9
Follow-up of Safety Information......................................................................59
14
DATA REVIEW AND HANDLING ....................................................................59
14.1
Subject Confidentiality.....................................................................................59
14.2
Completion of Source Documents and Case Report Forms.............................60
14.3
Data Review and Clarifications........................................................................61
14.4
Quality Assurance and Quality Control............................................................62
15
ANALYSIS PLAN ...............................................................................................62
15.1
Subject Evaluability..........................................................................................62
15.2
Analysis Data Sets............................................................................................62
15.3
Demographics and Baseline Characteristics ....................................................63
15.4
Performance Analyses ......................................................................................63
15.4.1
Primary Performance....................................................................................63
15.4.1.1
Statistical Hypotheses...............................................................................63
15.4.1.2
Analysis Methods .....................................................................................63
15.4.2
Secondary Performance................................................................................63
15.4.2.1
Statistical Hypotheses...............................................................................64
15.4.2.2
Analysis Methods .....................................................................................64
15.5
Handling of Missing Data ................................................................................65
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15.7
Safety Analysis .................................................................................................65
15.9
Sample Size Justification..................................................................................66
16
ADMINISTRATIVE PROCEDURES..................................................................67
16.1
Regulatory and Ethical Compliance.................................................................67
16.2
Informed Consent Procedures ..........................................................................67
16.3
Responsibilities of the Investigator and IRB/IEC ............................................68
16.4
Sponsor and Monitoring Responsibilities ........................................................68
16.5
Regulatory Documentation and Records Retention .........................................69
16.6
Clinical Trial Results ........................................................................................69
17
REFERENCES .....................................................................................................71
List of Tables
Table 11–1
Test Article.......................................................................................................32
Table 11-2
Qualified Combinations of Compatible Products............................................36
Table 18–1
Postoperative Adverse Event Definitions for Intraocular Events (Masket 2017)
..........................................................................................................................75
Table 18-2
Definitions of Indications for Device Exchange, Removal, or Reposition 
(Masket 2017)..................................................................................................76
List of Figures
Figure 7–1
Study Design....................................................................................................21
Figure 11–1
Clareon aspheric hydrophobic acrylic intraocular lens (IOL) Model SY60WF
..........................................................................................................................35
Figure 13-1
Categorization of all Adverse Events...............................................................52
Figure 13–2
Categorization of all Serious Adverse Events..................................................53
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3
ABBREVIATIONS
Abbreviation
Definition
AAS
All-Implanted Analysis Set
ACD
Anterior chamber depth
ADE
Adverse device effect
AE
Adverse event
AL
Axial length
ASADE
Anticipated serious adverse device effect
BCDVA
Best corrected distance visual acuity
BSS
Balanced salt solution
CE
Conformité Européene or European Conformity
CFR
Code of Federal Regulations
CM
Clinical manager
CRF
Case report form
CSM
Clinical site manager
D
Diopter
DFE
Dilated fundus examination
DFU
Directions for use
DoH
Declaration of Helsinki
eCRF
Electronic case report form
EDC
Electronic data capture
EN
European Standard
EU
European Union
FA
Fluorescein angiography
FDA
Food and Drug Administration
FLACS
Femtosecond laser-assisted cataract surgery
GCP
Good Clinical Practice
HCL
Hydrogen chloride
ICF
Informed consent form
ICH
International Council for Harmonisation of Technical Requirements 
for Pharmaceuticals for Humans Use
IEC
Independent ethics committee
IOL
Intraocular lens
IOP
Intraocular pressure
IRB
Independent review board
IP
Investigational product
ISO
International Organization for Standardization
LASIK
Laser-assisted in-situ keratomileusis
logMAR
Logarithm of minimum angle of resolution
MedDRA®
Medical Dictionary for Regulatory Activities
m
Meter
mm
Millimeter
mmHg
Millimeters of mercury
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Abbreviation
Definition
MOP
Manual of procedures
N/A
Not applicable
OCT
Optical coherence tomography
OD
Right eye
OVD
Ophthalmic viscosurgical device
PC
Posterior capsulotomy
PCO
Posterior capsule opacification
RD
Retinal detachment
SADE
Serious adverse device effect
SAE
Serious adverse event
SOP
Standard operating procedure
SPE
Safety and Performance Endpoints
SSI
Secondary surgical intervention
SUN
Standardization of Uveitis Nomenclature
UCDVA
Uncorrected distance visual acuity
USADE
Unanticipated serious adverse device effect
US
United States
USV
Unscheduled visit
UV
Ultraviolet
WHO
World Health Organization
wk
Week
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4
GLOSSARY OF TERMS
Adverse Device 
Effect (ADE)
Adverse event related to the use of an investigational medical device or 
comparator, if applicable. 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 of the investigational medical 
device or comparator, if applicable.
Adverse Event 
(AE)
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device. Note: For subjects, this definition 
includes events related to the investigational medical device, the 
comparator, or the procedures involved. For users or other persons, 
this definition is restricted to events related to investigational medical 
devices.
Anticipated 
Serious Adverse 
Device Effect 
(ASADE)
Serious adverse device effect which by its nature, incidence, severity, 
or outcome has been identified in the risk analysis.
Assessment
A procedure used to generate data required by the study.
Device 
Deficiency
Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. Note: This definition 
includes malfunctions, misuse or use errors, and inadequate labeling.
Performance 
(Clinical)
Behavior of a medical device or response of the subject to that medical 
device in relation to its intended use, when correctly applied to 
appropriate subjects.
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.
Nonserious 
Adverse Event
Adverse event that does not meet the criteria for a serious adverse 
event.
Period
A minor subdivision of the study timeline; divides phases into smaller 
functional segments such as screening, baseline, operative, post-
implantation, etc.
Randomization 
Number
A unique identifier assigned to each randomized subject, corresponding 
to a specific treatment arm assignment.
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Serious Adverse 
Device Effect 
(SADE)
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event.
Serious Adverse 
Event (SAE)
Adverse event that led to any of the following: 

Death.

A serious deterioration in health that either resulted in:
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, ie, 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.
c) in-patient hospitalization or prolonged hospitalization.
Note: Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigation plan, without 
serious deterioration in health, is not considered a serious 
adverse event. In general, hospitalization signifies that the 
individual remained at the hospital or emergency ward for 
observation and/or treatment (usually involving an overnight 
stay) that would not have been appropriate in the physician's 
office or an out-patient setting. Complications that occur 
during hospitalization are AEs. If a complication prolongs 
hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” 
occurred, the event should be considered serious.
d) a medical or surgical intervention to prevent a) or b), or any 
ocular secondary surgical intervention excluding posterior 
capsulotomy.
e) any indirect harm as a consequence of incorrect diagnostic test 
results when used within manufacturer's instructions for use.

Fetal distress, fetal death, or a congenital abnormality or birth 
defect.
Subject Number
A number assigned to each subject who enrolls in the study. When 
combined with the site number, a unique identifier is created for each 
subject in the study.
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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 analysis.
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5
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 an Independent Ethics Committee (IEC)/Institutional Review Board (IRB) 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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7
INTRODUCTION
7.1
Background
The Clareon IOL (Model SY60WF) is a foldable, monofocal IOL intended as an optical 
implant for the replacement of the human crystalline lens in the visual correction of aphakia 
in adult patients following cataract surgery. The lens IOL is intended to be placed in the 
capsular bag in the posterior chamber of the eye.
The Clareon IOL is a UV-absorbing IOL composed of a high refractive-index foldable acrylic 
material. Its design is equivalent in dimensions to the globally approved ACRYSOF Natural 
IQ IOL (Model SN60WF). The Clareon IOL is a monofocal lens of single-piece construction, 
with a 6.0 mm diameter asymmetric biconvex posterior optic with an aspheric surface 
incorporated on the anterior side of the optic, and an overall length of 13.0 mm. The haptics 
are constructed from the same material as the optic with no angulation. The Clareon IOL is 
qualified for use with existing Alcon Monarch III-D cartridge and delivery systems (see 
Table 11-2 for more information).
A summary of known and potential risks and benefits to humans of the Clareon IOL, as 
identified in the literature or through preclinical testing and/or prior clinical evaluations, for 
the investigational product can be found in the Directions for Use (DFU).
The rationale to conduct this post-market study is to provide long-term (3 years) safety and 
effectiveness data on the Clareon IOL to support the Market Access requirements including 
the development of a product value dossier. 
7.2
Clinical Trial Design
An overview of the study flow is depicted in Figure 7–1.
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Figure 7–1
Study Design
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8
CLINICAL TRIAL OBJECTIVES
8.1
Primary Objective
The primary objective of this study is to evaluate the long-term (3 years) favorable visual 
acuity and adverse event outcomes for the Clareon IOL. 
One-year visual acuity and adverse event outcomes will be compared to historical SPE rates 
as reported in EN ISO 11979-7:2014.
8.2
Secondary Objectives
The secondary objective of this study is to evaluate the visual acuity outcomes obtained with 
up to 3 years follow-up in eyes implanted with the Clareon IOL.
8.4
Study Endpoints
8.4.1
Primary Effectiveness Endpoint
Percentage of subjects achieving BCDVA of 0.3 logMAR or better at 1 year post-
implantation (Visit 5A).
8.4.2
Secondary Effectiveness Endpoints

