Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00
Phase: NA
Conditions: Cataract
Sponsor: Alcon Research

Alcon - Business Use Only 
Document: TDOC-0053702 
Effective Date: 28-Mar-2018 
Protocol - Clinical 
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a Novartis company 
Clinical Trial Protocol 
 
Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00 
 
Protocol Number: 
Sponsor Name & Address: 
 
 
Project Name / Number: 
Test Article(s) / Product(s): 
Release Date: 
Investigator Agreement: 
ILH297-C001 / NCT03280108 
Alcon Research, Ltd. and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
PanOptix Trifocal IOL / A01875 
AcrySof IQ PanOptix 
IOL Model TFNT00 
Refer to e-signature date 
I have read the clinical study described herein, recognize 
its confidentiality, and agree to conduct the described 
trial in compliance with Good Clinical Practices (GCP), 
the ethical principles contained within the Declaration of 
Helsinki, this protocol, and all applicable regulatory 
requirements. 
 
Principal Investigator: 
Principal Investigator Name: 
 
 
Signature 
Date 
Principal Investigator Address: 
 
 
 
Property of Alcon Laboratories 
Confidential 
May not be used, divulged, published, or otherwise disclosed without the consent of Alcon 
Laboratories 

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1 
PROTO C OL SYN OP SIS 
 
 
Financ ial 
Disclosure for US 
FDA Submission 
Required? 
Yes 
Test Alticle(s) I 
Product(s): 
The Ac1ySofIQ PanOptix Intraocular lens (IOL) Model TFNT00 is a 
single-piece ultraviolet and blue light filtering foldable multifocal IOL. 
The biconvex optic is 6.0 mm in diameter and the lens has an overall 
diameter of 13.0 mm. The trifocal optic diffractive strncture is in the 
central 4.5 mm p01t ion of the anterior surface of the optical zone and 
divides the incoming light to create a +2.17 D inte1mediate and a 
+3.25 D near add power (IOL plane) in addition to the distance focus. 
The anterior surface is designed with 0.IO µm of negative spherical 
aben ation to compensate for the positive spherical abe1rntion of the 
average human cornea. 
The Ac1ySofIQ PanOptix IOL is indicated for prima1y implantation in 
the capsular bag in the posterior chamber for the visual conection 
of aphakia in adult subjects with less than I diopter of pre-existing 
corneal astigmatism in whom a cataractous lens has been removed. 
The lens mitigates the effects of presbyopia by also providing 
improved inte1mediate and near visual acuity compared to a monofocal 
IOL. 
Objective(s): 
Effectiveness: 
The co-primary effectivenessobjectives are to: 
• 
Demonstrate non-inferiority of Ac1ySof IQ PanOptix IOL Model 
TFNT00 compared to the concun ent control AcrySof Monofocal 
IOL Model SN60AT in mean photopic monocular best con ected 
distance visual acuity (4 m) for the first operative eye at Month 6 
(Visit 4A). 
• 
Demonstrate superiority of Ac1ySof IQ PanOpt ix IOL Model 
TFNT00 compared to the concun ent control Ac1ySof Monofocal 
IOL Model SN60AT in mean photopic monocular distance 
conected visual acuity at near (40 cm) for the first operative eye 
at Month 6 (Visit 4A). 
The secondary effectiveness objectives are to: 
• 
First seconda1y: Demonstrate superior ity of Ac1y Sof IQ 
PanOptix IOL Model TFNT0O compared to the concun ent 
control Ac1ySofMonofocal IOL Model SN60AT in mean 
photopic monocular distance conected visual acuity at 
intermediate (66 cm) for the first operative eye at Month 6 
(Visit 4A). 

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• 
Second seconda1y:Demonstrate superiority of AcrySof IQ 
PanOptix IOL Model TFNT00 compared to the concun ent control 
Ac1ySof Monofocal IOL Model SN60AT in proportion of subjects 
who respond ''Never" to Q1 of the IOLSAT questionnaire 
(Overall, in the past 7 days, how often did you need to wear 
eyeglasses to see?) at Month 6 (Visit 4A). 
Safety: 
The co-primarysafety objectives are to 
• 
Estimate the cumulative rate of secondary surgical interventions 
(SSis) related to the optical properties of the IOL for the first 
operative eye up to Month 6 (Visit 4A). 
• 
Evaluate the mean binocular contrast sensitivity with and without 
glare for photopic and mesopic conditions at Month 6 (Visit 4A). 
The secondary safety objective is to estimate rates of severe and most 
bothersome (separately) visual disturbances as rep01ted by the subjects 
using a questionnaire (QUVID) at Month 6 (Visit 4A). 
The third safety objective is to evaluate rates of cumulative and persistent 
Adverse Events in first operative eyes at Month 6 (Visit 4A) in 
comparison to ISO 11979-7 Safety and Perfo1mance Endpoint (SPE) grid 
rates. 
Clinical Trial 
Design: 
This study is a prospective, multicenter, non-randomized, vision assessor- 
masked, parallel-group confirmatory trial. 
No. of Subjects: 
Required: 113 subjects bilaterally implanted with the AcrySof IQ 
PanOptix IOL Model TFNT00 and 113 subjects bilaterallyimplanted 
with the concunent control AcrySof Monofocal IOL Model SN60AT. 
Planned: Approximately 125 subjects bilaterally implanted with the 
AcrySofI Q PanOptix IOL Model TFNT00 and 125 subjects bilaterally 
implanted with the concunent control AcrySof Monofocal IOL Model 
SN60AT to achieve the required numbers assuming a dropout rate of 
10%, approximately, at 6 months post implantation. 
Region(s): 
United States 
Clinical Trial 
Duration: 
a. Total expected duration of the clinical investigation: 13 months 
b. Expected  duration of  each subject'sparticipation:~7 months 
c. Planned follow up dmation: 6-months post second eye 
implantation 
d. Estimated time needed to select the number of subjects(ie, 
emollment period): 6 months 

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Clini cal Tria l 
Pop ulat ion: 
Ad ults subjects, 22 years of age or older, who require bilateral cataract 
extraction. 
Treatments: 
Test Article: 
AcrySof IQ PanOptix IOL Model TFNT00 
Administration: 
Routine small incision cataract surgery with 
IOL implantation. 
General Description: 
A range of commonly utilized spherical 
powers (15 to 26.5 D) will be available. 
Durationof 
Treatment: 
Intraocular lenses are implantable medical 
devices and are intended for long term use 
over the lifetime of the cataract subject. 
Control Article: 
AcrySof Monofoca l IOL Model SN60AT 
Administration: 
Routine small incision cataract surgery with 
IOL implantation. 
General Description: 
A range of commonly utilized spherical 
powers (15 to 26.5 D) will be available. 
Durationof 
Treatment: 
Intraocular lenses are implantable medical 
devices and are intended for long term use 
over the lifetime of the cataract subject. 
Inclusion & 
Exclusion 
Criteria: 
etails can be found in Section 10 Subject Population 
Effectiveness 
Assessments 
and best con ected distance VA (4 m) 
• 
Binocu lar 
 
and best corTected distance VA (4 m) 
In term ediate Visua 
cm 
• 
Monocular- 
and distance conected intermediate VA 
(66 cm) 
• 
Binocular·- 
and distance conected intermediate VA 
(66 cm) 
Near Visual Acuity 
• 
Monocular 
and distance conected near VA (40 cm) 
• 
Binocular 
and distance conected near VA (40 cm) 
• 
Monocular mesopic distance conected near VA (40 cm) 
• 

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Safety 
Assessments 
• 
Adverse events (AEs) including seconda1y surgical intervention 
(SSI) 
• 
Device deficiencies (DD) 
• 
Surgical problems 
• 
ln traocular pressure (IOP) 
• 
Slit lamp examination 
• 
IOL observations 
• 
IOL position change 
• 
Subjective posterior capsule opacification (PCO) 
• 
Posterior capsulotomy 
• 
Fundus visualization 
• 
Dilated fundus examination 
• 
Binocular contrast sensitivity 
Photopic without glare 
Photopic with glare 
Mesopic without glare 
Meso ic with lare 
• 
 
 
 
 
Planned 
alyses relating to key endpoints are described below. See Section 15 
Analyses: 
alysis Plan for additional details. 
o account for multiplicity, the effectiveness hypotheses will be tested in 
equence: 2 co-primaries, followed by first seconda1y, followed by second 
econdaiy. The prima1y effectiveness objective is considered met only if 
oth co-prima1yhypotheses are met. The type I enor for the non- 
· nferiority test is 5% (I-sided) and for the superiority test is 2.5% (1- 
ided). Each of the secondaiy hypotheses will be tested at 2.5% (I -sided). 
he statistical hypotheses in supp01i of the co-primaiy effectiveness 
bjectives are: 
• 
Ac1ySofIQ PanOptix IOL is non-inferior to Ac1ySof Monofocal 
IOL in mean photopic monocular best c01Tected dist ance visual 
acuity (BCDVA) for the first operative eye at Month 6. 
• 
Ac1ySofIQ PanOptix IOL is superior to Ac1ySofMonofocal IOL 
in mean photopic monocular distance conected visual acuity at 
near (40 cm) for the first operative eye at Month 6. 
he statistical hypotheses in supp01i of the secondaiy effectiveness 
bjectives are: 
• 
Ac1ySofIQ PanOptix IOL is superior to Ac1ySof Monofocal IOL 
in mean photopic monocular distance conected visual acuity at 

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. 
inte rmediate (66 cm) for the first operative eye at Month 6. 
• 
Ac1ySofIQ PanOptix IOL is superior to Ac1ySof Monofocal IOL 
in the propmtion of subjects who respond " Never" to Question 1 
of the IOLSAT questionnaire (Overall, in the past 7 days, how 
often did you need to wear eyeglasses to see?) at Month 6. 
alysis of each co-prima1yeffectiveness endpoint and the first seconda1y 
ndpoint (at Visit 4A) will be based on a mixed effects model. Two 
odels will be fit to the first co-prima1y endpoint (BCDVA), 1 with a 
·andom effect for site and another with random effects for site and for 
reatment by site interaction. Both will include a fixed effect for treatment. 
he 2 models will be compared using Bayesian Infmmation C1i terion 
BIC) and the model with lower BIC will be the chosen model to estimate 
e Least Squares Means (LSMEANS) difference in means (Ac1ySof IQ 
anOptix IOL minus Ac1ySof Monofocal IOL) and the associated 
onfidence intervals for  all  3 aforementioned endpoints. The non- 
feriority hypothesis will be deemed suppmted  if  the  upper 95% 
onfidence limit is less than the non-inferiority margin of 0.1 logMAR. 
Superiority hypotheses will be deemed suppmted if the upper 97.5% 
onfidence limit is less than 0.0 logMAR. 
he second secondary effectiveness endpoint will be analyzed by 
stimating the Mantel-Haenszel common difference of propmt ions 
Ac1ySofIQ PanOptix IOL minus Ac1ySofMonofocal  IOL)  along with 
he con esponding confidence interval with site as a stratification variable. 
Superiority will be declared if the lower 97.5% confidence limit exceeds 
he co-primaiy safety objectives are to 
• 
Estimate the cumulative rate of secondary smgical interventions 
related to the optical prope1ties of the IOL for first operative eyes 
up to Month 6 
• 
Evaluate the mean binocular contrast sensitivity with and without 
glai·e for photopic and mesopic conditions at Month 6. 
he secondaiy safety objective is to 
• 
Estimate rates of severe and most bothersome (separately) visual 
disturbances as repo1ted by the subjects using a questionnaire 
(QUVID) at Month 6. 
he third safety objective is to 
• 
Evaluate rates of cumulative and persistent adverse events in first 
operative eyes at Month 6 in compai·ison to the ISO 11979-7 SPE 
grid rates. 
nalysis for the co-prima1yand secondaiy safety objectives will involve 
resenting point estimates (rates or means, depending on type of endpoint) 
nd the con esponding confidence intervals for difference between IOL 
tive statistics for adverse events will be 

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first and all eyes. Incidence rates observed in each treatment arm (for first 
operative eyes, and for all eyes) will be compared to the cumulative and 
persistent adverse event SPE (safety and performance endpoint) rates 
based on 1-sided exact binomial calculation. 
QUVID outcomes will be summarized using standard descriptive 
measures. 
Sample Size 
Justification 
Approximately 250 subjects will be bilaterally implanted with either the 
AcrySof IQ PanOptix IOL Model TFNT00 or the AcrySof Monofocal IOL 
Model SN60AT in a 1:1 ratio in order to ensure that at least 113 eligible 
subjects complete the study in the test group and the control group. This 
assumes a drop-out rate of 10%, approximately. 
Power calculations for the effectiveness objectives are summarized in the 
table below: 
Margin 
Expected 
Difference 
Std. 
dev 
Type I 
error 
(1-sided) 
Power 
Non- Inferiority 
BCDVA (4 m) 
0.1 
0.0 
0.18 
5% 
99% 
Superiority 
DCNVA (40 cm) 
0.1 
0.18 
2.5% 
98% 
DCIVA (66 cm) 
0.1 
0.18 
2.5% 
98% 
Spectacle Wear 
20% 
2.5% 
83% 
All expected differences for tests of superiority favor the test lens. Estimates of VA endpoints 
reported in logMAR. 
Adverse Events: For any event where a 0 incidence is observed in 113 
first-operative eyes in the AcrySof IQ PanOptix IOL test group, the upper 
exact binomial 95% confidence limit is less than 3%. Thus, with 95% 
confidence, the true adverse event rate is less than 3%. 
See section 15 for additional details. 

