Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal IOLs
Phase: NA
Conditions: Cataracts
Sponsor: Alcon Research

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Clinical Trial Protocol
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Protocol Number: 
Sponsor Name & Address:
Project Name / Number:
Test Article(s) / Product(s):
Release Date:
Investigator Agreement:
ILH297-P0031&7
Alcon Research, Ltd. and its affiliates (“Alcon”)
6201South Freeway
Fort Worth, Texas  76134-2099
PanOptix Comparative Study / A02622
ACRYSOF®IQ PanOptix™ Presbyopia-Correcting 
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:
Signature
Date
Principal Investigator Name:
Principal Investigator Address:
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Financial Disclosure 
for US FDA 
Submission Required?
Yes
X No
Test Article(s) / 
Product(s):
The ACRYSOF IQ PanOptix Presbyopia-Correcting 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 multifocal optic 
diffractive structure is in the central 4.5 mm portion of the anterior 
surface of the optical zone and divides the incoming light to create a 
+2.17 D intermediate and a +3.25 D near add power (IOL plane). 
The anterior surface is designed with 0.10 microns of negative 
spherical aberration to compensate for the positive spherical 
aberration of the average human cornea.
This IOL is intended for primary implantation in the capsular bag in 
the posterior chamber for the visual correction of aphakia secondary 
to removal of a cataractous lens in adult patients with and without 
presbyopia, who desire near, intermediate and distance vision with 
increased spectacle independence.
Objective(s):
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To demonstrate QRQLQIHULRULW\ of ACRYSOF IQ PanOptix
presbyopia-correcting IOL Model TFNT00 to the AT LISA tri IOL 
Model 839MP in mean photopic binocular uncorrected 
LQWHUPHGLDWH (60 cm) visual acuity at Visit 4A 
6HFRQGDU\2EMHFWLYHV
1. To demonstrate VXSHULRULW\ of ACRYSOF IQ PanOptix IOL 
versus the AT LISA tri IOL Model 839MP in mean photopic 
binocular uncorrected LQWHUPHGLDWH (60 cm) visual acuity at 
Visit 4A 
2. To demonstrate QRQLQIHULRULW\ of ACRYSOF IQ PanOptix IOL 
versus the AT LISA tri IOL Model 839MP in mean photopic 
binocular uncorrected GLVWDQFH(4 m) visual acuity at Visit 4A
3. To demonstrate QRQLQIHULRULW\ of ACRYSOF IQ PanOptix IOL 
versus the AT LISA tri IOL Model 839MP in mean photopic 
binocular uncorrected QHDU (40 cm) visual acuity at Visit 4A
4. To demonstrate VXSHULRULW\ of ACRYSOF IQ PanOptix IOL 
versus the AT LISA tri IOL Model 839MP in mean photopic 
binocular uncorrected QHDU (40 cm) visual acuity at Visit 4A.
5. To demonstrate VXSHULRULW\ of ACRYSOF IQ PanOptix IOL 
versus the AT LISA tri IOL Model 839MP in mean photopic 
binocular uncorrected GLVWDQFH (4 m) visual acuity at Visit 4A
6. To FKDUDFWHUL]H the binocular defocus curve profiles, contrast 
sensitivity and patient satisfaction with  ACRYSOF IQ PanOptix 
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IOL versus the AT LISA tri IOL Model 839MP at Visit 4A
Clinical Trial Design: This study is a prospective, multi-center, randomized, double 
masked, parallel group postmarket trial.
No. of Subjects:
a) Required for statistical analysis: 152 evaluable completers
b) Successfully screened: Approximately 180
c) Bilaterally Implanted: Approximately 160 
Region(s):
Asia, EU, LACAR
Clinical Trial 
Duration:
a) Total expected duration of the clinical investigation: 13 months
b) Expected duration of each subject's participation: ~7 months 
c) Planned follow up duration: 6-months post 2nd eye implantation
d) Estimated time needed to select the number of subjects (ie, 
enrollment period): 6 months
Clinical Trial 
Population:
Adults subjects, 22 years of age or older, with no ocular pathology 
that confound study outcomes, who require cataract extraction by 
phacoemulsification and desire an IOL that provides the potential for 
near, intermediate and distance vision.
Treatments:
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ACRYSOF IQ PanOptix Presbyopia-
Correcting IOL Model TFNT00
Administration:
Routine small incision cataract surgery with 
IOL implantation.
General Description: A range of commonly utilized spherical 
powers (diopters) will be available.
Duration of 
Treatment:
Intraocular lenses are implantable medical 
devices and are intended for long term use 
over the lifetime of the cataract subject.
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AT LISA tri IOL Model 839MP
Administration:
Routine small incision cataract surgery with 
IOL implantation.
General Description: A range of commonly utilized spherical 
powers (diopters) will be available.
Duration of 
Treatment:
Intraocular lenses are implantable medical 
devices and are intended for long term use 
over the lifetime of the cataract subject.
Inclusion & Exclusion 
Criteria:
Details can be found in Section 10: Subject Population
Performance
Assessments
Intermediate Visual Acuity
x
x
Binocular uncorrected intermediate VA (60 cm)
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Distance Visual Acuity
x
x
Binocular uncorrected distance VA (4 m)
Near Visual Acuity (VA)
x
x
Binocular uncorrected near VA (40 cm)
Safety
Assessments
Adverse Events (AEs) including secondary surgical intervention (SSI)
Device Deficiencies (DD)
Surgical Problems
Intraocular Pressure (IOP)
Slit Lamp Examination 
IOL Observations
IOL Position Change
Subjective Posterior Capsule Opacification (PCO)
Posterior Capsulotomy
Fundus Visualization 
Dilated Fundus Examination
Other
Assessments
Photopic Pupil Size
Binocular Uncorrected Defocus Curve
Binocular Contrast Sensitivity
x
Photopic without Glare
x
Photopic with Glare
x
Mesopic without Glare
x
Mesopic with Glare
Subject Satisfaction
Planned 
Analyses:
Analyses:
A total of six hypothesis tests will be conducted to address the primary 
and secondary objectives of the study. The primary, second secondary
and third secondary will be tests of non-inferiority while the first 
secondary, fourth secondary and fifth secondary will be tests of 
superiority.
Non-inferiority, with a non-inferiority margin of 0.1 logMAR, will be 
tested for the mean binocular uncorrected photopic visual acuity at each 
of the following distances, respectively:
x
Intermediate (60 cm) (primary)
x
Distance (4 m) (second secondary)
x
Near (40 cm) (third secondary)
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Superiority will be tested for the mean binocular uncorrected photopic 
visual acuity at each of the following distances, respectively:
x
Intermediate (60 cm) (first secondary)
x
Near (40 cm) (fourth secondary)
x
Distance (4 m) (fifth secondary)
Hypothesis testing will be conducted in the order presented above for 
both non-inferiority and superiority. A combination of gate-keeping and 
Bonferroni adjustment strategies will be employed to control the overall 
type I error rate. 
Descriptive statistics generated for safety and performance parameters 
will be based upon the type of parameter (ie, whether the data are 
categorical or continuous) being analyzed and by 1st and 2nd operative 
eyes for monocular measures. For categorical parameters, the statistics 
used to summarize the data descriptively include sample size, number in 
the category, and percent in the category. For continuous parameters, 
sample size, mean, median, standard deviation, minimum, and 
maximum will be presented.
Summaries of logMAR visual acuity will also include two-sided 90% 
confidence intervals.
 
