A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus IOL
Phase: NA
Conditions: Cataract
Sponsor: Alcon Research

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Clinical Trial Protocol 
 
A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the 
ACRYSOF® IQ Extended Depth of Focus IOL 
 
Protocol Number: 
ILI875-C002 
Sponsor Name & Address: 
Alcon Research, Ltd. and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
Test Article(s) / Product(s): 
ACRYSOF IQ Extended Depth of Focus IOL 
Investigator Agreement: 
I have read the clinical study described herein, recognize 
its confidentiality, and agree to conduct the described 
trial in compliance with Good Clinical Practice (GCP), 
ISO 14155, the ethical principles within the Declaration 
of Helsinki, this protocol, and all applicable regulatory 
requirements. Additionally, I will comply with all 
procedures for data recording and reporting, will permit 
monitoring, auditing, and inspection of my research 
center, and will retain all records until notified by the 
Sponsor. 
 
 
 
Principal Investigator: 
 
Name and Investigator Number: 
Address: 
 
 
Signature 
Date 
 
Telephone: 
Release Date: 
Refer to e-signature date 
 
 
Property of Alcon Laboratories 
Confidential 
May not be used, divulged, published, or otherwise disclosed without the consent of Alcon 
Laboratories 

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1 
PROTOCOL SYNOPSIS 
 
Financial Disclosure 
for US FDA 
Submission Required? 
X Yes 
No 
Test Article(s) / 
Product(s): 
ACRYSOF IQ Extended Depth of Focus (EDF) IOL 
model number DFT015 
Objective(s): 
Primary 
1. ACRYSOF IQ EDF IOL is superior to ACRYSOF IQ 
Monofocal IOL with respect to mean monocular photopic 
distance corrected intermediate visual acuity (DCIVA) 66 cm 
from spectacle plane at Visit 4A (120-180 days 
postoperative) 
2. ACRYSOF IQ EDF IOL is non-inferior compared to 
ACRYSOF IQ Monofocal IOL with respect to mean 
monocular photopic best corrected distance visual acuity 
(BCDVA) at Visit 4A (120-180d postoperative) 
3. Monocular mean defocus curve for ACRYSOF IQ EDF IOL 
has a range of defocus at least 0.5 D greater negative range 
than ACRYSOF IQ Monofocal IOL at 0.2 logMAR at Visit 
4A (120-180d postoperative) 
4. ACRYSOF IQ EDF IOL has at least 50% of eyes achieving 
monocular photopic DCIVA of 0.2 logMAR or better at Visit 
4A (120-180d postoperative) 
A successful outcome on the co-primary effectiveness endpoints is 
indicated by successful outcomes on all 4 of these endpoints. 
Objective(s): 
Secondary 
1. ACRYSOF IQ EDF IOL is superior to ACRYSOF IQ 
Monofocal IOL with respect to mean monocular photopic 
distance corrected near visual acuity (DCNVA) 40 cm from 
spectacle plane at Visit 4A (120-180d postoperative) 
In addition, the following performance targets will also be 
assessed to demonstrate clinical significance: 
o At least 50% of eyes with ACRYSOF IQ EDF IOL 
achieve a monocular DCNVA of 0.3 logMAR or 
better, 
o Percentage of eyes achieving monocular DCNVA 
of 0.3 logMAR or better in ACRYSOF IQ EDF 
IOL group is at least 25 percentage points higher 

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than in ACRYSOF IQ Monofocal IOL group 
2. ACRYSOF IQ EDF IOL is superior to ACRYSOF IQ 
Monofocal IOL with respect to proportion of subjects who 
respond “Never” to Q1 of the Intraocular Lens Satisfaction 
(IOLSAT) questionnaire (Overall, in the past 7 days, how often 
did you need to wear eyeglasses to see?) at Visit 4A (120-180d 
postoperative) 
3. Describe mean monocular photopic uncorrected intermediate
visual acuity (UCIVA) 66 cm from spectacle plane outcomes
at Visit 4A (120-180d postoperative) 
4. Describe mean monocular photopic uncorrected distance 
visual acuity (UCDVA) outcomes at Visit 4A (120-180d 
postoperative) 
Objective(s): 
Primary Safety 
1. To demonstrate that the adverse event (AE) rates of 
ACRYSOF IQ EDF IOL are not worse than the historical 
control safety and performance endpoint (SPE) rates, as 
defined in IS EN ISO 11979-7:2014, at Visit 4A (120-180d 
postoperative) 
2. To describe monocular mesopic contrast sensitivity test (with 
and without glare) outcomes at Visit 4A (120-180d 
postoperative) 
Objective(s): 
Secondary Safety 
To estimate rates of severe and most bothersome (separately) visual 
disturbances as reported by subjects using a questionnaire (QUVID, 
Questionnaire for Visual Disturbances) at Visit 4A (120-180d 
postoperative) 
Clinical Trial Design: Prospective, multi-center, randomized, double-masked, 
parallel-group, safety and performance clinical trial 
No. of Subjects: 
a) Required for statistical analysis: 200 
b) Randomized: 220 
c) Approximately enrolled: 240 
Region(s): 
United States 
Clinical Trial 
Duration: 
a) Total expected duration of the clinical investigation: 14 months 
b) Expected duration of each subject's participation: 7-8 months 
c) Planned follow-up duration: 6 months 
d) Estimated time needed to select the number of subjects (ie, 
enrollment period): 6 months 

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Clinical Trial 
Population: 
Treatments: 
Adults (22 years and older) with cataract in both eyes requiring 
surgery with implantation of a monofocal IOL 
Test Article: 
ACRYSOF IQ EDF IOL (Model DFT015) 
Administration: 
Routine cataract surgery 
General Description: Lens powers 18.0 D to 25.0 D in 0.5 D 
increments 
Duration of 
Treatment: 
 
Control Article: 
 
Administration: 
General Description: 
 
Duration of 
Treatment: 
IOLs are implantable medical devices and are 
intended for long-term use over the lifetime of 
the pseudophakic subject. 
ACRYSOF IQ Monofocal IOL (Model 
SN60WF) 
Routine cataract surgery 
Lens powers 18.0 D to 25.0 D in 0.5 D 
increments 
IOLs are implantable medical devices and are 
intended for long-term use over the lifetime of 
the pseudophakic subject. 
 
Inclusion & Exclusion Details can be found in Section 10: Subject Population 
Criteria: 
Distance visual acuity (VA) (photopic lighting conditions) 
• Monocular BCDVA 
• Monocular UCDVA 
 
 
 
 
 
 
 
 
Assessment(s): 
Performance 
 
Intermediate VA 66 cm (photopic lighting conditions) 
• Monocular DCIVA 
• Monocular UCIVA 
 
 
Near VA 40 cm (photopic lighting conditions) 
• Monocular DCNVA 
 
 
 
 
 
 
Defocus curve (photopic lighting conditions) 

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• Monocular 
Manifest refraction 
Pupil size 
• Photopic 
• Mesopic 
IOLSAT subject survey 
Assessment(s): 
Safety 
AEs including secondary surgical interventions (SSIs) 
Device deficiencies (DDs) 
Mesopic monocular distance contrast sensitivity 
• With glare 
• Without glare 
QUVID subject survey 
IOP 
Slit lamp examination including 
• IOL observations 
• Aqueous Signs 
• IOL position change (tilt/decentration) 
• Subjective posterior capsular opacification (PCO) 
• Posterior capsulotomy 
Dilated fundus examination including fundus visualization 
Intraoperative surgical problems 
Other procedures at surgery (combined and/or additional) 
Incision location 
Final incision size (in event of surgical complication) 
Assessment(s) 
Other 
Demographics 
Medical history 
Concomitant medications 
Urine pregnancy test 
Anterior chamber depth 
Axial length 
Keratometry 
Lens information 
Planned Analyses 
In general, descriptive statistics generated for an endpoint will be based upon the type 
of parameter (ie, whether the data is categorical or continuous) being analyzed. For 
categorical parameters, the statistics used to summarize the data descriptively included 
sample size, number in the category, and percent in the category. For continuous 
parameters, sample size, mean, median, standard deviation, minimum, and maximum 
will be presented. 
The primary analysis set for effectiveness analyses will be the All-Implanted Analysis 

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Set (AAS). AAS includes all randomized eyes with successful IOL implantation. 
 
BAS includes all eyes successfully implanted that had 
• at least 1 postoperative visit 
• no preoperative ocular pathology 
• no macular degeneration detected at any time 
• no previous surgery for correction of refractive errors 
• no major protocol violation 
 
Analyses on performance targets are based on point estimates. 
 
Only the first eye of each subject will be included in the primary statistical analysis (as 
described in IS EN ISO 11979-7:2014). 
 
The statistical hypotheses in support of the primary effectiveness objectives are: 
• ACRYSOF IQ EDF IOL is superior to ACRYSOF IQ Monofocal IOL with 
respect to mean monocular photopic DCIVA distance corrected intermediate 
visual acuity (66 cm from spectacle plane) at Visit 4A (120-180d postoperative) 
• ACRYSOF IQ EDF IOL is non-inferior compared to ACRYSOF IQ Monofocal 
IOL with respect to mean monocular photopic BCDVA best corrected distance 
visual acuity at Visit 4A (120-180d postoperative). The non-inferiority margin will 
be 0.1 logMAR. 
 
Analysis of the first primary effectiveness endpoint (DCIVA) will be based on a two- 
sample t-test, with a type I error rate of 2.5%, 1-sided. The difference in means 
(ACRYSOF IQ EDF IOL minus ACRYSOF IQ Monofocal IOL) and the associated two- 
sided 95% confidence interval will be presented. 
 
Analysis of the second primary effectiveness endpoint (BCDVA) will be based on a two- 
sample t-test, with a type I error rate of 5%, 1-sided. The difference in means (ACRYSOF 
IQ EDF IOL minus ACRYSOF IQ Monofocal IOL) and the associated one-sided 95% 
upper confidence limit will be presented. 
 
Two performance targets in support of the primary effectiveness objectives are: 
• Monocular mean defocus curve for ACRYSOF IQ EDF IOL has a range of 
defocus at least 0.5 D greater negative range than ACRYSOF IQ Monofocal 
IOL at 0.2 logMAR at Visit 4A (120-180d post-operative). 
• ACRYSOF IQ EDF IOL has at least 50% of eyes achieving monocular 
photopic distance corrected intermediate vision of 0.2 logMAR or better at Visit 
4A (120-180d post-operative). 
For the first performance target (depth of focus), the line plot of the average visual 
acuity at each defocus level (ie, defocus curve) will be used to estimate the negative 

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lens induced depth of focus at 0.2 logMAR. The difference in depth of focus between 
ACRYSOF IQ EDF IOL and ACRYSOF IQ Monofocal IOL will be presented. The 
defocus data will be presented for overall and by 3 photopic pupil size ranges 
[  3.0 mm (small),  3.0 mm to  4.0 mm (medium), and  4.0 mm (large)] and 3 axial 
length ranges [  21.0 mm (short),  21.0 mm to  26.0 mm (medium), and  26.0 mm 
(long)]. 
 
For the second performance target (DCIVA), the percentage of eyes achieving distance 
corrected intermediate visual acuity of 0.2 logMAR or better in each IOL group will be 
presented. 
 
A success on the 4 co-primary effectiveness endpoints will be indicated by successful 
outcomes on all 4 of these endpoints (2 hypothesis tests and 2 performance targets). A 
total of 4 hypothesis tests will be conducted to address the primary and secondary 
effectiveness objectives of the study. Overall Type I error will be maintained at the 5% 
level using a sequential testing approach. 
 
Hypothesis tests on secondary effectiveness endpoints will be conducted only after 
successful outcomes on all 4 co-primary effectiveness endpoints are demonstrated. 
 
The statistical hypothesis in support of the first secondary effectiveness objective is: 
• ACRYSOF IQ EDF IOL is superior to ACRYSOF IQ Monofocal IOL with respect 
to mean monocular photopic distance corrected near visual acuity (40 cm from 
spectacle plane) at Visit 4A (120-180d post-operative) 
 
Analysis of the first secondary effectiveness endpoint (DCNVA) will be based on a 
two-sample t-test, with a type I error rate of 2.5%, 1-sided. The difference in means 
(ACRYSOF IQ EDF IOL minus ACRYSOF IQ Monofocal IOL) and the associated 
two-sided 95% confidence interval will be presented. 
 
Two performance targets in support of the first secondary effectiveness objective are: 
• At least 50% of eyes with ACRYSOF IQ EDF IOL achieve a monocular 
DCNVA of 0.3 logMAR or better 
• The percentage of eyes achieving monocular DCNVA 0.3 logMAR or better in 
ACRYSOF IQ EDF IOL group is at least 25 percentage points higher than in 
ACRYSOF IQ Monofocal IOL group. 
 
For the first performance target, the percentage of eyes achieving distance corrected 
near visual acuity of 0.3 logMAR or better in ACRYSOF IQ EDF IOL group will be 
presented and compared against the performance target of 50%. For the second 
performance target, the percentage of eyes achieving distance corrected near visual 
acuity of 0.3 logMAR or better in each IOL group will be presented and the difference 
between the IOL groups (ACRYSOF IQ EDF IOL – ACRYSOF IQ Monofocal IOL) 

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will be compared against the performance target of 25%. 
 
A success on the first secondary effectiveness endpoint will be indicated by successful 
outcomes on the hypothesis test and 2 performance targets. A hypothesis test on the 
second secondary effectiveness endpoint will be conducted only after successful 
outcomes on the first secondary endpoint are demonstrated. 
 