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2 
TABLE OF CONTENTS 
Table of Contents 
Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00 ..................................... 1 
1 
PROTOCOL SYNOPSIS ............................................................................................ 2 
2 
TABLE OF CONTENTS ............................................................................................ 8 
Table of Contents ........................................................................................................................... 8 
List of Tables ........................................................................................................................................... 11 
List of Figures .............................................................................................................................. 11 
3 
ABBREVIATIONS ....................................................................................................... 12 
4 
GLOSSARY OF TERMS ......................................................................................... 14 
5 
AMENDMENTS ...................................................................................................... 16 
16 
17 
18 
6 
SCHEDULE OF VISITS .......................................................................................... 22 
7 
INTRODUCTION .................................................................................................... 27 
7.1 
Background 
27 
7.2 
Clinical Trial Design 
27 
8 
CLINICAL TRIAL OBJECTIVES ........................................................................... 28 
8.1 
Primary Objective 
28 
8.2 
Secondary Objectives 
29 
8.3 
Other Objectives 
29 
8.4 
Study Endpoints 
29 
8.4.1 
Effectiveness Endpoints .................................... 29 
8.4.2 
Safety Endpoints ............................................... 31 
9 
INVESTIGATIONAL PLAN .................................................................................... 33 
9.1 
Outline of Clinical Trial 
33 
9.2 
Study Design 
33 
9.3 
Rationale for Study Design 
34 
9.4 
Procedures per Study Visit 
34 
9.5 
Known and Potential Risks 
34 
9.5.1 
Potential Benefits .............................................. 35 

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9.5.2 
Risk Benefit Assessment .................................................................... 35 
10 
SUBJECT POPULATION ................................................................................................ 36 
10.1 
Inclusion Criteria 
36 
10.2 
Exclusion Criteria 
37 
10.3 
Reasons not to implant a study IOL 
38 
11 
TREATMENT .................................................................................................................... 39 
11.1 
Investigational Products 
39 
11.2 
Usage 
40 
11.3 
Accountability Procedures 
40 
11.4 
Assessor Masking 
41 
12 
CLINICAL TRIAL PROCEDURES ........................................................................ 42 
12.1 
Clinical Trial Assessments 
42 
12.2 
Preoperative Visit (Visit 0) 
42 
12.2.1 Operative Visit (Visit 00/00A) ........................................................... 43 
12.2.2 1-Day Postoperative Visit (Visit 1/1A) .............................................. 44 
12.2.3 1-Week Postoperative Visit (Visit 2/2A) ............................................ 45 
12.2.4 1-Month Postoperative Visit (Visit 3/3A) .......................................... 46 
12.2.5 6-Month Postoperative Visit (Visit 4A) ............................................. 47 
 
12.3
Unscheduled Visits 
50 
12.4
Directions Related to Secondary Surgical Interventions 
50 
12.5
Missed Visits 
53 
12.6
Discontinued Subjects 
54 
13 
12.7
Clinical Trial Termination 
54 
ADVERSE EVENTS AND DEVICE DEFICIENCIES .......................................... 55 
13.1
General Information 
55 
13.2
Monitoring for Adverse Events 
58 
13.3
Procedures for Recording and Reporting 
58 
60 
13.5
Return product analysis 
60 
13.6
Follow-Up of Subjects with Adverse Events 
61 
14 
13.7
Pregnancy in the Clinical Trial 
61 
DATA REVIEW AND HANDLING ........................................................................ 61 
14.1
Completion of Source Documents and Case Report Forms 
61 
14.2
Data Review and Clarifications 
62 

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15 
ANALYSIS PLAN .................................................................................................... 63 
15.1 
Subject Evaluability 
63 
15.2 
Analysis Data Sets 
63 
15.3 
Demographics and Baseline Characteristics 
64 
15.4 
Performance Analyses 
64 
15.4.1 Primary Performance ......................................................................... 64 
15.4.1.1 
Statistical Hypotheses ..................................................... 64 
15.4.1.2 
Analysis Methods ........................................................... 65 
15.4.2 Secondary Performance ..................................................................... 65 
15.4.2.1 
Statistical Hypotheses ..................................................... 65 
15.4.2.2 
Analysis Methods ........................................................... 66 
66 
67 
67 
15.5 
Handling of Missing Data 
68 
15.6 
Multiplicity 
68 
15.7 
Safety Analysis 
68 
15.7.1 Analysis for Co-Primary Safety Objectives ....................................... 69 
15.7.1.1 
Secondary Surgical Interventions Related to Optical 
Properties of the IOL ...................................................... 69 
15.7.1.2 
Binocular Contrast Sensitivity ........................................ 69 
15.7.2 Analysis for Secondary Safety Objective .......................................... 69 
15.7.3 Analysis for Third Safety Objective .................................................. 70 
 
70 
15.8 
Interim Analyses 
71 
15.9 
Adaptive Study Design 
72 
15.10 Sample Size Justification 
72 
16 
ADMINISTRATIVE PROCEDURES ...................................................................... 74 
16.1 
Regulatory and Ethical Compliance 
74 
16.2 
Informed Consent Procedures 
74 
16.3 
Responsibilities of the Investigator and IRB/IEC 
74 
16.3.1 Sponsor and Monitoring Responsibilities .......................................... 75 
16.4 
Regulatory Documentation and Records Retention 
75 
16.5 
Clinical Trial Results 
75 
16.6 
Publication of the Clinical Trial 
76 
17 
REFERENCES ......................................................................................................... 77 
78 
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List of Tables 
Table 7-1 
Study Design ........................................................................................................ 28 
 
Table 11-1  Unmasked Individuals ............................................................................................... 41 
 
78 
 
79 
 
 
List of Figures 
Figure 13–1 
Categorization of All Adverse Events .................................................................. 55 
 
Figure 13-2 
Categorization of All Serious Adverse Events ..................................................... 56 

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3 
ABBREVIATIONS 
 
 
Abbreviation 
Definition 
AAS 
All implanted analysis set 
ADE 
Adverse device effect 
AE 
Adverse event 
ASADE 
Anticipated serious adverse device effect 
BAS 
Best case analysis set 
BCDVA 
Best corrected distance visual acuity 
BIC 
Bayesian Information Criterion 
CFR 
Code of Federal Regulations 
cm 
Centimeter 
CM 
Clinical Manager 
cpd 
Cycles per degree 
CRF 
Case report form 
CSM 
Clinical site management 
D 
Diopter 
DCDVA 
Distance corrected distance visual acuity 
DCIVA 
Distance corrected intermediate visual acuity 
DCNVA 
Distance corrected near visual acuity 
DD 
Device deficiency 
DFU 
Directions for use 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
FA 
Fluorescein angiography 
GCP 
Good Clinical Practice 
GPCMS 
Global Product Complaint Management System 
IB 
Investigator’s brochure 
ICH 
International Conference on Harmonization 
IEC 
Independent ethics committee 
IOL 
Intraocular lens 
IOLSAT 
Intraocular Lens Satisfaction questionnaire 
IOP 
Intraocular pressure 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
IP 
Investigational product 
MOP 
Manual of procedures 
LASIK 
Laser-assisted in-situ keratomileusis 
LCSM 
Lead Clinical Site Manager 
LCVA 
Low contrast visual acuity 
LSMEANS 
Least squares means 
logMAR 
Logarithm of minimum angle of resolution 

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m 
Meter 
µm 
® 
Micrometer 
MedDRA 
Medical Dictionary for Regulatory Activities 
mm 
Millimeter 
mmHg 
Millimeters of mercury 
nm 
Nanometer 
Nd:YAG 
Neodymium-doped yttrium aluminium garnet 
OCT 
Optical coherence tomography 
PCO 
Posterior capsule opacification 
PI 
Principal Investigator 
QUVID 
Questionnaire for Visual Disturbances 
RD 
Retinal detachment 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SAS 
Safety analysis set 
SOP 
Standard operating procedures 
SPE 
Safety and Performance Endpoint 
SS 
Safety set 
SSI 
Secondary surgical intervention 
SUN 
Standardization of Uveitis Nomenclature 
UNSV 
Unscheduled visit 
US 
United States 
USADE 
Unanticipated serious adverse device effect 
VA 
Visual acuity 
YAG 
Yttrium aluminum garnet 

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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, 
postoperative, etc. 
Rhegmatogenous 
RD 
Rhegmatogenous Retinal Detachment 
Cumulative 
Adverse Events 
Total number of Adverse Events that have occurred at any time up to 
a specified time point, postoperatively. 
Persistent Serious 
Adverse events present at the conclusion of the clinical investigation. 

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Ad verse Even ts 
Serio us Ad verse 
Device Effect 
(SADE) 
Ad verse 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. 
• Aserious deterioration in health that either resulted in: 
a) a life-threatening illness or injmy. 
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) pe1manent impaitment to a body structure or a bod y fu nction. 
c) in-pat ient hospitaliza tion or pro lon ged ho spitalization . 
Note: Plan ned 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 hospitalizationare 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 smgical intervention to prevent a) or b). This 
includes any ocular secondary smgical intervention excluding 
posterior capsulotomy. 
e) any indirect haim as a consequence of incon ect diagnostic 
test results when used within manufacturer's instru ctions fo r 
use. 
• Fetal disu-ess , fe tal death , o r a con genit al abn o1m ali ty or bitt h 
defect. 
Subject Number 
A number assigned to each subject who emolls in the study. When 
combined with the site number, a unique identifier is created for each 
subject in the study. 
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 will be created by the Sponsor and must be approved by 
the Institutional Review Board (IRB)/ Independent Ethics Committee (IEC) prior to 
implementation except when required to mitigate immediate safety risks or when the changes 
involve only logistical or administrative revisions. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Section 12.3: Unscheduled Visits 

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Page 22 of 79 
 
 
 
6 
SCHEDULE OF VISITS 
 
Visit 0 
Visit 00 
Visit 
1 
Visit 
2 
Visit 
3 
Visit 
00A 
Visit 
1A 
Visit 
2A 
Visit 
3A 
Visit 4A* 
USV 
Part 1 
Part 2 
Procedure/ 
Assessment 
Screen 
(Day -30 
to 0) 
Implant 
1 
Day 
1-2 
Day 
7-14 
Day 
30- 
60 
Implant 
2 
Day 
1-2 
Day 
7-14 
Day 
30- 
60 
Day 120-180 
(from 2nd eye) 
N/A 
Informed Consent 
X 
Demographics 
X 
Medical History 
X 
Concomitant 
Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Inclusion/Exclusion 
X 
X 
X 
Urine Pregnancy Test 
X 
Administer Treatment(s) 
X 
X 
Device Deficiencies 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events 
(Both Volunteered and 
Elicited) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
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Visit 0 
Visit 00 
Visit 
1 
Visit 
2 
Visit 
3 
Visit 
00A 
Visit 
1A 
Visit 
2A 
Visit 
3A 
Visit 4A* 
USV 
Part 1 
Part 2 
Procedure/ 
Assessment 
Screen 
(Day -30 
to 0) 
Implant 
1 
Day 
1-2 
Day 
7-14 
Day 
30- 
60 
Implant 
2 
Day 
1-2 
Day 
7-14 
Day 
30- 
60 
Day 120-180 
(from 2nd eye) 
N/A 
 
 
 
 
 
 
 
 
 