Percentage of subjects achieving BCDVA of 0.3 logMAR or better at 2 years post-
implantation (Visit 6A)

Percentage of subjects achieving BCDVA of 0.3 logMAR or better at 3 years post-
implantation (Visit 7A)

UCDVA at 1 year (Visit 5A) post-implantation

UCDVA at 2 years (Visit 6A) post-implantation
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
UCDVA at 3 years (Visit 7A) post-implantation
8.5
Safety Endpoints
The following safety endpoints will be collected:

AEs (ocular and nonocular, serious and non-serious) including SSIs 

Device deficiencies

IOL observations

Surgical problems

Intraocular pressure 

Posterior capsular opacification 

Posterior capsulotomy 

IOL position change (tilt and decentration)
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9
INVESTIGATIONAL PLAN
9.1
Outline of Clinical Trial
The current study is designed as a prospective, multicenter, single-arm trial assessing the 
long-term (3-year) safety and effectiveness of the Clareon IOL. The study includes adults 
(≥22 years of age) who require bilateral cataract extraction and who meet study entry 
criteria. Subjects will attend a total of 12 study visits over a period of approximately 
36 months. Of these twelve visits, one is a preoperative screening visit (Visit 0) and two are 
operative visits (Visit 00 and Visit 00A). The remaining nine are post-implantation visits 
(Visits 1-7A) which will occur at the following intervals: Visit 1 and Visit 1A (Day 1-2
post-implantation, first and second eye), Visit 2 and 2A (Day 7-14 post-implantation, first and 
second eye), Visit 3A (Day 30-45 post-implantation from 2nd eye surgery), Visit 4A
(Day 120-180 post-implantation from 2nd eye surgery), Visit 5A (Day 330-420
post-implantation from 2nd eye surgery), Visit 6A (Day 630-780 post-implantation from 
2nd eye surgery), and Visit 7A (Day 990-1140 post-implantation from 2nd eye surgery). 
Visit day calculations for Visits 1 and 2 are based off of the day of first eye surgery (Visit 00)
and calculations for Visits 1A-7A are based off of the day of second eye surgery (Visit 00A). 
Unscheduled visits may be conducted if needed for medical attention. Refer to Figure 7-1 
above for a study outline diagram.
Primary endpoint data will be collected at Visit 5A (330-420 days post-implantation from 2nd
eye surgery), and secondary endpoint data will be collected at Visit 5A (330-420 days post-
implantation from 2nd eye surgery), Visit 6A (630-780 days post-implantation from 2nd eye 
surgery) and Visit 7A (990-1140 days post-implantation from 2nd eye surgery). The study will 
be considered successful if the data at Visit 5A indicate a favorable outcome in relation to the 
SPE rates as reported in EN ISO 11979-7:2014. Additional details, including a risk-benefit 
assessment can be found in the sections below.
Section 12 CLINICAL TRIAL PROCEDURES outlines the procedures and assessments to 
be conducted at each study visit. This information is presented in tabular format in 
Section 6 SCHEDULE OF VISITS.
9.2
Study Design
This is a prospective, multicenter, single-arm safety and performance clinical study, requiring 
no masking. The trial will evaluate the safety and performance of the Clareon IOL in 
approximately 200 bilaterally implanted subjects. To qualify for enrollment into the trial, 
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adult (≥ 22 years of age) subjects must require routine, bilateral cataract surgery. Potential 
subjects will be screened for enrollment into the trial in accordance with the entry criteria 
found in Section 10 SUBJECT POPULATION. Subjects will attend a total of 12 study visits 
(7 post-implantation) over a period of approximately 3 years.
Primary endpoint data will be collected at Visit 5A (330-420 days post-implantation from 2nd
eye surgery).
 