 
Responses to the satisfaction question will be analyzed as a categorical 
variable. Contrast sensitivity will be scored and analyzed per CSV-
1000E instructions.
Defocus curves will be generated for binocular defocus data, including 
90% confidence intervals, with amount of defocus along the x-axis and 
logMAR VA at each defocus point along the y-axis. To examine the 
inter-site variation in outcome, a forest plot will be produced by plotting 
the difference in means and associated standard error for each site.
An interim analysis will be performed when all subjects complete Visit 
3A (20-40 days post 2nd eye implantation) in order to support the study 
publication plan of the test articles for near, intermediate and distance 
visual acuity, contrast sensitivity, defocus curves and adverse events.
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The interim analysis results will be distributed to a limited audience to 
limit potential bias in Visit 4A assessments. The clinical trial team with 
the exception of the Brand Lead will be masked to the interim analysis 
results.
Sample Size 
Justification
Sample size estimations are based on minimum sample size needed to 
achieve 90% power for all hypothesis tests. A type I error rate of 2.5%, 
one-sided, is used for calculations to account for simultaneous testing in 
first and second secondary hypotheses.
Assuming a dropout rate of 5%, approximately 160 subjects will be 
bilaterally implanted in 1:1 allocation ratio (test: control) to achieve at 
least 152 subjects who complete the study. With 152 subjects (76 per 
group) there is 98% probability that an upper one-sided 97.5% 
confidence limit on the difference (test-control) in visual acuity will be 
less than 0.1 logMAR, assuming the mean difference of 0.0 logMAR 
and a common standard deviation of 0.16 logMAR, the maximum 
observed for binocular uncorrected distance, intermediate and near 
visual acuity in a previous Alcon study (C-06-40, ReSTOR +3.0 D 
IOL).
Also, with 76 subjects per group, there is more than 90% power to 
detect a difference of 0.09 logMAR (4.5 letters) between means in a two 
sample t-test conducted at a 2.5% chance of a Type I error and assuming 
a standard deviation of 0.16 logMAR for binocular uncorrected 
distance, intermediate and near visual acuity.
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1
PROTOCOL SYNOPSIS........................................................................................2
2
TABLE OF CONTENTS........................................................................................7
List of Tables............................................................................................................................10
List of Figures..........................................................................................................................10
3
ABBREVIATIONS...............................................................................................11
4
GLOSSARY OF TERMS .....................................................................................13
15
15
6
SCHEDULE OF VISITS......................................................................................16
7
INTRODUCTION................................................................................................21
7.1
Background.......................................................................................................21
7.2
Clinical Trial Design.........................................................................................21
8
CLINICAL TRIAL OBJECTIVES.......................................................................23
8.1
Primary Objective.............................................................................................23
8.2
Secondary Objectives .......................................................................................23
8.3
Exploratory Objectives.....................................................................................23
8.4
Study Endpoints................................................................................................24
8.4.1
Effectiveness Endpoints ...............................................................................24
8.4.2
Safety Endpoints...........................................................................................25
9
INVESTIGATIONAL PLAN ...............................................................................26
9.1
Outline of Clinical Trial....................................................................................26
9.2
Study Design ....................................................................................................26
9.3
Rationale for Study Design ..............................................................................26
9.4
Procedures per Study Visit ...............................................................................27
9.5
Risk Benefit Assessment ..................................................................................27
9.5.1
Known and Potential Risks ..........................................................................27
9.5.2
Potential Benefits..........................................................................................27
9.5.3
Risk Benefit Assessment ..............................................................................28
10
SUBJECT POPULATION....................................................................................29
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10.1
Inclusion Criteria..............................................................................................29
10.2
Exclusion Criteria.............................................................................................30
10.3
Exclusion Criteria During Surgery...................................................................31
11
TREATMENT.......................................................................................................33
11.1
Investigational Products ...................................................................................33
11.2
Usage ................................................................................................................35
11.3
Accountability Procedures................................................................................35
11.3.1
Procurement..................................................................................................35
11.3.2
Labeling........................................................................................................35
11.3.3
Handling .......................................................................................................35
11.3.4
Dispensing ....................................................................................................36
11.3.5
Final Disposition ..........................................................................................36
12
CLINICAL TRIAL PROCEDURES ....................................................................37
12.1
Clinical Trial Assessments................................................................................37
12.1.1
Preoperative Visit (Visit 0) ...........................................................................37
12.1.2
Operative Visit (Visit 00/00A)......................................................................38
12.1.3
1-Day Postoperative Visit (Visit 1/1A).........................................................40
12.1.4
1-Week Postoperative Visit (Visit 2/2A) ......................................................41
12.1.5
1-Month Postoperative Visit (Visit 3A)........................................................42
12.1.6
6-Month Postoperative Visit (Visit 4A)........................................................44
12.2
Unscheduled Visits ...........................................................................................46
12.3
Missed Visits.....................................................................................................47
12.4
Discontinued Subjects ......................................................................................47
12.5
Clinical Trial Termination ................................................................................47
13
DEVICE DEFICIENCIES AND ADVERSE EVENTS.......................................49
13.1
General Information .........................................................................................49
13.2
Recording and Reporting Adverse Events and Device Deficiencies................52
13.3
Return product analysis ....................................................................................54
13.4
Unmasking of the Study Treatment..................................................................55
13.5
Follow-Up of Subjects with Adverse Events....................................................55
13.6
Pregnancy in the Clinical Trial.........................................................................55
14
DATA REVIEW AND HANDLING ....................................................................56
14.1
Completion of Source Documents and Case Report Forms.............................56
14.2
Data Review and Clarifications........................................................................56
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15
ANALYSIS PLAN ...............................................................................................58
15.1
Subject Evaluability..........................................................................................58
15.2
Analysis Data Sets............................................................................................58
15.3
Demographics and Baseline Characteristics ....................................................58
15.4
Performance Analyses ......................................................................................58
15.4.1
Primary Performance....................................................................................59
15.4.1.1
Statistical Hypotheses...............................................................................59
15.4.1.2
Analysis Methods .....................................................................................59
15.4.2
Secondary Performance................................................................................59
15.4.2.1
Statistical Hypotheses...............................................................................60
15.4.2.2
Analysis Methods .....................................................................................61
62
62
62
15.5
Handling of Missing Data ................................................................................62
15.6
Multiplicity.......................................................................................................62
15.7
Safety Analysis .................................................................................................63
15.8
Interim Analyses...............................................................................................64
15.9
Adaptive Study Design.....................................................................................64
15.10
Sample Size Justification..................................................................................65
16
ADMINISTRATIVE PROCEDURES..................................................................66
16.1
Regulatory and Ethical Compliance.................................................................66
16.2
Informed Consent Procedures ..........................................................................66
16.3
Responsibilities of the Investigator and IRB/IEC ............................................66
16.4
Sponsor and Monitoring Responsibilities ........................................................67
16.5
Regulatory Documentation and Records Retention .........................................67
16.6
Clinical Trial Results ........................................................................................67
16.7
Publication of the Clinical Trial .......................................................................68
17
REFERENCES .....................................................................................................70
71
71
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Figure .7–1
Study Design....................................................................................................22
Figure. 13–1 Categorization of All Adverse Events ................................................................51
Figure. 13–2 Categorization of All Serious Adverse Events ...................................................51
Figure .15–1
Multiple Testing Strategy.................................................................................63
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AAS
All implanted analysis set
ADE
Adverse device effect
AE
Adverse event
ASADE
Anticipated serious adverse device effect
BAS
Best case analysis set
CE
&onformité Européene
CFR
Code of Federal Regulations
CJD
Creutzfeldt-Jacob disease
cm
Centimeter
CM
Clinical Manager
CRF
Case report form
CSM
Clinical site management
D
Diopter
DD
Device deficiency
DFU
Directions for use
EDC
Electronic data capture
EU
Europe
GCP
Good Clinical Practice
HIV
Human immunodeficiency virus 
ICH
International Conference on Harmonization
IEC
Independent ethics committee
IRB
Institutional review board
IOL
Intraocular lens
IOP
Intraocular pressure
ISO
International Organization for Standardization
MOP
Manual of procedures
LASIK
Laser-assisted in-situ keratomileusis
LCSM
Lead Clinical Site Manager
logMAR
Logarithm of minimum angle of resolution
m
Meter
MedDRA®
Medical Dictionary for Regulatory Activities
mm
Millimeter
PCO
Posterior capsule opacification
PI
Principal Investigator
PP
Per protocol
SADE
Serious adverse device effect
SAE
Serious adverse event
SAS®
SAS statistical software, SAS Institute Inc., Cary, NC
SOP
Standard operating procedures
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SS
Safety set
SSI
Secondary surgical intervention
UCDVA
Uncorrected distance visual acuity
UCIVA
Uncorrected intermediate visual acuity
UCNVA
Uncorrected Near Visual Acuity
UNSV
Unscheduled visit
USADE
Unanticipated serious adverse device effect
VA
Visual acuity
WHO
World Health Organization
YAG
Yttrium aluminum garnet
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Adverse Device 
Effect (ADE)
Adverse event related to the use of an investigational medical device 