 
Photopic Best Corrected 
Distance Visual Acuity 
(4m) 
X 
X 
X 
X 
X 
X, Xb 
Photopic Distance 
Corrected Intermediate 
Visual Acuity (66 cm) 
X 
X 
X, Xb 
Photopic Distance 
Corrected Near Visual 
Acuity (40 cm) 
X 
X 
X, Xb 
Distance Contrast 
Sensitivity – photopic 
Xb 
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Visit 0 
Visit 00 
Visit 
1 
Visit 
2 
Visit 
3 
Visit 
00A 
Visit 
1A 
Visit 
2A 
Visit 
3A 
Visit 4A* 
USV 
Part 1 
Part 2 
Procedure/ 
Assessment 
Screen 
(Day -30 
to 0) 
Implant 
1 
Day 
1-2 
Day 
7-14 
Day 
30- 
60 
Implant 
2 
Day 
1-2 
Day 
7-14 
Day 
30- 
60 
Day 120-180 
(from 2nd eye) 
N/A 
with glare 
Distance Contrast 
Sensitivity – photopic 
without glare 
Xb 
Distance Contrast 
Sensitivity – mesopic 
with glare 
Xb 
Distance Contrast 
Sensitivity – mesopic 
without glare 
Xb 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
QUVID questionnaire for 
visual disturbances)† 
Xb 
Xb 
Xb 
Xb 
IOLSAT questionnaire 
Xb 
Xb 
Xb 
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Visit 0 
Visit 00 
Visit 
1 
Visit 
2 
Visit 
3 
Visit 
00A 
Visit 
1A 
Visit 
2A 
Visit 
3A 
Visit 4A* 
USV 
Part 1 
Part 2 
Procedure/ 
Assessment 
Screen 
(Day -30 
to 0) 
Implant 
1 
Day 
1-2 
Day 
7-14 
Day 
30- 
60 
Implant 
2 
Day 
1-2 
Day 
7-14 
Day 
30- 
60 
Day 120-180 
(from 2nd eye) 
N/A 
for spectacle need 
Operative Eye 
X 
X 
Surgical Problems 
X 
X 
Other Procedures at 
Surgery 
X 
X 
Incision Site 
X 
X 
Final Incision Size 
X 
X 
Lens Information 
X 
X 
IOL Damage 
X 
X 
Slit Lamp Examination 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Fundus Visualization 
X 
X 
X 
Dilated Fundus 
Examination 
X 
X 
X 
X 
X 
IOL Observations 
X 
X 
X 
X 
X 
X 
X 
X 
Secondary Surgical 
Interventions 
X 
X 
X 
X 
X 
X 
X 
X 
Subjective Posterior 
Capsule Opacification 
X 
X 
X 
X 
X 
X 
X 
X 
Posterior Capsulotomy 
X 
X 
X 
X 
X 
X 
X 
X 
Lens decentration 
and tilt 
X 
X 
X 
X 
X 
X 
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Visit 0 
Visit 00 
Visit 
1 
Visit 
2 
Visit 
3 
Visit 
00A 
Visit 
1A 
Visit 
2A 
Visit 
3A 
Visit 4A* 
USV 
Part 1 
Part 2 
Procedure/ 
Assessment 
Screen 
(Day -30 
to 0) 
Implant 
1 
Day 
1-2 
Day 
7-14 
Day 
30- 
60 
Implant 
2 
Day 
1-2 
Day 
7-14 
Day 
30- 
60 
Day 120-180 
(from 2nd eye) 
N/A 
Intraocular pressure 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Xb - Binocular testing is performed on the study group subjects who are implanted bilaterally with the MIOL and on the 
control group subjects who are implanted bilaterally with the control IOL. The questionnaires will be completed in all subjects. 
 
 
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7 
INTRODUCTION 
7.1 
Background 
Monofocal IOLs are designed to replace the focusing power of the natural lens (typically after 
cataract surgery) by providing good visual function through a single, fixed, focal length; thus, 
generally correcting a subject’s distance vision. However, many pseudophakic subjects 
implanted with monofocal IOLs ultimately require reading glasses to compensate for the loss of 
the ability to see clear at intermediate or near distances. Several IOL designs for treating 
presbyopia in pseudophakic subjects exist in modern day clinical practice, including the use of 
multifocal IOLs. Multifocal IOLs offer the subject an opportunity to overcome the loss of 
accommodation by providing multiple focal points. The majority of commercially available 
multifocal IOLs have 2 optical zones – one that provides distance vision and a second that 
provides near vision. The investigational AcrySof IQ PanOptix IOL Model TFNT00 test IOL 
(hereto referenced as TFNT00) improves on commercially available multifocal IOLs by 
creating an additional focal point for intermediate vision. The TFNT00 has a multifocal optical 
design that provides distance vision, near vision at approximately 40 cm and intermediate 
vision at approximately 60 cm. The control lens, the AcrySof Monofocal IOL Model SN60AT 
(hereto referenced as SN60AT) is a monofocal which provides distance vision only. 
 
The purpose of this clinical study is to compare the visual outcomes of this multifocal IOL 
against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to 
demonstrate comparable distance vision and superior near and intermediate vision. 
 
7.2 
Clinical Trial Design 
This study is a prospective, multicenter, non-randomized, vision assessor-masked, parallel- 
group confirmatory trial. It compares an investigational trifocal IOL and a commercially 
available monofocal IOL. 
(Note that neither laser nor any other 
types of refractive procedures are allowed at any time in the clinical trial.) The study will 
include adults (≥22 years of age) who require bilateral cataract extraction. Potential subjects 
will be screened for enrollment into the trial. Those qualifying will attend a total of 10 visits 
(7 visits occur postoperatively) over a 7 month period. 
 
This study is not randomized. Because the test and control IOL designs offer different risks and 
benefits, trial subjects will be allowed to select the lens model that best fits his or her lifestyle. 
After careful consideration and consultation, the subject will be allowed at the time of consent 
to select the lens model that will be bilaterally implanted. Post consent, the electronic data 
capture (EDC) system will assign the subject number. To mitigate the risk of bias, the assessor 

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will be masked for all vision assessments. The subject will be provided with his/her pe1manent 
implant card at the time of implant. 
 
Standard clinical trial methods that minimize bias in multicenter studies will be used such as 
standardized test procedures, commonInvestigator training, and common inclusion/exclusion 
criteria. 
 
No interim analysis of the data will be conducted. Final data analysis will be conducted at study 
completion. 
 
An overview of the study design is depicted in Table7-1. 
 
Table 7-1 
Study Design 
 
Time From Implantation 
First Eye 
Second Eye 
-30 to 0 days pre-operatively 
Visit 0 (monocular [First and Second eye] and binocular) 
Operative (IOL implantation) 
Visit 00 
Visit 00A* 
1 - 2 days post-operatively 
Visit 1 (monocular) 
Visit IA (monocular) 
7 - 14 days post-operatively 
Visit 2 (monocular) 
Visit 2A (monocular) 
30 - 60 days post-operatively 
Visit 3 (monocular) 
Visit 3A (monocular) 
120 - 180 days post-operatively 
(after Second eye implantation) 
Visit 4A" (monocular [First and Second eye] and 
binocular) 
*NOTE: IOL implantation in the second eye is intended to occur between 7 and 30 days after 
IOL im lantation in the first e e. 
 
 
 
8 
CLINICAL TRIAL OBJECTIVES 
8.1 
Primary Objective 
The co-primary effectiveness objectives are to: 
• 
Demonstrate non-inferiority of Ac1ySofI Q PanOptix IOL Model TFNT00 compared to 
the concmTent contro l Ac1yS of Monofocal IOL Model SN60AT in mean photopic 
monocular best coITected dis tance vis ual acuity (4 m) for the first operative eye at 
Month 6 (Visit 4A). 

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• 
Demonstrate superiority of Acry Sof IQ PanOpt ix IOL Model TFNT00 compared to the 
concunent control AcrySof Monofocal IOL Model SN60AT in mean photopic 
monocular distance conected visual acuity at near (40 cm) for the first operative eye at 
Month 6 (Visit 4A). 
 
The co-primary safety objectives are to 
 
• 
Estimate the cumulative rate of secondary surgical interventions (SSis) related to the 
optical properties of the IOL for first operative eye up to Month 6 (Visit 4A). 
• 
Evaluate the mean binocular contrast sensitivity with and without glare for photopic and 
mesopic conditions at Month 6 (Visit 4A). 
 
8.2 
Secondary Objectives 
The secondary effectiveness objectives are to: 
• 
First secondary: Demonstrate superiority of AcrySof IQ PanOptix IOL Model TFNT00 
compared to the concunent control AcrySof Monofocal IOL Model SN60AT in mean 
photopic monocular distance conected visual acuity at intermediate (66 cm) for the first 
operative eye at Month 6 (Visit 4A). 
• 
Second secondary: Demonstrate superiority of Acry Sof IQ PanOptix IOL Model 
TFNT00 compar·ed to the concurrent control AcrySofMonofocal IOL Model SN60AT in 
proportion of subjects who respond "Never" to Ql of the IOLSATquestionnaire 
(Overall, in the past 7 days, how often did you need to wear eyeglasses to see?) at 
Month 6 (Visit 4A). 
The secondary safety objective is to: 
• 
The secondary safety objective is to estimate rates of severe and most bothersome 
(separ·ately) visual disturbances as reported by the subjects using a questionnaire 
(QUVID) at Month 6 (Visit 4A). 
 
8.3 
Other Objectives 
The third safety objective is to evaluate rates of cumulative and persistent Adverse Events in 
first operative eyes at 6 months (Visit 4A) in comparison to ISO 11979-7 SPE grid rates. 
 
8.4 
Study Endpoints 
8.4.1 
Effectiveness Endpoints 
 
Primary,   secondary, 
  effectiveness endpoints ar·e listed be lo w. 
Primary Effectiveness 

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• 
Mean photopic monocular best coITec ted d istan ce visua l acu ity (4 m ) 
• 
Mean photopic monocular distance coITec te d v is u a l ac ui ty at near (40 cm) 
 
Seconda1yEffectiveness 
• 
Mean photopic monocular distance conected visual acuity at intermediate (66 cm) 
• 
Propo1tion of subjects who respond " Never" to Ql of the IOLSAT questionnaire 

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8.4 .2 
Safe ty E ndpoint s 
Primaiy Safety (6 months) 
 
• 
Cumulative rate of secondary surgical inte1ventions (SSis) related to the optical 
prope1ties of the IOL 
• 
Mean photopic without glare binocular distance contrast sensitivity 
• 
Mean photopic with glare binocular distance contrast sensitivity 
• 
Mean mesopic without glare binocular distance contrast sensitivity 
• 
Mean mesopic with glare binocular distance contrast sensitivity 
Secondaiy Safety (6 months) 
Rates of severe and most bothersome (separately) visual disturbances as rep01ted by the 
subjects using a questionnaire (QUVID). 
 
Third Safety (6 months) 
 
• 
Cumulative and persistent rates of adverse events in first operative eyes and all eyes at 
6 months. 
Other Safety 
 
• 
Rates of all visual disturbances as reported by the subjects using the QUVID 
questionnaire at 1 and 6 months 
• 
 
• 
IOP 
• 
Slit lamp obse1vations 
• 
Dilated fundus obse1vations 
• 
Ability to evaluate the fundus 
• 
Rates of ocular adverse events, including SSis related to the optical prope1ties, for either 
eye 
• 
Adverse events 
• 
Device deficiencies 
• 
IOL observations 

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• 
IOL position change 
• 
Subjective PCO 
• 
Posterior capsulotomies 
• 
Surgical problems 

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9 
INVESTIGATIONAL PLAN 
9.1 
Outline of Clinical Trial 
This is a prospective, non-randomized parallel-group confirmatory study in which unmasked 
subjects will be bilaterally implanted with either a test IOL (TFNT00) or a control IOL 
(SN60AT). To mitigate the risk of bias, the assessor will be masked for all vision assessments. 
 
Subjects participating in the trial will attend a total of 10 visits study visits over a 7 month 
period. Of these 10 visits, 1 is preoperative, 2 are operative, and the remaining 7 are 
postoperative visits. Refer to Table 7-1 above for a study outline. Unscheduled visits (UNSV) 
may be attended if needed for medical attention. 
 
Primary endpoint data will be collected at the final visit, Visit 4A (120-180 days post Second 
eye implantation). 
 
 
 
9.2 
Study Design 
This study is a prospective, multicenter, confirmatory trial comparing a trifocal IOL and a 
monofocal IOL following bilateral implantation. The study will include adults (≥ 22 years of 
age) who require bilateral cataract extraction. Potential subjects will be screened for enrollment 
into the trial. Those qualifying will attend a total of 10 visits (7 postoperative) over a 7 month 
period. 
 
Note: Month 6 (Visit 4A) will be completed over 2 days within a 2 week period. All visits must 
be completed within the specified visit window. 
 
 
No interim analysis of the data will be conducted. Final data analysis will be conducted at study 
completion. 

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9.3 
Rationale for Study Design 
The purpose of this clinical study is to compare the visual outcomes of this multifocal IOL 
against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to 
demonstrate comparable distance vision and superior near and intermediate vision. 
 
9.4 
Procedures per Study Visit 
Section 12 Clinical Trial Procedures contains procedures per study visit. 
 
9.5 
Known and Potential Risks 
Complications may occur on the surgery day or throughout the postoperative period. As with 
any type of intraocular surgery, there is a possibility of complications due to anesthesia, drug 
reactions, and surgical problems. The surgical procedure can exacerbate a 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, 
hyphema, and retinal damage. An IOP increase may occur from the surgical procedure, residual 
viscoelastic in the eye, or a steroid response to postoperative medications. 
 