The statistical hypothesis in support of the second secondary effectiveness objective is: 
• ACRYSOF IQ EDF IOL is superior to ACRYSOF IQ Monofocal IOL with respect 
to proportion of subjects who respond “Never” to Q1 of the IOLSAT questionnaire 
(Overall, in the past 7 days, how often did you need to wear eyeglasses to see?) at 
Visit 4A (120-180d post-operative) 
 
For the second secondary effectiveness endpoint, a two-sided 95% confidence interval 
for the difference in proportions (ACRYSOF IQ EDF IOL – ACRYSOF IQ Monofocal 
IOL) will be calculated using the Miettinen-Nurminen method (1985), and ACRYSOF 
IQ EDF IOL will be determined to be superior to ACRYSOF IQ Monofocal IOL if the 
lower boundary of the confidence interval is greater than zero. This is equivalent to 
using a type I error rate of 2.5%, 1-sided. 
 
If the IOLSAT questionnaire generates scores, the cumulative distribution curves showing 
the percentage of subjects with a given change in their score compared to baseline by IOL 
group will be presented to help determine whether any observed differences are 
meaningful. In addition, the frequencies of each item in IOLSAT will be summarized by 
visit, with counts and percentages. 
 
For the third and the fourth secondary effectiveness endpoints (UCIVA and UCDVA, 
respectively), the difference in means (ACRYSOF IQ EDF IOL minus ACRYSOF IQ 
Monofocal IOL) and the associated two-sided 95% confidence interval will be presented. 
 
Overall type I error will be maintained at 5% level using a sequential testing approach 
summarized in the figure below. 

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The Safety Analysis Set will include all eyes with attempted IOL implantation (successful 
or aborted after contact with the eye). 
 
Descriptive summaries (counts and percentages) for specific AEs, including SSIs, will be 
presented by IOL group. The one-sided exact 95% lower confidence limit of incidence rates 
(proportion of eyes with events) observed for each IOL group will be compared to the 
relevant cumulative and persistent adverse event SPE (safety and performance endpoint) 
rate. In addition to SPE rates predefined in IS EN ISO 11979-7, the rate of adverse events 
that may be specifically related to ACRYSOF IQ EDF IOL design features; and any other 
significant events will be provided. These rates will be accompanied by two-sided exact 
95% confidence intervals. 
 
All measured contrast sensitivity values will be converted to logarithmic form before 
performing statistical calculations. Analyses of log contrast sensitivity will be performed for 
each testing condition and spatial frequency. If a subject is unable to see a targeted spatial 
frequency at any available contrast (including the contrast of the reference patch), the lowest 
contrast score will be given, preceded by the appropriate inequality symbol (<) to indicate that 
the actual sensitivity is below the given value. Prior to any averaging or other statistical 
calculations, all contrast threshold values will be converted to log contrast sensitivity values. 
The number and percentage of subjects who cannot see any contrast will be recorded and 
tabulated for each spatial frequency to provide a qualitative extent of the bias. Descriptive 
statistics will include number of eyes, mean, standard deviation, median, minimum, maximum, 
and additional percentiles (10th, 25th, 75th, and 90th percentiles). Descriptive tables will 
include a note that the corresponding mean values are biased upward and variability values are 
biased downward (using < and > symbols). The 5th percentile of log contrast sensitivity values 
will be calculated for the control group, then the percentage of eyes in the test group that 
achieved a log contrast sensitivity lower than this value will be presented. 
 
For the secondary safety endpoint, descriptive summaries (counts and percentages) for the 
severe and most bothersome (separately) visual disturbances as reported by the subjects using 
the QUVID questionnaire will be presented by IOL group. These rates will be accompanied 
by two-sided exact 95% confidence intervals. 
 
If the QUVID questionnaire generates scores, the cumulative distribution curves showing the 

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percentage of subjects with a given change in their score compared to baseline by IOL group 
will be presented to help determine whether any observed differences are meaningful. 
 
Counts and percentages of subjects who did not have a given visual disturbance at 
baseline but developed and present at Visit 4A (120-180d postoperative) will be presented. 
 
In addition, the presence and absence of these symptoms, and how frequent, severe, and 
bothersome they appear will be summarized by visit with counts and percentages. 
 
Sample Size Justifications 
 
Approximately 220 subjects will be randomized to achieve 200 subjects who complete the 
study. 
 
Effectiveness 
The proposed sample size (N = 200; 100 for each IOL group) provides >99% power for the 
superiority hypothesis test on mean monocular photopic distance corrected intermediate visual 
acuity (66 cm) when tested at the 2.5% level of significance (one-sided). This assessment 
assumes: 
Difference in DCIVA (66 cm) [logMAR]: Mean (SD) = -0.12 (0.18) 
 
The proposed sample size will provide 84% power for the non-inferiority hypothesis with 
respect to mean photopic monocular best corrected distance visual acuity when tested at the 5% 
level of significance (one-sided) with a non-inferiority margin of 0.1 logMAR assuming: 
Difference in BCDVA [logMAR]: Mean (SD) = 0.04 (0.16) 
 
The proposed sample size provides >99% power for the superiority hypothesis test on mean 
photopic monocular distance corrected near visual acuity (40 cm) when tested at the 2.5% level 
of significance (one-sided). This assessment assumes: 
Difference in DCNVA (40 cm) [logMAR]: Mean (SD) = -0.12 (0.18) 
 
The proposed sample size will provide 94% power, with α=2.5%, 1-sided, to detect a difference 
of 25% in proportion of subjects who respond “Never” to Q1 of the IOLSAT questionnaire 
(Overall, in the past 7 days, how often did you need to wear eyeglasses to see?), assuming a 
50% rate in the ACRYSOF IQ EDF IOL group. 
 
Adverse Events 
For any event where zero incidence is observed in 100 operative eyes with ACRYSOF IQ EDF 
IOL, the one-sided exact 95% upper confidence limit is less than 3%. Thus, with 95% 
confidence the true adverse event rate is less than 3%. 

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2 
TABLE OF CONTENTS 
1 
PROTOCOL SYNOPSIS ........................................................................................ 2 
2 
TABLE OF CONTENTS ...................................................................................... 11 
List of Tables ....................................................................................................................................... 14 
List of Figures .......................................................................................................................... 15 
3 
ABBREVIATIONS................................................................................................... 16 
4 
GLOSSARY OF TERMS ..................................................................................... 18 
5 
AMENDMENTS .................................................................................................. 21 
5.1 
Amendment 1 ................................................................................................... 21 
5.2 
Amendment 2 ................................................................................................... 24 
5.3 
Amendment 3 ................................................................................................... 34 
6 
SCHEDULE OF VISITS ...................................................................................... 37 
7 
INTRODUCTION ................................................................................................ 40 
7.1 
Background ....................................................................................................... 40 
7.2 
Purpose of the Study ......................................................................................... 41 
7.3 
Risks and Benefits ............................................................................................ 41 
7.3.1 
Known and Potential Risks .......................................................................... 41 
7.3.2 
Potential Benefits .......................................................................................... 42 
8 
CLINICAL TRIAL OBJECTIVES ....................................................................... 43 
8.1 
Primary Effectiveness Objective(s) .................................................................. 43 
8.1.1 
Primary Effectiveness Endpoint(s) ............................................................... 43 
8.2 
Secondary Effectiveness Objective(s) .............................................................. 43 
8.2.1 
Secondary Effectiveness Endpoint(s) ........................................................... 44 
8.3 
Co-Primary Safety Objective ............................................................................ 45 
8.3.1 
Primary Safety Endpoint............................................................................... 45 
8.4 
Secondary Safety Objective(s) ......................................................................... 45 
8.4.1 
Secondary Safety Endpoint(s) ...................................................................... 45 
8.4.2 
Supportive Safety Endpoint(s) ...................................................................... 45 
9 
INVESTIGATIONAL PLAN ................................................................................ 47 
9.1 
Study Design ..................................................................................................... 47 

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9.2 
Rationale for Study Design ............................................................................... 48 
9.3 
Rationale for Choice of Control Article ........................................................... 48 
9.4 
Data Monitoring Committee ............................................................................. 49 
10 
SUBJECT POPULATION ........................................................................................... 50 
10.1 
Inclusion Criteria .............................................................................................. 50 
10.2 
Exclusion Criteria ............................................................................................. 51 
10.3 
Reasons for Non-Implantation.......................................................................... 52 
10.4 
Rescreening of Subjects.................................................................................... 53 
11 
TREATMENT ................................................................................................................ 54 
11.1 
Other Medical Device Specified for Use during the Study .............................. 58 
11.2 
Treatment Assignment / Randomization .......................................................... 58 
11.3 
Accountability Procedures ................................................................................ 58 
11.4 
Treatment Masking ........................................................................................... 59 
11.5 
Changes to Concomitant Treatments or Procedures ......................................... 60 
12 
CLINICAL TRIAL PROCEDURES .................................................................... 61 
12.1 
Informed Consent and Screening ..................................................................... 61 
12.2 
Clinical Trial Assessments ................................................................................ 61 
12.2.1 
Prohibited Procedures ................................................................................... 61 
12.2.2 
Screening/Preoperative Visit (Visit 0) .......................................................... 61 
12.2.3 
Operative Visits (Visit 00/00A) .................................................................... 63 
12.2.4 
1-Day Postoperative Visit (Visit 1/1A) ......................................................... 65 
12.2.5 
1-Week Postoperative Visit (Visit 2/2A) ....................................................... 66 
12.2.6 
1-Month Postoperative Visit (Visit 3A) ........................................................ 67 
12.2.7 
6-Month Postoperative Visit (Visit 4A) ........................................................ 68 
12.3 
Schedule of Procedures and Assessments for Discontinued Subjects .............. 70 
12.4 
Unscheduled Visits ............................................................................................... 71 
12.5 
Missed Visit .......................................................................................................... 73 
12.6 
Discontinued Subjects ...................................................................................... 73 
12.6.1 
Screen Failures ............................................................................................. 73 
12.6.2 
Discontinuations ........................................................................................... 73 
12.6.3 
Aborted Implantation .................................................................................... 74 
12.7 
Clinical Study Termination ............................................................................... 74 
13 
DEVICE DEFICIENCIES AND ADVERSE EVENTS ....................................... 76 

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13.1 
General Information ......................................................................................... 76 
13.2 
Serious Adverse Events (SAEs) ....................................................................... 77 
13.3 
Specific Events Relevant to this Protocol ........................................................ 78 
13.3.1 
Cumulative Serious Adverse Events ............................................................. 78 
13.3.2 
Persistent Serious Adverse Events ................................................................ 78 
13.4 
Supportive Characterization of Ocular Adverse Events ................................... 79 
13.5 
Secondary Surgical Interventions (SSI) ........................................................... 79 
13.6 
Device Deficiencies .......................................................................................... 79 
13.7 
Monitoring for Adverse Events ........................................................................ 80 
13.8 
Procedures for Recording and Reporting ......................................................... 80 
13.8.1 
Intensity and Causality Assessments ............................................................ 82 
13.8.1.1 
Intensity (Severity) ................................................................................... 82 
13.8.1.2 
Causality ................................................................................................... 82 
13.9 
Return Product Analysis ................................................................................... 82 
13.10 
Unmasking of the Study Treatment .................................................................. 83 
13.11 
Follow-Up of Subjects with Adverse Events .................................................... 83 
13.12 
Pregnancy in the Clinical Study ....................................................................... 83 
14 
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS................... 84 
14.1 
Subject Confidentiality ..................................................................................... 84 
14.2 
Completion of Source Documents and Case Report Forms ............................. 85 
14.3 
Data Review and Clarifications ........................................................................ 86 
14.4 
Sponsor and Monitoring Responsibilities ........................................................ 86 
14.5 
Regulatory Documentation and Records Retention ......................................... 86 
14.6 
Quality Assurance and Quality Control ............................................................ 87 
14.7 
Publication of the Clinical Trial .......................................................................... 87 
15 
ANALYSIS PLAN ................................................................................................ 89 
15.1 
Subject Evaluability .......................................................................................... 89 
15.2 
Analysis Data Sets ............................................................................................ 89 
15.3 
Demographics and Baseline Characteristics .................................................... 89 
15.4 
Performance Analyses ...................................................................................... 89 
15.4.1 
Primary Performance .................................................................................... 90 
15.4.1.1 
Statistical Hypotheses ............................................................................... 90 
15.4.1.2 
Analysis Methods ..................................................................................... 91 

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15.4.2 
Secondary Performance ................................................................................ 92 
15.4.2.1 
Statistical Hypotheses ............................................................................... 92 
15.4.2.2 
Analysis Methods ..................................................................................... 93 
15.5 
Handling of Missing Data ................................................................................ 98 
15.6 
Multiplicity ....................................................................................................... 99 
15.7 
Safety Analysis ................................................................................................. 99 
15.7.1 
Primary Safety .............................................................................................. 99 
15.7.1.1 
Adverse Events ......................................................................................... 99 
15.7.1.2 
Mesopic contrast sensitivity (with and without glare) ............................ 100 
15.7.2 
Secondary Safety ........................................................................................ 100 
15.7.3 
Supportive Safety ....................................................................................... 101 
15.8 
Interim Analyses ............................................................................................. 102 
15.9 
Adaptive Study Design ................................................................................... 102 
15.10 
Sample Size Justification ................................................................................ 103 
16 
Ethics .................................................................................................................. 104 
17 
REFERENCES ................................................................................................... 106 
18 
APPENDICES .................................................................................................... 107 
18.1 
Adverse Event Tables ............................................................................................. 107 
 
 
List of Tables 
Table 11–1 
Test Article ....................................................................................................... 54 
 
Table 11–2 
Control Article ................................................................................................. 56 
Table 11–3 
Delivery System ............................................................................................... 58 
Table 11-4 
Unmasked Individuals ..................................................................................... 59 
Table 12–1 
Contact Lens Discontinuation Prior to Preoperative Visit .................................. 61 
Table 18–1 
Additional Supportive Characterizations of Ocular Adverse Events ............. 107 
Table 18-2 
Definitions of Indications for Device Exchange, Removal, or Reposition ... 108 

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List of Figures 
Figure 9–1 
Study Design Diagram ..................................................................................... 48 
 
Figure 13–1 
Categorization of All Adverse Events .............................................................. 76 
 