or comparator, if applicable. 1RWH7KLVGHILQLWLRQLQFOXGHVDGYHUVH
HYHQWVUHVXOWLQJIURPLQVXIILFLHQWRULQDGHTXDWHLQVWUXFWLRQVIRUXVH
GHSOR\PHQWLPSODQWDWLRQLQVWDOODWLRQRURSHUDWLRQDQ\
PDOIXQFWLRQDQGXVHHUURURULQWHQWLRQDOPLVXVHRIWKH
LQYHVWLJDWLRQDOPHGLFDOGHYLFHRUFRPSDUDWRULIDSSOLFDEOH
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. 
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. 1RWH7KLVGHILQLWLRQ
LQFOXGHVPDOIXQFWLRQVXVHHUURUVDQGLQDGHTXDWHODEHOLQJ
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 a device to meet its performance specifications or 
otherwise perform as intended. Performance specifications include all
claims made in the labeling of the device. The intended performance 
of the device refers to the intended use for which the device is labeled 
or marketed.
Nonserious 
Adverse Event
Any 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.
Randomization 
Number
A unique identifier assigned to each randomized subject, 
corresponding to a specific treatment arm assignment.
Serious Adverse 
Device Effect 
(SADE)
A serious adverse device effect (SADE) is an ADE that has resulted 
in any of the consequences characteristic of a SAE.
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Serious Adverse 
Event (SAE)
Adverse event that led to any of the following: 
x
Death.
x
A serious deterioration in health that either resulted in:
a) A life-threatening illness
b) Permanent impairment of a body function or permanent 
damage to a body structure
c) A condition necessitating medical or surgical intervention to 
prevent a) or b)
d) A condition that requires hospitalization or significant 
prolongation of existing hospitalization
e) Any indirect harm as a consequence of incorrect diagnostic 
test results when used within manufacturer's instructions for 
use.
x
Fetal distress, fetal death, or a congenital abnormality or birth 
defect.
Subject Number
A number assigned to each subject who enrolls in the study. When 
combined with the site number, a unique identifier is created for each 
subject in the study.
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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Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments will be created by the Sponsor and must be approved 
by the IRB/IEC prior to implementation except when required to mitigate immediate safety 
risks or when the changes involve only logistical or administrative revisions.
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Preoperative
Day 0
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1-2 Day Post 
1st Eye Implantation
7-14 Days Post 
1st Eye Implantation
2-21 Days Post
Visit 00
2nd Eye Implantation
1-2 Day Post 
2nd Eye Implantation
7-14 Days Post 
2nd Eye Implantation
20-40 Days Post
2nd Eye Implantation
120-180 Days Post
2nd Eye Implantation
N/A
Informed Consent
X
Demographics
X
Medical History
X
Concomitant 
Medication
X
X
X
X
X
X
X
X
X
X
Urine Pregnancy 
Test3,4
X
Inclusion/Exclusion
X
X
X
Randomization
X
Surgery/Treatment
X
X
Report Implanted 
Lens Model
X
X
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Day 0
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1-2 Day Post 
1st Eye Implantation
7-14 Days Post 
1st Eye Implantation
2-21 Days Post
Visit 00
2nd Eye Implantation
1-2 Day Post 
2nd Eye Implantation
7-14 Days Post 
2nd Eye Implantation
20-40 Days Post
2nd Eye Implantation
120-180 Days Post
2nd Eye Implantation
N/A
Surgical Report
(Including: lens power, 
implant success, target 
refractive error6, and 
success of 
implantation)
X
X
Problems During 
Surgery
X
X
Other Surgical 
Procedures
X
X
Patient Satisfaction
X
Distance VA (4 m)
x
Monocular 
Uncorrected
X
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1-2 Day Post 
1st Eye Implantation
7-14 Days Post 
1st Eye Implantation
2-21 Days Post
Visit 00
2nd Eye Implantation
1-2 Day Post 
2nd Eye Implantation
7-14 Days Post 
2nd Eye Implantation
20-40 Days Post
2nd Eye Implantation
120-180 Days Post
2nd Eye Implantation
N/A
x
Binocular 
Uncorrected
X
X
Near VA (40 cm)
x
Binocular 
Uncorrected
X
X
Intermediate VA
(60cm)
x
Binocular 
Uncorrected
X
X
Defocus Curve 
(Binocular)
X
X
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1-2 Day Post 
1st Eye Implantation
7-14 Days Post 
1st Eye Implantation
2-21 Days Post
Visit 00
2nd Eye Implantation
1-2 Day Post 
2nd Eye Implantation
7-14 Days Post 
2nd Eye Implantation
20-40 Days Post
2nd Eye Implantation
120-180 Days Post
2nd Eye Implantation
N/A
Contrast Sensitivity
(Binocular)
x
Mesopic
without Glare
X
X
x
Mesopic with 
Glare
X
X
x
Photopic 
without Glare
X
X
x
Photopic with 
Glare
X
X
Slit-Lamp Examination
(Including IOL 
Observations)
X
X
X
X
X
X
X
X
IOL Position Change
X
X
X
X
X
X
X
Subjective PCO
X
X
X
X
X
X
X
Posterior Capsulotomy
(Report if performed)
X
X
X
X
X
X
X
Fundus Visualization
X
X
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1-2 Day Post 
1st Eye Implantation
7-14 Days Post 
1st Eye Implantation
2-21 Days Post
Visit 00
2nd Eye Implantation
1-2 Day Post 
2nd Eye Implantation
7-14 Days Post 
2nd Eye Implantation
20-40 Days Post
2nd Eye Implantation
120-180 Days Post
2nd Eye Implantation
N/A
Dilated Fundus 
Examination
X
X
X
X
IOP
X
X
X
X
X
X
X
X
Adverse Events
(Including SSI)
X
X
X
X
X
X
X
X
X
X
Device Deficiencies
X
X
X
X
X
X
X
X
X
1 If a subject exits early, the Visit 4A procedures should be performed at the last available visit, if at all possible.
2 UNSV assessments listed are recommended. Only complete assessments required per the PI medical judgment. 
3 Women of child-bearing potential only
5 Within 10 business days of treatment (Visit 00).
6 Data is reported in EDC at the surgical visit, but may be collected at a previous visit. 
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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 patient’s distance vision. However, many pseudophakic patients 
implanted with monofocal IOLs ultimately require reading glasses to compensate for the loss 
of the ability to see clear at intermediate or near distances (presbyopia). Several IOL designs 
for treating presbyopia in pseudophakic patients exist in modern day clinical practice, 
including the use of multifocal IOLs. Multifocal IOLs offer the patient an opportunity to have 
the effects of presbyopia corrected after cataract surgery by providing multiple focal points. 
The majority of commercially available multifocal IOLs have two optical zones – one that 
provides distance vision and a second that provides near vision. The ACRYSOF IQ PanOptix 
Presbyopia IOL Model TFNT00 test IOL (hereto referenced as TFNT00) and the AT LISA tri 
IOL model 839MP control IOL (hereto referenced as 839MP) improve on commercially 
available multifocal IOLs by creating an additional focal point for intermediate vision.
The TFNT00 IOL has a trifocal design and provides a near focal point at 40 cm and distance 
vision similar to the currently marketed ACRYSOF IQ ReSTOR +3.0 D IOL Model 
SN6AD1, and it has the additional benefit to patients of an intermediate focal point at 60 cm. 
The TFNT00 IOL has recently received a CE Mark in Europe and is also approved in other 
countries outside of the European Union.
Optical bench studies and modeling & simulation studies conducted by Alcon to support the 
CE mark for the TFNT00 IOL have demonstrated equivalence or superior performance to the
marketed trifocal 839MP IOL in simulated expected visual performance, namely VA at near 
(40cm), intermediate (60cm) and distance (4m). In addition, the studies predict equivalent or 
superior halo propensity and contrast sensitivity of the TFNT00 IOL to the 839MP IOL. 
The purpose of this study is to clinically qualify the bench studies and model predictions of 
visual performance of the TFNT00 IOL by demonstrating the non-inferiority in binocular 
visual performance to 839MP IOL and to characterize the low contrast performance and 
patient satisfaction with both IOLs.
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This study is a prospective, multi-center, postmarket trial comparing the visual function of 2 
presbyopia-correcting trifocal IOLs following bilateral implantation. Both trifocal IOLs are 
commercially available in the countries where the study is being conducted. The study will 
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include adults (22 years of age) who require bilateral cataract extraction and who desire an 
IOL that provides the potential for functional near, intermediate and distance vision. Potential 
subjects will be screened for enrollment into the trial. Those qualifying will attend a total of 9 
visits (6 postoperative) over a 7 month period. 
Post consent, the EDC system will assign the subject number. Within 10 business days of 
surgery, qualified subjects will be randomized to either the TFNT00 or 839MP IOL. 
Randomization is 1:1 test IOL (TFNT00) to control IOL (839MP). In order to reduce bias, the 
observer (ie, study technician assessing primary and secondary endpoint data) and the subject 
will remain masked to the treatment assignment.  The subject will remain masked for the 
duration of his/her trial participation, and will be provided with his/her permanent implant 
card upon study exit. 
An interim analysis of the data will be conducted upon the completion of Visit 3A (20-40 
days post 2nd eye implantation). Final data analysis will be conducted at study completion. 
An overview of the study design is depicted in Figure 7-1.
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The primary objective of this study is to demonstrate QRQLQIHULRULW\ of ACRYSOF IQ 
PanOptix presbyopia-correcting IOL (TFNT00) to the AT LISA tri IOL Model 839MP in 
mean photopic binocular uncorrected LQWHUPHGLDWH (60 cm) visual acuity (UCIVA) at Visit 
4A (120-180 days post 2nd eye implantation).
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The first secondary objective of this study is to demonstrate VXSHULRULW\ of the TFNT00 IOL 
versus the 839MP IOL in mean photopic binocular uncorrected LQWHUPHGLDWH (60 m) visual 
acuity (UCIVA) at Visit 4A (120-180 days post 2nd eye implantation).
The second secondary objective of this study is to demonstrate QRQLQIHULRULW\ of the 
TFNT00 IOL versus the 839MP IOL in mean photopic binocular uncorrected GLVWDQFH (4 m) 
visual acuity (UCDVA) at Visit 4A (120-180 days post 2nd eye implantation).   
The third secondary objective of this study is to demonstrate QRQLQIHULRULW\ of the TFNT00
IOL versus the 839MP IOL in mean photopic binocular uncorrected QHDU (40 cm) visual 
acuity (UCNVA) at Visit 4A (120-180 days post 2nd eye implantation).   
The fourth secondary objective of this study is to demonstrate VXSHULRULW\ of the TFNT00
IOL versus the 839MP IOL in mean photopic binocular uncorrected QHDU (40 cm) visual 
acuity (UCNVA) at Visit 4A (120-180 days post 2nd eye implantation).
The fifth secondary objective of this study is to demonstrate VXSHULRULW\ of the TFNT00 IOL 
versus the 839MP IOL in mean photopic binocular uncorrected GLVWDQFH (4 m) visual acuity 
(UCDVA) at Visit 4A (120-180 days post 2nd eye implantation).
The sixth secondary objective of this study is to FKDUDFWHUL]H the Binocular Defocus Curve 
profiles, contrast sensitivity and patient satisfaction with the TFNT00 IOL versus the 839MP
IOL at Visit 4A (120-180 days post 2nd eye implantation).    
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Primary, secondary, 
effectiveness endpoints are listed below. All endpoints 
pertain to 120-180 days post 2nd eye implantation (Visit 4A) unless otherwise noted.
Primary Effectiveness
x
Mean  binocular uncorrected intermediate VA (60 cm)
1RWH For non-inferiority testing
Secondary Effectiveness
x
Mean  binocular uncorrected intermediate VA (60 cm)  
1RWH For superiority testing
x
Mean  binocular uncorrected distance VA (4 m) 
x
Mean  binocular uncorrected near VA (40 cm) 
x
Mean photopic binocular defocus curve 
x
Mean photopic ZLWKRXW glare binocular distance contrast sensitivity 
x
Mean photopic ZLWK glare binocular distance contrast sensitivity 
x
Mean mesopic ZLWKRXW glare binocular distance contrast sensitivity 
x
Mean mesopic ZLWK glare binocular distance contrast sensitivity 
x
Subject satisfaction
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Safety endpoints are listed below.
x
Rates of ocular adverse events, including SSIs related to the optical properties for 
either eye
x
Adverse events 
x
Device deficiencies 
x
IOL observations 
x
Subjective PCO
x
Posterior Capsulotomies
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This is a prospective, randomized parallel group post market study in which masked subjects 
will be randomized to bilateral implantation of either a test IOL (TFNT00) or a control IOL 
(839MP) in a 1:1 fashion. In addition to the subject, the observer collecting primary and 
secondary effectiveness data including visual acuity, defocus curves, contrast sensitivity and 
patient satisfaction will be masked. 
Subjects participating in the trial will attend a total of 9 visits study visits over a 7 month 
period. Of these 9 visits, 1 is preoperative, 2 are operative and the remaining 6 are 
postoperative visits. Refer to Figure 7-1 above for a study outline diagram. Unscheduled 
visits may be attended if needed for medical attention. 
Primary endpoint data will be collected at the final visit, Visit 4A (120-180 days post 2nd eye 
implantation). An interim analysis summarizing the visual acuity, contrast sensitivity, defocus 
curves and AEs will be conducted when all subjects complete Visit 3A (20-40 days post 2nd
eye implantation) to support the study publication plan objectives.
Additional details, including a thorough risk-benefit assessment can be found in the sections
below. 
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This study is a prospective, multi-center, postmarket trial comparing the visual function of 2 
commercially available presbyopia-correcting trifocal IOLs following bilateral implantation. 
The study will include adults (22 years of age) who require bilateral cataract extraction and 
who desire an IOL that provides the potential for functional near, intermediate and distance 
vision. Potential subjects will be screened for enrollment into the trial. Those qualifying will 
attend a total of 9 visits (6 postoperative) over a 7 month period. 
An interim analysis of the data will be conducted upon the completion of Visit 3A (20-40 
days post 2nd eye implantation). Final data analysis will be conducted at study completion. 