Additionally, potential postoperative 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 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, 
etc.). An SSI (eg, IOL repositioning, replacement, or explantation) may be appropriate if the 
IOL position significantly differs from the intended placement. Alternatively, spectacles or 
contact lenses may be prescribed to resolve residual refractive error. Other secondary surgical 
interventions include, but are not limited to: IOL repositioning, refractive laser treatment, 
paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak 
repair, and retinal detachment repair. 
 
A summary of known and potential risks and benefits to humans, as identified in the literature 
or through preclinical testing and/or prior clinical evaluations, for each investigational product 
can be found in the Investigator’s Brochure (IB-0143) and the Directions for Use (AcrySof 
Monofocal IOL Model SN60AT). 

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9.5.1 
Potential Benefits 
The TFNT00 IOL is a single-piece, trifocal diffractive lens with a +3.25 D near ADD and 
+2.17 D intermediate ADD intended to provide vision to aphakic subjects at near, intermediate, 
and distance (García-Pérez 2017; Kohnen 2015; Lawless 2017) without the need, in many 
subjects, for additional correction with spectacles or contact lenses. 
 
9.5.2 
Risk Benefit Assessment 
Based on the formal risk assessment, TFNT00 demonstrates a risk profile that is comparable to 
the FDA-approved ACRYSOF IQ ReSTOR +3.0 Add Power IOL (Model SN6AD1), 
Furthermore, it was concluded that 
the benefits of increased intermediate vision while maintaining visual performance at near 
distance significantly outweigh the risks of suboptimal surgical outcomes 
when the TFNT00 is used in cataract surgery. Potential risks 
following implantation of the TFNT00 include visual disturbances such as glare and halos 
which are known risks for multifocal IOLs. The benefits of improved near and intermediate 
vision (Garcia-Perez 2017), when weighed against the risks of visual disturbances, result in a 
benefit to risk profile that is favorable for the both the test and control IOLs. 

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10 
SUBJECT POPULATION 
The study population includes approximately 250 subjects (125 in each arm) to be bilaterally 
implanted at approximately 12 sites with a minimum of 20 subjects per site (approximately 10 in 
each arm). 
 
Each site should contribute a minimum of 20 subjects but not more than 25% of the total study 
sample size. 
 
Enrollment is anticipated to take approximately 6 months. 
 
To participate in the clinical trial, subjects must be ≥ 22 years of age with no ocular pathology that 
could confound study outcomes, and must require clear cornea cataract extraction in both eyes. 
Additional entry criteria are listed below in Sections 10.1 through 10.3. 
 
Check all entry criteria at baseline (Visit 0) and at both surgical visits (Visit 00, Visit 00A). If a 
subject is excluded prior to first eye surgery (IOL does not come in contact with the eye), the 
subject should be discontinued from participation in the study. Refer to Section 12.4 Discontinued 
Subjects for further details. 
 
If a subject reschedules surgery, and this rescheduling results in preoperative/baseline assessments 
(Visit 0) falling outside of the -30 to 0 day window, assessments should be repeated, and 
inclusion/exclusion criteria re-verified. Subjects failing to pass entry criteria may not be re- 
screened. 
 
10.1 
Inclusion Criteria 
Inclusion criteria must be met in both eyes. 
 
1. Adults, 22 years of age or older at the time of surgery, diagnosed with bilateral cataracts 
with planned cataract removal by phacoemulsification with a clear cornea incision 
2. Able to comprehend and willing to sign informed consent and complete all required 
postoperative follow-up procedures 
3. BCDVA projected to be 0.2 logMAR or better 
4. Calculated lens power within the available range 
5. Preoperative keratometric astigmatism of less than 1.0 D in both operative eyes. 
6. Clear intraocular media other than cataract in both eyes 

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10.2 
Exclusion Criteria 
Exclusion criteria must be met in both eyes. 
 
1. Clinically significant corneal abnormalities including corneal dystrophy (eg, epithelial, 
stromal, or endothelial dystrophy), irregularity (including irregularity due to dry eye 
syndrome), 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. 
2. Previous corneal transplant; 
3. Previous refractive surgery or refractive surgery procedures (including, but not limited to 
LASIK, astigmatic keratotomy, and limbal relaxing incisions) 
4. History of or current retinal conditions or predisposition to retinal conditions, previous 
history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy that 
the Investigator judges could confound outcomes 
Note: Conditions including but not limited to background of diabetic retinopathy, diabetic 
macular edema or proliferative diabetic retinopathy, macular degeneration). 
5. Amblyopia 
6. Rubella, congenital, traumatic, or complicated cataracts 
7. Extremely shallow anterior chamber not due to swollen lens 
8. History of or current anterior or posterior segment inflammation of any etiology, or any 
disease producing an inflammatory reaction in the eye (eg, iritis or uveitis) 
9. Iris neovascularization 
10. Glaucoma (uncontrolled or controlled with medication) 
11. Optic nerve atrophy 
12. Subjects with diagnosed degenerative eye disorders (e.g. macular degeneration or other 
retinal disorders) 
13. Pregnancy or lactation 
14. Any subject currently participating in another investigational drug or device study 
15. Subjects who may reasonably be expected to require a SSI at any time during the study 
(other than YAG capsulotomy) 
16. Subjects who are expected to require retinal laser treatment 

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17. Any disease or pathology, other than cataract, that (in the expert opinion of the Investigator) 
is expected to reduce the potential postoperative BCDVA to a level worse than 0.30 
logMAR 
Note: Conditions including, but not limited to the following: amblyopia, clinically severe 
corneal dystrophy (eg, epithelial, stromal, or endothelial dystrophy), diabetic retinopathy, 
extremely shallow anterior chamber, not due to swollen cataract, microphthalmos, previous 
retinal detachment, previous corneal transplant, recurrent severe anterior or posterior 
segment inflammation of unknown etiology, iris neovascularization, uncontrolled 
glaucoma, aniridia, or optic nerve atrophy, or diagnosis of pseudoexfoliation. 
18.  
 
 
10.3 
Reasons not to implant a study IOL 
Below is a list of criteria that when occurring prior to IOL implantation prevents the study or 
control lens from being implanted. This is true for both eyes. A subject discontinuing at the time of 
surgery will be considered an enrolled subject, not a screen failure. 
 
1. Any other additional procedures during the phacoemulsification and IOL implant due to 
intraoperative complications that require further intervention (including but not limited to 
posterior capture rupture, with vitreous loss, zonular dehiscence that may make the IOL 
implant less stable, etc.) 
2. Excessive iris mobility 
3. Mechanical or surgical manipulation required to enlarge the pupil prior to or at IOL 
implantation 
4. Zonular or capsule rupture 
5. Significant anterior chamber bleeding 
6. Unrecognized (pre-existing but discovered during surgery) ocular conditions or 
complications in which the IOL stability could be compromised, including zonular 
weakness 
7. Bag-sulcus, sulcus-sulcus or unknown placement of the haptics 
8. Any other capsulorhexis other than circular continuous capsulorhexis (eg, no anterior 
radial inconsistencies in the capsulorhexis such as anterior capsular tears or any areas of 
‘can-opener’ capsulotomy) 

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11 
TREATMENT 
Upon signing informed consent, subjects are considered enrolled in the study. All subjects will be 
assigned a single subject identifier at the Screening Visit. The subject identifier consists of a 
combination of a 4 digit investigator number and a 5 digit subject number. The number is 
automatically generated sequentially by the EDC system. As an example: “4584.00001” (The 
investigator number and subject number are separated by a “.” character). This number will be 
used throughout the clinical trial. 
 
11.1 
Investigational Products 
Throughout the clinical trial, the Investigator will be responsible for the accounting of all test and 
control articles and will ensure that the investigational products are used in accordance with the 
manufacturer’s IB or DFU. 
 
Test Article: AcrySof IQ PanOptix IOL Model TFNT00 
 
The TFNT00 IOL is not approved in the United States (US), and therefore considered 
investigational, but it is a CE marked device that is commercially available in other countries 
across the globe. 
 
The lens is an ultraviolet and blue-light filtering foldable multifocal IOL of single-piece design 
with a central optic and 2 open-loop haptics. The optic is 6.0 mm in diameter and the lens has an 
overall diameter of 13.0 mm. The optic consists of a proprietary high refractive index hydrophobic 
acrylic material with a blue light filtering chromophore which filters light in a manner that 
approximates the human crystalline lens in the 400-475 nm blue light wavelength range (Boettner 
1962). It is biconvex and consists of a soft acrylic material capable of being folded prior to 
insertion, allowing placement through an incision smaller than the optic diameter of the lens. After 
surgical insertion into the eye, the lens gently unfolds to its intended shape. The optic diffractive 
structure is in the central 4.5 mm portion of the optic zone and divides the incoming light to create 
a +2.17 D intermediate and a +3.25 D near add power. The anterior surface is designed with 0.10 
μm of negative spherical aberration to compensate for the positive spherical aberration of the 
average human cornea. 
 
More information on the test article can be found in IB-0143. 
 
Control Article: AcrySof Monofocal IOL Model SN60AT 
 
The SN60AT IOL is approved in the US and is a CE marked device approved for use and 
commercially available in other countries across the globe. 
 
The lens is an ultraviolet and blue-light filtering foldable monofocal IOL of single-piece design 
with a central optic and 2 open-loop haptics. The optic is 6.0 mm in diameter and the lens has an 

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overall diameter of 13.0 mm. The optic consists of a proprietaiy high refractive index hydrophobic 
ac1ylic material with a blue light filtering chromophore which filters light in a manner that 
approximates the human c1ystalline lens in the 400-475 nm blue light wavelength range (Boettner 
1962). It is biconvex and consists of a soft ac1ylic material capable of being folded prior to 
inse1tion, allowing placement through an incision smaller than the optic diameter of the lens. After 
surgical inse1tion into the eye, the lens gently unfolds to its intended shape. 
 
More information on the control a1ticle can be found in the Package Inse1t/DFU. 
 
Both test and control IOLs will be individually packaged and will have unique serial numbers. 
The IOLs packages will contain the following items: 
 
• 
The IOL 
• 
A subject registration card (Lens Implant Card) 
• 
A subject identification card 
• 
Adhesive labels containing the IOL inf01matio n an d unique serial number 
• 
A package inse1t co ntainin g directions for use 
Both test and control IOLs will be available in a diopter range of 15.0 D-26.5 Din 0.5 D 
increments for this study. 
 
11.2 
Usage 
Intraocular lenses are single-use implantable medical devices and ai·e intended for long te1m use 
over the lifetime of the pseudophakic subject. See Section 11.1 Investigational Products for details 
on each lens. 
 
In order to implant the test and control articles, the surgeons participating in the study must be 
licensed ophthalmologists with cataract surge1y experience. Each surgeonwill use his/her 
standard of care to implant the lens following respective Package Inse1t/DFU/IB instructions for 
each device. 
 
11.3 
Accountability Procedures 
 
Upon receipt of IP, the Investigator or delegate must conduct an invento1yof all IOLs by serial 
number, complete study specific confumation of receipt procedures, and retain any required 
documentation in the Investigator 's clinical study records. Throughout the study, the Investigator 
or delegate must maintain records of IP use for each subject. This record must be made available 
to the study monitor for the purpose of verifying the accounting of IP supplies. Any discrepancies 
and/or deficiencies between the observed disposition and the written account must be recorded 

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along with an explanation. All IP sent to the Investigator must be accounted for by Study Sponsor 
personnel, and in no case be used in an unauthorized manner. 
 
The Investigator is responsible for proper disposition of all unused IPs at the conclusion of the 
study, according to the instructions provided by the Sponsor. 
 
11.4 
Assessor Masking 
The assessor associated with vision testing will be masked in this study. Site personnel 
performing 
, all VA assessments 
and all 
contrast sensitivity assessments will remain masked with regard to treatment assignment until 
after the final database lock (Visit 4A). 
 
Note: Any unmasking of the masked assessor must be reported to Alcon. 
 
Masked study personnel must avoid seeking information that may compromise masking. 
Unmasked study personnel must not disseminate information that is potentially unmasking to any 
masked personnel. A list of unmasked individuals can be found in Table 11-1 below. 
 