Figure 13–2 
Categorization of All Serious Adverse Events ................................................. 77 

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3 
ABBREVIATIONS 
 
Abbreviation 
Definition 
AAS 
All-implanted analysis set 
ACD 
Anterior chamber depth 
ADE 
Adverse device effect 
AE 
Adverse event 
AL 
Axial length 
ARMD 
Age-related macular degeneration 
ASADE 
Anticipated serious adverse device effect 
BAS 
Best-case analysis set 
BCDVA 
Best corrected distance visual acuity 
BSS 
Balanced Salt Solution 
CDVA 
Corrected distance visual acuity 
CI 
Coordinating Investigator 
cm 
Centimeter 
D 
Diopter 
DD 
Device Deficiency 
DCIVA 
Distance corrected intermediate visual acuity 
DCNVA 
Distance corrected near visual acuity 
DEP 
Deviations and Evaluability Plan 
DOF 
Depth of focus 
DoH 
Declaration of Helsinki 
DFU 
Directions for use 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EDF 
Extended depth of focus 
ETDRS 
Early Treatment Diabetic Retinopathy Study 
EU 
European Union 
FA 
Fluorescein Angiography 
FDA 
US Food and Drug Administration 
FLACS 
Femtosecond laser-assisted cataract surgery 
GCP 
Good Clinical Practice 
GPCMS 
Global Product Complaint System 
IB 
Investigator’s brochure 
IDE 
Investigational Device Exemption 
IEC 
Independent ethics committee 
ICF 
Informed consent form 
ICH 
International Conference on Harmonization 
IOL 
Intraocular lens 
IOLSAT 
Intraocular Lens Satisfaction 
IOP 
Intraocular pressure 
IP 
Investigational product 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 

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LASIK 
Laser-assisted in situ keratomileusis 
LogMAR 
Logarithm of the minimum angle of resolution 
LRI 
Limbal relaxing incision 
m 
Meter 
mm 
Millimeter 
mmHg 
Millimeters of mercury 
MOP 
Manual of procedures 
MRSE 
Manifest refraction spherical equivalent 
Nd:YAG 
Neodymium-doped yttrium aluminium garnet 
N/A 
Not applicable 
OCT 
Ocular Coherence Tomography 
OD 
Right eye 
OVD 
Ophthalmic Viscosurgical Device 
PC 
Posterior capsulotomy 
PCO 
Posterior capsular opacification 
QUVID 
Questionnaire for Visual Disturbances 
RD 
Retinal detachment 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SD 
Standard deviation 
SME 
Sponsor Medical Expert 
SOP 
Standard operating procedures 
SPE 
Safety performance endpoint 
SSI 
Secondary surgical intervention 
SUN 
Standardization of Uveitis Nomenclature 
TPS 
Trapezoidal phase shift 
UCDVA 
Uncorrected distance visual acuity 
UCIVA 
Uncorrected intermediate visual acuity 
UCNVA 
Uncorrected near visual acuity 
UNSV 
Unscheduled visit 
US 
United States 
USADE 
Unanticipated serious adverse device effect 
VA 
Visual acuity 
YAG 
Yttrium Aluminum Garnet 

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4 
GLOSSARY OF TERMS 
 
ACRYSOF IQ Extended 
Depth of Focus (EDF) 
IOL (Model DFT015) 
Throughout this document, this investigational product (IP) 
will also be referred to as ACRYSOF IQ EDF IOL, Model 
DFT015, and test article. 
ACRYSOF IQ 
Monofocal IOL (Model 
SN60WF) 
Throughout this document, this IP will also be referred to as 
ACRYSOF IQ Monofocal IOL, Model SN60WF, and control 
article. 
Adverse Device Effect 
(ADE) 
Adverse event related to the use of an investigational medical 
device (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. 
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 
(test article). Note: For subjects, this definition includes 
events related to the test article, the control article, or the 
procedures involved. For users or other persons, this 
definition is restricted to events related to the test article. 
Anticipated Serious 
Adverse Device Effect 
(ASADE) 
Serious adverse device effect which by its nature, incidence, 
severity or outcome has been identified in the risk 
management file. 
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. 
Enrolled Subject 
Any subject who signs an informed consent form (ICF) for 
participation in the study. 
Interventional Study 
A study in which prospective subject assignment is decided 
by a protocol and use of the product is linked to the decision 
to include the subject in the study. Interventions include, but 
are not restricted to, drugs, cells and other biological 
products, surgical procedures, radiologic procedures, devices, 
behavioral treatments, process-of-care changes, and 
preventive care. Additional diagnostic or monitoring 
procedures are applied and methods other than 
epidemiological methods are being used for analysis of the 
data. 
Malfunction 
Failure of a medical device to perform in accordance with its 

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intended purpose when used in accordance with the 
instructions for use or clinical investigation plan. 
Nonserious Adverse 
Event 
Adverse event that does not meet the criteria for a serious 
adverse event. 
Pre-screened Subject 
Chart review completed on potential subjects by study site for 
inclusion/exclusion criteria that do not require study specific 
testing. This is based on routine clinical testing and/or cataract 
evaluation. 
Randomization Subject 
Any subject who is assigned a randomized treatment. 
Screened Subject 
Any subject who is considered for the study and may or may 
not have signed an ICF. 
Serious Adverse Device 
Effect (SADE) 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
Serious Adverse Event 
(SAE) 
Adverse event that led to any of the following: 
• Death. 
• A serious deterioration in health that either resulted in: 
a) a life-threatening illness or injury. 
Note: Life-threatening means that the individual was 
at immediate risk of death from the event as it 
occurred, ie, it does not include an event which 
hypothetically might have caused death had it 
occurred in a more severe form. 
b) any potentially sight-threatening event or permanent 
impairment to a body structure or a body function. 
c) in-patient hospitalization or prolonged hospitalization. 
Note: Planned hospitalization for a pre-existing 
condition, without serious deterioration in health, is 
not considered a serious adverse event. In general, 
hospitalization signifies that the individual remained 
at the hospital or emergency ward for observation 
and/or treatment (usually involving an overnight stay) 
that would not have been appropriate in the 
physician’s office or an out-patient setting. 
Complications that occur during hospitalization are 
adverse events. If a complication prolongs 
hospitalization or fulfills any other serious criteria, 
the event is serious. When in doubt as to whether 
“hospitalization” occurred, the event should be 
considered serious. 
d) a medical or surgical intervention to prevent a) or b), 
or any ocular secondary surgical intervention 

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excluding posterior capsulotomy. 
e) any indirect harm as a consequence of incorrect 
diagnostic test results when used within 
manufacturer’s instructions for use. 
• Fetal distress, fetal death, or a congenital abnormality or 
birth defect. 
Refer to Section 13 for additional SAEs. 
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 
management file. 
Use Error 
Act or omission of an act that results in a different medical 
device response than intended by manufacturer or expected by 
user. 
Note: This definition includes slips, lapses, and mistakes. An 
unexpected physiological response of the subject does not in 
itself constitute a use error. 

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5 
AMENDMENTS 
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments will be created by the Sponsor and must be approved 
by the institutional review board/ independent ethics committee (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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. 

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. 

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6 
SCHEDULE OF VISITS 
 
Both 
Eyes 
1st Operative Eye 
2nd Operative Eye 
Both Eyes 
 
Visit 
Visit 0 
Day -28-0 Preoperative 
Visit 00 1 
Day 0 Operative 
Visit 1 
Day 1-2 Post Visit 00 
Visit 2 
Day 7-14 Post Visit 00 
Visit 00A2 
7-14 Days Post Visit 00 
Visit 1A 
Day 1-2 Post Visit 00A 
Visit 2A 
7-14 Days Post Visit 00A 
Visit 3A 
30-60 Days Post Visit 00A 
Visit 4A3 
120-180 Days Post Visit 00A 
Early Exit 
General Assessments and Procedures 
Informed Consent 
X 
Demographics 
X 
Medical History 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Urine Pregnancy Test4 
X 
Inclusion/Exclusion 
X 
X 
X 
Ophthalmic Assessments 
QUVID questionnaire 
(for visual disturbance) 
X 
X 
X 
X 
IOLSAT questionnaire 
(for spectacle need) 
X 
X 
X 
X 
Anterior Chamber Depth 
X 
Axial Length 
X 
Keratometry 
X 
Predicted Target Residual Refractive 
Error5 
X 
Manifest Refraction (4 m) 
X 
X 
X 
X 
X 
X 
Distance VA at 4 m 
• 
Photopic Uncorrected 
X 
X 
X 
X 
X 
X 
X6 
X 
• 
Photopic Corrected 
X 
X 
X 
X 
X6 
X 
 
X 
Defocus Curve (4 m) 
X6 
X 
X 
Intermediate VA at 66 cm 
• 
Photopic Uncorrected 
X 
X6 
• 
Photopic Distance 
Corrected 
X 
X6 
• 
X 

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Both 
Eyes 
 
1st Operative Eye 
 
2nd Operative Eye 
 
Both Eyes 
 
 
 
 
 
 
Visit 
 
 
 
 
X 
 
Near VA at 40 cm 
• 
• 
Photopic Distance 
Corrected 
 
X 
X6 
X 
X6 
 
 
 
X 
X 
Contrast Sensitivity 
• 
Mesopic without Glare 
• 
Mesopic with Glare 
Slit Lamp Examination 
X 
Aqueous Signs 
IOL Observations 
IOL Position Change 
Subjective PCO 
Posterior Capsulotomy 
Intraocular Pressure 
X 
Dilated Fundus Exam 
X 
Fundus Visualization 
Surgical Procedure & Assessments 
Cataract Surgery 
X 
Lens Information 
X 
Incision Location7 
X 
Final Incision Size7,8 
X 
Problems during Surgery 
X 
Other Surgical Procedures 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
Adverse Events & Device Deficiencies 
Adverse Events9 
Secondary Surgical Interventions 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Visit 0 
Day -28-0 Preoperative 
Visit 00 1 
Day 0 Operative 
Visit 1 
Day 1-2 Post Visit 00 
Visit 2 
Day 7-14 Post Visit 00 
Visit 00A2 
7-14 Days Post Visit 00 
Visit 1A 
Day 1-2 Post Visit 00A 
Visit 2A 
7-14 Days Post Visit 00A 
Visit 3A 
30-60 Days Post Visit 00A 
Visit 4A3 
120-180 Days Post Visit 00A 
Early Exit 

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Both 
Eyes 
1st Operative Eye 
2nd Operative Eye 
Both Eyes 
 
Visit 
Visit 0 
Day -28-0 Preoperative 
Visit 00 1 
Day 0 Operative 
Visit 1 
Day 1-2 Post Visit 00 
Visit 2 
Day 7-14 Post Visit 00 
Visit 00A2 
7-14 Days Post Visit 00 
Visit 1A 
Day 1-2 Post Visit 00A 
Visit 2A 
7-14 Days Post Visit 00A 
Visit 3A 
30-60 Days Post Visit 00A 
Visit 4A3 
120-180 Days Post Visit 00A 
Early Exit 
Device Deficiencies 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
1. 
Visit 00 (1st eye surgery) must occur within 28 calendar days from Pre-Operative Visit (Visit 0). 
2. 
Visit 00A (2nd eye surgery) must occur between 7 and 14 calendar days after Visit 00. 
3. 
If necessary, Visit 4A may be completed over 2 days within a two-week period. Both days must fall within the 
specified visit window. 
4. 
In women of child bearing potential only. 
5. 
Data is reported in EDC at the surgical visit, but may be collected at a previous visit. 
6. 
Testing is conducted monocular (bilaterally) 
. 
7. 
Capture in source (not captured in EDC). 
8. 
Only measure in cases with surgical complications. 
9. 
Collected from time of consent onward. 

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7 
INTRODUCTION 
7.1 
Background 
Depth of focus (DOF) is the amount of focal plane displacement behind a lens that does not 
degrade the image quality of a distant object. The distance between the nearest and farthest 
objects in a scene that appear acceptably sharp depends upon the eye’s DOF. Larger DOF 
allows sharp images of closer objects. A young, healthy human eye provides large DOF due 
to the large range of accommodation of the crystalline lens; however, the amplitude of depth 
of focus or accommodation gradually declines with age. For most people, accommodation is 
completely lost in the mid-fifties. While subjects implanted with a monofocal IOL have good 
distance vision, quality of vision at intermediate and near is often insufficient to support 
activities of daily living 
 
Premium IOL solutions, such as multifocal IOLs, provide functional intermediate vision and 
near vision, but can also result in complaints of visual disturbance. In view of this, there 
exists a medical need to provide functional vision at intermediate and near distances, while 
maintaining good distance vision and a visual disturbance profile similar to that of a 
monofocal IOL. The ACRYSOF IQ EDF IOL was developed to provide an extended depth of 
focus at intermediate distance (approximately 66 cm) while maintaining distance VA and a 
safety profile similar to that of the ACRYSOF IQ Monofocal IOL. 
 
 
A summary of known and potential risks and benefits to humans, as identified in the literature 
or through preclinical testing and/or prior clinical evaluations, for each investigational 
product can be found in the respective Directions for Use (DFU) - ACRYSOF IQ model 

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SN60WF, ACRYSOF IQ EDF model DFT015. Additional relevant information on the test 
article can be found in the Investigator’s Brochure. 
 
7.2 
Purpose of the Study 
The ACRYSOF IQ EDF IOL was developed to provide an extended DOF for provision of 
functional intermediate and near vision while maintaining both a distance VA and a safety 
profile similar to that of the ACRYSOF IQ Monofocal IOL. The purpose of the study is to 
demonstrate the safety and performance of ACRYSOF IQ EDF IOL at Month 6/Visit 4A. 
 
7.3 
Risks and Benefits 
The risk of unanticipated adverse device effects with use of ACRYSOF IQ EDF IOL is 
considered to be low and the benefits of receiving the IOL should outweigh the risks for 
subjects that qualify for implantation in this study. 
 