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The purpose of this study is to clinically qualify the bench studies and model predictions of 
visual performance of the TFNT00 IOL by demonstrating the non-inferiority in binocular 
visual performance to 839MP IOL and to characterize the low contrast performance and 
patient satisfaction with both IOLs.
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Section 12 Clinical Trial Procedures contains procedures per study visits.
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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.). 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. 

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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 optical performance and spectacle 
independence similar to the ACRYSOF IQ ReSTOR +3.0 D Multifocal IOL (Model 
SN6AD1) at near range (40 cm) and distance, with the additional benefit of intermediate 
vision at 60 cm.
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Maxwell (2009) performed a randomized, parallel group, subject masked, multicenter 6 
month follow-up study comparing ACRYSOF IQ ReSTOR +3.0 D Add Power IOL (Model 
SN6AD1) to ACRYSOF ReSTOR +4.0 D Add Power IOL (Model SN6AD3). Both lenses 
were implanted bilaterally. The effectiveness results at 6 months showed mean uncorrected 
distance visual acuity of 20/20 and binocular defocus curves demonstrated 20/20 visual 
acuity at 40 cm. The Patient Reported Outcomes with the SN6AD1 IOL were very favorable 
with  reported spectacle independence rates in 76% of subjects in the ACRYSOF IQ ReSTOR 
+3.0 D Multifocal IOL (Model SN6AD1), high patient satisfaction, self-rated visual quality 
and substantial improvements in patient reported outcomes. 
The 839MP is a single-piece, trifocal diffractive IOL with a +3.33D near ADD and +1.66D 
intermediate ADD indicated to provide presbyopia correction in patients with or without 
cataract.  In a case series study comprised of 30 patients who had bilateral implantation of the 
839MP IOL after phacoemulsification for either cataract or refractive lens exchange surgery,
the effectiveness results at 6 months showed mean uncorrected distance visual acuity of close 
to 20/20 for mean uncorrected monocular and binocular visual acuity (Law 2014).  Similarly, 
binocular defocus demonstrated 20/30 visual acuity between distance and 33 cm. The 
majority of patients (77%) were satisfied with their distance, intermediate and near vision at 
the end of the follow up. Difficulties associated with photic phenomena (night vision, glare 
and halo perception) decreased significantly over time. 

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Based on the formal risk assessment, the TFNT00 IOL 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 and 
 when the TFNT00 IOL is used in 
cataract surgery. Potential risks following implantation of both the TFNT00 IOL and the 
839MP IOL (Law 2014) include visual disturbances such as glare and halos which are known 
risks for multifocal IOLs. The benefits of improved near and intermediate vision, 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 (Law 2014).
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The study population includes approximately 160 subjects to be bilaterally implanted at 
approximately 15 sites with approximately 10 subjects per site. Enrollment is anticipated to 
take approximately 6 months. 
1RWH Randomization of 10 subjects per site is a target recommendation.  No minimum or 
maximum requirement exists.  
To participate in the clinical trial, subjects must be  22 years of age with no ocular pathology 
that could confound study outcomes, must require clear cornea cataract extraction in both 
eyes, and must desire an IOL that provides the potential for near, intermediate and distance 
vision. 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 post randomization and prior to 1st 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 -60 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. If subject reschedules surgery after randomization, proceed with the
original randomized treatment (ie, do not attempt to re-randomize and do not attempt to
assign a new subject number).
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Below is a list of inclusion criteria. Ocular criteria must be met in both eyes with exception to 
criterion 4 below.
1. Adults, 22 years of age or older at the time of surgery, of either gender or any race,
diagnosed with bilateral cataracts with planned clear cornea cataract removal
2. Able to comprehend and willing to sign informed consent and complete all required 
postoperative follow-up procedures
3. Calculated lens power between 13.0 and 30.0 D
4.
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5.
 
1RWH Subjects with any pathology that could reduce visual potential should not be 
enrolled in this trial
6. Preoperative regular corneal astigmatism of < 1.00 D, in both eyes
7. Clear intraocular media other than cataract in both eyes

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Below is a list of exclusion criteria. Ocular criteria must be met in both eyes. 
1. Subjects who may reasonably be expected to require an ocular surgical treatment at 
any time during the study (other than YAG capsulotomy)
2. Previous refractive surgery or planned refractive surgery procedures throughout the 
entire duration of the subjects’ participation in the clinical study (including, but not 
limited to LASIK, astigmatic keratotomy and limbal relaxing incisions);
3. Clinically significant corneal abnormalities including corneal dystrophy (eg, 
epithelial, stromal, or endothelial dystrophy), inflammation or edema per the 
Investigator’s expert medical opinion.
Note: conditions including, but not limited to: keratitis, keratoconjunctivitis, 
keratouveitis, keratopathy, or keratectasia should be excluded
4. Amblyopia
5. Previous corneal transplant
6. Extremely shallow anterior chamber ( 2.5 mm), not due to swollen cataract
7. Any recurrent severe anterior or posterior segment inflammation of any etiology, and 
/or history of any disease producing an intraocular inflammatory reaction
8. Rubella, congenital, traumatic, or complicated cataracts
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9. Situations where the need for a large capsulotomy can be anticipated (eg, diabetics,
retinal detachment in the fellow eye, peripheral retinal pathology, etc.)
10. Iris neovascularization
11. Glaucoma (uncontrolled or controlled with medication) 
12. Subjects with diagnosed degenerative eye disorders
13. 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 
1RWH Including but not limited to background diabetic retinopathy, diabetic macular 
edema or proliferative diabetic retinopathy, macular degeneration
14. Optic nerve atrophy
15. Subjects who are expected to require retinal laser treatment.
16. Known color vision deficiencies
17. Pregnancy or lactation current or planned during the course of the study
18. Any subject currently participating in another investigational drug or device study that
may confound the results of this investigation
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Below is a list of criteria that when occurring prior to IOL implantation prevent the study lens 
from being implanted.  This is true for both eyes.  
19. 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, vitreous loss, zonular dehiscence that may make 
the IOL implant less stable, etc.)
20. Uncontrolled intraocular pressure
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21. Significant anterior chamber bleeding
22. Excessive iris mobility
23. Mechanical or surgical manipulation required to enlarge the pupil prior to or at IOL
implantation (pupil size must be at least 4.5 mm or larger just prior to implantation)
24. Capsulorhexis tears or any areas of “can-opener” capsulotomy
25. Unrecognized (pre-existing but discovered during surgery) ocular conditions or
complications in which the IOL stability could be compromised, including zonular
weakness
26. Zonular or Capsule rupture
27. Intended IOL haptic placement other than bag-bag
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75($70(17
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. 
Within 10 business days of surgery, subjects will be randomized in a 1:1 manner to receive 
treatment with either the test or control IOL. Throughout the clinical trial, the Investigator 
will be responsible for the accounting of all investigational products and will ensure that the 
clinical trial products are used in accordance with the manufacturer’s DFU.