 Final data analysis will be conducted at study completion 
(Visit 7A, 990-1140 days post implantation from the date of 2nd eye surgery.
The study will be considered successful if the data at Visit 5A indicate a favorable outcome in 
relation to the SPE rates as informed by EN ISO 11979-7:2014. Although study follow-up 
will continue until Visit 7A is completed for all subjects, the comparison of the vision and 
adverse events data to the SPE rates will be performed once all subjects have completed 
Visit 5A. This comparison will only be performed at Visit 5A, as the SPE rates in EN ISO
11979-7:2014 were developed from 1-year post-op clinical investigations (ie, the SPE rates 
are not appropriate for studies with greater than one year of follow up). Additional details, 
including a risk-benefit assessment can be found in the sections below. 
Section 12 CLINICAL TRIAL PROCEDURES outlines the procedures and assessments to be 
conducted at each study visit. This information is presented in tabular format in Section 6 
SCHEDULE OF VISITS.
9.3
Rational for Study Design
The design of this study will allow for the assessment of long-term (3-year) safety and 
efficacy of the Clareon monofocal IOL.
9.4
Procedures Per Study Visit
Section 12 CLINICAL TRIAL PROCEDURES contains procedures per study visits.
9.5
Risk Benefit Assessment
For a full and comprehensive risk benefit assessment including a summary of known and 
potential risks and benefits to humans as identified in the literature, through pre-clinical 
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testing, or via prior clinical investigations, refer to the DFU. Abbreviated details are provided 
in Section 9.6 and 9.7 below. 
Based on the below outlined risks and benefits, the risk of unanticipated adverse device 
effects with use of the Clareon IOL is considered to be low and the benefits of receiving the 
IOL should outweigh the risks for subjects that qualify for implantation in this study.
9.6
Known and Potential Risks
Complications may occur on the surgery day or throughout the postoperative period. Known 
and potential risks of the Clareon IOL are outlined here. 
Surgical Risk
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 
pre-existing 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 (IOP), hyphema, and retinal damage. An IOP increase 
may occur from the surgical procedure, residual viscoelastic in the eye, or a steroid response 
to post-implantation medications.
Post-implantation Risk
Potential post-implantation adverse events 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 significant residual 
refractive error, ocular infection, subject dissatisfaction, or visual disturbances (eg, glare, 
halos, starbursts, hazy vision, blurred vision, double vision, visual distortions, and color 
distortions). In most/majority of cases, spectacles or contact lenses may be prescribed to 
resolve residual refractive error. Other secondary surgical interventions include, but are not 
limited to: IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, 
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and iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal 
detachment repair.
Unknown Risk
There may also be unknown risks with the use of the Clareon IOL. Any foreseen risk to 
subjects in this clinical study will be minimized by compliance with the eligibility criteria, 
study procedures, and clinical monitoring.
9.7
Potential Benefits
Known and potential benefits of the Clareon IOL are outlined here.
Cataract surgery with IOL lens implantation benefits patients by restoring sight - the result of 
replacing the natural cataractous lens with an IOL. IOL implantation may also improve color 
vision, enhance image sharpness, and decrease nighttime photic phenomena (eg, glare, halo). 
This enhancement of vision may increase overall lifestyle satisfaction (eg, more 
independence, participation in social and/or sporting activities). The Clareon IOL is expected 
to have benefits comparable to other available monofocal IOLs.
This clinical trial may benefit the medical community and future cataract patients via 
contribution to the available scientific literature and the potential availability of an IOL with a 
new lens material. 
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10
SUBJECT POPULATION
The study population includes approximately 200 bilaterally implanted subjects, enrolled at 
approximately 10-20 investigative sites, over an enrollment period of approximately 
6 months. Each Investigator will implant approximately 10 subjects with no Investigator 
implanting more than 25% of the total study population. Each site will use only one 
implanting surgeon.
To participate in the clinical trial, subjects must be an adult (age 22 years or older at time of 
surgery) requiring routine, bilateral cataract surgery. A full list of entry criteria is provided in 
Sections 10.1 to 10.3 below. The Investigator may also refer to the lens DFU for further 
guidance, and may exclude potential subjects based upon his/her medical judgement.
Subjects will be implanted bilaterally and both eyes must meet all ocular inclusion/exclusion 
criteria to qualify for participation in the study. In the event that either eye fails to meet entry 
criteria, the subject may not be re-screened at a later date for qualification into the study. 
10.1
Inclusion Criteria
Listed below are criteria that must be met for inclusion into the study. Criteria must be met in 
both eyes unless noted otherwise.
1. Adults, 22 years of age or older at the time of surgery, of either gender or any race, 
diagnosed with bilateral cataracts
2. Able to comprehend and willing to sign an IRB/IEC approved statement of 
informed consent and complete all required post-implantation visits
3. Planned small incision cataract removal surgery
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10.2
Exclusion Criteria (Prior to Surgery)
Listed below are criteria that exclude entry into the study. Ocular criteria must be met in both 
eyes.
1. Subjects who may reasonably be expected to require an ocular surgical treatment 
at any time during the study 
2. Previous refractive surgery or planned refractive surgery procedures throughout 
the entire duration of the subjects’ participation in the clinical study (including, 
but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions)
3. Clinically significant corneal abnormalities including corneal dystrophy (eg, 
epithelial, stromal, or endothelial dystrophy), inflammation or edema per the 
Investigator’s expert medical opinion
(Note: Conditions including, but not limited to: keratitis, keratoconjunctivitis, 
keratouveitis, keratopathy, or keratectasia should be excluded.)
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18. Pregnancy or lactation current or planned during the course of the study
10.3 Reasons for Discontinuation During Surgery
Listed below are criteria that, when occurring at the time of first eye surgery, may result in 
discontinuation from the study. A subject discontinuing at the time of surgery for the first eye 
will be not be considered a screen failure. 
In the event that a criterion listed below occurs for either eye during surgery, do not implant 
the study lens. Proceed according to the physician’s professional medical judgement for what 
is in the best interest of the subject, including, if warranted, an alternate lens. See protocol 
Section 12.14 Aborted Implantation and Manual of Procedures (hereto referred to as MOP) 
Table 5-1 Subject Status After Exclusion During Surgery for additional instructions regarding 
follow-up.
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20. Any other additional procedures during the cataract removal and IOL implant due 
to intraoperative complications that require further intervention (including but not 
limited to posterior rupture, with vitreous loss, zonular dehiscence that may make 
the IOL implant less stable
21. Uncontrolled intraocular pressure
22. Significant anterior chamber bleeding
23. Excessive iris mobility
24. Mechanical or surgical intervention required to manipulate the pupil
Note: Pupil size must be 4.5mm or larger just prior to implantation
25. Any capsulorhexis other than continuous curvilinear capsulorhexis (eg, no 
anterior radial inconsistencies in the capsulorhexis such as anterior capsular tears 
or any areas of “can-opener” capsulotomy)
26. Unrecognized (pre-existing but discovered during surgery) ocular conditions or 
complications in which the IOL positions could be less stable, including zonular 
weakness
27. Zonular or capsular rupture
28. Bag-sulcus, sulcus-sulcus, or unknown placement of the IOL haptics
Note: Intended IOL haptic placement in this study is bag-bag.
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11
TREATMENT
Throughout the clinical study, the Investigator is responsible for the accounting of all IP and 
must ensure that the clinical study product is used in accordance with the manufacturer’s 
DFU. 
All consented and qualified subjects will be implanted bilaterally with the test article. No 
control article is available in this study. 
11.1
Investigational Products
Test Article: Refer to Table 11-1 below for test article details. 
Control Article: N/A
Table 11–1
Test Article
Test Product
Clareon aspheric hydrophobic acrylic intraocular lens (IOL) 
Model SY60WF
Manufacturer
Alcon
Indication for use
This IOL is intended for primary implantation in the capsular bag in 
the posterior chamber for the visual correction of aphakia secondary 
to removal of a cataractous lens in adult patients. 
Intended Purpose in 
the current study
The Clareon Aspheric Hydrophobic Acrylic IOL is a foldable single-
piece posterior chamber IOL intended as an optical implant for the 
replacement of the human crystalline lens in the visual correction of 
aphakia in adult patients following cataract surgery. The lens is 
intended to be placed in the capsular bag in the posterior chamber of 
the eye.
Product description 
and parameters 
available for this 
study
Optic Type – Anterior asymmetric biconvex
Optics Material – Ultraviolet and blue light filtering acrylate/ 
methacrylate copolymer
Optic Powers: 15.0 to 25.0 D in 0.5 D steps
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Index of Refraction: 1.55
Haptic Configuration: STABLEFORCE® Modified-L Haptics
Haptic Material: Ultraviolet and blue light filtering hydrophobic 
acrylate/methacrylate copolymer
Optic Diameter (mm): 6.0
Overall Length (mm): 13.0
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.
Number/Amount of 
Product to be 
Provided to the 
Subject
Each subject is planned to have bilateral IOL implantation.
Packaging 
description
Each IOL will be individually packaged and will have a unique serial 
number. The IOL package will contain the following items:

The IOL

A subject registration card (Lens Implant Card)

A subject identification card

Adhesive labels containing the IOL information and unique 
serial number

A package insert containing directions for use
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 
manufacturer, storage condition, expiration date, sterile, single use, 
and per any local country requirements, when applicable. 
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Storage conditions
The IP must be stored in a safe, secure location with limited access 
separated from general stock. Transportation of product from one 
address to another must be documented and a Transportation Log (or 
similar documentation) used for appropriate accountability.
Additional 
information
In order to implant the test article in a study subject, the surgeon 
participating in the study must be a licensed ophthalmologist with 
cataract surgery experience and trained on the protocol.
More information on the test article can be found in the product DFU 
(Clareon Aspheric Hydrophobic Acrylic IOL Model SY60WF).
Supply
Investigators and study sites will obtain IOLs from Alcon through 
their regular commercial ordering process.
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Figure 11–1
Clareon aspheric hydrophobic acrylic intraocular lens (IOL) 
Model SY60WF
11.2
Usage
The Clareon IOL is a foldable single-piece posterior chamber IOL intended as an optical 
implant for the replacement of the human crystalline lens in the visual correction of aphakia 
in adult patients following cataract surgery. The lens is intended to be placed in the capsular 
bag in the posterior chamber of the eye. Additional information regarding the use of this IOL 
can be found in the DFU.
Each study surgeon should follow his/her routine cataract procedure for all study surgeries, 
and according to the site’s surgical protocol documented for the study (see Section 14.3, Data 
Review and Clarifications, for additional details). Femtosecond laser-assisted cataract surgery 
(FLACS) is permitted for Investigators that currently use this procedure as part of their 
standard of care for cataract surgery; however, it is NOT required. FLACS may ONLY be 
used for the following:

Primary and sideport incisions

Capsulorhexis

Lens fragmentation
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11.2.1
Procurement
The Investigator shall locally procure each product (test lens and control lens) through his/her
standard Alcon commercial channel.
11.2.2
Labeling
Each IOL will be individually packaged and will have a unique serial number. The IOL
package will contain the following items:

The IOL

A subject registration card (Lens Implant Card)