Table 11-1 Unmasked Individuals 
 
Unmasked Individual 
Extent of Unmasking 
Rationale 
Subject 
Unmasked to IP selection 
The test and control IOL 
designs offer different risks 
and benefits. The subject will 
select the lens model that best 
fits his or her lifestyle. 
Investigator 
Unmasked to IP selection 
Investigator will be advising 
the subject on the different 
risks and benefits of the IP to 
help the subject select the lens 
model that best fits his or her 
lifestyle. 
Site Personnel (not 
completing assessments noted 
in section 11.4) 
Unmasked to IP selection 
Site personnel involved with 
operative visits and data entry 
into EDC 
Monitor 
Unmasked to IP selection 
Monitor will complete IP 
accountability and monitoring 
responsibilities 

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12 
CLI NIC AL TRIAL PROCEDURES 
12.1 
Clinical Trial Assessments 
The following section outlines the assessments to be perfmmed in this clinical trial. Assessments 
are described in detail in the Manual of Procedures (hereto refened to as the MOP), and are 
outlined in tabular fmmat in Section 6 Schedule of Visits of this protocol. 
 
12.2 
Preoperative Visit (Visit 0) 
Visit 0: -30 to O D ays Prio r to V is it 00 , Bin oc ular Visit 
 
Below is a list of study procedures to be undert aken at Visit 0. It is recommended that procedures 
are performed in the order described below unless otherwise stated. All assessments must be 
documented in source documentation and case report fo rm s (if applicab le). 
Data from the Investigator's previous routine cataract evaluation may be used
 
 if the data 1) meet the requirements of this protocol and MOP, and 2) were 
collected less than 4 months before the preoperative examination for the study. All study specific 
testing not included in a routine cataract evaluation must be in the -30 to Oday preoperativetime 
period. 
 
• 
Review non-study specific inclusion/exclusion criteria (eg, age, previous ocular history) to 
ensure that a potential subject meets all qualifications for participation in the study. 
• 
For a potential subject meeting all entry criteria via pre-screening, invite him/her to 
pa1t icipate in the study, and cany out the inform ed co nsent proce ss if he/she is interested. 
Refer to Section 16.2 Inform ed Consent Procedures. 
Note: Subjects must formally consent to the trial prior to any study specific testing. 
• 
Document demographics, ocular and non-ocular medical histmy, ocular and non-ocular 
concomitant medications and pregnancy status (where applicable). 
• 
Perform a urine pregnancy test, IF the subject is a woman of childbearing potential. 
• 
• 
 
 
• 
 
• 

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• 
• 
• 
• 
Perfmm tonometJ.y to measure IOP . [Bo th Eyes, Bila teral] 
 
• 
Record any AEs. Refer to Section 13 Adverse Events and Device Deficiencies for fmther 
detail. 
• 
• 
• 
Evaluate subject against all entJ.y c riteria . If s ubje ct fa il s cr it er i a screen fail the subject. 
• 
 
• 
Proceedwith scheduling surge1y. 
 
• 
Prior to the operative visit, perfo1m surgical planning using the following 
recommendations: 
 
If implanting the contJ.·ol lens , model SN60AT, use established formulae and 
associated constants for this commercialized lens. 
 
Note: Surgeons may use their personalized A-constant for model SN60AT. 
 
• 
 
 
 
 
 
 
12.2.1 
Operative Visit (Visit 00/00A) 
Visit 00: Day 0, Monocular First Eye 
 
Visit 00A: 7-30 Days Post First Eye Implantation, Monocular Second Eye 
 
Below is a list of study procedures to be unde1taken at Visit 00 and Visit OOA. It is reco mmend ed 
that procedures are perf01med in the order described below unless othe1wise stated . Activities 
involving multiple delegated staff members may be perfmmed in parallel. 

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• 
All assessments must be documented in somce documentation and case repo1t f01ms (if 
applicable). 
Note: the Visit 00A window may overlap with other study visit windows (eg, Visit 3). In 
this case, both visits may be conducted on the same day at the discretion of the Investigator. 
• 
In preparation for the operative visit, 1) confilm willingness to continue trial paiticipation, 
and 2) confnm scheduled surgical date and time. 
• 
Prior to treatment, review inclusion/exclusion criteria and ensme the subject has been 
properly consented for participation in the trial. 
• 
Documentany changes to oculai·and non-ocular concomitant medications. 
• 
Record operative eye. 
• 
Prepare subject for surgery in accordance to site specific operating procedures. [Operative 
Eye Only, Monocular] 
• 
Perform surgery and implantation with the IOL chosen by the subject on the consent form 
• 
Record incision site. [Operative Eye Only, Monocular] 
• 
Measure and record final incision size. [Operative Eye Only, Monocular] 
• 
Record any surgical problems, complications, or other procedures that occur during 
surge1y.Other procedures include those perfo1med outside of routine cataract surgery. 
Note: Other planned procedures at the time of surgery are exclusionaiy. [Operative Eye 
Only, Monocular] 
• 
Record the lens information that is located on the IOL sticker or place sticker on the source 
document. Both successful and aborted (if applicable) test aiticle information should be 
recorded. [Operative Eye Only, Monocular] 
• 
Record any adverse events including SSis. 
Note: Se ri o u s adverse events (SAEs) including SSis must be entered into EDC within 
24 hours of the Investigator's knowledge. Refer to Section 13 Adverse Events and Device 
Deficiencies for further detail. 
• 
Record any device deficiencies. Refer to Section 13 Adverse Events and Device 
Deficiencies for further detail. 
 
12.2.2 
1-Day Postoperative Visit (Visit 1/lA) 
Visit 1: 1-2 Days Post First Eye Implantation, Monocular First Eye 

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•
 
Visit 1A: 1-2 Days Post Second Eye Implantation, Monocular Second Eye 
 
Below is a list of study procedures to be undertaken at Visit 1 and Visit l A. It is recommended 
that procedures are perfo1med in the order described below unless othe1wise stated. All 
assessments must be documented in source documentation and case repmi forms (if applicable). 
 
• 
Record changes in medical/ocular histmy and ocular and non-ocular concomitant 
medications. 
• 
Perfmm slit lamp examination of the anterior segment. Include documentation ofI OL 
observations, if any. [Operative Eye Only, Monocular] 
 
• -
Obse1ve any IOL position changes (ie, tilt and decentration) occurring since the previous 
visit. [Operative Eye Only, Monocular] 
 
• 
Assess subjective PCO, and record info1mation for any posterior capsulotomy that has 
occuned since surge1y, if applicable. [Operative Eye Only, Monocular] 
• 
Perfmm tonomet:J.y to me as ure the IOP. [Operative Eye Only, Monocular] 
 
• 
Record any AEs including SSis. 
Note: SAEs including SSis must be entered into EDC within 24 hours of the Investigator's 
knowledge. Refer to Section 13 Adverse Events and Device Deficiencies for fmiher detail. 
• 
Record any device deficiencies. Refer to Section 13 Adverse Events and Device 
Deficiencies for fmther detail. 
 
12.2.3 
1-Week Postoperative Visit (Visit 2/2A) 
Visit 2: 7-14 Days Post First Eye Implantation, Monocular First Eye 
 
Visit 2A: 7-14 Days Post Second Eye Implantation, Monocular Second Eye 
 
Below is a list of study procedures to be undetiaken at Visit 2 and Visit 2A. It is recommended 
that procedures are perfo1med in the order described below unless othe1wise stated. All 
assessments must be documented in source documentation and case repo11fo1ms (if applicable). 
• 
Record changes in medical/oc ular histo1y and ocular and non-ocular concomitant 
medications. 
• 
• 

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• 
 
• 
Perfo1m slit lamp examination of the anter ior seg ment. Include document ation of IOL 
observations , if any. [Operative Eye Only, Monocular] 
• 
Grade cell and flare according to SUN system (refer to MOP for grading scheme). 
[Operative Eye Only, Monocular] 
• 
Assess subjective PCO, and record inf01mation for any posterior capsulotomy that has 
occmTed since surge1y, if applicable. [Operative Eye Only, Monocular] 
• 
Perf01m tonome tly to meas ure the IOP. [Operative Eye Only, Monocular] 
 
• 
Record any AEs including SSls. 
Note: SAEs including SSis must be enteredinto EDC within 24 hours of the Investigator's 
knowledge. Refer to Section 13 Adverse Events and Device Deficiencies for fu1ther detail. 
• 
Record any device deficiencies. Refer to Section 13 Adverse Events and Device 
Deficiencies for fmther detail. 
12.2.4 
1-Month Postoperative Visit (Visit 3/3A) 
Visit 3: 30-60 Days Post First Eye Implantation, Monocular First Eye 
 
Visit 3A: 30-60 Days Post Second Eye Implantation, Monocular Second Eye 
 
Below is a list of study procedures to be unde1taken at Visit 3/3A. It is recommended that 
procedures are perf01med in the order described below unless othe1wise stated . All assessme nts 
must be documented in source documentation and case repo1t fo1ms (if applicable). 
 
• 
Administer the QUVID and IOLSAT questionnaires. 
 
• -
Record changes in medical/ocular histo1y and ocular and non-ocular concomitant 
medications. 
• 
• 
• 
• 
• - 

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-
 
• 
 
• 
 
• 
Perfo1m slit lamp examinat ion of the anter ior segment. Include documentation ofI OL 
observations, if any. [Operative Eye Only, Monocular] 
• 
Grade cell and flare according to SUN system (refer to MOP for grading scheme). 
[Operative Eye Only, Monocular] 
• 
Observ e any IO L position changes (i.e., tilt and decentration) occuning since the previous 
visit. [Operative Eye Only, Monocular] 
• 
Assess subjective PCO, and record inf01mation for any posterior capsulotomy that has 
occmTed since surgery, if applicable. [Operative Eye Only, Monocular] 
• 
Perfo1m dilated fundus exam noting any issues with fundus visualization due to the lens 
optic. [Operative Eye Only, Monocular] 
• 
Perfo1m tonometly to measure the IOP. [Operative Eye Only, Monocular] 
• 
Record any AEs including SSis. 
Note: SAEs including SSis must be entered into EDC within 24 hours of the Investigator's 
knowledge. Refer to Section 13 Adverse Events and Device Deficiencies for further detail. 
• 
Record any device deficiencies. Refer to Section 13 Adverse Events and Device 
Deficiencies for furth er detail. 
 
12.2.5 
6-Month Postoperative Visit (Visit 4A) 
Visit 4A: 120-180 Days Post Second Eye Implantation, Binocular 
 
Below is a list of study procedures to be undertaken at Visit 4A. Due to the number of assessments 
and expected duration of testing required for the final visit, this visit must be conducted over 2 
days (Part 1 and Part 2). The 2 visits must occur no more than 2 weeks (14 days) apart   from   
each other. Vision assessments must be performed in the order described to limit confounding 
effects. All assessments must be documented in source documentation and case repo1t fo1m s (if 
applicab le). 
 
Part 1 
 
• 
Reco rd changes in med ical/oc ular histo1y and ocular and non-ocular concomitant 
medications. 
• 
Administer the QUVID and IOLSAT questionnaires. 
-

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• -
Measure photopic pupil size at distance. [Both Eyes, Bilateral] 
• 
• 
• 
Assess monocular and binocular best con ected distance (4 m) visual acuity. [Both Eyes, 
Bilateral and Binocular] 
• 
Assess monocular and binocular distance co1Tected in te rmedi ate (66 cm) visual acuity. 
[Both Eyes, Bilateral and Binocular] 
• 
Assess monocular and binocular distance co1Tected near (40 cm) visual acuity. [Both Eyes, 
Bilateral and Binocular] 
• 
 
• 
 
• 
 
 
• 
Perform photopic without glare contrast sensitivity testing. [Both Eyes, Binocular] 
• 
Perform photopic with glare contrast sensitivity testing. [Both Eyes, Binocular] 
After patient mesopic lighting adaptation of at least 10 minutes, continue Part 1 testing by 
performing the following tests: 
• 
 
• 
• 
 
• 
 
• 
Perform mesopic without glare contrast sensitivity testing. [Both Eyes, Binocular] 
• 
Perform mesopic with glare contrast sensitivity testing. [Both Eyes, Binocular] 
Part 2 (within 2 weeks of Part 1 testing) 

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-
 
• 
Reco rd changes in medical/ocular histo1y and ocular and non-ocular concomitant 
medications. 
• 
 
• 
 
• 
 
• 
• 
• 
I 
• 
 
 
 
• 
Perfmm slit lamp examination of the anterior segment. Include documentation of IOL 
observations, if any. [Both Eyes, Bilateral] 
• 
 
[Operative Eye Only, Monocular] 
 
• 
Obse1ve any IOL position changes (ie, tilt and decentration) occmTing since the prev ious 
visit. [Both Eyes, Bilateral] 
• 
Assess subjective PCO, and record infmmation for any posterior capsulotomy that has 
occmTed since surge1y, if applicable. [Both Eyes, Bilateral] 
• 
Perfo1m tonometty to measure the IOP. [Both Eyes, Bilateral] 
• 
Perfmm dilated fundus exam noting any issues with fundus visualization due to the lens 
optic. [Both Eyes, Bilateral] 
• 
Record any AEs including SSis. 
Note: Serious adverse events (SAEs) including SSis must be entered into EDC within 
24 hours of the Investigator's knowledge. Refer to Section 13 Adverse Events and Device 
Deficiencies for further detail. 
• 
Record any device deficiencies. Refer to Section 13 Adverse Events and Device 
Deficiencies for further detail. 