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Test Article: ACRYSOF IQ PanOptix Presbyopia-Correcting IOL Model TFNT00
The TFNT00 IOL is a CE Marked device that is commercially available in the countries of 
the participating Investigators as well as 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 two 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 negative spherical aberration to 
compensate for the positive spherical aberration of the cornea. 
The lens is available in a diopter range of 13.0 – 30.0 D in 0.5 D increments and 31.0 D –
34.0 D in 1.0 D increments. The manufacturer suggested A-constant for optical biometry 
equipment is 119.1. 
1RWH Subjects in this study required a lens power between DQG'. While available, 
IOLs out of this power range will not be utilized for this study. 
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Each IOL will be individually packaged and will have a unique serial number. The IOL 
package will contain the following items:
x
The IOL;
x
A subject registration card (Lens Implant Card);
x
A subject identification card;
x
Adhesive labels containing the IOL information and unique serial number; and
x
A package insert containing directions for use.
More information on the test article can be found in the Package Insert/Directions for Use 
(DFU).
The 839MP IOL is a CE Marked device approved for use and commercially available in the 
countries with participating Investigators as well as other countries across the globe. 
The lens is a foldable multifocal IOL made from 25% hydrophilic acrylic material with 
hydrophobic surface properties.  The lens has a total diameter of 11.0 mm with 360o square 
edge and can be inserted through a corneal incision 1.8 mm. The IOL is a single-piece 
design with a central optic and 4 haptics with 0o angulation. The optic is 6.0 mm in diameter 
with a diffractive structure in the central 4.3 mm portion of the optic zone. The diffractive 
structure divides the incoming light to create a +1.66 D intermediate and a +3.33 D near add 
power. The posterior surface is designed with negative spherical aberration (-0.18) to 
compensate for the positive spherical aberration of the cornea.
The lens is available in a diopter range of 0.0 – 32.0 D in 0.5 D increments. The manufacturer 
suggested A-constant for optical biometry equipment is 118.6. 
1RWH Subjects in this study required a lens power between DQG'. While available, 
IOLs out of this power range will not be utilized for this study. 
Each IOL will be individually packaged and will have a unique serial number. The IOL 
package will contain the following items:
x
The IOL;
x
A subject registration card (Lens Implant Card);
x
A subject identification card;
x
Adhesive labels containing the IOL information and unique serial number; and
x
A package insert containing directions for use.
More information on the test article can be found in the Package Insert/DFU.
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24-Feb-2016

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Other national regulations for labeling may apply for studies conducted outside the United 
States or for studies using previously approved products.

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Intraocular lenses are implantable medical devices and are intended for long term use over 
the lifetime of the pseudophakic subject. Lenses utilized in this trial are intended for 
presbyopic correction allowing the pseudophakic subject to see across a range of distances 
with foci at near, intermediate and far distances. See Section 111 Investigational Products for 
details related to near and intermediate add power specific to each lens. 
In order to implant the test and control articles, the surgeons participating in the study must 
be licensed ophthalmologists with cataract surgery experience. Each surgeon will use his/her
standard of care to implant the lens following respective Package Insert/DFU instructions for 
each device. 

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The Investigator will procure ERWK investigational products (test and control lenses). Details 
related to the procurement, labeling, handling, dispensing and final disposition are outlined 
below. The product must be tracked/accounted for through all steps of the procedure.  

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The Investigator shall locally procure each product (test lens and control lens) through his/her 
standard commercial channel. 

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Product is locally procured via commercial channel and will arrive in country compliant 
commercial packaging with commercial label. 

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Once designated for trial use, product will be stored in a safe, secure location with limited 
access separated from general stock. Transportation of product from one address to another 
must be documented and a Transportation Log (or similar documentation) utilized for 
appropriate accountability. 
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The Investigator is to keep a current record of the dispensing of all test articles. This record 
will be made available to the Sponsor’s monitor to account for all test articles. Any 
discrepancy and/or deficiency must be recorded, with an explanation.

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At the conclusion of the trial, remaining product may be returned to the Investigator’s general 
stock.
1RWH Return deficient product to the manufacturer following the each manufacturer’s 
respective complaint process. Refer to Section 13.3 for further details on the return process
for Alcon product. Additionally, the investigator must follow any recalls from the 
distributor/manufacturer.
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The following section outlines the assessments to be performed in this clinical trial. 
Assessments are described in detail in the ILH297-P003 Manual of Procedures (hereto 
referred to as the MOP), and are outlined in tabular format in Section 6 of this protocol.

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Below is a list of study procedures to be undertaken 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 forms (if 
applicable). 
Data from the Investigator’s previous routine clinical evaluation (eg, slit lamp exam) may be 
used, if the data 1) meet the requirements of this protocol and MOP, and 2) were collected 
within the -60 to 0 day preoperative time period.
1. 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.
2. For a potential subject meeting all entry criteria via pre-screening, invite him/her to 
participate in the study, and carry out the informed consent process if he/she is interested. 
Refer to Section 16.2 Informed Consent Procedures.
1RWH Subjects must formally consent to the trial prior to any study specific testing.
3. Document demographics, ocular and non-ocular medical history, ocular and non-ocular
concomitant medications and pregnancy status (where applicable).
4. Perform a urine pregnancy test, IF the subject is a woman of childbearing potential.
5.
 
6.
 
 
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7. Document the target residual refractive error based the IOL calculation power. 
[Both Eyes, Bilateral]
8.
9.
10. Conduct slit lamp examination.
[Both Eyes, Bilateral]
11. Conduct dilated fundus examination.
[Both Eyes, Bilateral]
12. Perform tonometry to measure IOP.
[Both Eyes, Bilateral]
13. Record any AEs. Refer to Section 13 for further detail.
14. Evaluate subject against all entry criteria. If subject fails criteria screen fail the subject. 
15.
 
 
 
 
16. Proceed with scheduling surgery. 

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Below is a list of study procedures to be undertaken at Visit 00 and Visit 00A. It is 
recommended that procedures are performed in the order described below unless otherwise 
stated. Activities involving multiple delegated staff members may be performed in parallel. 
All assessments must be documented in source documentation and case report forms (if 
applicable).
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1RWH the Visit 00A window may overlap with other study visit windows (eg, Visit 1, Visit 2).  
In this case, both visits may be conducted on the same day at the discretion of the 
Investigator.
1. In preparation for the operative visit, randomize the subject. Randomization should be 
performed within 10 business days of Visit 00. It is recommended that subjects are 
contacted prior to randomization to 1) confirm willingness to continue trial participation, 
and 2) confirm scheduled surgical date and time.
2. Prior to treatment, review inclusion/exclusion criteria and ensure the subject has been 
properly consented for participation in the trial.
3. Document any changes to ocular and non-ocular concomitant medications.
4. Record operative eye.
5. Prepare subject for surgery in accordance to site specific operating procedures.
[Operative Eye Only, Monocular]
6. Perform surgery and implantation with the randomized IOL.
[Operative Eye Only, Monocular]
7. Record any surgical problems, complications, or other procedures that occur during
surgery. Other procedures include those performed outside of routine cataract surgery.
1RWH Other planned procedures at the time of surgery are exclusionary.
[Operative Eye Only, Monocular]
8. Record the lens information that is located on the IOL sticker. Both successful and 
aborted (if applicable) test article information should be recorded.
[Operative Eye Only, Monocular]
9. Record any adverse events 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 for further detail. 
10. Record any device deficiencies. Refer to Section 13 for further detail. 
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Below is a list of study procedures to be undertaken at Visit 1 and Visit 1A. 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 forms 
(if applicable).
1. Record changes in medical/ocular history and ocular and non-ocular concomitant 
medications.
2. Perform slit lamp examination of the anterior segment. Include documentation of IOL 
observations, if any. 
[Operative Eye Only, Monocular]
3. Observe any IOL position changes (ie, tilt and decentration) occurring since the previous 
visit.
[Operative Eye Only, Monocular]
4. Assess subjective PCO, and record information for any posterior capsulotomy that has 
occurred since surgery, if applicable.
[Operative Eye Only, Monocular]
5. Perform tonometry to measure the IOP.
[Operative Eye Only, Monocular]
6. Record any AEs including SSIs.
1RWH SAEs including SSIs must be entered into EDC within 24 hours of the 
Investigator’s knowledge.  Refer to Section 13 for further detail. 
7. Record any device deficiencies. Refer to Section 13 for further detail.
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Below is a list of study procedures to be undertaken at Visit 2 and Visit 2A. 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 forms 
(if applicable).
1. Record changes in medical/ocular history and ocular and non-ocular concomitant 
medications.
2.
3.
 
4.
 
5.
 
6. Perform slit lamp examination of the anterior segment. Include documentation of IOL 
observations, if any. 
[Operative Eye Only, Monocular]
7. Observe any IOL position changes (ie, tilt and decentration) occurring since the previous 
visit.
[Operative Eye Only, Monocular]
8. Assess subjective PCO, and record information for any posterior capsulotomy that has 
occurred since surgery, if applicable.
[Operative Eye Only, Monocular]
9. Perform tonometry to measure the IOP.
[Operative Eye Only, Monocular]
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10. Record any AEs including SSIs.
1RWH SAEs including SSIs must be entered into EDC within 24 hours of the 
Investigator’s knowledge. Refer to Section 13 for further detail. 
11. Record any device deficiencies. Refer to Section 13 for further detail.

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Below is a list of study procedures to be undertaken at Visit 3A. 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 forms (if 
applicable).
1. Record changes in medical/ocular history and ocular and non-ocular concomitant 
medications.
2.
3.
4.
 