7.3.1 
Known and Potential Risks 
Refer to the IB and DFU for comprehensive risk information on ACRYSOF IQ EDF IOL 
model DFT015. A summary of this information is found below. 
 
Surgical Complications: 
 
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 
(IOP), 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. 

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The ACRYSOF IQ EDF IOL may provide benefits to the subject by: 
ACRYSOF IQ EDF IOL Model DFT015: 
 
An IOL replacement or explantation may be appropriate in some cases of significant residual 
refractive error, ocular infection, subject dissatisfaction, or visual disturbances (eg, glare, 
halos, starbursts, hazy vision, blurred vision, double vision, visual distortions, and color 
distortions). In most/majority of cases, spectacles or contact lenses may be prescribed to 
resolve residual refractive error. Other secondary surgical interventions include, but are not 
limited to: IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, 
and iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal 
detachment repair. 
 
There may also be unknown risks with the use of the ACRYSOF IQ EDF IOL. Any foreseen 
risk to subjects in this clinical study will be minimized by compliance with the eligibility 
criteria, study procedures, and clinical monitoring. 
 
7.3.2 
Potential Benefits 
 
 
• Extending the range of functional vision to intermediate distances 
• Maintaining the distance VA and safety profile similar to ACRYSOF IQ 
Monofocal IOL 
• Providing improved near vision in comparison to a monofocal IOL 
• Eliminating the visual disturbances commonly associated with diffractive IOLs 

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8 
CLINICAL TRIAL OBJECTIVES 
8.1 
Primary Effectiveness Objective(s) 
Below are listed the study’s co-primary objectives. Each objective is assessed at Visit 4A 
(120-180d postoperative). 
1. To demonstrate ACRYSOF IQ EDF IOL is superior to ACRYSOF IQ Monofocal IOL 
in mean monocular photopic DCIVA 
2. To demonstrate that ACRYSOF IQ EDF IOL is non-inferior to ACRYSOF IQ 
Monofocal IOL in mean monocular photopic BCDVA 
3. To demonstrate that the monocular mean defocus curve for ACRYSOF IQ EDF IOL 
has a range of defocus at least 0.5 D greater negative range than ACRYSOF IQ 
Monofocal IOL at 0.2 logMAR 
4. To demonstrate that ACRYSOF IQ EDF IOL has at least 50% of eyes achieving 
DCIVA of 0.2 logMAR or better 
A successful outcome on the co-primary effectiveness endpoints is indicated by successful 
outcomes on all 4 of these endpoints. 
 
8.1.1 
Primary Effectiveness Endpoint(s) 
Below are listed the study’s primary effectiveness endpoints. 
 
1. Monocular photopic DCIVA (logMAR) 66 cm from spectacle plane 
2. Monocular photopic BCDVA (logMAR) 
3. Monocular depth of focus (measured in the negative direction from 0) at 0.2 logMAR 
4. Percentage of eyes achieving monocular photopic DCIVA of 0.2 logMAR or better 
8.2 
Secondary Effectiveness Objective(s) 
Below are listed the study’s co-secondary objectives. Each objective is assessed at Visit 4A 
(120-180d postoperative). 
1. To demonstrate that ACRYSOF IQ Extended Depth of Focus IOL is superior to 
ACRYSOF IQ Monofocal IOL in mean monocular photopic DCNVA 
In addition, the following performance targets will also be assessed to 
demonstrate clinical significance: 

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• At least 50% of eyes with ACRYSOF IQ EDF IOL achieve a monocular 
DCNVA of 0.3 logMAR or better 
• Percentage of eyes achieving monocular DCNVA of 0.3 logMAR or better in 
ACRYSOF IQ EDF IOL group is at least 25 percentage points higher than in 
ACRYSOF IQ Monofocal IOL group 
2. To demonstrate that ACRYSOF IQ Extended Depth of Focus IOL is superior to 
ACRYSOF IQ Monofocal IOL with respect to proportion of subjects who respond 
“Never” to Q1 of the IOLSAT questionnaire (Overall, in the past 7 days, how often did 
you need to wear eyeglasses to see?) 
3. To describe mean monocular photopic UCIVA outcomes 
4. To describe mean monocular photopic UCDVA outcomes 
8.2.1 
Secondary Effectiveness Endpoint(s) 
Below are listed the study’s secondary effectiveness endpoints. 
 
1. Monocular photopic DCNVA (logMAR) 40 cm from spectacle plane 
2. Proportion of subjects who respond “Never” to Q1 of the IOLSAT questionnaire: 
“Overall, in the past 7 days, how often did you need to wear eyeglasses to see?” 
3. Monocular photopic UCIVA (logMAR) 66 cm from spectacle plane 
4. Monocular photopic UCDVA (logMAR) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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• IOL tilt/decentration 
• Subjective PCO assessment 
• Posterior capsulotomy 
• Dilated fundus exam findings including fundus visualization 
• Intraoperative surgical problems 
• Other procedures at surgery (combined and/or additional) 
• Adverse events (including SSIs) 
• Device deficiencies 

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9 
INVESTIGATIONAL PLAN 
9.1 
Study Design 
This is a prospective, multi-center, randomized, parallel-group, controlled, assessor- and 
subject-masked study. Both eyes of a subject must require cataract surgery to qualify for 
enrollment into this study. To reduce bias, subjects will be randomly assigned in a 1:1 ratio to 
receive either ACRYSOF IQ EDF IOL model DFT015 (test article) or ACRYSOF IQ 
Monofocal IOL model SN60WF (control article) in both eyes. To further reduce bias, all 
subjects and site assessors will be masked to subject treatment assignment until the end of the 
study. 
 
The first operative eye is defined as the eye with the worse BCDVA. If the BCDVA is the 
same in both eyes, identify the right eye (OD) as the first operative eye. The second eye 
implant must occur within 14 days of the first eye implant. 
 
A total of 9 scheduled visits are planned and subject participation is expected to last 7-8 
months. The visits include a Screening visit (Visit 0), 2 Operative Visits (Visit 00 and Visit 
00A), and 6 postoperative visits at the following intervals: Day 1-2 (Visit 1/1A), Day 7-14 
(Visit2/2A), Day 30-60 (Visit 3A), and Day 120-180 (Visit 4A) (See Figure 9-1 Study 
Design). Primary endpoint data will be collected at the Month 6/ Visit 4A (120-180 day post 
2nd eye implantation). 
Note: Visit 4A may be completed over 2 days within a 2-week period. Both days must fall 
within the specified visit window. 

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Figure 9–1 
Study Design Diagram 
 
 
9.2 
Rationale for Study Design 
The study is designed to assess performance and safety parameters of interest in compliance 
with guidance from the draft ANSI Z80.35 Extended Depth of Focus Intraocular Lenses 
(11 July 2016) and the American Academy of Ophthalmology Task Force Consensus 
Statement for Extended Depth of Focus Intraocular Lenses (MacRae 2017). Compliance 
includes subject number requirement (100 per lens model), follow-up period (6 months 
postoperative), control article (see Section 9.3 below), randomization, masking, and 
assessments. 
 
9.3 
Rationale for Choice of Control Article 
ACRYSOF IQ EDF IOL is a modification of the United States (US) Food and Drug 
Administration (FDA) approved, commercially available control article (ACRYSOF IQ 
Monofocal IOL). The control article has the same physical properties and is composed of the 
same material as the test article. Based on optical bench testing and simulation of the test 
article, the contrast sensitivity under mesopic conditions is expected to be comparable to the 

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control article. Further, the ACRYSOF IQ Monofocal IOL is well established in the literature 
and is considered the industry standard of care. For these reasons, the ACRYSOF IQ 
Monofocal IOL is scientifically the most appropriate control article for this study, and 
functions to reduce bias. 
 
9.4 
Data Monitoring Committee 
Not applicable. 

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1. Adults (22 years or older at the time of participation in the study) diagnosed with 
cataract in both eyes 
2. BCDVA of 0.3 logMAR (20/40 Snellen) or worse either with or without a glare 
source present (e.g., Brightness Acuity Tester). 
3. Clear intraocular media other than cataract 
4. Planned cataract removal by routine small incision surgery 
5. Calculated lens power between 18.0 and 25.0 D [when targeted for emmetropia (0.00 
D)] 
10 
SUBJECT POPULATION 
The study population consists of male and female subjects 22 years of age and older, with a 
diagnosis of cataract in both eyes, requiring surgery with implantation of a monofocal IOL in 
the capsular bag. It is aimed to randomize approximately 220 subjects at approximately 12 
US investigative sites. Each site will aim to randomize approximately 20 subjects, and no site 
will randomize more than 55 subjects (25% of total). Site specific targets may be adjusted 
based on individual site capabilities. Enrollment projections are as follows: 
 
• 240 subjects to be enrolled/sign consent (approximately 10% screen failure rate is 
expected) 
• 220 subjects to be randomized (approximately 10% discontinuation rate is 
expected) 
• 200 subjects to successfully complete the final study visit (Visit 4A) 
o 100 subjects in the ACRYSOF IQ EDF IOL arm 
o 100 subjects in the ACRYSOF IQ Monofocal IOL arm 
Sites must check all entry criteria at Screening/Visit 0 and at both surgical visits (Visit 00, 
Visit 00A). If a subject is excluded post randomization and prior to first eye surgery (IOL 
does not come in contact with the eye), the subject should be discontinued from participation 
in the study. Refer to Section 12.6 Discontinued Subjects for further details. 
 
10.1 
Inclusion Criteria 
Subjects eligible for inclusion in this study must fulfill all of the below listed criteria. When 
criteria are ocular, both eyes must meet criteria. 
 

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10.2 
Exclusion Criteria 
Subjects fulfilling any of the below listed criteria are not eligible for inclusion in this study. 
When criteria are ocular, the subject is not eligible if either eye meets the criteria. 
 
1. Any disease or pathology, other than cataract, that (in the expert opinion of the 
Investigator) is expected to reduce the potential postoperative best corrected distance 
visual acuity (BCDVA) to a level worse than 0.2 logMAR (including, but not limited 
to the following: amblyopia, clinically severe corneal dystrophy (e.g., epithelial, 
stromal, or endothelial dystrophy), diabetic retinopathy, extremely shallow anterior 
chamber, not due to swollen cataract, microphthalmos, previous retinal detachment, 
previous corneal transplant, recurrent severe anterior or posterior segment 
inflammation of unknown etiology, iris neovascularization, uncontrolled glaucoma, 
aniridia, or optic nerve atrophy, epiretinal membrane, macular degeneration, or 
diagnosis of pseudoexfoliation) 
 
2. History of recurrent anterior segment/posterior segment inflammation. 
 
3. Clinically significant (in the Investigator’s opinion) corneal pathology (epithelial, 
stromal, endothelial) or ocular surface disease that would adversely affect the visual 
outcome including but not limited to old significant corneal scars (including 
Salzman’s nodular degeneration), corneal irregularity (including dry eye syndrome), 
active or inactive keratitis with compromise of the refractive capability of the cornea, 
keratoconjunctivitis sicca with compromise of visual function, active keratouveitis, 
endothelial dystrophy (Fuch’s and non-guttate), keratoconus, etc. 
4. Clinically significant ocular surface disease that would affect study measurements 
based on Investigator expert medical opinion 
 
5. History of previous intraocular or corneal surgery 
6. Willing and able to complete all required postoperative visits 
7. Able to comprehend and sign an IRB/IEC approved statement of informed consent 
8. Potential postoperative BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye 
based on Investigator’s medical opinion 
9. Preoperative keratometric astigmatism of less than 1.0 D in both operative eyes 

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1. Surgical complications including but not limited to loss of zonular integrity/zonular 
weakness, zonular rupture, anterior capsular rupture interfering with the stability of the 
IOL, posterior capsule rupture, any evidence of fluid misdirection during the cataract 
procedure with progressive shallowing of the anterior chamber, uncontrollable IOP 
2. Mechanical or surgical manipulation of the pupil 
3. Excessive iris mobility 
6. Pregnant/lactating or has another condition with associated fluctuation of hormones 
that could lead to refractive changes 
 
7. History of amblyopia or monofixation syndrome with poor stereoscopic vision 
 
8. Current or recent use of an alpha-1-selective adrenoceptor blocking agent or an 
antagonist of alpha1A adrenoceptor (e.g. Flomax (tamsulosin HCL), Hytrin, or 
Cardura) that in the opinion of the investigator would potentially require mechanical 
or surgical manipulation to enlarge the pupil 
 
9. Concurrent participation in another clinical trial that, in the Investigator’s opinion, 
may confound the results of the current study 
 
10. Any other ocular condition or systemic co- morbidity that, in the opinion of the 
Investigator, may confound the results of this study or prohibit the completion of the 
study assessments or increase the risk for the subject 
 
11. Subjects with conditions that, in the Investigator’s opinion, increase the risk of 
zonular rupture during cataract extraction procedure (eg, pseudoexfoliation syndrome, 
Marfan syndrome) that may affect the postoperative centration or tilt of the lens 
 
12. Any other planned ocular surgical procedures including but not limited to limbal 
relaxing incision (LRI), astigmatic keratotomy, laser-assisted in situ keratomileusis 
(LASIK), and retinal laser treatment within the study time frame 
 
13. Patients who desire monovision correction 
 
10.3 
Reasons for Non-Implantation 
Below are listed reasons to not implant the study lens, where study lens refers to both the test 
lens and the control lens. 
 

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If the study implantation is aborted due to a reason for non-implantation, follow standard of 
care and implant a non-study lens. In the event the first eye is not implanted and the IOL did 
not touch the eye, the subject is discontinued from the study. If the implantation is aborted 
and the IOL did touch the eye (first operative eye), then the second eye should not be 
implanted and the subject is encouraged to attend all follow-up study visits for safety 
evaluation on this eye only. In the event the second eye is not implanted, the subject 
continues in the study. Refer to Manual of Procedures (MOP) Section 5.4 for complete details 
on subject discontinuation and/or follow-up when a lens is not implanted. 
 