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12.3 
Unscheduled Visits 
An unscheduled visit (UNSV) is defined as follows: 
 
• 
Ocular examination that is not standard of care and not required by the protocol; 
Examination conducted by the study staff; new findings, or a change to a previous finding 
was discovered; and Not site standardof care/routine. 
An UNSV may or may not result in the capture of an adverse event. Likewise an adverse event 
may be captured without the report of an UNSV (eg, AE identified subsequent to study eye 
examination by non-study personnel). 
 
The assessments captured at the UNSV are dictated by the Investigator per his/her medical 
judgment. The following assessments are recommended. 
• 
 
• 
Concomitant medications 
• 
Slit lamp exam including IOL position change 
• 
Subjective PCO and posterior capsulotomy assessment 
• 
Grade cell and flare according to SUN system (refer to MOP for grading scheme) 
• 
Dilated fundus exam 
 
• 
IOP 
• 
Adverse events 
• 
Device deficiencies 
 
Note: Assessments are not limited to the above list. 
 
If the subject is discontinued at the unscheduled visit, pe1f01m all Early Exit procedures. Refer to 
Section 6 Schedule of Visits. For safety pmposes, if an UNSV is required after the final study 
visit, document the visit. Refer to Section 13.6 Follow-Up of Subjects with Adverse Events for 
further detail. 
 
12.4 
Directions Related to Secondary Surgical Interventions 
One of the co-primary safe ty object ives of the study is to estimate the rate of secondary surgical 
interventions (SSis) related to the optical prope11ise of the IOL for first operative eye up to month 
6 (Visit 4A). This section is intended to provide guidance on the documentation and procedures 
related to SSis in this investigation. 

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The main procedural steps in the decision process for SSis and notification to the Sponsor are 
detailed below. 
 
1. The Investigator must dete1mine whether an SSI is related to the optical prope1t ies of the IOL. 
 
2. Any SSI (other than posterior capsulotomy laser treatment) perfo1med for any reason should be 
recorded as a serious adverse event and reported to the Sponsor within 24 hours of its occmTence. 
 
Note: If the SSI is a lens exchange or repositioning, the subsequent study post-operative visits 
should be based on the date of this surge1y.Unscheduled Visit Case Report F01ms (CRFs) should 
be used for other post-operative follow-up visits, where applicable. If the study lens is exchanged 
and replaced with a non-study lens, the subject will be required to complete all original 
subsequent study visits through Visit 4A(6 months). 
 
Evaluation of Need for a Seconda1ySurgical Intervention 
 
• 
The need for consideration of an SSI includes one or more of the following: 
 
1. An Investigator assessment of subject's clinical outcome. 
 
2. A subject spontaneously complaining about visual symptoms to the investigational site 
personnel. 
 
3. Other reason(s) for an SSI, e.g., retained lens fragments. 
 
The Investigator should perfo1m a thorough evaluation including diagnostic testing as needed and 
a subject interview to understand subject observations in detail to dete1mine if an SSI is the 
appropriate treatment for the subject's undesired outcome (e.g., blmTed vision, visual 
disturbances/disto1tions, or other reasons). Case management should be based on the 
Investigator's clinical assessment with consideration of the subject's postoperative_ 
, 
BCDVA, IOL stability after implantation, and any subjective complaints. Careful consideration of 
the potential risks and benefits associated with the SSI for the subject is required, and these should 
be discussed with the subject prior to electing to reposition or explant the IOL or othe1wise 
 
 
Guidance on determining whether the SSI cause is related to the co-primary safety endpoint 
 
 
The following causes are considered unrelated to the optical properties of the IOL: 
 
• 
smgically intervene. For any visit in which an SSI is planned, 

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• Surgical complications noted at the operative visit that may reasonably affect postoperative 
outcomes 
 
• Pre-existing or newly developed ocular pathologies 
 
• Corneal disorders (e.g., dry eye syndrome, edema, and corneal irregularities) 
 
• Macular edema – confirmed by optical coherence tomography and/or fluorescein 
angiography 
 
• Anisometropia (≥ 1 D difference in sphere or cylinder between contralateral eyes) due to 
cataractous lens in fellow eye rather than post-operative outcomes of the first eye 
 
• Posterior capsular opacification 
 
• Wearing corrective lenses with unsuitable prescription 
 
 
The following are considered as related to the optical properties of the IOL: 
 
• IOL repositioning or explantation/replacement 
 
a) IOL repositioning due to IOL instability (e.g., decentration and tilt) 
 
b) Subject intolerance of visual symptoms that are not expected to resolve if an SSI 
is not performed. 
 
 
If the Investigator determines that an SSI is warranted and the reason is not defined above or if 
there is any uncertainty as to whether the SSI is related to the optical properties of the IOL or 
some other, unrelated factor(s), the Investigator should consult with the Medical Monitor. The 
Investigator should determine the most suitable SSI procedure for each case. Please note that 
limbal relaxing incisions and keratorefractive procedures to address residual refractive error are 
disallowed by the protocol. Subjects who undergo such procedures will be excluded from the best 
case analysis set, but will be evaluable for the safety and all implanted analysis sets. 
 
Additional recommendations regarding Secondary Surgical Interventions 
 
The following information is not intended to replace or limit the surgeon’s decision-making 
process but rather to establish general guidance for time point and conditions for secondary 
surgical interventions. 
 
1. IOL Repositioning 
• 

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If IOL repositioning is required, it should be done in the early postoperative period before capsule 
fibrosis, preferably within the first 30 days following surgery. Repositioning should only be 
considered in cases when tilt or decentration, either due to instability or placement, is necessary to 
improve the visual outcomes of the subject. 
 
2. IOL Explantation and Replacement 
 
Should explantation of the investigational IOL (AcrySof® IQ PanOptix™ IOL Model TFNT00 ) 
or control IOL (AcrySof® Monofocal IOL Model SN60AT) and IOL replacement be necessary, it 
should be done in the early postoperative period in the case of inaccurate preoperative planning 
and/or surgical error. In the case where an investigational or control IOL is explanted, it should be 
replaced with another Alcon AcrySof® IOL. 
 
In the case of an incorrect IOL power or residual refractive error, any SSI to replace the IOL 
should be considered if the placement of a different IOL power or IOL type is expected to improve 
the visual outcomes of the subject. 
 
In the case where the subject complains of visual disturbances/distortions in the early 
postoperative period, the surgeon should remind the subject that these symptoms generally 
improve over time due to neural adaptation. Therefore, adequate time must be allowed for neural 
adaptation to occur. The medical judgment of the Investigator, consultation with the Medical 
Monitor and careful consideration of the potential benefits and risks of the SSI should be 
discussed with the subject. If the subject is intolerant of persistent visual disturbances/distortions 
and the Investigator identifies the primary cause as related to intrinsic IOL properties, lens 
replacement should be considered. 
 
Summary 
 
The Investigator must consider subject complaints and clinical outcome in his or her consideration 
of the need for a SSI, determine whether the cause of a needed SSI is due to optical properties of 
the IOL, and report findings to the Sponsor within defined timelines. 
 
Note: Table 18-2 contains additional indications for secondary IOL interventions and their 
associated definitions. (Masket, 2017). 
 
12.5 
Missed Visits 
If a subject misses a scheduled visit, reschedule the subject within the same visit period. Show 
diligence in trying to schedule the subject for all visits, and document all attempts to contact the 
subject in the subject’s chart. In documentation, include dates, times, method of contact, etc. 
 
If a subject is unable to return for the final study visit, complete the Exit Case Report Form with 
the appropriate reason for discontinuation. If attempts to contact the subject are unsuccessful, 

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document the date the subject is considered lost to follow-up. Complete the subject's Exit Case 
Report Form after the last window (Pa1t 2 of Visit 4A) closes, indicating the subject is lost to 
follow-up. 
 
12.6 
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 shall be considered 
discontinued due to screen failure, and the failed entry cri terion documented (eg, inclusion 
criterion 2, exclusion criterion 5). Refer to Section 10 Subject Population. 
 
Subjects may discontinue study participation at any time and for any reason. Subjects may be 
discontinued from the study at any time if in the medical opinion of the PI or designated, qualified 
medical personnel, continued pa1ticipation poses a health risk to the subject. Subject numbers 
from discontinued subjects will not be reissued. Discontinued subjectswill not be replaced. 
 
12.7 
7 Clinical Trial Termination 
The Sponsor reserves the right to close the investigational site 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 GCP guidelines 
• 
Safety concerns 
• 
Inadequate recruitment of subjects by the Investigator 
If the clinical study is prematurely terminated or suspended, the Sponsor will inform the 
Investigator and the regulat01y authorities (where applicable) of the termi nation/ suspe nsion and 
the reason(s) for the termi nation/suspe nsion. 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 
ADVERSE EVENTS AND DEVICE DEFICIENCIES 
13.1 
General Information 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical 
signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not 
related to the investigational medical device (test article). Refer to the Glossary of Terms and 
figures below for categories of AEs and SAEs. 
 
Figure 13–1 
Categorization of All Adverse Events 
 
 

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All SAEs 
No 
SAE 
SADE 
Anticipated? 
 
Figure 13-2 
Categorization of All Serious Adverse Events 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Unanticipated 
SADE 
 
 
 
Anticipated 
SADE 
 
 
 
 
Specific Events Relevant to this Protocol 
 
In addition to repo1ting all AEs (serious and non-serious) meeting the definitions, the Investigator 
must repmt any occmTence of the follo wing as an SAE: 
 
Cumulative Serious Adverse Events 
 
• 
Cystoid macular edema 
• 
Hypopyon 
• 
Endophthalmitis 
• 
Lens dislocation from posterior chamber 
• 
Pupillary block 
• 
Retinal detachment 
• 
Seconda1y smgical intervention (excluding posterior capsulotomy) 
Yes 
No 

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Per sis tent Serious Adverse Events 
 
• 
Corneal stromal edema 
 
• 
Cystoid macular edema 
 
• 
Iritis 
 
• 
Raised IOP requiring treatment 
 
This list is consistent with the categories provided in ISO 11979-7 SPE grid rates. A persistent AE 
is an AE that is present at the conclusion of a clinical investigation per ISO 11979-1 te1ms and 
definition s. Any other potentially sight-threatening event may also be considered serious based on 
the judgment of the Investigator and should be repo1ied appropriately as delineated in Section 
13.3 Procedures for Recording and Reporting Deficiencies. 
 

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SecondarySurgical Interventions (SSI) 
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Seconda1y Surgical Interventionsrepmting will be sub-categorized using the following 
tenni nology: exchange, removal, and repositioning. Indications and associated definitions for 
these outcomes are provided in Section 18 Appendices, Table 18-2. 
 
13.2 
Monitoring for Adverse Events 
At each visit, after the subject has had the opporiunity tospontaneously mention anyproblems, 
the Investigatorshouldinquire about AEs by asking the standard questions: 
 
• 
"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 parameters and/or questionnaires evaluated during the study are 
to be reviewed by the Investigator. Any untoward (unfavorable and unintended) change in a 
protocol-specific parameter or questionnaire response that is clinically relevant, in the opinion of 
the Investigator, is to be repmted as an AE. These clinically relevant changes will be repmted 
regardless of causality. 
 
13.3 
Procedures for Recording and Reporting 
AEs are collected from the time of infmmed consent. Any pre-existing medical conditions or 
signs/symptoms present in a subject prior to the start of the study (ie, before informed conse nt is 
signed) are not considered AEs in the study and should be recorded in the Medical Histmy section 
of the eCRF. 
 
In addition, aqueous cells and flare, corneal  edema,  raised IOP and  superficial  punctate keratitis 
ar·e examp les o f ear ly post -o pe rative fi ndi ngs that are typically observed follow ing ocular surge ry. 
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 occunence, 
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 eC RF. The site must submit all available inform ation on 
ADEs, SAEs, and device deficiencies to the Study Sponsor immediately as follows: 
 
• 
ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device Effect 
eCRF within 24 hours of the Investigator's or site's awareness. 
• 
Device deficiencies are documented on the Device Deficiency eCRF within 24 hours of the 
Investigator's or site's awareness. 