5. Assess binocular uncorrected distance visual acuity. 
[Both Eyes, Binocular]
6.
 
7. Assess binocular uncorrected near (40 cm) visual acuity. 
[Both Eyes, Binocular]
8.
 
9. Assess binocular uncorrected intermediate (60 cm) visual acuity. 
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24-Feb-2016

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[Both Eyes, Binocular]
10. Perform defocus testing.
[Both Eyes, Binocular]
11. Perform mesopic without glare contrast sensitivity testing.
[Both Eyes, Binocular]
12. Perform mesopic with glare contrast sensitivity testing.
[Both Eyes, Binocular]
13. Perform photopic without glare contrast sensitivity testing.
[Both Eyes, Binocular]
14. Perform photopic with glare contrast sensitivity testing.
[Both Eyes, Binocular]
15. Perform slit lamp examination of the anterior segment. Include documentation of IOL 
observations, if any. 
[Both Eyes, Bilateral]
16. Observe any IOL position changes (ie, tilt and decentration) occurring since the previous 
visit.
[Both Eyes, Bilateral]
17. Assess subjective PCO, and record information for any posterior capsulotomy that has 
occurred since surgery, if applicable. 
[Both Eyes, Bilateral]
18. Perform dilated fundus exam noting any issues with fundus visualization due to the lens 
optic.
[Both Eyes, Bilateral]
19. Perform tonometry to measure the IOP.
[Both Eyes, Bilateral]
20. Record any AEs including SSIs.
1RWH SAEs including SSIs must be entered into EDC within 24 hours of the 
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Investigator’s knowledge.  Refer to Section 13 for further detail. 
21. Record any device deficiencies. Refer to Section 13 for further detail.

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Below is a list of study procedures to be undertaken at Visit 4A. 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 forms (if 
applicable).
1. Record changes in medical/ocular history and ocular and non-ocular concomitant 
medications.
2. Administer patient satisfaction question. For question, refer to Appendix Section 18.1.
3.
4.
5.
 
6. Assess binocular uncorrected distance visual acuity. 
[Both Eyes, Binocular]
7.
 
8. Assess binocular uncorrected near (40 cm) visual acuity. 
[Both Eyes, Binocular]
9.
 
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10. Assess binocular uncorrected intermediate (60 cm) visual acuity. 
[Both Eyes, Binocular]
11. Perform defocus testing.
[Both Eyes, Binocular]
12. Perform mesopic without glare contrast sensitivity testing.
[Both Eyes, Binocular]
13. Perform mesopic with glare contrast sensitivity testing.
[Both Eyes, Binocular]
14. Perform photopic without glare contrast sensitivity testing.
[Both Eyes, Binocular]
15. Perform photopic with glare contrast sensitivity testing.
[Both Eyes, Binocular]
16. Perform slit lamp examination of the anterior segment. Include documentation of IOL 
observations, if any. 
[Both Eyes, Bilateral]
17. Observe any IOL position changes (ie, tilt and decentration) occurring since the previous 
visit.
[Both Eyes, Bilateral]
18. Assess subjective PCO, and record information for any posterior capsulotomy that has 
occurred since surgery, if applicable. 
[Both Eyes, Bilateral]
19. Perform dilated fundus exam noting any issues with fundus visualization due to the lens 
optic.
[Both Eyes, Bilateral]
20. Perform tonometry to measure the IOP.
[Both Eyes, Bilateral]
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21. Record any AEs including SSIs.
1RWH Serious adverse events (SAEs) including SSIs must be entered into EDC within 24 
hours of the Investigator’s knowledge.  Refer to Section 13 for further detail. 
22. Record any device deficiencies. Refer to Section 13 for further detail.

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An unscheduled visit (UNSV) is defined as follows:
x
Ocular examination that is not standard of care and not required by the protocol;
x
Examination conducted by the study staff; 
x
New findings, or a change to a previous finding was discovered; and 
x
Not site standard of 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. 
x
Concomitant medications
x
Monocular uncorrected distance VA
x
Slit lamp exam including IOL position change
x
Subjective PCO and posterior capsulotomy assessment
x
Fundus exam
x
IOP
x
Adverse events 
x
Device deficiencies
1RWH Assessments are not limited to the above list. 
If the subject is discontinued at the unscheduled visit, perform all Early Exit procedures. 
Refer to Section 6 SCHEDULE OF VISITS. For safety purposes, if an UNSV is required 
after the final study visit, document the visit.  Refer to Section 13.5 for further detail.
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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, document the date the subject is considered lost to follow-up. Complete the
subject’s Exit Case Report Form after the last window (Visit 4A) closes, indicating the 
subject is lost to follow-up. 

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Discontinued subjects withdraw, or are withdrawn from the study after signing consent, and 
prior to completing all study visits. Subjects signing consent, but withdrawing or withdrawn
prior to randomization shall be considered discontinued due to screen failure, and the failed 
entry criterion 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 participation poses a health risk to the subject. Subject 
numbers from discontinued subjects will not be reissued. Discontinued subjects will not be 
replaced.
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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:
x
The Investigator fails to comply with the protocol or GCP guidelines
x
Safety concerns
x
Inadequate recruitment of subjects by the Investigator
If the clinical study is prematurely terminated or suspended, the Sponsor will inform the 
Investigator and the regulatory authorities (where applicable) of the termination/ suspension 
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and the reason(s) for the termination/suspension. The Investigator should promptly notify the 
IEC/IRB of the termination or suspension and of the reasons. 
If the Sponsor terminates the study for safety reasons, it will immediately notify the 
Investigator(s), and provide written instructions for study termination and applicable subject 
follow-up.
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Product Complaint
Any oral, electronic, or written communication that alleges deficiencies related to the identity 
(labeling), quality, durability, reliability, safety, effectiveness, or performance of a marketed 
product, including failure of the product, labeling or packaging to meet specifications, 
whether or not the product is related to or caused the alleged deficiency. A complaint may 
allege that an adverse event or medical device malfunction has occurred.
Device Deficiency
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, 
safety or performance. Note: This definition includes malfunctions, use errors, and  
inadequate labeling.
x
0DOIXQFWLRQis defined as a failure of a device to meet its performance specifications
or otherwise perform as intended. Performance specifications include all claims made 
in the labeling of the device. The intended performance of the device refers to the 
intended use for which the device is labeled or marketed.
x
8VHHUURUis defined as the act or omission of an act that results in a different medical
device response than intended by manufacturer or expected by user.
Examples of device deficiencies include the following:
x
Failure to meet product specifications (eg, incorrect IOL power)
x
IOL defect
x
Broken IOL optic
x
Broken IOL haptic
x
Scratched IOL optic
x
Unsealed device packaging
x
Suspect product contamination (IOL)
x
Lack of efficacy
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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 medical device.
Serious Adverse Event (SAE)
Adverse event that led to any of the following:
x
Death
x
A serious deterioration in the health of the subject that either resulted in:
a) A life-threatening illness
b) Permanent impairment of a body function or permanent damage to a body
structure
c) A condition necessitating medical or surgical intervention to prevent a) or b)
d) A condition that requires hospitalization or significant prolongation of existing
hospitalization
e) any indirect harm as a consequence of incorrect diagnostic test results when 
used within manufacturer's instructions for use
x
Fetal distress, fetal death, or a congenital abnormality or birth defect
Non-serious adverse event
Any adverse event that does not meet seriousness criteria described above.
Adverse Device Effect (ADE)
Adverse event related to the use of a test article or control article. 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 test article or control article.
Serious Adverse Device Effect
A serious adverse device effect (SADE) is an ADE that has resulted in any of the 
consequences characteristic of a SAE. 
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Serious Public Health Threat
Any event type which results in imminent risk of death, serious deterioration in state of 
health, or serious illness that requires prompt remedial action. This would include: Events 
that are of significant and unexpected nature such that they become alarming as a potential 
public health hazard, eg, human immunodeficiency virus (HIV) or Creutzfeldt-Jacob Disease 
(CJD).
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Protocol - Clinical
24-Feb-2016

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6SHFLILF(YHQWV5HOHYDQWWRWKLV3URWRFRO
In addition to reporting all AEs (serious and non-serious) meeting the definitions, the 
Investigator must report any occurrence of the following as an SAE:
&XPXODWLYH6HULRXV$GYHUVH(YHQWV
x Cystoid macular edema
x Hypopyon
x Endophthalmitis
x Lens dislocation
x Pupillary block
x Retinal detachment
x Secondary surgical intervention (excluding posterior capsulotomy)
3HUVLVWHQW6HULRXV$GYHUVH(YHQWV
x Corneal stromal edema
x Cystoid macular edema
x Iritis
x Raised IOP requiring treatment
This list is consistent with the categories provided in EN ISO 11979-7:2014. A persistent AE
is an AE that is present at the conclusion of a clinical investigation per EN ISO 11979-
1:2012. Any other potentially sight-threatening event may also be considered serious based 
on the judgment of the Investigator and should be reported appropriately as delineated in
Section 13.2.
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'HILFLHQFLHV
All AEs (serious and non-serious) and device deficiencies are collected from the time of
informed consent in the electronic Case Report Form (eCRF). Any pre-existing medical
conditions or signs/symptoms present in a subject prior to the start of the study (ie, before
informed consent is signed) are not considered AEs in the study and should be recorded in 
the Medical History section of the eCRF.
A separate eCRF must be filled out for each event. When possible, signs and symptoms
indicating a common underlying pathology should be documented as one comprehensive
event.
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24-Feb-2016