A subject identification card

Adhesive labels containing the IOL information and unique serial number

A package insert containing directions for use
Product is locally procured via Alcon commercial channel and will arrive in country 
compliant commercial packaging with commercial label.
11.2.3
Handling
Once designated for trial use, product will be stored in a safe, secure location with limited
access separated from general stock. Transportation of product from one address to another
must be documented and a Transportation Log (or similar documentation) used for
appropriate accountability.
11.2.4
Dispensing and 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 dispensation 
for each subject. This record must be made available to the study monitor for the purposes of 
verifying the disposition of all received IP. Any discrepancies and/or deficiencies between the 
observed disposition and the written account must be recorded along with an explanation. All 
IP obtained by the Investigator must be accounted for by Study Sponsor personnel, and in no 
case be used in an unauthorized manner.
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If possible, return to the Study Sponsor investigational and control products associated with a 
device deficiency. Refer to Section 12.14 of this protocol and the MOP Section 8 for 
additional information.
The Investigator is responsible for proper disposition of all unused IP at the conclusion of the 
study, according to instructions provided by the Sponsor.
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12
CLINICAL TRIAL PROCEDURES
12.1
Clinical Trial Assessments
The following section describes in general the assessments to be performed in this clinical 
trial. Assessments are described in detail in the MOP. Refer to Section 6 SCHEDULE OF 
VISITS for an overview of assessments by visit.
Refer to Section 10 SUBJECT POPULATION for information on subject selection. AEs are 
collected and reported for both eyes. Refer to Section 13 DEVICE DEFICIENCIES AND 
ADVERSE EVENTS and APPENDICES Tables 18-1 and 18-2.
12.2 Identification of Potential Subjects
Identify potential subjects most likely to meet the qualifications for participation in the study
based on available medical records and exams. Invite those candidates who may qualify for 
the study to learn more about the trial. For those interested in participation, carry out the 
informed consent process. Refer to Section 16.2 Informed Consent Procedures. 
Note: Subjects must formally consent to the trial prior to any study specific testing.
12.3 Prohibited Procedures
Refractive surgical procedures are prohibited at surgery and throughout the duration of the 
subject’s participation in the clinical study. Prohibited procedures include, but are not limited 
to, LASIK, astigmatic keratotomy, and limbal relaxing incisions.
12.4 Preoperative Screening Visit (Visit 0)
Subjects will be considered enrolled upon consent. Each subject that signs a consent form 
must be entered into the EDC system. Upon entry into the system, each subject will be 
assigned a number. This subject number will be used to identify the subject throughout the 
study.
Below is a list of study procedures to be undertaken at Visit 0 (-60 to 0 days preoperative). 
The order of procedures is recommended. All assessments must be documented in source 
documentation and eCRFs (if applicable). 
For Visit 0, data from the Investigator’s previous routine clinical evaluation for DFE may be 
used, if the data 1) meet the requirements of this protocol and MOP, and 2) were collected 
within 30 days prior to the preoperative screening visit date. All other ocular assessments 
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must be collected after the subject signs the Informed Consent Form, and should be 
conducted in the order recommended.
1. Ensure subject has been properly consented for trial participation. Refer to 
Section 15.2 Informed Consent Procedures.
2. Document demographics, ocular and nonocular medical history, ocular and 
nonocular concomitant medications and pregnancy status (where applicable). 
3. Perform a urine pregnancy test IF the subject is a woman of child-bearing potential. 
4. Assess biometry measures including AL, keratometry, and ACD. 
[Both eyes]
5. Perform manifest refraction. 
Note: UCDVA may be performed prior to manifest refraction.
[Both eyes]
6. Perform monocular UCDVA and BCDVA testing with study specified equipment. 
Note: Lighting conditions must be measured and recorded in source prior to vision 
testing.
[Both eyes]
7. Perform an ophthalmic examination including slit-lamp, and DFE (if required, ie 
historical DFE not available within 30 days prior to screening). 
[Both eyes].
8. Perform tonometry to measure the IOP.
[Both eyes]
9. Calculate the required lens power for an emmetropic spherical equivalent target 
(defined as 0.00 ± 0.50 D). See Section 11.2 Usage for available IOL calculation 
formulae.
[Both eyes]
10. Record the target refractive error based on IOL power selected.
[Both eyes]
11. Assess, document and report adverse events. Refer to Section 13 DEVICE
DEFICIENCIES AND ADVERSE EVENTS for further detail.
12. Review inclusion/exclusion criteria and subject’s willingness to continue 
participation.
13. Identify the 1st surgical eye. This is defined as the eye with the worse BCDVA. If 
the BCDVA is the same in both eyes, identify the right eye (OD) as the 1st surgical 
eye.
14. Document the subject status (eg, continuing, screen failure). If the subject is a 
screen failure, document the primary reason the subject fails to qualify.
15. Schedule the subject for surgery within 60 days if they qualify.
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16. Order lenses for each eye (ensure a back-up lens is available and order if necessary) 
in the selected IOL power through local commercial channel prior to surgery.
12.5 Operative Visit (Visit 00 and Visit 00A)
Below is a list of study procedures to be undertaken at Visit 00 (Day 0, first eye surgery) and 
Visit 00A (Day 0, second eye surgery). The order of procedures is recommended. All 
assessments must be documented in source documentation and eCRFs (if applicable). The 
Visit 00A window may overlap with other study visit windows (eg, Visit 2). In this case, both 
visits may be conducted on the same day at the discretion of the Investigator.
1. Prior to treatment, review inclusion/exclusion criteria and ensure the subject has 
been properly consented for participation in the trial. 
2. Document any changes to ocular and nonocular concomitant medications. 
3. Record operative eye.
4. Proceed with Investigator’s routine cataract procedure while following guidance in 
Section 11 TREATMENT.
[Operative Eye Only]
5. Document the Surgical Report outcomes, including use of FLACs, implant success, 
target refractive error, IOL calculation formula, capsule polishing, and IOL capsule 
coverage. Refer to MOP for further detail.
[Operative Eye Only]
6. Document any problems during surgery including intraoperative complications and 
other procedures at surgery. Other procedures include those performed outside of
routine cataract surgery.
[Operative Eye Only]
7. Record the lens information that is located on the IOL sticker, including lens 
power. Both successful and aborted (if applicable) investigational product 
information should be recorded.
[Operative Eye Only]
8. Record any AEs including SSIs.
Note: SAEs including SSIs must be entered into Electronic Data Capture (EDC) 
system within 24 hours of the Investigator or site’s knowledge. Refer to Section 13 
DEVICE DEFICIENCIES AND ADVERSE EVENTS for further detail.
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9. Record any device deficiencies. Refer to Section 13 DEVICE DEFICIENCIES 
AND ADVERSE EVENTS for further detail.
10. Document the subject status (eg, continuing).
12.6 1-2 Days Post-implantation Visit (Visit 1 and Visit 1A)
Below is a list of study procedures to be undertaken at Visit 1 (1-2 days post-implantation, 
first eye) and Visit 1A (1-2 days post-implantation, second eye). The order of procedures is 
recommended. All assessments must be documented in source documentation and eCRFs (if 
applicable).
1. Record changes in medical/ocular history and ocular and nonocular concomitant 
medications.
2. Assess monocular UCDVA. Refer to MOP for further detail.
[Operative Eye Only]
3. Perform slit-lamp examination of the anterior segment. Include documentation of 
IOL observations, if applicable.
[Operative Eye Only]
4. Assess subjective PCO, and record information for any posterior capsulotomy that 
has occurred since surgery, if applicable.
[Operative Eye Only]
5. Observe any IOL position changes (ie, tilt and decentration) occurring since the 
previous visit.
[Operative Eye Only]
6. Perform tonometry to measure the IOP.
[Operative Eye Only]
7. Record any AEs including SSIs.
Note: SAEs including SSIs must be entered into Electronic Data Capture (EDC) 
system within 24 hours of the Investigator or site’s knowledge. Refer to Section 13 
DEVICE DEFICIENCIES AND ADVERSE EVENTS for further detail.
8. Record any device deficiencies. Refer to Section 13 DEVICE DEFICIENCIES 
AND ADVERSE EVENTS for further detail.
9. Document the subject status (eg, continuing).
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12.7 1-2 Week Post-implantation Visit (Visit 2 and Visit 2A)
Below is a list of study procedures to be undertaken at Visit 2 (7-14 days post-implantation, 
first eye surgery) and Visit 2A (7-14 days post-implantation, second eye). The order of 
procedures is recommended. All assessments must be documented in source documentation 
and eCRFs (if applicable).
1. Record changes in medical/ocular history and ocular and nonocular concomitant 
medications.
2. Perform manifest refraction.
Note: UCDVA may be performed prior to manifest refraction.
[Operative Eye Only]
3. Assess monocular UCDVA.
[Operative Eye Only]
4. Assess monocular BCDVA.
[Operative Eye Only]
5. Perform slit-lamp examination of the anterior segment. Include documentation of 
IOL observations, if applicable. 
[Operative Eye Only]
6. Assess subjective PCO, and record information for any posterior capsulotomy that 
has occurred since surgery, if applicable. 
[Operative Eye Only]
7. Observe any IOL position changes (ie, tilt and decentration) occurring since the 
previous visit. Refer to MOP for further detail. 
8. Perform tonometry to measure the IOP. Refer to MOP for further detail. 
9. Record any AEs including SSIs.
Note: SAEs including SSIs must be entered into EDC within 24 hours of the 
Investigator or site’s knowledge. Refer to Section 13 DEVICE DEFICIENCIES 
AND ADVERSE EVENTS for further detail.
10. Record any device deficiencies. Refer to Section 13 DEVICE DEFICIENCIES 
AND ADVERSE EVENTS for further detail.
11. Document the subject status (eg, continuing).
12.8 1-Month Post-implantation Visit (Visit 3A)
Below is a list of study procedures to be undertaken at Visit 3A (30-45 days post-implantation
from second eye surgery). The order of procedures is recommended. All assessments must be 
documented in source documentation and eCRFs (if applicable).
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10. Perform fundus exam. Refer to MOP for further detail.
11. Record any AEs including SSIs.
Note: SAEs including SSIs must be entered into EDC within 24 hours of the 
Investigator or site’s knowledge. Refer to Section 13 DEVICE DEFICIENCIES 
AND ADVERSE EVENTS for further detail.
12. Record any device deficiencies. Refer to Section 13 DEVICE DEFICIENCIES 
AND ADVERSE EVENTS for further detail.
13. Complete Disposition status. 
12.13 Unscheduled Visits
An unscheduled visit (USV) is defined as follows:

an ocular examination that is not standard of care and not required by the protocol; and

an examination conducted by the study staff; and

a new finding(s), or a change to a previous finding(s) was discovered.
A USV may or may not result in the capture of an AE. Likewise an AE may be captured 
without the report of a USV (eg, AE identified subsequent to examination by non-study 
personnel). The assessments captured at the USV are dictated by the Investigator per his/her 
medical judgment. The following assessments are recommended:

Concomitant medications

Monocular UCDVA

Slit-lamp exam 

IOL position change

Subjective PCO assessment

DFE

IOP

Adverse events

Device deficiencies
Note: Assessments are not limited to the above list.
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If the subject is discontinued at the USV, perform all Visit 7A/Early Exit procedures. Refer to 
Section 6 SCHEDULE OF VISITS. For safety purposes, if a USV is required after the final 
study visit, document the visit. Refer to Section 13.9 Follow-up of Safety Information for 
further detail.
12.14
Aborted Implantation
If the IOL implantation is attempted and aborted due to a Device Deficiency then a Device 
Deficiency form must be completed and the IOL must be returned to the Study Sponsor in 
appropriate safe packaging. Specific guidance with regards to aborted implantation is detailed 
in the MOP Table 5-1, Subject Status after Exclusion During Surgery.
12.15
Discontinued Subjects
Discontinued subjects withdraw, or are withdrawn from the study after signing consent, and 
prior to completing all study visits. Subjects signing consent, but withdrawing or withdrawn 
prior to surgery shall be considered discontinued due to screen failure, and the failed entry 
criterion documented in source documents and in EDC. Refer to Section 10 SUBJECT 
POPULATION.
Subjects may discontinue study participation at any time and for any reason. However, it is 
incumbent upon the Investigator to carefully select subjects who understand the commitment 
involved in participating in this clinical trial.
Subjects may be discontinued from the study at any time if, in the medical opinion of the 
Principal Investigator or designated, qualified medical personnel, continued participation 
poses a health risk to the subject, or other reasonable cause.
Subjects signing consent, but who voluntarily withdraw or are withdrawn by the Investigator 
prior to the final study visit shall be considered discontinued of study participation. For 
subjects discontinuing from the study, the Investigator should complete Exit procedures 
according to Section 12.12 3-Year Post-implantation Visit (Visit 7A/ Early Exit Visit), if the 
subject is willing and able, and if in the opinion of the Investigator it is safe for the subject to 
do so. The reason for discontinuation must be documented in source documents and in EDC. 
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.
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Subject numbers from discontinued subjects will not be reissued. Discontinued subjects will 
not be replaced.
12.16
Subject Lost to Follow-up
If a subject is overdue for a visit and all efforts to contact the subject for an examination have 
failed, this subject is considered lost to follow-up. The Exit Case Report Form should not be 
completed until after the subject’s last visit window closes, in case the subject is able to 
attend future visits. Any intermediate visits not attended will be considered Missed Visits.
12.17
Clinical Trial Termination
The Sponsor reserves the right to close an investigational site(s) or terminate the study in its 
entirety at any time, for reasonable cause. The Investigator also may terminate the study at 
his/her site for reasonable cause. Reasons for the closure of an investigational site or 
termination of a study may include:

the Investigator fails to comply with the protocol or Good Clinical Practice (GCP) 
guidelines;

inadequate recruitment of subjects by the Investigator; or

subject safety concerns.
If the clinical study is prematurely terminated or suspended, the Sponsor will inform the 
Investigator and the regulatory authorities of the termination/ suspension and the reason(s) 
for the termination/suspension. The Investigator should promptly notify the IEC/IRB of the 
termination or suspension and of the reasons. If the Sponsor terminates the study for safety 
reasons, it will immediately notify the Investigator(s), and provide written instructions for 
study termination and applicable subject follow-up.
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13
DEVICE DEFICIENCIES AND ADVERSE EVENTS
13.1
General Information
An Adverse Event (AE) is any untoward medical occurrence in a subject who is administered 
a clinical trial treatment (ie, implant with an investigational device) regardless of whether or 
not the event has a causal relationship with the treatment. An AE, therefore, can be any 
unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or 
disease temporally associated with the clinical trial treatment, whether or not related to the 
treatment. Below are Figures that categorize AEs and SAEs.
Figure 13-1
Categorization of all Adverse Events
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Figure 13–2
Categorization of all Serious Adverse Events
13.2 Serious Adverse Events (SAEs)
A serious adverse event is an AE that led to any of the following:

Death

A serious deterioration in the health of the subject that either resulted in:
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, ie, 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.
c) in-patient hospitalization or prolonged hospitalization.
NOTE: Planned hospitalization for a pre-existing condition, without serious 
deterioration in health, is not considered a SAE. In general, hospitalization signifies 
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that the individual remained at the hospital or emergency ward for observation and/or 
treatment (usually involving an overnight stay) that would not have been appropriate 
in the physician's office or an out-patient setting. Complications that occur during 
hospitalization are AEs. If a complication prolongs hospitalization or fulfills any other 
serious criteria, the event is serious. When in doubt as to whether “hospitalization” 
occurred, the event should be considered serious.
d) a medical or surgical intervention to prevent a) or b) or any ocular secondary 
surgical intervention (excluding PC).
e) any indirect harm as a consequence of incorrect diagnostic test results when used 
within manufacturer’s instructions for use.

Fetal distress, fetal death, or a congenital abnormality or birth defect.
Potentially sight-threatening events may also be considered serious based on the judgment of 
the Investigator and should be reported appropriately as delineated in Section 13.7 
Procedures for Recording and Reporting.
13.2.1 Cumulative Serious Adverse Events
Total number of Adverse Events that have occurred at any time up to a specified time point 
postoperatively.