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• 
A printed copy of the completed Serious Adverse Event and Adverse Device Effect and/or 
Device Deficiency eCRF must be included with product returns. 
• 
Additional relevant inf01mat ion after initial rep01ting must be entered into the eCRF as 
soon as the data become available. 
• 
Document any changes to concomitant medications on the appropriate eCRFs. 
• 
Documentall relevant inf01mation from Discharge Summary, Autopsy Rep01t, 
• 
Ce1tificate of Death etc ., if appli cab le, in nan ati ve sec tion of the Serious Adverse Event and 
Adverse Device Effect eCRF. 
• 
UADEs must be rep01ted to the IRB 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 Serious Adverse Event and Adverse Device Effect and/or Device 
Deficiency Form. The completed fo1m is faxed or emailed to the Study Sponsor at 
 or 
  according to the timelines outlined 
above; however, the repo1ted info1mation 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, 
Delive1y systems, etc.) 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 may be contacted for any protocol related question and their 
contact information is provided in the Manual of Procedures that accompanies this protocol. 
 
Fmther, depending upon the nature of the AE or device deficiency being repo1ted, the Study 
Sponsor may request copies of applicable p01tions of the subject's medical records. The 
Investigator must also repo1tall AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulat01y authorities or IRB/IEC. 
 
Intensity and Causality Assessments 
 
Where appropriate, the Investigator must assess the intensity (severity) of the AE based on 
medical judgment with consideration of any subjective symptom(s), as defined below: 
 
Intensity (Severity) 
 
Mild 
 An AE is mild if the subject is aware of but can easily tolerate the sign or 
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Moderate 
An AE is moderate if the sign or symptom results in discomfort significant enough 
to cause interference with the subject’s usual activities. 
Severe 
An AE is severe if the sign or symptom is incapacitating and results in the subject’s 
inability to work or engage in their usual activities. 
 
For every AE in the study, the Investigator must assess the causality (Related or Not Related to the 
medical device or study procedure). An assessment of causality will also be performed by Study 
Sponsor utilizing the same definitions, as shown below: 
 
Causality 
 
Related 
An AE classified as related may be either definitely related or possibly 
related where a direct cause and effect relationship with the medical device 
or study procedure has not been demonstrated, but there is a reasonable 
possibility that the AE was caused by the medical device or study 
procedure. 
Not Related 
An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (ie, there are other more likely causes for the AE). 
The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the Investigator of any AEs that are 
upgraded from non-serious to serious or from unrelated to related. 
13.5 
Return product analysis 
Study Sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol. 
 
Alcon Products associated with device deficiencies and/or product related AEs should be returned 
as specified in the MOP and must include the Complaint # which will be provided by study 
Sponsor after the case is entered in the Study Sponsor’s Global Product Complaint Management 
System (GPCMS). 

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13.6 
Follow-Up of Subjects with Adverse Events 
The Investigator is responsible for adequate and safe medical care of subjects during the study and 
for ensuring that appropriate medical care and relevant follow-up procedures are maintained after 
the study. 
 
The Investigator should provide the study Sponsor with any new safety info1mation (which 
include s new AEs and changes to previously repmted 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 info1mation received at follow-up should be documented in the eCRFs up to study 
completion (ie, database lock). 
 
Any additional data received 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 
tin1e period will be considered and processed as spontaneous (following the post-market vigilance 
procedures) and should be communicated to the medical device's manufacturer as per local 
requirements. 
 
The Investigator should report complaints on non-Alcon products directly to the manufacturer as 
per the manufacturer's instiuctions or local regulato1y requirements. 
 
13. 7 
Pregnancy in the Clinical Trial 
Pregnancy is not repmtable as an AE; however, complications may be repmtable and will be 
decided on a case-by-case basis. An Alcon fo1m will be utilized to capture all pregnancy related 
info1mation until bi1th of the child. 
 
14 
DATA REVIEW AND HANDLING 
14.1 
Completion of Source Documents and Case Report Forms 
The nature and locationof all source documents will be identified to ensure that original data 
required to complete the electi·onic case report fo1ms (eC RFs) exists and are accessible for 
verification by the monitor. It is required that the author of each entiy in the source documents be 
identifiable (eg, initials or signature and date). At a minimum, source documents should include 
the following info1mation for each subject: 
 
• 
Subject identification (name, date of bi.1th or age , sex) 
• 
Documentationof subject eligibility 
• 
Date of info1med consent 
• 
Dates of visits 
• 
Documentation that protocol-specific procedures were perfo1med 

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• 
Res ults of study testin g, as required by the protocol 
• 
Test a1ticle accountability records 
• 
Documentation of SAEs and other safety parameters (as applicable) 
• 
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study 
• 
Date of study completion and reason for early discontinuation, if applicable 
Note: If electronic source records are maintained, the method of verification must be determined 
in advance of sta1t ing the study. 
 
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 
repo1ted 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 con ection 
to data reported on a source document shall be dated, initialed, and explained if necessa1y, and 
shall not obscure the original entry (i.,e.  an audit tr·ail shall be maintained) ; this applies to both 
written and electr·onic cha nges and con ections. eCRFs shall be signed and dated by the Principal 
Investigator or his/her authorized designee(s). 
 
14.2 
Data Review and Clarifications 
Upon completion of the eCRFs, targeted data will be reviewed by the assigned Sponsor global 
clinical site management (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. Con ections and/or any  necessa1y  additions to the data 
will be applied and if required, queries will be generated. Designated investigative staff is  
expected to respond to data queries in a timely manner and ensure that the con ections and changes 
made to the data are reflected in the subjects' source documentation. 
 
Deviations from this protocol, regulato1y requirements and GCP must be recorded. An explanation 
of the deviation should be included, as applicable. In addition, corTective 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 Drng Reference 
List. Operative medications will be detailed in site-specific surgical study protocols and will not  
be entered in the eCRFs; any deviation to the site's standard surgical protocol for the study will 
require entry into the eCRF. Medical history and adverse events will be coded using the medical 
dictionaiy for regulatory activities (MedDRA) terminology. In addition, standardized definitions 

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to allow for additional supportive characterization of AEs based on Postoperative Adverse Event 
Definitions for Intraocular Lenses are provided in the appendices, Table 18-1 (These are 
additional characterizations and are not intended to change the ISO defined events), and will be 
collected in eCRFs. Upon completion of the study and once the database is declared completed 
and accurate, the database will be locked and 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 depa1i ments, and will be 
completedfollowing the Sponsor's procedures for changes to a database after database lock. 
 
15 
ANALYSIS PLAN 
15.1 
Subject Evaluability 
The final subject evaluability will be dete1mined prior to locking the database. 
 
15.2 
Analysis Data Sets 
The All-Implanted Analysis Set (AAS) includes all eyes with successful IOL implantation with at 
least 1 post-operative visit and will be the prima1y analysis set for all effectiveness analyses 
 
 
The Best-Case Analysis Set (BAS) will be the primruy analysis set for c 
s   ,
nd includes all eyes successfully implanted that had 
 
• 
at least 1 post-operative visit; 
• 
no preoperative ocular pathology; 
• 
no macular degeneration detected at any time; and 
• 
no major protocol deviations. 
tntra 
 
 
 
The Safety Analysis Set (SAS) will include all eyes with attempted IOL implantation (successful 
or ab01ied after contac t with the eye). The SAS will be the prima1y set for all safety analyses 
except contrnst sensitivity. 
 
All monocular measures from eyes implanted with a non-study lens and binoculru· measures 
assessed in subjects with at least 1 non-study IOL implant will be excluded from all analysis sets. 
Treatment assignments for final analysis will be based on the lens implanted. 
 
Although all sites are expected to contribute both test and control subjects, due to the non- 
randomized nature of the study it is possible that a site may emoll all subjects in 1 group. Such 
sites, and possibly additional sites with low emollment, will be combined into 1 pseudo site to 

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ensure that at least 2 subjects are in each treatment group to avoid estimation issues with the use 
of mixed effects models. 
 
15.3 
Demographics and Baseline Characteristics 
Summaiy statistics will be provided for demographic and baseline characteristics by IOL group. 
Number and percentage will be presented for categorical variables and descliptive statistics 
including mean, standard deviation, minimum and maximum will be presented for continuous 
variables. 
 
15.4 
Performance Analyses 
A total of 4 hypothesis tests will be conducted to address the co-primaiy and seconda1y 
effectiveness objectives of the study. To account for multiplicity, a sequential testing approach 
consisting of the 2 co-prima1y hypotheses , followed by the first secondaiy hypothesis, followed 
by the second seconda1y hypothesis will be employed. The primary effectiveness objective is 
considered met only if both co-primaiy hypotheses are met. The type I enor for thenon-inferiority 
test is 5% (I -sided) and for the superiority test is 2.5% (I-sided). Each of the secondaiy 
hypotheses will be tested at 2.5% (I-sided). 
 
Analysis of the co-primary and first seconda1y endpoints will begin with a model selection step in 
an effort to select the most parsimonious model. Two mixed effects models, the first with a fixed 
effect for treatment and random effect for site, and the second with a fixed effect for treatment and 
random effects for site and treatment by site interaction, will be fit to the first co-primaiy endpoint 
(best coITected di sta nce visual acuity). The 2 models will  be compared  using  Bayesian 
infonnation criterion (BIC) and the model with lower BIC will be employed for analysis of all 3 
aforementioned endpoints. 
 
15.4.1 
Primary Performance 
The co-prima1yeffectiveness endpoints are: 
 
• 
Mean photopic monocular best con ected distance visual acuity (4 m) for the first operative 
eye at Month 6 
• 
Mean photopic monocular distance con ected visual acuity at neai·(40 cm) for the first 
operative eye at Month 6 
15.4.1.1 
Statistical Hypotheses 
The null and alternative hypotheses for the first co-primaiy analysis are: 
 
H o:  µJFNToo_vA -    µ s N60AT_VA 
l:l. 
 
H A: µTFNTOO_VA -  µ s N60AT_VA < l:l. 

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Where , !).. refer s  to  the non-inferiority margin, set at 0.10 logMAR, µ TFNToo_vA and µ SN60AT_VA,  refer 
to the population mean monocular best conected distance visual  acuity  at  4  m  for  the test and 
control lenses respectively, in the first operative eye at Month 6. 
 
The null and alternative hypotheses for the second co-primary anal ysis are: 
 
H   o:    µTFNToo_vA 2': µSN60AT_VA 
 
 
Where , µ TFNToo_vA and µsN60AT_VA refer to the population mean monocular distance con ected 
visual acuity at near (40 cm) for the test and control lenses respectively, in the first operative eye 
at Month 6. 
 
15.4.1.2 
Analysis Methods 
Least Squares Means (LSMEANS) from the mixed effects model chosen dming the model 
selection step will be employed to estimate the difference in means (Ac1ySofI Q PanOptix IOL 
Model TFNT00 minus Ac1ySof Monofocal IOLModel SN60AT) and the associated confidence 
intervals for each co-prima1y endpoint. 
 
The non-inferiority hypothesis (first co-prima1y) will be deemed supported if the upper 95% 
confidence limit is less than the non-inferiority margin of 0.10 logMAR. 
The superiority hypothesis (second co-primary ) will be deemed suppo1t ed if the upper 97.5% 
confidence limit is less than 0.0 logMAR. 
 
The above analysis will be repeated for the second eyes 
 
An analysis with a mixed-effect model analysis of variance (ANOVA)accounting for con elation 
between the first and the second eye will be perfo1med as a sensitivity analyses. 
 
15.4.2 
Secondary Performance 
The secondaryeffectiveness endpoints are: 
 
• 
First seconda1y: Mean photopic monocular distance c01Tected visual acui ty at inte rmediate 
(66 cm) for the first operative eye at Month 6 
• 
Second seconda1y: Propmtion of subjects who respond ''Never" to Question 1 of the 
IOLSAT questionnaire (Ql: Overall, in the past 7 days, how often did you need to wear 
eyeglasses to see?) at Month 6 
15.4.2.1 
Statistical Hypotheses 
The null and alternative hypotheses for the first seconda1y  analysis are: 

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H0: μTFNT00_VA ≥ μSN60AT_VA 
HA: μTFNT00_VA < μSN60AT_VA 
Where μTFNT00_VA and μSN60AT_VA refer to the population mean monocular distance corrected visual 
acuity at intermediate (66 cm) for the test and control lenses respectively, in the first operative eye 
at Month 6. 
 
The null and alternative hypotheses for the second secondary analysis are: 
 
H0: πTFNT00_IOLSAT ≤ πSN60AT_IOLSAT 
HA: πTFNT00_IOLSAT > πSN60AT_IOLSAT 
Where, πTFNT00_IOLSAT and πSN60AT_IOLSAT refer to the population proportion of subjects who 
respond “Never” to Question 1 of the IOLSAT questionnaire at Month 6 for the test and control 
lenses, respectively. 
 
15.4.2.2 
Analysis Methods 
Least Squares Means (LSMEANS) from the mixed effects model chosen during the model 
selection step will be employed to estimate the difference in means (AcrySof IQ PanOptix IOL 
Model TFNT00 minus AcrySof Monofocal IOL Model SN60AT) and the associated confidence 
interval. 
 
The first secondary superiority hypothesis will be deemed supported if the upper 97.5% 
confidence limit is less than 0.0 logMAR. 
 