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The site must submit all available information to the Study Sponsor as follows:
x
All SAEs must be reported immediately (within 24 hours) of the Investigator’s or 
site’s awareness. 
x
ADEs (related AEs) that do not meet seriousness criteria and Device Deficiencies 
must be reported within 10 calendar days of the Investigator’s or site’s awareness.
Please also include a printed copy of the completed Device Deficiency and/or the SAE-ADE
eCRF with product returns. Additional relevant information after initial reporting is to be 
entered into the eCRF as soon as the data become available.
x
Document any changes to concomitant medications on the appropriate eCRFs.
x
Document all relevant information from Discharge Summary, Autopsy Report,
Certificate of Death etc., if applicable, in narrative section of the Adverse Device
Effect (for related AEs) and Serious Adverse Event eCRF.
1RWHShould the EDC system become non-operational, the site must complete the 
appropriate paper AE and/or Device Deficiency Form. The completed form is faxed or 
emailed to the Study Sponsor at 
or
 within 
24 hours of the Investigator’s or site’s awareness; however, the reported information must be 
entered into the EDC system once it becomes operational.
Further, depending upon the nature of the AE or device deficiency being reported, the study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies according to the requirements of 
regulatory authorities or IRB/IEC.
Study Sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol. 
In the very unlikely event of a Serious Public Health Threat being detected, the site must 
contact the Study Sponsor and the accredited ethics committee immediately.
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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:
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&DXVDOLW\
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).
Where appropriate, the Investigator must assess the intensity (severity) of the AE as mild, 
moderate, or severe based on medical judgment with consideration of any subjective 
symptom(s), as defined below:
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Mild 
An AE is mild if the subject is aware of but can easily tolerate the sign 
or symptom.
Moderate 
An AE is moderate if the sign or symptom results in discomfort 
significant enough to cause interference with the subject’s usual 
activities.
Severe 
An AE is severe if the sign or symptom is incapacitating and results in 
the subject’s inability to work or engage in their usual activities.
If an AE reported for an Investigator’s subject is upgraded to a SAE or if a SAE reported by 
an Investigator as not related that is subsequently upgraded to be related by the study  
Sponsor, the Investigator will receive a notification by the study Sponsor.

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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.
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Masked information on the identity of the assigned medical device should not be disclosed
during the study (see Section 9.2) If the treatment code needs to be broken in the interest of 
subject safety, the Investigator is encouraged to contact an appropriate study Sponsor 
representative prior to unmasking the information if there is sufficient time. Dependent upon 
the individual circumstances (ie, medical emergency), the code may be broken prior to 
contact with the study Sponsor. The study Sponsor must be informed of all cases in which the 
code was broken and of the circumstances involved. Additionally, the study Sponsor may be 
required to unmask the information in order to fulfill expedited regulatory reporting 
requirements.

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The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study.
The Investigator should provide the study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock). 
All complaints received after study completion (ie, after database lock) 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 instructions or local regulatory requirements.
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Pregnancy is not reportable as an AE; however, complications may be reportable and will be 
decided on a case–by-case basis. An Alcon form will be utilized to capture all pregnancy 
related information until birth of the child.
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The nature and location of all source documents will be identified to ensure that original data 
required to complete the electronic case report forms (eCRFs) exists and are accessible for 
verification by the monitor. It is required that the author of each entry in the source 
documents be identifiable (eg, initials or signature and date). At a minimum, source 
documents should include the following information for each subject:
x
Subject identification (name, date of birth or age, sex)
x
Documentation of subject eligibility
x
Date of informed consent
x
Dates of visits
x
Documentation that protocol-specific procedures were performed
x
Results of study testing, as required by the protocol
x
Test article accountability records
x
Documentation of SAEs and other safety parameters (as applicable)
x
Records regarding medical histories and the use of concomitant therapies prior to and
during the study
x
Date of study completion and reason for early discontinuation, if applicable
1RWH If electronic source records are maintained, the method of verification must be 
determined in advance of starting 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 reported on the eCRFs shall be derived from source documents and be consistent with 
these source documents, and any discrepancies shall be explained in writing. Any change or 
correction to data reported on a source document  shall be dated, initialed, and explained if 
necessary, and shall not obscure the original entry (ie, an audit trail shall be maintained); this 
applies to both written and electronic changes and corrections. eCRFs shall be signed and 
dated by the Principal Investigator or his/her authorized designee(s).
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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 
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separate document, the Protocol Monitoring Plan. Corrections and/or any necessary additions 
to the data will be applied and if required, queries will be generated. Designated investigative 
staff are expected to respond to data queries in a timely manner and ensure that the 
corrections and changes made to the data are reflected in the subjects’ source documentation.
Deviations from this protocol, regulatory requirements and GCP must be recorded. An 
explanation of the deviation should be included, as applicable. In addition, corrective and 
preventive action should be identified, implemented and documented within the study 
records. Prior to study start, a plan for data validation will be completed by Alcon clinical 
data management, and agreed upon by the study clinical manager (CM) and other team 
members.
Concomitant medications entered into the database will be coded using the WHO Drug 
Reference List. Medical history and adverse events will be coded using the medical 
dictionary for regulatory activities (MedDRA) terminology. Upon completion of the study 
and once the database is declared completed and accurate, the database will be locked and 
data will be available for data analysis. Any changes to the database after lock will be 
implemented upon agreement between the Sponsor’s clinical trial management, medical 
safety clinical data management and biostatistics departments, and will be completed 
following the Sponsor’s procedures for changes to a database after database lock.
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The final subject evaluability will be determined prior to breaking the code for masked 
treatment assignment and locking the database. All eyes will be analyzed as implanted.
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The all-implanted analysis set (AAS) will include all eyes with successful test or control
article bilateral implantation.
The best-case analysis set (BAS) will include all eyes successfully implanted with the test or 
control article that had at least one postoperative visit, and with no macular degeneration at 
any time, and no major protocol deviations.  Subjects who become pregnant at any time 
during the study will also be excluded from the BAS.
All eyes with attempted test or control article implantation (successful or aborted after 
contact with the eye) will be considered evaluable for the Safety Set (SS).
The primary analysis set for performance analyses will be the AAS for all performance 
endpoints, except for binocular defocus and contrast sensitivity for which it will be 
considered supportive. The BAS will be the primary set for binocular defocus and contrast 
sensitivity. 
 The SS 
will be used for analysis of safety endpoints.

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Summary statistics will be provided for demographic and baseline characteristics by 
treatment group. Number and percentage will be presented for categorical variables and 
descriptive statistics including mean, standard deviation, minimum and maximum will be 
presented for continuous variables.

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A total of six hypothesis tests will be conducted to address the primary and secondary 
objectives of the study.
The primary, second secondary and third secondary will be tests of non-inferiority while the 
first secondary, fourth secondary and fifth secondary will be tests of superiority. A 
combination of gate-keeping and Bonferroni adjustment strategies will be employed to 
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24-Feb-2016

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control the overall type I error rate at 0.05. The hypothesis tests and the testing order 
(multiplicity adjustment) are outlined in Figure 15-1.

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The primary objective is to demonstrate non-inferiority of the TFNT00 IOL to the 839MP
IOL in mean photopic binocular uncorrected intermediate (60 cm) visual acuity (UCIVA) at 
Visit 4A.

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The null and alternative hypotheses for the primary analysis are:
H0: TFNT00VA - 839MPVA  ¨
HA: TFNT00VA - 839MPVA < ¨
where, ¨ refers to the non-inferiority margin, set at 0.1 logMAR, and TFNT00VA, 839MPVA, 
refer to the mean binocular high contrast UCIVA for the test and control lenses, respectively.

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The primary hypothesis will be tested by generating a two-sided 90% confidence interval 
using repeated measures analysis of variance at a type I error rate of 5%, 1-sided. Tests at 
each visit will be reported with Visit 4A (120-180 days) prospectively identified as the 
primary time point of interest. The upper bound of the two-sided 90% confidence interval 
will be compared to the margin, 0.1. If the upper bound is less than the margin, the null 
hypothesis will be rejected and the TFNT00 IOL will be concluded non-inferior to the 839MP 
IOL for UCIVA.
The two sided 90% confidence intervals will be reported for the difference between the 
treatment groups at each visit.

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The first secondary objective is to demonstrate superiority of the TFNT00 IOL to the 839MP
IOL in mean photopic binocular uncorrected intermediate (60 cm) visual acuity (UCIVA) at 
Visit 4A.
The second secondary objective is to demonstrate non-inferiority of the TFNT00 IOL to the 
839MP IOL in mean photopic binocular uncorrected distance (4 m) visual acuity (UCDVA) 
at Visit 4A.
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The third secondary objective is to demonstrate non-inferiority of the TNFT00 IOL to the 
839MP IOL in mean photopic binocular uncorrected near (40 cm) visual acuity (UCNVA) at 
Visit 4A.
The fourth secondary objective is to demonstrate superiority of the TFNT00 IOL to the 
839MP IOL in mean photopic binocular uncorrected near (40 cm) visual acuity (UCNVA) at 
Visit 4A.
The fifth secondary objective is to demonstrate superiority of the TFNT00 IOL to the 839MP
IOL in mean photopic binocular uncorrected distance (4 m) visual acuity (UCDVA) at Visit 
4A.
The sixth secondary objective is to characterize the Binocular Defocus Curve profiles, 
contrast sensitivity and patient satisfaction with the TFNT00 IOL versus the 839MP IOL at 
Visit 4A.
The secondary endpoints are UCNVA, UCIVA, UCDVA, Binocular Defocus, Contrast 
Sensitivity and Patient Satisfaction.