Cystoid macular edema

Hypopyon

Endophthalmitis

Lens dislocation from posterior chamber

Pupillary block

Retinal detachment

Secondary surgical intervention (excluding PC)
13.2.2 Persistent Serious Adverse Events

Corneal stromal edema

Cystoid macular edema
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
Iritis

Raised IOP requiring treatment
This list is consistent with the categories provided in EN ISO 11979-7:2014. A persistent AE 
is an AE that is present at the conclusion of a clinical investigation per EN ISO 11979-
7:2014. Any other potentially sight-threatening event may also be considered serious based 
on the judgement of the Investigator and must be reported appropriately as delineated in 
Section 13.2. Serious Adverse Events (SAEs).
13.3 Device Deficiencies
A device deficiency may or may not be associated with subject harm (ie, ADE or SADE); 
however, not all ADEs or SADEs are due to a device deficiency. The Investigator should 
determine the applicable category for the identified or suspect device deficiency and report 
any subject harm separately. Examples of device deficiencies include the following:

Failure to meet product specifications (eg, incorrect IOL power)

IOL defect

Broken IOL optic

Broken IOL haptic

Scratched IOL optic

Unsealed device packaging

Suspect product contamination

Lack of effectivity
13.4 Supportive Characterization of Ocular Adverse Events
Additional supportive characterizations of ocular adverse events will be assessed by the 
Investigator according to the terms and definitions in Section 18, APPENDICES, Table 18-1.
13.5 Secondary Surgical Interventions (SSI)
Secondary surgical interventions reporting will be sub-categorized using the following 
terminology: exchange, removal, and repositioning. Indications and associated definitions for 
these outcomes are provided in Section 18, APPENDICES, Table 18-2.
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13.6 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 such as:

“Have you had any health problems since your last study visit?”

“Have there been any changes in the medicines you take since your last study visit?”
Changes in any protocol-specific ocular or systemic parameter evaluated during the study are 
to be reviewed by the Investigator. In addition, the subject’s responses to any questionnaire 
utilized during the study are to be reviewed by the Investigator. Any untoward (unfavorable 
and unintended) change in a protocol-specific parameter or questionnaire response that is 
clinically relevant, in the opinion of the Investigator, is to be reported as an AE. These 
clinically relevant changes will be reported regardless of causality.
13.7
Procedures for Recording and Reporting
AEs are collected from the time of informed consent. Any pre-existing medical conditions or 
signs/symptoms present in a subject prior to the start of the study (ie, before ICF 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 post-operative findings that are typically observed following 
ocular surgery. These are not considered AEs if they can be reasonably expected to resolve 
within a week 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 test and control articles 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:

ADEs or SAEs are documented on the Adverse Device Effect and Serious Adverse 
Event eCRF within 24 hours of the Investigator’s or site’s awareness.
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
Device deficiencies are documented on the Device Deficiency eCRF within 
24 hours of the Investigator’s or site’s awareness. Please include a printed copy of 
the completed Device Deficiency eCRF with product returns.

Additional relevant information after initial reporting is to be entered into the 
eCRF as soon as the data become available.

Document any changes to concomitant medications on the appropriate eCRFs.

All relevant documentation such as Discharge Summary, Autopsy Report, 
Certificate of Death, etc, should be faxed to the Study Sponsor at 1-817-302-1927.

USADEs must be reported to the IRB/IEC as soon as possible, but not later than 
10 working days after the investigator’s or site’s awareness.
NOTE: Should the EDC system become non-operational, the site must complete the 
appropriate paper Adverse Device Effect and Serious Adverse Event Form or Device 
Deficiency Form. The completed form is faxed to the Study Sponsor at 1-817-302-1927 or 
emailed to FTW.medical_safety@alcon.com within 24 hours of the Investigator’s or site’s 
awareness; however, the reported information must be entered into the EDC system once it 
becomes operational.
Any AEs and device deficiencies for non-study marketed devices/products (ie, BSS, OVD, 
delivery systems) 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.
Study Sponsor representatives and their contact information are provided in the Manual of 
Procedures that accompanies this protocol.
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IEC/IRB.
Intensity and Causality Assessments
For every AE and device deficiency, the Investigator must assess the causality as Related or 
Not Related to the medical device or test procedure in the study. An assessment of causality 
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will also be performed by a study Sponsor physician utilizing the same definitions, as shown 
below:
Causality
Related
An AE or device deficiency classified as related may be either definitely 
related or possibly related where a direct cause and effect relationship with the 
medical device or test procedure has not been demonstrated, but there is a 
reasonable possibility that the AE or device deficiency was caused by the 
medical device or test procedure.
Not Related
An AE or device deficiency classified as not related may either be definitely 
unrelated or simply unlikely to be related (ie, there are other more likely 
causes for the AE or device deficiency).
Where appropriate, the Investigator must assess the intensity (severity) of the AE as mild, 
moderate, or severe, based on medical judgment with consideration of any subjective 
symptom(s), as defined below: 
Intensity (Severity)
Mild
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom.
Moderate
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities.
Severe
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities.
The Investigator must document any action taken (ie, medication, intervention, or treatment 
plan) and outcome of the AE or device deficiency when applicable.
13.8
Unmasking of the Study Information
Not applicable.
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13.9
Follow-up of Safety Information
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 must 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 (ie, database lock).
Any additional data from these follow-up procedures performed up to 6 months after subject 
discontinuation or exit must 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 postmarket vigilance procedures) and should be communicated to 
the medical device’s manufacturer as per local requirements.
The Investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements.
14
DATA REVIEW AND HANDLING
14.1
Subject Confidentiality
The Investigator must ensure that the subject’s anonymity is maintained 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. At the end of the clinical study, the Study Sponsor will collect a copy 
of the enrollment log without any identifying subject information. All documents 
submitted to the Study Sponsor will identify the subjects exclusively by number and 
demographic information. No other personally identifying information will be transmitted to 
the Study Sponsor. 
The Study Sponsor may release anonymized study data to external researchers for purposes 
of future research directly related to the study objectives, or future research that is beyond the 
scope of the current study objectives. The ICF explains this to study subjects. Anonymization 
means that all identifiable information will be removed from the dataset and all links to the 
subjects in the study will be removed. Anonymization of the data will maintain 
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confidentiality of the subjects who participate in the study so that they cannot be identified by 
external researchers. The anonymized data set will contain records from all of the subjects in 
the current study, but the anonymization process might change the data set in some ways, so 
external researchers will be informed that they might not be able to duplicate some of the 
results from this study. 
External researchers who request permission to use anonymized data from studies for a new 
medicine or new indication of a medicine (studies for approved medicinal products, small 
molecule generics, and devices are excluded) must be approved by a central independent 
review panel that will adjudicate the scientific request and the competency of the external 
researcher(s), as well as determine the applicability to current standard operating procedures 
(SOPs). If approved, a data sharing agreement will be executed between the Study Sponsor 
and the external researcher(s), committing to a specified analysis and publication timeline. 
Anonymized data will be released to external researchers only after European Union (EU) 
and/or United States (US) submission of the investigational drug/biologic for the study 
indication. The Study Sponsor will not be able to influence the analyses that are performed by 
external researchers using the data from this study once the anonymized data are released.
14.2 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 electronic case report forms (eCRFs) exists and are accessible for 
verification by the Clinical Site Manager (CSM). It is required that the author of each entry in 
the source documents be identifiable (eg, initials or signature and date). At a minimum, 
source documents should include the following information for each subject:

Subject identification (name, date of birth or age, sex)

Documentation of subject eligibility

Date of informed consent

Dates of visits

Documentation that protocol-specific procedures were performed

Results of study testing, as required by the protocol

Test article accountability records

Documentation of SAEs and other safety parameters (as applicable)
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
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study