10.4 
Rescreening of Subjects 
Rescreening of subjects is not allowed in this study. 
4. Inability to place the IOL in the capsular bag due to surgical complications 

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11 
TREATMENT 
Throughout the clinical study, the Investigator is responsible for the accounting of all IP and 
must ensure that the clinical study product is used in accordance with the manufacturer’s 
DFU and IB. 
 
Table 11–1 
Test Article 
 
Test Product 
ACRYSOF IQ EDF IOL (Model DFT015) 
Manufacturer 
Alcon 
Indication for use 
The ACRYSOF IQ EDF IOL model DFT015 IOL is intended for 
primary implantation for the visual correction of aphakia in adult 
patients with < 1.00 D of preoperative corneal astigmatism, in whom 
a cataractous lens has been removed by extracapsular cataract 
extraction. Compared to a monofocal aspheric IOL, the lens may 
provide a continuous extended DOF, with improved intermediate and 
near visual acuity, while maintaining comparable distance visual 
acuity. The lens is intended for capsular bag placement only. 
Intended Purpose in 
the current study 
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. The lens is intended 
to provide distance vision and a continuous range of functional vision 
between distance and intermediate and improved near acuity. 
Product description 
and parameters 
available for this 
study 
Optic Type - Biconvex Aspheric Optic 
Optics Material – Ultraviolet and blue light filtering Acrylate/ 
Methacrylate Copolymer 
Optic Powers: 18.0 to 25.0 D in 0.5 D steps 
Index of Refraction: 1.55 
Haptic Configuration: STABLEFORCE® Haptics 
Haptic Material: Ultraviolet and blue light filtering Acrylate/ 
Methacrylate Copolymer (Boettner 1962) 
Optic Diameter (mm): 6.0 
Overall Length (mm): 13.0 

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Haptic Angle: 0° 
Formulation 
N/A 
Usage 
IOLs are implantable medical devices and are intended for long-term 
use over the lifetime of the pseudophakic subject. 
Amount of Product 
to be Provided to the 
Subject 
Following randomization, each subject will be bilaterally implanted 
with the control or test article. 
Packaging 
description 
Each IOL will be individually packaged and will have a unique serial 
number. The IOL package will contain the following items: 
• The IOL 
• A subject registration card (Lens Implant Card) 
• A subject identification card 
• Adhesive labels containing the IOL information and unique 
serial number 
• A package insert containing directions for use 
Labeling description 
Packaged in a standard Alcon IOL carton. The carton is labeled with 
the following information: name of the lens, model number, overall 
diameter, optic diameter, diopter power, serial number, name of the 
manufacture, storage condition, expiration date, sterile, and single 
use. Each package is also labeled “Exclusively for Clinical 
Investigations” and “Caution – Investigational device. Limited by 
Federal (or United States) law to investigational use”. 
Storage conditions 
The IP must be stored in a safe, secure location with limited access 
separated from general stock. Transportation of product from one 
address to another must be documented and a Transportation Log (or 
similar documentation) utilized for appropriate accountability. 
Additional 
information 
• In order to implant IOLs in study subjects, the surgeons 
participating in the study must be licensed ophthalmologists 
with cataract surgery experience and trained on the protocol. 
• Subjects in this protocol must be targeted for an emmetropic 
postoperative refraction (ie, the lens power selected must be 
that which has a predicted residual refraction closest to 
emmetropia (0.00 D)). 
• More information on the test article can be found in the IB 

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(0138) and DFU for ACRYSOF IQ EDF IOL. 
Supply 
A designated amount of IOLs will be supplied to the site by the 
Sponsor. 
 
Table 11–2 
Control Article 
 
Control Product 
ACRYSOF IQ Monofocal IOL (Model SN60WF) 
Manufacturer 
Alcon 
Indication for use 
The ACRYSOF IQ Monofocal IOL model SN60WF IOL is indicated 
for the replacement of the human lens to achieve visual correction of 
aphakia in adult patients following cataract surgery. This lens is 
intended for placement in the capsular bag. 
Intended Purpose in 
the current study 
This lens is indicated for the replacement of the human lens to achieve 
visual correction of aphakia in adult patients following cataract 
surgery. This lens is intended for placement in the capsular bag. 
Product description 
and parameters 
available for this 
study 
Optic Type: Biconvex Aspheric Optic 
Optics Material: Ultraviolet and blue light filtering Acrylate/ 
Methacrylate Copolymer 
Optic Powers: 18.0-25.0 D in 0.5 D steps 
Index of Refraction: 1.55 
Haptic Configuration: STABLEFORCE® Haptics 
Haptic Material: Ultraviolet and blue light filtering Acrylate/ 
Methacrylate Copolymer (Boettner 1962) 
Optic Diameter (mm): 6.0 
Overall Length (mm): 13.0 
Haptic Angle: 0° 
Formulation 
N/A 
Usage 
IOLs are implantable medical devices and are intended for long-term 
use over the lifetime of the pseudophakic subject. 
Amount of Product 
to be Provided to the 
Following randomization, each subject will be bilaterally implanted 

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Subject 
with the control or test article. 
Packaging 
description 
Each IOL will be individually packaged and will have a unique serial 
number. The IOL package will contain the following items: 
• The IOL 
• A subject registration card (Lens Implant Card) 
• A subject identification card 
• Adhesive labels containing the IOL information and unique 
serial number 
• A package insert containing directions for use 
Labeling description 
This lens is marketed in the countries conducting this clinical study. In 
countries where applicable, an additional label will be added to the 
marketed product noting, “Investigational Device” and “To Be Used 
by Qualified Investigators Only” or alternate country required text 
(text in English and translation as appropriate). 
Storage conditions 
IP must be stored in a safe, secure location with limited access 
separated from general stock. Transportation of product from one 
address to another must be documented and a Transportation Log (or 
similar documentation) utilized for appropriate accountability. 
Additional 
information 
• In order to implant IOLs in study subjects, the surgeons 
participating in the study must be licensed ophthalmologists 
with cataract surgery experience and trained on the protocol. 
• Subjects in this protocol must be targeted for an emmetropic 
postoperative refraction (ie, the lens power selected must be 
that which has a predicted residual refraction closest to 
emmetropia (0.00 D)). 
• More information on the control article can be found in the 
DFU for ACRYSOF IQ Monofocal IOL. 
Supply 
A designated amount of IOLs will be supplied to the site by the 
Sponsor. 

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11.1 
Other Medical Device Specified for Use during the Study 
 
Table 11–3 
Delivery System 
 
Delivery System 
Qualified Diopter Range 
ACRYSOF IQ EDF IOL 
(Model DFT015) 
ACRYSOF IQ Monofocal 
IOL 
(Model SN60WF) 
MONARCH® II/III C Cartridge with: 
• 
MONARCH II (green) handpiece 
• 
MONARCH III (blue) handpiece 
18.0 – 25.0 D 
18.0 – 25.0 D 
MONARCH III D Cartridge only with: 
• 
MONARCH III (blue) handpiece 
18.0 – 25.0 D 
18.0 – 25.0 D 
11.2 
Treatment Assignment / Randomization 
Subjects will be randomized in a 1:1 ratio to receive either ACRYSOF IQ EDF IOL or 
ACRYSOF IQ Monofocal IOL. Randomization will be stratified by site. After signing the 
ICF, the subject is considered enrolled. After which he/she will be assigned a subject number 
by the electronic data capture (EDC) system. The Investigator (or delegate) will initiate 
randomization in EDC: 
 
• after confirming the subject meets eligibility criteria 
• post lens power calculation and IOL power selection for both lens types (ie, the 
power calculation for both the ACRYSOF IQ EDF IOL and the ACRYSOF IQ 
Monofocal IOL must be conducted prior to randomization) 
• within 2 business days of the first eye operative visit (Visit 00) 
11.3 
Accountability Procedures 
Upon receipt of IP, the Investigator or delegate must conduct an inventory of all IOLs by 
serial number, complete study specific confirmation of receipt procedures, and retain any 
required documentation in the Investigator’s clinical study records. Throughout the study, the 
Investigator or delegate must maintain records of IP use for each subject. This record must be 
made available to the study monitor for the purposes of verifying the accounting of IP 
supplies. Any discrepancies and/or deficiencies between the observed disposition and the 
written account must be recorded along with an explanation. All IP sent to the Investigator 
must be accounted for by Study Sponsor personnel, and in no case be used in an unauthorized 
manner. 

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If possible, investigational and control products associated with a DD must be returned to the 
Study Sponsor. Refer to Section 13 of this protocol for additional information on the 
reporting of device deficiencies and to the MOP for information on return of study products 
associated with these events. 
 
The Investigator is responsible for proper disposition of all unused IPs at the conclusion of 
the study, according to the instructions provided by the Sponsor. 
 
11.4 
Treatment Masking 
The assessor and subject will be masked in this study. Subjects will be masked to treatment 
assignment for the entire duration of the study. Site personnel performing the manifest 
refraction, all VA assessments (including defocus curve testing), and all contrast sensitivity 
assessments will remain masked with regard to treatment assignment until after the final 
database lock. Should a subject safety concern arise, refer to Section 13.10 Unmasking of the 
Study Treatment. Note: Any unmasking of assessor or subject must be reported to Alcon. 
 
After the subject is implanted with the appropriate lens, a generic implant card is provided to 
the subject. The implant card will not reveal his/her treatment assignment. The treatment 
assignment will only be revealed to the study subject after the final database lock and when 
investigative sites are notified by the Study Sponsor. 
 
Masked study personnel must avoid seeking information that may compromise masking. 
Unmasked study personnel must not disseminate information that is potentially unmasking to 
any masked personnel. A list of unmasked individuals can be found in Table 10-4 below. 
 
Table 11-4 
Unmasked Individuals 
 
Unmasked Individual 
Extent of Unmasking 
Rationale 
Investigator 
Unmasked to IP treatment 
assignment 
Investigator will be implanting 
the IOL and will have knowledge 
of the treatment assigned to study 
subjects 
Site Personnel (not 
completing assessments 
noted Section 11.4) 
Unmasked to IP treatment 
assignment 
Site personnel involved with 
operative visits and data entry 
into EDC 
Monitor 
Unmasked to IP treatment 
assignment 
Monitor will complete IP 
accountability and monitoring 
responsibilities 

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11.5 
Changes to Concomitant Treatments or Procedures 
After the subject is enrolled (signed an ICF) into the study, the Investigator must instruct the 
subject to notify the study site about: 
 
• Any new medications 
• Alterations in dose or dose schedules for current medications 
• Any medical procedure or hospitalization that occurred or is planned 
• Any non-drug therapies (including physical therapy and blood transfusions) 
The Investigator must document this information in the subject’s case history source 
documents. 

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12 
CLINICAL TRIAL PROCEDURES 
12.1 
Informed Consent and Screening 
The subject must sign the ICF BEFORE any study specific procedures or assessments can be 
performed. The Investigator must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IEC/IRB approved ICF. Additionally, the individual obtaining 
consent from the subject must sign and date the ICF. The Investigator must provide a copy of 
the signed document to the subject and place the original signed document in the subject’s 
chart, or provide documentation as required by local regulations. 
 
12.2 
Clinical Trial Assessments 
The following section outlines the assessments to be performed in this clinical study. 
Assessments are described in detail in the ILI875-C002 MOP, and are outlined in tabular 
format in Section 6 of this protocol. 
 
12.2.1 
Prohibited Procedures 
Refractive surgical procedures are prohibited in the study eye at surgery and throughout the 
duration of the subject’s participation in the clinical study. Prohibited procedures include, but 
are not limited to, LASIK, astigmatic keratotomy and limbal relaxing incisions (qualify as 
LRI outside of PI's predetermined placement of corneal incision locations). Retinal laser 
treatments are also prohibited. 
 
12.2.2 
Screening/Preoperative Visit (Visit 0) 
Visit 0: -28-0 Days Prior to Visit 00, Bilateral Visit 
 
To ensure corneal stability subjects who wear contact lenses must discontinue use prior to the 
preoperative visit measurements. Discontinuation guidelines are provided below in 
Table 12-1. 
 
Table 12–1 
Contact Lens Discontinuation Prior to Preoperative Visit 
 
Type of Contact Lens 
Minimum Time to Stop Wearing 
before Preoperative 
Hard or rigid gas permeable lenses 
3 weeks 
Daily wear soft lenses 
2 weeks 
Soft extended-wear lenses 
2 weeks 

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Below is a list of study procedures to be done at Visit 0. It is recommended that procedures 
are performed in the order described below unless otherwise stated. All assessments must be 
documented in the source documentation and, if applicable, electronic case report form 
(eCRF). 
 
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 -28 to 0 day preoperative time period. 
 
1. Review 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 Ethics. 
 
3. Collect subject demographic, medical history information, and concomitant 
medication use. 
 
4. Perform a urine pregnancy test, IF the subject is a woman of childbearing potential. 
 
5. Assess anterior chamber depth (ACD) and axial length (AL) with an optical biometer. 
[Both Eyes, Bilateral] 
 
6. Perform keratometry measurements with a biometer. From this measure, determine if 
the subject qualifies with <1.00 D of keratometric astigmatism in both eyes. [Both 
Eyes, Bilateral] 
 
7. For both the ACRYSOF IQ EDF IOL and the ACRYSOF IQ monofocal IOL select 
and document the subject’s required lens power. The power selected must be that 
which has a predicted residual refraction closest to emmetropia (0.00 D). Refer to the 
MOP for acceptable formulas. [Both Eyes, Bilateral] 
Note: This determination may be made any time after required biometry has been 
collected and must be made prior to randomization. Lens power cannot be changed 
post randomization. 
 
8. Perform manifest refraction. [Both Eyes, Bilateral] 
Note: UCDVA testing may be performed prior to manifest refraction. 