The above analysis will be repeated for the second eyes and will be considered supportive. 
 
The second secondary endpoint will be analyzed by estimating the Mantel-Haenszel common 
difference of proportions (AcrySof IQ PanOptix IOL Model TFNT00 minus AcrySof Monofocal 
IOL Model SN60AT) along with the corresponding confidence interval with site as a stratification 
variable. The superiority hypothesis will be deemed supported if the lower 97.5% confidence limit 
of the confidence interval exceeds 0. 
 

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Superiority 
: DCIVA 
a = 0.025, 1-sided 
 
 
15.5 
5 Handlin g of M iss in g Data 
Sensitivity analyses are planned to assess the impact of missing data on the conclusions from the 
co-prima1yeffectiveness analyses and the second co-prima1ysafety objective. Details are 
provided in the statistical analysis plan. 
 
15.6 
Multiplicity 
To account for multiplicity, the effectiveness hypotheses will be tested in sequence, 2 co- 
primaries, followed by first secondaiy, followed by second seconda1y. The prima1y effectiveness 
objective is considered met only if both co-prima1yhypotheses are met. The type I enor for the 
non-inferiority test is 5% (I-sided) and for the superiority test is 2.5% (I-sided). Each of the 
secondaiy hypotheses will be tested at 2.5% (I-sided). 
 
 
 
 
NI:BCDVA 
a = 0.05, 1-sided 
Superiority: DCNVA 
a = 0.025, 1-sided 
', 
 
 
 
 
 
w 
 
 
 
 
 
15.7 
Safety Analysis 
The co-prima1y safety objectives are to: 
 
• 
Estimate the cumulative rate of seconda1y surgical inte1ventions (SSis) related to the 
optical properties of the IOL for first operative eye up to Month 6. 
• 
Evaluate the mean binocular contrast sensitivity with and without glare for photopic and 
mesopic conditions at 6 months. 
S uperiority : Spectacle need 
a = 0.025, 1-sided 

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The secondary safety objective is to estimate rates of severe and most bothersome (separately) 
visual disturbances as reported by the subjects using a questionnaire (QUVID) at Month 6. 
 
The third safety objective is to evaluate rates of cumulative and persistent Adverse Events in first 
eyes at month 6 in comparison to ISO 11979-7 SPE grid rates. 
 
15.7.1 
Analysis for Co-Primary Safety Objectives 
15.7.1.1 
Secondary Surgical Interventions Related to Optical Properties 
of the IOL 
Descriptive summaries (count, rate and 95% (two-sided) exact confidence interval) of secondary 
surgical interventions will be presented for each IOL group and the difference between the groups, 
separately for first operative eyes and all eyes in each of the following categories: 
 
1. Related to IOL - due to optical properties 
2. Related to IOL - not due to optical properties 
3. Unrelated to IOL 
4. Overall 
A listing of all SSIs will be also be presented. 
 
15.7.1.2 
Binocular Contrast Sensitivity 
Analyses of log contrast sensitivity will be performed for each testing condition and spatial 
frequency. 
 
 
 
 
 
 
 
 
 
 
 
 
 
15.7.2 
Analysis for Secondary Safety Objective 
The secondary safety endpoint is rates of severe and most bothersome visual disturbances as 
reported by subjects using the QUVID questionnaire at Month 6. Descriptive summaries (rates 

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and 95% (two-sided) exact confidence intervals) of severe and most bothersome visual 
disturbances will be presented for each IOL group and the difference between the IOL groups. 
 
15.7.3 
Analysis for Third Safety Objective 
The third safety endpoint is adverse events. Incidence rates observed for each IOL group will be 
compared to the cumulative and persistent adverse event Safety and Performance Endpoint rates 
in IS EN ISO 11979-7 SPE grid rates. An eye with multiple ocular adverse events of the same 
preferred term is only counted once toward the total of this preferred term. The Safety and 
Performance Endpoint rate is considered not exceeded if the lower exact binomial 95% 
confidence limit does not exceed the Safety and Performance Endpoint rate. 
 
The frequencies of adverse events will be presented overall, and by subcategories of age 
(<65 years vs. ≥65 years) and investigative site, separately for cumulative and persistent adverse 
events. Additionally, frequencies and two-sided 95% confidence intervals will be reported for 
adverse events related to the IOL for each IOL group. Adverse events related to the IOL may also 
be referred to as adverse device effects. 
 

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15.8 
Interim Analyses 
Interim reports pertaining to the progress of this study will be submitted to the US FDA for review 
annually until study completion. There are no planned interim analyses of the endpoints. 

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15.9 
Adaptive Study Design 
Not applicable. 
 
15.10 Sample Size Justification 
Approximately 250 subjects will be bilaterally implanted with either the AcrySof IQ PanOptix 
IOL Model TFNT00 or the AcrySof Monofocal IOL Model SN60AT in a 1:1 ratio in order to 
ensure that at least 113 eligible subjects complete the study in the test group and the control group. 
This assumes a drop-out rate of 10%, approximately. 
 
For co-primary and first secondary effectiveness objectives, the proposed sample size will provide 
≥98% power for each of the hypotheses, with α=0.05, 1-sided for the non-inferiority test, and 
α=0.025, 1-sided, for superiority tests. For tests of superiority, assumptions include a difference of 
means of 0.1 logMAR between the groups for distance corrected visual acuity at intermediate (66 
cm) and distance corrected visual acuity at near (40 cm) and a common standard deviation of 0.18 
logMAR. For test of non-inferiority, assumptions include a difference in means of 0 between the 
groups for best corrected distance visual acuity (4 m), a non-inferiority margin of 0.1 logMAR and 
a common standard deviation of 0.18 logMAR. The standard deviation of 0.18 is based on the 
maximum variability of logMAR observed in study C-06-40 (Clinical Study Report: Clinical 
Investigation of ACRYSOF ReSTOR Aspheric +3.0 D Add Power IOL). 
 
For the second secondary effectiveness objective, the proposed sample size will provide 83% 
power, with α=0.025, 1-sided, to detect a difference in proportion of 20%, assuming a ≥50% rate 
in the AcrySof IQ PanOptix IOL test group. The estimates of rates of spectacle need for the test 
and control lenses are inferred from studies ILH297-P002 and C-10-016, respectively, using a 
binocular 
visual acuity threshold of 0.2 logMAR or better at near (40 cm) and 
distance (4 m) as a proxy measure. 
 
Power calculations for the effectiveness objectives are summarized in the table below: 
 
 
Margin 
Expected 
Difference 
Std. 
dev 
Type I error 
(1-sided) 
Power 
Non- Inferiority 
BCDVA (4 m) 
0.1 
0.0 
0.18 
5% 
99% 
Superiority 
DCNVA (40 cm) 
0.1 
0.18 
2.5% 
98% 
DCIVA (66 cm) 
0.1 
0.18 
2.5% 
98% 
Spectacle need 
20% 
2.5% 
83% 
All expected differences for tests of superiority favor the test lens. Estimates for VA endpoints reported 
in logMAR. 

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Adverse Events: For any event where a 0 incidence is observed in 113 first-operative eyes in the 
AcrySof IQ PanOptix IOL test group, the upper exact binomial 95% confidence limit is less than 
3%. Thus, with 95% confidence, the true adverse event rate is less than 3%. 
 

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16 
ADMINISTRATIVE PROCEDURES 
16.1 
Regulatory and Ethical Compliance 
This clinical trial will be conducted in accordance with the principles of the Declaration of 
Helsinki, and in compliance with ISO 14155:2011 Clinical investigation of medical devices for 
human subjects – Good clinical practice, Code of Federal Regulations (CFR), and laws and 
regulations of foreign countries, whichever affords greater protection to subjects. The 
 
trial shall also be conducted in accordance with the Sponsor’s Standard Operating Procedures 
(SOPs) and all other applicable regulations. 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 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 (and assent form, if 
applicable), 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). A master list of IRBs/IECs for this clinical trial can be found in the Trial 

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Master File. The Investigator must provide documentation of IRB/IEC approval to the Sponsor. 
The approval must be dated and must identify the applicable protocol, amendments (if any), 
informed consent form, assent form (if any), all applicable recruiting materials, written 
information for subjects, and subject compensation programs. The IRB/IEC must be provided with 
a copy of the Investigator’s Brochure, 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 will notify the IRB/IEC of the clinical trial’s final status. 
Finally, the Investigator will report to the IRB/IEC on the progress of the clinical trial at intervals 
stipulated by the IRB/IEC. 
 
16.3.1 
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 Good Clinical Practice (GCP), and with applicable 
regulatory requirements. 
 
All investigative sites will have a site initiation. Monitoring will be conducted periodically while 
the clinical study is ongoing. Monitoring methods may include site visits, telephone, written and 
fax correspondence. The assigned CSM will contact each site at appropriate intervals. The Lead 
Clinical Site Manager (LCSM) will determine the frequency of site visits. Closeout visits will take 
place after the last visit of the last subject. 
 
16.4 
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. 
 
16.5 
Clinical Trial Results 
The Investigator will notify the accredited ethics committee of the end of the study as required by 
the ethics committee. The end of the study is defined as database lock. In case the study is ended 
prematurely, the Investigator will notify the accredited ethics committee, including the reasons for 
the premature termination. Within 1 year after the end of the study, the Investigator/sponsor will 

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submit a final study report with the results of the study, including any publications/abstracts of the 
study, to the accredited ethics committee as required. 
 
16.6 
Publication of the Clinical Trial 
Any information other than that which is disclosed upon registration should not be discussed with 
persons outside the study. The protocol, study data, and information related to the study or to 
Alcon’s products or research programs that is provided by Alcon (Confidential Information) is to 
be kept confidential, and not disclosed directly or indirectly to any third party other than those 
involved in the study who has a need to know. 
 
All data and discoveries arising out of the study, patentable or non-patentable, shall be the sole 
property of Alcon, Inc. Alcon reserves the right of prior review of any publication or presentation 
of information related to the study. Alcon may use these data now and in the future for 
presentation or publication at Alcon’s discretion or for submission to government regulatory 
agencies. 
 
The existence of this clinical study is confidential and should not be discussed with persons 
outside of the study. You shall hold confidential, and not disclose directly or indirectly to any third 
party other than those persons involved in the study who have a need to know, the protocol, the 
data arising out of the study, and any other information related to the study or to Alcon’s products 
or a research program that is provided by Alcon to you (the “Confidential Information”). All such 
persons must be instructed not to further disseminate this information to others. You shall not use 
the Confidential Information for any purpose other than the study. 
 
The foregoing obligations of confidence and non-use assumed by you shall not apply to: (a) 
information which at the time of disclosure is in the public domain; (b) information which 
thereafter lawfully becomes part of the public domain other than through disclosure by or through 
you; (c) information which, as evidenced by your written records, was known by you prior to 
Alcon’s disclosure; (d) information which is lawfully disclosed to you by a third party not under 
any obligation of confidence to Alcon; or (e) information which is required to be disclosed by law 
or government regulatory agency, provided reasonable advance notice of such disclosure is given 
to Alcon. 
 
In signing this protocol, you agree to the release of the data from this study and acknowledge the 
above confidentiality and publication policy. The provisions of this Statement shall survive the 
completion of the study. 

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17 
REFERENCES 
Boettner EA, Wolter JR. Transmission of the Ocular Media. IOVS. 1962; 1:776-83. 
 
García-Pérez JL, Gros-Otero J, Sánchez-Ramos C, Blázquez V, Contreras I. Short term visual 
outcomes of a new trifocal intraocular lens. BMC Ophthalmol 2017;17(1):72. 
 
ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical 
practice. 
 
ISO 11979-1:2012 Ophthalmic implants – intraocular lenses – part 1: vocabulary 
 
ISO 11979-7:2014 Ophthalmic implants – intraocular lenses – part 7: clinical investigations 
 
ISO 11979-9:2014 Ophthalmic implants – intraocular lenses – part 9: multifocal intraocular 
lenses 
 
Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) 
Working Group. Standardization of Uveitis Nomenclature for Reporint Clinical Data. Results of 
the First International Workshop. Am J Ophthalmol. 2005; 140(3):509–516. 
 
Kohnen, T. First implantation of a diffractive quadrafocal (trifocal) intraocular lens. J Cataract 
Refract Surg. 2015;41(10):2330-2. 
 
Lawless M, Hodge C, Reich J, Levitz L, Bhatt UK, McAlinden C, Roberts K, Roberts TV. Visual 
and refractive outcomes following implantation of a new trifocal intraocular lens. Eye Vis (Lond). 
2017; 4:10. 
 

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Date/Time 
(mm/dd/yyyy GMT): 
Signed by: 
Justification: 
03/26/2018 20:11:16 
03/26/2018 23:53:32 
03/27/2018 06:16:13 
03/27/2018 20:22:27