Date of study completion and reason for early discontinuation, if applicable
Note: If electronic source records are maintained, the method of verification must be 
determined in advance of starting the study.
It is required that the author of an entry in the source documentation be identifiable. Direct 
access to source documentation (medical records) must be allowed for the purpose of 
verifying that the data recorded on the eCRF are consistent with the original source data. 
Data reported on the eCRFs shall be derived from source documents and be consistent with 
these source documents, and any discrepancies shall be explained in writing. Any change or 
correction to data reported on a source document shall be dated, initialed, and explained if 
necessary, and shall not obscure the original entry (ie, an audit trail shall be maintained); this 
applies to both written and electronic changes and corrections. eCRFs shall be signed and 
dated by the Principal Investigator or his/her authorized designee(s).
14.3 Data Review and Clarifications
Upon completion of the eCRFs, targeted data will be reviewed by the assigned Sponsor 
global CSM team for accuracy and completeness. The planned source document verification 
and overall monitoring activities for this study are outlined in a separate document, the 
Protocol Monitoring Plan. Corrections and/or any necessary additions to the data will be 
applied and if required, queries will be generated. Designated investigative staff are expected 
to respond to data queries in a timely manner and ensure that the corrections and changes 
made to the data are reflected in the subjects’ source documentation.
Deviations from this protocol, regulatory requirements and GCP must be recorded. An 
explanation of the deviation should be included, as applicable. In addition, corrective and 
preventive action should be identified, implemented and documented within the study 
records. Prior to study start, a plan for data validation will be completed by Alcon clinical 
data management, and agreed upon by the study clinical manager (CM) and other team 
members.
Concomitant medications entered into the database will be coded using the WHO Drug 
Reference List. Medical history and adverse events will be coded using the medical 
dictionary for regulatory activities (MedDRA) terminology. Upon completion of the study 
and once the database is declared completed and accurate, the database will be locked and 
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data will be available for data analysis. Any changes to the database after lock will be 
implemented upon agreement between the Sponsor’s clinical trial management, medical 
safety clinical data management and biostatistics departments, and will be completed 
following the Sponsor’s procedures for changes to a database after database lock.
14.4 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.
15
ANALYSIS PLAN
15.1
Subject Evaluability
The final subject evaluability will be determined prior locking the database.
15.2
Analysis Data Sets
The primary analysis set for effectiveness analyses will be the All-Implanted Analysis Set 
(AAS). AAS includes all eyes with successful test article implantation. 
 
 
The Safety Analysis Set will include all eyes with attempted implantation with the test article 
(successful or aborted after contact with the eye) and will be used for the safety analyses.
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15.3
Demographics and Baseline Characteristics
Summary statistics will be provided for demographic and baseline characteristics. Number 
and percentage will be presented for categorical variables and descriptive statistics including 
mean, standard deviation, minimum, and maximum will be presented for continuous 
variables.
15.4
Performance Analyses
15.4.1
Primary Performance
The number and percentage of subjects with BCDVA of 0.3 logMAR or better at 1 year 
postoperative (Visit 5A) will be summarized along with the corresponding one-sided exact 
95% upper confidence limit.
The performance target in support of the primary effectiveness objective is to show that the 
one-sided exact 95% upper confidence limit for the percentage of subjects with monocular 
BCDVA of 0.3 logMAR or better at 1 year postoperative (Visit 5A) is not worse than the SPE 
rate of 92.5% for AAS (as reported in EN ISO 11979-7:2014).
15.4.1.1
Statistical Hypotheses
Not applicable.
15.4.1.2
Analysis Methods
Categorical statistics (sample size, number in the category, percent in the category, and the 
corresponding one-sided exact 95% upper confidence limit) will be provided for the primary 
endpoint. In addition, descriptive statistics (sample size, mean, median, standard deviation, 
number of subjects/eyes, minimum, maximum, and the two-sided 95% confidence interval) 
will be provided for BCDVA. 
15.4.2
Secondary Performance
The secondary effectiveness endpoints are: 

Percentage of subjects achieving BCDVA of 0.3 LogMAR or better at 2 years post-
implantation (Visit 6A)

Percentage of subjects achieving BCDVA of 0.3 LogMAR or better at 3 years post-
implantation (Visit 7A)
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
UCDVA at 1 year (Visit 5A) post-implantation

UCDVA at 2 years (Visit 6A) post-implantation

UCDVA at 3 years (Visit 7A) post-implantation
15.4.2.1
Statistical Hypotheses
Not applicable. Only descriptive statistics will be presented.
15.4.2.2
Analysis Methods
For categorical parameters, the statistics used to summarize the data descriptively include 
sample size, number in the category, and percent in the category. For continuous parameters, 
the statistics used to summarize the data descriptively include sample size, mean, median, 
standard deviation, number of subjects/eyes minimum, and maximum.
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15.4.3.2
Analysis Methods
For categorical parameters, the statistics used to summarize the data descriptively include 
sample size, number in the category, and percent in the category. For continuous parameters, 
the statistics used to summarize the data descriptively include sample size, mean, median, 
standard deviation, number of subjects/eyes minimum, and maximum.
15.5
Handling of Missing Data
The AAS 
 do not include any imputed values. Although missing data will occur, the 
influence of the missing data is expected to be minimal.
15.7
Safety Analysis
The primary safety objective is to evaluate the safety of the Clareon IOL for first and second 
operative eyes separately up to 3 years (Visit 7A).
Adverse Events
Descriptive statistics for adverse events will be presented separately for first and second eyes. 
The one-sided exact 95% lower confidence limits for incidence rates observed up to one year 
of follow-up (ie, after all implanted subjects have completed Visit 5A) will be compared to 
the cumulative and persistent adverse event SPE rates in EN ISO 11979-7:2014. An eye with 
multiple ocular adverse events of the same preferred term is only counted once toward the 
total of this preferred term. All information obtained on adverse events will be displayed by 
subject.
Other Safety Assessments
All other safety assessments (such as device deficiencies, surgical problems, other procedures 
during surgery, IOP, slit-lamp examination, IOL observations, IOL position change, 
subjective PCO, posterior capsulotomy, and DFE) will be summarized with descriptive 
statistics. For categorical parameters, the statistics used to summarize the data descriptively 
include sample size, number in the category, and percent in the category. For continuous 
parameters, the statistics used to summarize the data descriptively include sample size, mean, 
median, standard deviation, minimum, and maximum.
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15.9
Sample Size Justification
If more than 110 of 125 eyes show monocular BCDVA of 0.3 logMAR or better at 1 year 
(Visit 5A), the one-sided exact 95% upper confidence limit for the rate is not worse than SPE 
rate of 92.5%. Assuming that the mean and the standard deviation of monocular BCDVA are 
0.0 and 0.18 logMAR respectively, the study has greater than 99% chance to meet this 
performance target.
For any event where zero incidence is observed in 125 first-operative eyes with Clareon IOL, 
the one-sided exact 95% upper confidence limit for the adverse event rate is less than 2.4%. 
Thus, with 95% confidence, the true adverse event rate is less than 2.4%.
Approximately 200 subjects will be bilaterally implanted with the Clareon IOL in order to 
ensure at least 125 evaluable subjects complete the study.
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16
ADMINISTRATIVE PROCEDURES
16.1
Regulatory and Ethical Compliance
This clinical trial will be conducted in accordance with the ethical principles contained within 
the following:

the Declaration of Helsinki (DoH), and in compliance with the International Council 
for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 
(ICH) E6 GCP Consolidated Guideline

ISO 14155:2011 Clinical investigation of medical devices for human subjects, Good 
Clinical Practice