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9. Assess UCDVA and BCDVA under photopic conditions at 4 m. [Both Eyes, Bilateral] 
 
10. Identify the first operative eye for this study. To reduce bias, first operative eye is 
defined as the eye with the worse BCDVA, or the right eye if the VA is equal in both 
eyes. 
Note: This determination may be made at any time after BCDVA measurement. 
 
11. Measure photopic pupil size with subject fixated on 4m VA chart under photopic 
conditions. [Both Eyes, Bilateral] 
Note: Pupil diameter should be measured under the same photopic light conditions as 
the VA tests. 
 
12. Conduct slit lamp examination. [Both Eyes, Bilateral] 
 
13. Perform tonometry to measure IOP. [Both Eyes, Bilateral] 
 
14. Conduct dilated fundus examination. [Both Eyes, Bilateral] 
 
15. Assess for and record any AEs. Refer to Section 13 for further details. 
 
16. Evaluate subject against all entry criteria. If subject fails criteria, screen fail the 
subject. 
 
17. Provide the QUVID and IOLSAT questionnaires to the subject for completion. 
Note: Questionnaires may be completed any time after entry criteria have been met. 
Subjects screen failing should not be given the questionnaire. 
 
18. Proceed with scheduling study surgery(ies). 
 
12.2.3 
Operative Visits (Visit 00/00A) 
Visit 00: Day 0, Monocular First Eye 
Visit 00A: 7-14 Days Post First Implantation, Monocular Second Eye 
Note: The Visit 00A window may overlap with other study visit windows (eg, Visit 2). In this 
case, both visits may be conducted on the same day at the discretion of the Investigator. 
 
Each study surgeon should follow his/her routine cataract procedure for all study surgeries, 
and according to the site’s documented surgical protocol. 

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It is permitted to have 1 study-trained surgeon at each site perform IOL implantations. For 
surgeons with experience prior to the start of the trial, femtosecond laser-assisted cataract 
surgery (FLACS) is permitted, however it is NOT required. The laser may ONLY be used for 
the following: 
 
• Primary and sideport incisions 
• Capsulorhexis 
• Lens fragmentation 
Use of any intraoperative power assessment is not permitted during surgery. 
 
Below is a list of study procedures to be completed 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, if applicable, eCRF. 
 
1. In preparation for the operative visit, randomize the subject. 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. 
Note: Randomization must occur within 2 business days of the scheduled first eye 
surgery. Lens power cannot be changed after the subject is randomized. 
 
2. Document any changes to ocular and non-ocular concomitant medications. 
 
3. Prior to treatment, review inclusion/exclusion criteria and ensure the subject has been 
properly consented for participation in the study. 
 
4. Prepare subject for surgery in accordance to site specific operating procedures. 
[Operative Eye Only, Monocular] 
 
5. Perform surgery and implantation with the randomized IOL. [Operative Eye Only, 
Monocular] Implantation may be attempted twice. After 2 aborted implants, the 
subject must be implanted with a non-study IOL (IOL not provided as part of study 
consignment). 
 
6. If a surgical complication occurs, measure and record incision size at the completion 
of IOL implantation. [Operative Eye Only, Monocular] 
 
7. Record incision location. [Operative Eye Only, Monocular] 

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1. Record changes in medical/ocular history and ocular and non-ocular concomitant 
medications. 
2. Assess UCDVA under photopic conditions at 4 m. [Operative Eye Only, Monocular] 
3. Perform slit lamp examination of the anterior segment. Include documentation of IOL 
observations, if any. [Operative Eye Only, Monocular] 
4. Grade cell and flare according to Standardization of Uveitis Nomenclature (SUN) 
system (SUN Working Group, 2005). Refer to MOP for grading scheme. [Operative 
Eye Only, Monocular] 
5. Observe and record any IOL position changes (ie, tilt and decentration) occurring 
since the previous visit. [Operative Eye Only, Monocular] 
6. Assess subjective PCO, and record information for any posterior capsulotomy (PC) 
 
 
12.2.4 
1-Day Postoperative Visit (Visit 1/1A) 
Visit 1: 1-2 Day Post First Eye Implantation, Monocular First Eye 
Visit 1A: 1-2 Days Post Second Eye Implantation, Monocular Second Eye 
 
Below is a list of study procedures to be completed 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, if applicable, eCRF. 
 
8. Record any intraoperative surgical problems, complications or other procedures that 
occur during surgery. Other procedures include those performed outside of routine 
cataract surgery whether combined and/or additional. [Operative Eye Only, 
Monocular] 
Note: Other planned procedures at the time of surgery are exclusionary. 
9. Record the lens information that is located on the IOL sticker. Both successful and 
aborted (if applicable) test and control article information should be recorded. 
[Operative Eye Only, Monocular] 
10. Evaluate for and record any AEs including SSIs. Refer to Section 13 for further detail. 
11. Evaluate for and record any DDs. Refer to Section 13 for further detail. 

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12.2.5 
1-Week Postoperative Visit (Visit 2/2A) 
Visit 2: 7-14 Days Post First Eye Implantation, Monocular First Eye 
Visit 2A: 7-14 Days Post Second Eye Implantation, Monocular Second Eye 
 
Below is a list of study procedures to be completed 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, if applicable, eCRF. 
 
1. Record changes in medical/ocular history and ocular and non-ocular concomitant 
medications. 
 
2. Perform manifest refraction. [Operative Eye Only, Monocular] 
NOTE: UCDVA testing may be performed prior to manifest refraction. 
 
3. Assess UCDVA and BCDVA under photopic conditions at 4 m. [Operative Eye Only, 
Monocular] 
 
4. Perform slit lamp examination of the anterior segment. Include documentation of IOL 
observations, if any. [Operative Eye Only, Monocular] 
 
5. Grade cell and flare according to SUN system (refer to MOP for grading scheme). 
[Operative Eye Only, Monocular] 
 
6. Observe any IOL position changes (ie, tilt and decentration) occurring since the 
previous visit. [Operative Eye Only, Monocular] 
 
7. Assess subjective PCO, and record information for any PC that has occurred since 
surgery, if applicable. [Operative Eye Only, Monocular] 
 
8. Perform tonometry to measure IOP. [Operative Eye Only, Monocular] 
that has occurred since surgery, if applicable. [Operative Eye Only, Monocular] 
7. Perform tonometry to measure IOP. [Operative Eye Only, Monocular] 
8. Evaluate for and record any AEs including SSIs. Refer to Section 13 for further detail. 
9. Evaluate for and record any DDs. Refer to Section 13 for further detail. 

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12.2.6 
1-Month Postoperative Visit (Visit 3A) 
Visit 3A: 30-60 Days Post Second Eye Implantation, Bilateral 
 
Below is a list of study procedures to be completed 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, if applicable, eCRF. 
 
1. Provide the QUVID and IOLSAT questionnaires to the subject for completion. 
Questionnaires should be completed by the subject prior to administration of any 
other assessment. 
 
2. Record changes in medical/ocular history and ocular and non-ocular concomitant 
medications. 
 
3. Perform manifest refraction. [Both Eyes, Bilateral] 
Note: UCDVA testing may be performed prior to manifest refraction. 
 
4. Assess monocular UCDVA and BCDVA under photopic conditions at 4 m. [Both 
Eyes, Bilateral] 
 
5. Assess monocular UCIVA and DCIVA under photopic conditions at 66 cm. [Both 
Eyes, Bilateral] 
 
6. Assess monocular UCNVA and DCNVA under photopic conditions at 40 cm. [Both 
Eyes, Bilateral] 
 
7. Perform slit lamp examination of the anterior segment. Include documentation of IOL 
observations, if any. [Both Eyes, Bilateral] 
 
8. Grade cell and flare according to SUN system (refer to MOP for grading scheme). 
[Both Eye, Bilateral] 
 
9. Observe any IOL position changes (ie, tilt and decentration) occurring since the 
previous visit. [Both Eyes, Bilateral] 
 
10. Assess subjective PCO, and record information for any PC that has occurred since 
9. Evaluate for and record any AEs including SSIs. Refer to Section 13 for further detail. 
10. Evaluate for and record any DDs. Refer to Section 13 for further detail. 

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4. Assess monocular UCDVA and BCDVA under photopic conditions at 4 m. [Both 
Eyes, Bilateral] 
) may be performed prior to 
monocular 
Note: UCDVA testing 
manifest refraction. 
1. Provide the QUVID and IOLSAT questionnaires to the subject for completion. 
Questionnaires should be completed by the subject prior to administration of any 
other assessment. 
2. Record changes in medical/ocular history and ocular and non-ocular concomitant 
medications. 
3. Perform manifest refraction. [Both Eyes, Bilateral] 
 
 
12.2.7 
6-Month Postoperative Visit (Visit 4A) 
Visit 4A: 120-180 Days Post Second Eye Implantation, Bilateral 
 
This visit may be completed over 2 days within a two-week period. Both days must fall 
within the specified visit window. Below is a list of study procedures to be completed at 
Visit 4A. It is recommended that procedures are performed in the order described below 
unless otherwise stated. If a subject appears fatigued, or requests a break from testing, 
provide a rest. All assessments must be documented in source documentation and, if 
applicable, eCRF. 
 
surgery, if applicable. [Both Eyes, Bilateral] 
11. Perform tonometry to measure IOP. [Both Eyes, Bilateral] 
12. Conduct dilated fundus exam noting any issues with fundus visualization due to the 
lens optic. [Both Eyes, Bilateral] 
13. Evaluate for and record any AEs including SSIs. Refer to Section 13 for further detail. 
14. Evaluate for and record any DDs. Refer to Section 13 for further detail. 

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8. Perform monocular defocus curve testing. [Both Eyes, Bilateral] 
 
 
 
 
 
 
 
 
 
 
11. Assess monocular UCIVA and DCIVA under photopic conditions at 66 cm. [Both 
Eyes, Bilateral] 
 
 
 
 
 
 
 
 
 
 
 
 
 
15. Assess monocular 
Eyes, Bilateral] 
DCNVA under photopic conditions at 40 cm. [Both 

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1. Provide the QUVID and IOLSAT questionnaires to the subject for completion. 
Note: The questionnaire should be completed by the subject prior to administration of 
 
 
12.3 
Schedule of Procedures and Assessments for Discontinued 
Subjects 
For subjects that discontinue from the study post-implantation, it is recommended to 
complete the applicable assessments noted in the Schedule of Visits (Section 6) for an Early 
Exit Visit. All assessments must be documented in source documentation and, if applicable, 
eCRF. It is recommended that procedures are performed in the order described below unless 
otherwise stated. 
 
20. Perform monocular mesopic without glare contrast sensitivity testing. [Both Eyes, 
Bilateral] 
21. Perform monocular mesopic with glare contrast sensitivity testing. [Both Eyes, 
Bilateral] 
22. Perform slit lamp examination of the anterior segment. Include documentation of IOL 
observations, if any. [Both Eyes, Bilateral] 
23. Grade cell and flare according to SUN system (refer to MOP for grading scheme). 
[Both Eye, Bilateral] 
24. Observe any IOL position changes (ie, tilt and decentration) occurring since the 
previous visit. [Both Eyes, Bilateral] 
25. Assess subjective PCO, and record information for any PC that has occurred since 
surgery, if applicable. [Both Eyes, Bilateral] 
26. Perform tonometry to measure IOP. [Both Eyes, Bilateral] 
27. Conduct dilated fundus exam noting any issues with fundus visualization due to the 
lens optic. [Both Eyes, Bilateral] 
28. Evaluate for and record any AEs including SSIs. Refer to Section 13 for further detail. 
29. Evaluate for and record any DDs. Refer to Section 13 for further detail. 

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any other assessment. 
 
2. Document any changes to medical/ocular history and ocular and non-ocular 
concomitant medications. 
 
3. Perform manifest refraction. [Both Eyes, Bilateral] 
Note: UCDVA testing may be performed prior to manifest refraction. 
 
4. Assess UCDVA and BCDVA. [Both Eyes, Bilateral] 
 
5. Perform slit lamp examination of the anterior segment. Include documentation of IOL 
observations, if any. [Both Eyes, Bilateral] 
 
6. Grade cell and flare according to SUN system (refer to MOP for grading scheme). 
[Both Eye, Bilateral] 
 
7. Observe any IOL position changes (ie, tilt and decentration) occurring since the 
previous visit. [Both Eyes, Bilateral] 
 
8. Assess subjective PCO, and record information for any PC that has occurred since 
surgery, if applicable. [Both Eyes, Bilateral] 
 
9. Perform tonometry to measure IOP. [Both Eyes, Bilateral] 
 
10. Conduct dilated fundus exam noting any issues with fundus visualization due to the 
lens optic. [Both Eyes, Bilateral] 
 
11. Evaluate for and record any AEs including SSIs. Refer to Section 13 for further detail. 
 
12. Evaluate for and record any DDs. Refer to Section 13 for further detail. 
 
12.4 
Unscheduled Visits 
An unscheduled visit (UNSV) is defined as follows: 
 
• Ocular examination that is not standard of care and is not required by the protocol, 
• Examination conducted by the study staff, and 
• New findings, or a change to a previous finding was discovered. 

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1. Mandatory: Provide the QUVID and IOLSAT questionnaires to the subject for 
completion. 
Note: Questionnaires should be completed by the subject prior to administration of 
any other assessment. 
2. Document any changes to medical/ocular history and ocular and non-ocular 
concomitant medications. 
3. Perform manifest refraction. 
Note: UCDVA testing may be performed prior to manifest refraction. 
4. Assess UCDVA and BCDVA. 
5. Perform slit lamp examination including IOL observations (if any). 
6. Grade cell and flare according to SUN system (refer to MOP for grading scheme). 
7. Observe any IOL position changes (ie, tilt and decentration) occurring since the 
previous visit. 
8. Assess subjective PCO, and record information for any PC that has occurred since 
surgery, if applicable. 
9. Perform tonometry to measure IOP. 
10. Conduct dilated fundus examination including fundus visualization. 
11. Evaluate for and record any AEs including SSIs. Refer to Section 13 for further detail. 
12. Evaluate for and record any DDs. Refer to Section 13 for further detail. 
An UNSV may or may not result in the capture of an AE. Likewise an AE may be captured 
without the report of an UNSV (eg, AE identified subsequent to study eye examination by 
non-study personnel). 
 