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The null and alternative hypotheses for the first, fourth and fifth secondary analysis are:
H0: TFNT00VA  839MPVA
HA:  TFNT00VA < 839MPVA
where  TFNT00VA, 839MPVA, refer to the mean binocular high contrast UCIVA, UCNVA or 
UCDVA for the test and control lenses, respectively.
The null and alternative hypotheses for the second and third secondary analysis are:
H0:  TFNT00VA - 839MPVA  ¨
HA:  TFNT00VA - 839MPVA < ¨
where, ¨ refers to the non-inferiority margin, set at 0.1 logMAR, and TFNT00VA, 839MPVA, 
refer to the mean binocular high contrast UCDVA or UCNVA for the test and control lenses, 
respectively.
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Protocol - Clinical
24-Feb-2016

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For the superiority hypothesis tests, treatment group comparison for UCIVA will be made and 
the first secondary objective will be demonstrated if p<0.025 from a repeated measures 
analysis of variance at a Type I error rate of 2.5%. Tests at each visit will be reported with 
Visit 4A (120-180 days) prospectively identified as the primary time point of interest.  The 
two-sided 95% confidence intervals will be reported for the difference between treatment 
groups at each visit. For the fourth and fifth secondary objectives, superiority will be 
demonstrated if p<0.05 (or p<0.025, depending on the gatekeeping) for UCNVA and UCDVA 
at Visit 4A (120-180 days), respectively.
For the non-inferiority hypothesis test of UCDVA, the second secondary objective, treatment 
group comparisons will be tested by generating a two-sided 95% confidence interval from a 
repeated measures analysis of variance, with site included as a covariate, at a Type I error rate 
of 2.5%. The variable ‘visit’ will be entered as a classification variable to avoid assumptions 
on the shape of the response and least squares means will be used to estimate the treatment 
effect at each visit with Visit 4A (120-180 days) prospectively identified as the primary point 
of interest. The upper bound of the two-sided 95% confidence interval will be compared to 
the margin, 0.1. If the upper bound is less than the margin, the null hypothesis will be 
rejected and the TNFT00 IOL will be concluded non-inferior to the 839MP IOL for UCDVA. 
The two-sided 95% confidence intervals will be reported for the difference between the 
treatment groups at each visit.
For the non-inferiority hypothesis test of UCNVA, the third secondary objective, treatment 
group comparisons will be tested by generating a two-sided 95% (or 90%, depending on the 
gatekeeping) confidence interval from a repeated measures analysis of variance, with site 
included as a covariate, at a Type I error rate of 2.5% (or 5%). The variable ‘visit’ will be 
entered as a classification variable to avoid assumptions on the shape of the response and 
least squares means will be used to estimate the treatment effect at each visit with Visit 4A 
(120-180 days) prospectively identified as the primary point of interest. The upper bound of 
the two-sided 95% (or 90%) confidence interval will be compared to the margin, 0.1. If the 
upper bound is less than the margin, the null hypothesis will be rejected and the TNFT00 IOL 
will be concluded non-inferior to the 839MP IOL for UCNVA. The two-sided 95% (or 90%) 
confidence intervals will be reported for the difference between the treatment groups at each 
visit.
Summaries of logMAR visual acuity will also include two-sided 90% confidence intervals. A 
composite visual acuity endpoint comprising binocular uncorrected visual acuity at Distance 
(4 m) and Near (40 cm) will be summarized as a categorical variable with the following 
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categories: 20/20 or better (0.04 logMAR), 20/32 or better (0.14 logMAR) and 20/40 or 
better (0.24 logMAR).
Defocus curves will be generated for binocular defocus data, including two-sided 90% 
confidence intervals, with the amount of defocus along the x-axis and logMAR VA at each 
defocus point along the y-axis. To examine inter-site variation in outcome, forest plots of 
near, intermediate and distance visual acuity will be produced by plotting the difference in 
means and associated standard error for each site.
Contrast Sensitivity will be scored and analyzed per contrast sensitivity unit instructions.
Responses to the satisfaction question will be analyzed as a categorical variable.
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The AAS and BAS do not include any imputed values. Although missing data will occur, the 
influence of the missing data is expected to be minimal.
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A total of six hypothesis tests will be conducted to address the primary and secondary 
objectives of the study.
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A combination of gate-keeping and Bonferroni adjustment strategies will be employed to 
control the overall type I error rate. The hypothesis tests and the testing order (multiplicity 
adjustment) are outlined in Figure 15-1.
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All information obtained on AEs will be displayed by treatment and subject.
The number and percentage of all ocular adverse events, including secondary surgical 
interventions (SSIs) for either eye, will be tabulated by preferred term with a breakdown by 
treatment and implanted eye. An eye with multiple ocular AEs of the same preferred term is 
only counted once toward the total of this preferred term.
The number and percentage of all adverse events will also be tabulated with a breakdown by 
treatment.
1st: NI: Inter. VA (60 cm)
(Į =0.05)
3rd: NI: Distance VA (4 m) 
(Į =0.025)
2nd: Sup: Inter. VA (60 cm)
(Į =0.025)
4th: NI: Near VA (40 cm)
(Į =0.05 or Į =0.025)
5th: Sup: Near VA (40 cm)
(Į =0.05 or Į =0.025)
6th: Sup: Distance VA (4 m)
(Į =0.05 or Į =0.025)
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A type I error rate of 0.025 will be 
used if only one of the simultaneous 
hypothesis tests in gate 2 is rejected. If 
both are rejected, Į = 0.05 will be 
used. Hypothesis tests in subsequent 
gates only interpretable if hypothesis 
test in prior gate is rejected.
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A Bonferroni adjustment is applied to 
test both hypotheses simultaneously, 
resulting in a Į = 0.025 for each test. 
Hypothesis tests in subsequent stages are 
only interpretable if at least one test is 
rejected in this gate
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Hypothesis tests in subsequent gates 
only interpretable if this test is rejected
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The number and percentage of all device deficiencies will be tabulated with a breakdown by 
treatment and implanted eye. A listing of all device deficiencies will also be provided.
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The number and percentage of all IOL observations will be tabulated with a breakdown by 
treatment and implanted eye.
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The number and percentage of eyes within each category of subjective posterior capsule 
opacification will be tabulated with a breakdown by treatment and implanted eye.
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The number and percentage of eyes with posterior capsulotomy will be tabulated with a 
breakdown by treatment and implanted eye.
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All other safety assessments (including intraocular pressure, slit lamp examination, IOL 
position change, fundus visualization, dilated fundus examination and surgical problems) will 
be summarized. Number and percentage will be presented for categorical variables and 
descriptive statistics including mean, standard deviation, minimum and maximum will be 
presented for continuous variables.
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An interim analysis will be performed when all subjects complete Visit 3A (20-40 days post 
2nd eye implantation) in order to support the study publication plan of the test articles for 
near, intermediate and distance visual acuity, contrast sensitivity, defocus curves and adverse 
events. The interim analysis results will be distributed to a limited audience to limit potential 
bias in Visit 4A assessments. The clinical trial team with the exception of the Brand Lead will 
be masked to the interim analysis results.
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Not applicable.
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The multiplicity adjustment strategy is outlined in Figure 15.-1. Sample size estimations are 
based on the minimum sample size needed to achieve 90% power for all hypothesis tests. A 
type I error rate of 2.5%, one-sided, is used for calculations to account for simultaneous 
testing in Gate 2 (see Figure 15-1).
Assuming a dropout rate of 5%, approximately 160 subjects will be bilaterally implanted in 
1:1 allocation ratio (test: control) to achieve at least 152 subjects who complete the study. 
With 152 subjects (76 per group) there is 98% probability that an upper one-sided 97.5% 
confidence limit on the difference (test-control) in visual acuity will be less than 0.1 
logMAR, assuming the mean difference of 0.0 logMAR and a common standard deviation of 
0.16 logMAR, the maximum observed for binocular uncorrected distance, intermediate and 
near visual acuity in a previous Alcon study (C-06-40, ReSTOR +3.0 D IOL). 
Also, with 76 subjects per group, there is more than 90% power to detect a difference of 0.09
logMAR (4.5 letters) between means in a two sample t-test conducted at a 2.5% chance of a 
Type I error and assuming a standard deviation of 0.16 logMAR for binocular uncorrected 
distance, intermediate and near visual acuity.
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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.
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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.
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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 / 
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Independent Ethics Committee (IRB/IEC). A master list of IRBs/IECs for this clinical trial 
can be found in the Trial 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.
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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 sties 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.
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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.
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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 
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study is ended prematurely, the Investigator will notify the accredited ethics committee, 
including the reasons for the premature termination. Within one year after the end of the 
study, the Investigator/sponsor will 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.
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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.
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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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Boettner EA, Wolter JR. Transmission of the Ocular Media. IOVS. 1962; 1:776-83.
Law E, Aggarwall R, Kasaby H. Clinical Outcomes with a new trifocal intraocular lens. Eur J 
Ophthalmol. 2014; 24 (4):501-508.
Maxwell WA, Cionni RJ, Lehmann RP, Modi SS. Functional outcomes after bilateral 
implantation of apodized diffractive aspheric acrylic intraocular lenses with a +3.0 or +4.0 
diopter addition power. Randomized multicenter clinical study. J Cataract Refract Surg. 
2009; 35(12):2054-61.
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