Code of Federal Regulations (CFR), and all other applicable regulations

Standard Operating Procedures of Alcon
The Investigator and all clinical trial staff will conduct the clinical trial in compliance with 
this protocol. The Investigator will ensure that all personnel involved in the conduct of the 
clinical trial are qualified to perform their assigned duties through relevant education, 
training, and experience.
16.2
Informed Consent Procedures
Voluntary informed consent will be obtained from every subject prior to the initiation of any 
screening or other clinical trial-related procedures. The Investigator must have a defined 
process for obtaining consent. Specifically, the Investigator, or designee, will explain the 
clinical trial 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 will provide subjects with information regarding the purpose, 
procedures, requirements, and restrictions of the clinical trial, along with any known risks 
and potential benefits associated with the investigational product, 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 clinical 
trial and will be provided with contact information for the appropriate individuals should 
questions or concerns arise during the clinical trial. The subject also will be told that their 
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records may be accessed by appropriate authorities and Sponsor-designated personnel. The 
Investigator must keep the original, signed copy of the consent and must provide a duplicate 
copy to each subject.
16.3
Responsibilities of the Investigator and IRB/IEC
Before clinical trial initiation, this protocol, the informed consent form, any other written 
information provided to subject, and any advertisements planned for subject recruitment must 
be approved by an Institutional Review Board / Independent Ethics Committee (IRB/IEC). 
Documentation of IRB/IEC approval must be provided to the Sponsor by the Investigator or 
IRB/IEC. 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 subjects, and subject compensation programs (if any). The IRB/IEC 
must be provided with a copy of the DFU, any periodic safety updates, and all other 
information as required by local regulation and/or the IRB/IEC. At the end of the clinical trial 
or in the case of early termination, the Investigator or Sponsor will notify the IRB/IEC of the 
clinical trial’s final status. Finally, the Investigator or Sponsor will report to the IRB/IEC on 
the progress of the clinical trial at intervals stipulated by the IRB/IEC.
16.4
Sponsor and Monitoring Responsibilities
The Sponsor will designate a monitor to conduct the appropriate site visits at the appropriate 
intervals. The clinical investigation will be monitored, following the Protocol Monitoring 
Plan, to ensure that: the rights and well-being of the subjects are protected; the reported data 
are accurate, complete, and verifiable from the source documents; the equipment used to 
assess variables in the clinical investigation is maintained and calibrated per manufacturer 
instructions and Sponsor requirements; the study is conducted in compliance with the current 
approved protocol (and amendment[s], if applicable), with current GCP, and with applicable 
regulatory requirements.
All investigative sites must have a site initiation. Prior to screening subjects or performing the 
informed consent process on any subject, the site must receive a Site Activation Notification 
from an appropriate study Sponsor representative. Monitoring will be conducted periodically 
while the clinical study is ongoing. Monitoring methods may include site visits, telephone
and written correspondence. Closeout visits will take place after the last visit of the last 
subject or after the database lock.
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16.5
Regulatory Documentation and Records Retention
Essential documents must be retained by the Investigator in compliance with the medical 
device directive and its local transposition as well as other applicable national and 
international regulations. The Investigator(s)/institution(s) must comply with record retention 
stipulations outlined in the Clinical Study Agreement. Additionally the Investigator will be 
supplied with further instruction at study completion.
16.6
Clinical Trial Results 
The Investigator or the Sponsor will notify the IRB/IEC of the end of the study. The end of 
the study is defined as database lock. In case the study is ended prematurely, the Investigator 
or the Sponsor will notify the IRB/IEC, including the reasons for the premature termination. 
Within one year after the end of the study, the Investigator or the sponsor will submit a final 
study report with the results of the study, including any publications/abstracts of the study, to 
the IRB/IEC as required.
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The Study Sponsor assures that the key design elements of this protocol will be registered in 
www.clinicaltrials.gov as required by current regulations and, if applicable, other public 
databases as required by local country regulations. In addition, results of this study will be 
made publicly available in www.clinicaltrials.gov regardless of outcome as required by 
current regulations and, if applicable, in other public databases as required by local country 
regulations.
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17
REFERENCES
EN ISO 11979-7:2014 Ophthalmic implants – Intraocular lenses – Part 7: Clinical 
Investigations
Isotani H, Fukumoto Y, Kitaoka H, Furukawa K, Ohsawa N, Utsumi T. Oval pupil in patients 
with diabetes mellitus: examination by measurement of the dark-adapted pupillary area and 
pupillary light reflex. Diabetes Res Clin Pract. 1995;29:43-8.
Masket S, Rorer E, Stark W, Holladay J, MacRae S, Tarver ME, et al. Special report: the 
Academy of Ophthalmology Task Force consensus statement on adverse events with 
intraocular lenses. Ophthalmology. 2017;124(1):142-4.
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Table 18–1
Postoperative Adverse Event Definitions for Intraocular Events 
(Masket 2017)
Adverse Event
Deﬁnition
Chronic anterior uveitis
Persistent anterior segment inﬂammation characterized by grade 1+ cell or 
greater using SUN criteria3, that is persistent for greater than 3 months after 
surgery, or relapses in less than 3 months after discontinuation of therapy, 
or the subject is maintained on therapy for more than 3 months to control 
inflammation.
Clinically signiﬁcant cystoid 
macular edema
Macular edema diagnosed by clinical examination and adjunct testing (eg, 
OCT, FA) resulting in BCDVA of 20/40 at ≥1 month
Corneal edema
Corneal swelling (stromal or epithelial) resulting in BCDVA of 20/40 at 
≥1 month
Endophthalmitis
Intraocular inﬂammation requiring diagnostic vitreous tap and intraocular 
antibiotics
Mechanical pupillary block
Shallowing of anterior chamber due to obstruction of aqueous humor ﬂow 
from the posterior to anterior chamber through the pupil by the crystalline 
lens, vitreous face, or implanted device
Increased IOP
Elevation of IOP by ≥10 mmHg above baseline to a minimum of 25 mmHg
Rhegmatogenous RD
Partial or complete RD associated with retinal tear
Toxic anterior segment 
syndrome
Acute, noninfectious inﬂammation of the anterior segment that starts within 
24 hours after surgery, usually resulting in hypopyon and commonly 
presenting with corneal edema, that improves with steroid treatment
Secondary IOL intervention
Exchange
Removal
Reposition
The investigational device is replaced with the same lens model.
The investigational device is removed and replaced with a non-
investigational lens or no lens is implanted
The existing IOL is surgically moved to another location or rotated
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Table 18-2
Definitions of Indications for Device Exchange, Removal, or 
Reposition (Masket 2017)
Indication
Deﬁnition
Capsular block syndrome
Hyper-distention of the lens capsular bag due to the IOL optic blocking egress 
of ﬂuid through the anterior capsulotomy typically inducing a myopic refractive 
error
Cataract
Any opaciﬁcation of the crystalline lens with or without reduced visual acuity
Chronic anterior uveitis
Persistent anterior segment inﬂammation characterized by grade ≥1+ cell
using SUN criteria (Isotani 1995)
Endothelial cell loss
Chronic endothelial cell loss at a rate greater than that due to normal aging
Incorrect IOL power
Postoperative refractive error different from predicted and not due to a
calculation or other user error
Iris pigment epithelium
loss*
New or worsening iris transillumination defects or increase in pigmented cells
in the anterior chamber noted after the 1-wk visit when assessed before
instillation of any dilating drops
Lens optic abnormality
Unanticipated visual outcome (eg, acuity, contrast sensitivity, symptoms)
associated with opaciﬁcation, vacuoles, microvacuoles, or subsurface
nanoglistenings and not due to other causes
Malpositioned IOL
Early
Late
Decentration, tilt, or rotation of IOL requiring reoperation. 
 
If noted before 120 days postoperatively
If noted at ≥120 days postoperatively
Damaged IOL
Crack of lens optic, breakage, or deformity of haptic, or other damage to the
IOL; 
Pupil ovalization
Progressive deformation of the pupil with elongation of the pupil in the 
meridian of the long axis of the IOL Documentation to be made under photopic 
conditions Appendix 1 (Masket 2017)
Pain
Graded as ≥4 on the standardized pain numeric rating scale of current pain 
intensity from 0 (no pain) to 10 (worst possible pain)
Peripheral anterior
synechiae
Progressive closure of the anterior chamber angle due to propagation of
anterior synechiae in the absence of obvious anterior uveitis
Patient-reported
undesirable optical
phenomena
Dysphotopsia (positive or negative or both), monocular diplopia, intolerable 
glare, halos, or other visual symptoms, not due to 1 of the indications listed
*If there is a transillumination defect preoperatively, then a photograph should be taken, and then at each
subsequent visit, a photograph should be taken and compared with the preoperative photograph via a
standardized photographic method.
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