With exception to the questionnaires, assessments captured at the UNSV are dictated by the 
Investigator per their medical judgment. The below listed assessments are recommended. All 
assessments must be documented in source documentation and, if applicable, eCRF. It is 
recommended that procedures are performed in the order described below unless otherwise 
stated. 
 

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Assessments are not limited to the above list. The Investigator may perform additional 
procedures for proper diagnosis and treatment of the subject. The Investigator must document 
this information in the subject’s case history source documents. 
 
If during an UNSV the subject is discontinuing from the study, then the Investigator must 
conduct Early Exit/Exit procedures. 
 
12.5 
Missed Visit 
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 chart documentation, include dates, times, 
method of contact, etc. 
 
If attempts to contact the subject are unsuccessful, document the date the subject is 
considered lost to follow-up. If a subject is unable to return for the final study visit, complete 
the Exit Case Report Form with the appropriate reason for discontinuation. Complete the 
subject’s Exit Case Report Form after the last window closes, indicating the subject is lost to 
follow-up. 
 
12.6 
Discontinued Subjects 
12.6.1 
Screen Failures 
Subjects who discontinue from the study prior to the randomization will be categorized as 
screen failures. The Investigator may replace a subject who fails study Screening/Visit 0, but 
the subject number must not be re-used. The Investigator must document the reason for 
screen failure in the subject’s case history source documents and enter the subject in EDC. 
Subjects failing screening may not be rescreened. 
 
12.6.2 
Discontinuations 
Discontinued subjects are individuals who have signed an ICF and who voluntarily withdraw 
or are withdrawn from the study by the Investigator post randomization. Subjects may 
discontinue from the study at any time for any reason. Subjects may also be discontinued at 
any time if, in the opinion of the Investigator, continued study participation poses a risk to 
their health. The Investigator must document the reason for study discontinuation in the 
subject’s case history source documents and complete the exit form in EDC. 
 
For subjects discontinuing from the study, the Investigator should complete Early Exit 
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for the subject to do so. To ensure the safety of all subjects who discontinue early, 
Investigators must assess each subject and, if necessary, advise them of any therapies and/or 
medical procedures that may be needed to maintain their health. 
 
Discontinued subjects will not be replaced; subject numbers of discontinued subjects must 
not be re-used. 
 
Note: Subjects not implanted at the time of surgery (first operative eye) and the study IOL 
did not touch the eye (refer to Section 10.3) must be captured as discontinuations. 
 
12.6.3 
Aborted Implantation 
Implantation may be attempted twice. After two aborted implants, the subject must be 
implanted with a non-study provided IOL. 
 
If an implantation is aborted and the study IOL did not touch the eye (first operative eye), 
then the subject is required to discontinue from the study and standard of care for IOL 
implantation is followed. If the implantation is aborted and the study IOL did touch the eye 
(first operative eye), then the second eye should not be implanted but the subject is 
encouraged to attend all follow-up study visits for safety evaluation on this eye only. Refer to 
Manual of Procedures (MOP) Section 5.4 for complete details on subject discontinuation 
and/or follow-up when a lens is not implanted. 
 
If the IOL implantation is attempted and aborted due to Device Deficiency, then a Device 
Deficiency form must be completed and the IOL must be returned to the Study Sponsor in 
appropriate safe packaging. 
 
12.7 
Clinical Study Termination 
The Study Sponsor reserves the right to close the investigational site or terminate the study in 
its entirety at any time, for reasonable cause. 
 
If the clinical study is prematurely terminated or suspended by the Study Sponsor: 
 
• The Study Sponsor must: 
o Immediately notify the Investigator(s) and subsequently provide 
instructions for study termination. 
o Inform the Investigator and the regulatory authorities of the 
termination/suspension and the reason(s) for the 
termination/suspension. 

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• The Investigator must: 
o Promptly notify the IEC/IRB of the termination or suspension and 
of the reasons. 
o Provide subjects with recommendations for post-study treatment 
options as needed. 
The Investigator may terminate the site’s participation in the study for reasonable cause. 

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13 
DEVICE DEFICIENCIES AND ADVERSE EVENTS 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other 
persons, whether or not related to the investigational medical device (test article). Refer to the 
Glossary of Terms and figures for categories of AEs and SAEs. 
 
13.1 
General Information 
An AE is any untoward medical occurrence in a subject who is administered a clinical trial 
treatment (eg, implanted with an investigational device) regardless of whether or not the 
event has a causal relationship with the treatment. An AE, therefore, can be any unfavorable 
or unintended sign (including an abnormal laboratory finding), symptom, or disease 
temporally associated with the clinical trial treatment, whether or not related to the treatment. 
Below are Figures that categorize AEs and SAEs. 
 
Figure 13–1 
Categorization of All Adverse Events 
 

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Figure 13–2 
Categorization of All Serious Adverse Events 
 
13.2 
Serious Adverse Events (SAEs) 
A serious adverse event is an AE that led to any of the following: 
 
• Death. 
• A serious deterioration in the health of the subject that either resulted in: 
a) 
a life-threatening illness or injury. 
NOTE: Life-threatening means that the individual was at immediate risk of 
death from the event as it occurred, ie, it does not include an event which 
hypothetically might have caused death had it occurred in a more severe form. 
b) any potentially sight-threatening event or permanent impairment to a body 
structure or a body function. 

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c) 
in-patient hospitalization or prolonged hospitalization. 
NOTE: Planned hospitalization for a pre-existing condition, without serious 
deterioration in health, is not considered a SAE. In general, hospitalization 
signifies that the individual remained at the hospital or emergency ward for 
observation and/or treatment (usually involving an overnight stay) that would 
not have been appropriate in the physician's office or an out-patient setting. 
Complications that occur during hospitalization are AEs. If a complication 
prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred, the event 
should be considered serious. 
d) a medical or surgical intervention to prevent a) or b) or any ocular secondary 
surgical intervention (excluding PC). 
e) 
any indirect harm as a consequence of incorrect diagnostic test results when 
used within manufacturer’s instructions for use. 
• Fetal distress, fetal death, or a congenital abnormality or birth defect. 
13.3 
Specific Events Relevant to this Protocol 
In addition to reporting all AEs (serious and non-serious) meeting the definitions, the PI must 
report any occurrence of the following as an SAE: 
 
13.3.1 
Cumulative Serious Adverse Events 
(Total number of Adverse Events that have occurred at any time up to a specified timepoint 
postoperatively) 
 
• Cystoid macular edema 
• Hypopyon 
• Endophthalmitis 
• Lens dislocation from posterior chamber 
• Pupillary block 
• Retinal detachment 
• Secondary surgical intervention (excluding PC) 
13.3.2 
Persistent Serious Adverse Events 
(Adverse Events present at the conclusion of the clinical investigation) 

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• Corneal stromal edema 
• Cystoid macular edema 
• Iritis 
• Raised IOP requiring treatment 
This list is consistent with the categories provided in IS EN ISO 11979-7:2014. A persistent 
AE is an AE that is present at the conclusion of a clinical investigation per IS EN ISO 11979- 
1. Any other potentially sight-threatening event may also be considered serious based on the 
judgment of the Investigator and must be reported appropriately as delineated in Section 13.5. 
 
13.4 Supportive Characterization of Ocular Adverse Events 
Additional supportive characterizations of ocular adverse events will be assessed by the 
investigator according to the terms and definitions in Section 18, Appendices, Table 18-1. 
This table is a modified version of the “The American Academy of Ophthalmology Task 
Force Consensus Statement on Adverse Events with Intraocular Lenses” (Masket, 2017). 
 
13.5 Secondary Surgical Interventions (SSI) 
Secondary Surgical Interventions reporting will be sub-categorized using the following 
terminology: exchange, removal, and repositioning. Indications and associated definitions for 
these outcomes are provided in Section 18, Appendices, Table 18-2 (Masket, 2017). 
 
13.6 
Device Deficiencies 
A device deficiency may or may not be associated with subject harm (ie, ADE or SADE); 
however, not all ADEs or SADEs are due to a device deficiency. The Investigator should 
determine the applicable category for the identified or suspect device deficiency and report 
any subject harm separately. Examples of device deficiencies include the following: 
 
• Failure to meet product specifications (eg, incorrect IOL power) 
• IOL defect 
• Broken IOL optic 
• Broken IOL haptic 
• Scratched IOL optic 
• Unsealed device packaging 
• Suspect product contamination 

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• Lack of effectiveness 
13.7 
Monitoring for Adverse Events 
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the Investigator should inquire about AEs by asking the standard questions such as: 
 
• “Have you had any health problems since your last study visit?” 
• “Have there been any changes in the medicines you take since your last study 
visit?” 
Changes in any protocol-specific ocular or systemic parameter evaluated during the study are 
to be reviewed by the Investigator. In addition, the subject’s responses to any questionnaire 
utilized during the study are to be reviewed by the Investigator. Any untoward (unfavorable 
and unintended) change in a protocol-specific parameter or questionnaire response that is 
clinically relevant, in the opinion of the Investigator, is to be reported as an AE. These 
clinically relevant changes will be reported regardless of causality and will be distinguished 
between protocol defined AEs and questionnaire related AEs. 
 
13.8 
Procedures for Recording and Reporting 
AEs are collected from the time of informed consent. Any pre-existing medical conditions or 
signs/symptoms present in a subject prior to the start of the study (ie, before ICF is signed) 
are not considered AEs in the study and should be recorded in the Medical History section of 
the eCRF. 
 
In addition, aqueous cells and flare, corneal edema, raised IOP and superficial punctate 
keratitis are examples of early postoperative findings that are typically observed following 
ocular surgery. These are not considered AEs if they resolve within a week post-operatively 
and do not result in any untoward long-term visual outcome impact as clinically assessed by 
the investigator. 
 
For each recorded event, the ADEs and SAEs documentation must include: date of 
occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness 
and causality. In addition, the Investigator must document all device deficiencies reported or 
observed with test and control articles on the Device Deficiency eCRF. The site must submit 
all available information on ADEs, SAEs, and device deficiencies to the Study Sponsor 
immediately as follows: 
 
• ADEs or SAEs are documented on the Adverse Device Effect and Serious 
Adverse Event eCRF within 24 hours of the Investigator’s or site’s awareness. 

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• Device deficiencies are documented on the Device Deficiency eCRF within 24 
hours of the Investigator’s or site’s awareness. Please include a printed copy 
of the completed Device Deficiency eCRF with product returns. 
• Additional relevant information after initial reporting is to be entered into 
the eCRF as soon as the data become available. 
• Document any changes to concomitant medications on the appropriate 
eCRFs. 
• All relevant documentation such as Discharge Summary, Autopsy Report, 
Certificate of Death etc, should be faxed to the Study Sponsor at 1-817-302- 
1927. 
• UADEs and USADEs must be reported to the Sponsor and to the IRB as soon 
as possible, but not later than 10 working days after the Investigator’s or 
site’s awareness (§812.150(a)(1)). 
• 
The Sponsor must immediately conduct an evaluation of UADEs and 
USADEs and must report the results of the evaluation to FDA, all reviewing 
IRBs, and participating investigators within 10 working days after the 
Sponsor first receives notice of the effect (§§ 812.46(b), 812.150(b)(1)). 
NOTE: Should the EDC system become non-operational, the site must complete the 
appropriate paper Adverse Device Effect and Serious Adverse Event Form or Device 
Deficiency Form. The completed form is faxed to the Study Sponsor at 1-817-302-1927 or 
FTW.medical_safety@alcon.com within 24 hours of the Investigator’s or site’s awareness; 
however, the reported information must be entered into the EDC system once it becomes 
operational. 
 
Any AEs and device deficiencies for non-study marketed devices/products (i.e. BSS, OVD, 
Delivery systems etc.) will be considered and processed as spontaneous (following the post- 
market vigilance procedures) and should be communicated to the device’s/product’s 
manufacturer as per local requirements. 
 
Study Sponsor representatives and their contact information are provided in the 
Manual of Procedures that accompanies this protocol. 
 
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IEC/IRB. 

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13.8.1 
Intensity and Causality Assessments 
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: 
 
13.8.1.1 
Intensity (Severity) 
Mild 
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom. 
 
Moderate 
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities. 
 
Severe 
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 
 
13.8.1.2 
Causality 
For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or test procedure). An assessment of causality will also be performed 
by a Study Sponsor physician utilizing the same definitions, as shown below: 
 
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 test 
procedure has not been demonstrated, but there is a reasonable possibility that 
the AE was caused by the medical device or test 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). 
 
13.9 
Return Product Analysis 
Study Sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol. 
 
Alcon Products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint # that will be provided by the Study Sponsor after 
the case is entered in the Study Sponsor’s Global Product Complaint System (GPCMS). 

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13.10 
Unmasking of the Study Treatment 
Masked information on the identity of the assigned medical device should not be disclosed 
during the study. 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. Depending 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 in 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. 
 
13.11 
Follow-Up of Subjects with Adverse Events 
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. 
 
The Investigator must provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock). 
 
Any additional data from these follow-up procedures performed up to 6 months after subject 
discontinuation or exit must be documented and available upon the Study Sponsor’s request. 
All complaints received after this time period will be considered and processed as 
spontaneous (following the post-market vigilance procedures) and should be communicated 
to the medical device’s manufacturer as per local requirements. 
 
The Investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements. 
 
13.12 
Pregnancy in the Clinical Study 
 
Pregnancy is not reportable as an AE; however, complications may be reportable and will be 
decided on a case-by-case basis. An Alcon form will be utilized to capture all pregnancy- 
related information until birth of the child. 

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14 
DATA HANDLING AND ADMINISTRATIVE 
REQUIREMENTS 
14.1 
Subject Confidentiality 
 
The Investigator must ensure that the subject’s anonymity is maintained throughout the 
course of the study. In particular, the Investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. At the end of the clinical study, the Study Sponsor will collect a copy 
of the enrollment log without any identifying subject information. All documents 
submitted to the Study Sponsor will identify the subjects exclusively by number and 
demographic information. No other personally identifying information will be transmitted to 
the Study Sponsor. 
 
The Study Sponsor may release anonymized study data to external researchers for purposes 
of future research directly related to the study objectives, or future research that is beyond the 
scope of the current study objectives. The ICF explains this to study subjects. Anonymization 
means that all identifiable information will be removed from the dataset and all links to the 
subjects in the study will be removed. Anonymization of the data will maintain 
confidentiality of the subjects who participate in the study so that they cannot be identified by 
external researchers. The anonymized data set will contain records from all of the subjects in 
the current study, but the anonymization process might change the data set in some ways, so 
external researchers will be informed that they might not be able to duplicate some of the 
results from this study. 
 
External researchers who request permission to use anonymized data from studies for a new 
medicine or new indication of a medicine (studies for approved medicinal products, small 
molecule generics, and devices are excluded) must be approved by a central independent 
review panel that will adjudicate the scientific request and the competency of the external 
researcher(s), as well as determine the applicability to current standard operating procedures 
(SOPs). If approved, a data sharing agreement will be executed between the Study Sponsor 
and the external researcher(s), committing to a specified analysis and publication timeline. 
Anonymized data will be released to external researchers only after European Union (EU) 
and/or US submission of the investigational drug/biologic for the study indication. The Study 
Sponsor will not be able to influence the analyses that are performed by external researchers 
using the data from this study once the anonymized data are released. 

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14.2 
Completion of Source Documents and Case Report Forms 
 
The nature and location of all source documents will be identified to ensure that original data 
required to complete the eCRFs exist and are accessible for verification by the site monitor, 
and all discrepancies must be appropriately documented via the query resolution process. 
Study monitors are appointed by the Study Sponsor and are independent of study site staff. 
 
If electronic records are maintained, the method of verification must be determined in 
advance of starting the study. At a minimum, source documents include the following 
information for each subject: 
 
• Subject identification (name, sex, race/ethnicity) 
• Documentation of subject eligibility 
• Date of informed consent 
• Dates of visits 
• Documentation that protocol specific procedures were performed 
• Results of study parameters, as required by the protocol 
• IP accountability records 
• Documentation of AEs and other safety parameters (if applicable) 
• Records regarding medical histories and the use of concomitant therapies prior to 
and during the study 
• Date of study completion and reason for early discontinuation, if applicable 
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the eCRF are consistent with the original source data. 
 
Only designated individuals at the site will complete the eCRFs. The eCRFs must be 
completed at regular intervals following the clinical study visit schedule. It is expected that 
all data reported have corresponding entries in the source documents. The Investigator is 
responsible for reviewing and certifying that the eCRFs are accurate and complete. The only 
subject identifiers recorded on the eCRFs will be subject number, and subject demographic 
information. 

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14.3 
Data Review and Clarifications 
 
A targeted review of eCRF data to the subject’s source data will be completed by the site 
monitor to ensure completeness and accuracy. After the eCRFs have been completed, 
additional data clarifications and/or additions may be needed as a result of the data cleaning 
process. Data clarifications are documented and are part of each subject’s eCRF. 
 
14.4 
Sponsor and Monitoring Responsibilities 
 
The Study Sponsor will designate a monitor to conduct the appropriate site visits at the 
appropriate intervals. The clinical investigation will be monitored 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, and the study is conducted in compliance with the 
current approved protocol (and amendments[s], if applicable), with current GCP, and with 
applicable regulatory requirements. 
 
All sites must have a site initiation. Prior to screening subjects or performing the informed 
consent process on any subject, the site must receive a Site Activation Notification from an 
appropriate Study Sponsor representative. Monitoring will be conducted periodically while 
the clinical study is ongoing. Monitoring methods may include site visits, telephone, written 
and fax correspondence. Close-out visits will take place after the last visit of the last subject 
or after database lock. 
 
A Coordinating Investigator (CI) may be identified by the Study Sponsor. In cases where a CI 
is required, the Study Sponsor will select the CI based upon their experience, qualifications, 
active study participation, and their willingness and availability to take on this role. The CI 
will be bound by confidentiality obligations described in a separate confidentiality agreement 
between the CI and the Study Sponsor. 
 
14.5 
Regulatory Documentation and Records Retention 
 
The Investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the Study Sponsor and the Investigator’s files will be reviewed as part of the 
ongoing study monitoring. Financial information is not subject to regulatory inspection and is 
to be kept separately. 
 
Additionally, the Investigator must keep study records and source documents until the Study 
Sponsor provides written approval for their destruction. If the Investigator retires, relocates, 
or for any other reason withdraws from responsibility of keeping the study records, then the 

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Study Sponsor must be notified and suitable arrangements made for retention of study 
records and source documents needed to comply with national and international regulations 
(generally 2 years after discontinuing clinical development or after the last marketing 
approval). 
 
14.6 
Quality Assurance and Quality Control 
The Study Sponsor will secure agreement from all involved parties to ensure direct access to 
all study related sites, source data and documents, and reports for the purpose of monitoring 
and auditing by the Study Sponsor, and inspection by domestic and foreign regulatory 
authorities. Quality control will be applied to each stage of data handling to ensure that all 
data are reliable and have been processed correctly. Agreements made by the Study Sponsor 
with the Investigator/Institution and any other parties involved in the clinical study will be 
provided in writing as part of the protocol or as a separate agreement. 
 
14.7 
Publication of the Clinical Trial 
Any information other than that which is disclosed upon registration should not be discussed 
with persons outside the study. The protocol, study data, and information related to the study 
or to Alcon’s products or research programs that is provided by Alcon (Confidential 
Information) are 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 foregoing obligations of confidence and non-use assumed by an Investigator or member 
of the Investigator’s team shall not apply to: (a) information that at the time of disclosure is in 
the public domain; (b) information that thereafter lawfully becomes part of the public domain 
other than through disclosure by or through the Investigator or a member of the Investigator’s 
team; (c) information that, as evidenced by an individual’s written records, was known to this 
individual prior to Alcon’s disclosure; (d) information that is lawfully disclosed to by a third 
party not under any obligation of confidence to Alcon; or (e) information that 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, the Investigator agrees to the release of the data from this study and 
acknowledges the above confidentiality and publication policy. The provisions of this 
Statement shall survive the completion of the study. 

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15 
ANALYSIS PLAN 
15.1 
Subject Evaluability 
The final subject evaluability will be determined using the Deviations and Evaluability Plan 
(DEP) prior to breaking the code for masked treatment assignment and locking the database. 
 
15.2 
Analysis Data Sets 
The primary analysis set for effectiveness analyses will be the all-implanted analysis set 
(AAS). AAS includes all randomized eyes with successful IOL implantation. 
 
Additional supportive analyses will be conducted using the best-case analysis set (BAS). 
BAS includes all eyes successfully implanted that had 
 
• at least 1 postoperative visit 
• no preoperative ocular pathology 
• no macular degeneration detected at any time 
• no previous surgery for the correction of refractive errors 
• no major protocol violation 
The Safety Analysis Set will include all eyes with attempted IOL implantation (successful or 
aborted after contact with the eye). 
 
15.3 
Demographics and Baseline Characteristics 
Summary statistics will be provided for demographic and baseline characteristics by IOL 
group. Number and percentage will be presented for categorical variables and descriptive 
statistics including mean, standard deviation (SD), minimum and maximum will be presented 
for continuous variables. 
 
15.4 
Performance Analyses 
A success on co-primary effectiveness endpoints would be indicated by successful outcomes 
on all 4 of these endpoints (2 hypothesis tests and 2 performance targets). A total of 4 
hypothesis tests will be conducted to address the primary and secondary effectiveness 
objectives of the study. Overall Type I error will be maintained at the 5% level using a 
sequential testing approach. 
 
Hypothesis tests on secondary effectiveness endpoints will be conducted only after successful 
outcomes on all 4 co-primary effectiveness endpoints are demonstrated. 

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Analyses on performance targets are based on point estimates. 
 
Only the first eye of each subject will be included in the primary statistical analysis (as 
described in IS EN ISO 11979-7:2014). 
 
15.4.1 
Primary Performance 
The co-primary effectiveness endpoints are: 
 
• Monocular distance corrected intermediate visual acuity (DCIVA) at 66 cm 
• Monocular best corrected distance visual acuity (BCDVA) 
• Monocular depth of focus assessed by the mean defocus curve evaluation 
• Percentage of eyes achieving monocular distance corrected intermediate visual 
acuity (DCIVA) of 0.2 logMAR or better at 66 cm 
15.4.1.1 
Statistical Hypotheses 
The statistical hypotheses in support of the primary effectiveness objectives are: 
 
• ACRYSOF IQ EDF IOL is superior to ACRYSOF IQ Monofocal IOL with respect 
to mean monocular photopic distance corrected intermediate visual acuity (66 cm 
from spectacle plane) at Visit 4A (120-180d postoperative) 
The null and alternative hypotheses for the first co-primary analysis are: 
H0: µDFT015VA  µSN60WFVA 
HA: µDFT015VA  < µSN60WFVA 
where µDFT015VA and µSN60WFVA refer to the mean monocular photopic DCIVA at 66 cm 
for the test and control lenses, respectively, in the first implanted eye. Second 
implanted eye analysis will be supportive. 
• ACRYSOF IQ EDF IOL is non-inferior compared to ACRYSOF IQ Monofocal 
IOL with respect to mean monocular photopic best corrected distance visual 
acuity at Visit 4A (120-180d postoperative). The non-inferiority margin will be 0.1 
logMAR. 
The null and alternative hypotheses for the second co-primary endpoint are: 
H0: µDFT015VA – µSN60WFVA ≥ Δ 
HA: µDFT015VA – µSN60WFVA < Δ 

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where Δ refers to the non-inferiority margin, set at 0.10 logMAR, and µDFT015VA and 
µSN60WFVA refer to the mean monocular photopic BCDVA for the test and control 
lenses, respectively, in the first implanted eye. Second implanted eye analysis will be 
supportive. 
Two performance targets in support of the primary effectiveness objectives are: 
 
• Monocular mean defocus curve for ACRYSOF IQ EDF IOL has a range of 
defocus at least 0.5 D greater negative range than ACRYSOF IQ Monofocal IOL 
at 0.2 logMAR at Visit 4A (120-180d postoperative). 
• ACRYSOF IQ EDF IOL has at least 50% of eyes achieving monocular photopic 
distance corrected intermediate vision of 0.2 logMAR or better at Visit 4A (120- 
180d postoperative). 
15.4.1.2 
Analysis Methods 
Analysis of the first primary effectiveness endpoint (DCIVA) will be based on a two-sample 
t-test, with a type I error rate of 2.5%, 1-sided. The difference in means (ACRYSOF IQ EDF 
IOL minus ACRYSOF IQ Monofocal IOL) and the associated two-sided 95% confidence 
interval will be presented. 
 
Analysis of the second primary effectiveness endpoint (BCDVA) will be based on a two- 
sample t-test, with a type I error rate of 5%, 1-sided. The difference in means (ACRYSOF IQ 
EDF IOL minus ACRYSOF IQ Monofocal IOL) and the associated one-sided 95% upper 
confidence limit will be presented. 
 
Data poolability will be analyzed by testing a treatment by site interaction effect: first, the 
interaction effect between treatment and site will be tested using an alpha of 0.15; second, if 
the interaction effect is found significant, the final analysis model will include site as a 
random effect. 
 
For the first performance target (depth of focus), the line plot of the average visual acuity at 
each defocus level (ie, defocus curve) will be used to estimate the negative lens induced 
depth of focus at 0.2 logMAR. The difference in the depth of focus between ACRYSOF IQ 
EDF IOL and ACRYSOF IQ Monofocal IOL will be presented. The following sensitivity 
analyses will be performed on the depth of focus endpoint: 
 
• Exclude extreme outliers (individual depth of focus values less than Q1 – 3*IQR 
or greater than Q3 + 3*IQR) 

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• Exclude mild outliers (individual depth of focus values less than Q1 – 1.5*IQR or 
greater than Q3 + 1.5*IQR), where Q1 = 25th percentile, Q3= 75th percentile, and 
IQR = Q3 – Q1. 
The depth of focus data will be presented by IOL group, 3 photopic pupil size ranges [3.0 
mm (small), 3.0 mm to 4.0 mm (medium), and 4.0 mm (large)] and three axial length 
ranges [21.0 mm (short), 21.0 mm to 26.0 mm (medium), and 26.0 mm (long)]. 
Descriptive summary statistics (number of eyes, mean, median, standard deviation, 
minimum, and maximum) on individual depth of focus value will be presented by IOL group. 
 
For the second performance target (DCIVA), the percentage of eyes achieving distance 
corrected intermediate visual acuity of 0.2 logMAR or better in each IOL group will be 
presented. 
 
15.4.2 
Secondary Performance 
The secondary effectiveness endpoints are: 
 
• Monocular distance corrected near visual acuity at 40 cm 
• Proportion of subjects who respond “Never” to Q1 of the IOLSAT questionnaire: 
“Overall, in the past 7 days, how often did you need to wear eyeglasses to see?” 
• Monocular uncorrected intermediate visual acuity at 66 cm 
• Monocular uncorrected distance visual acuity 
15.4.2.1 
Statistical Hypotheses 
The statistical hypothesis in support of the first secondary effectiveness objective is: 
 
• ACRYSOF IQ EDF IOL is superior to ACRYSOF IQ Monofocal IOL with respect 
to mean monocular photopic distance corrected near visual acuity (40 cm from 
spectacle plane) at Visit 4A (120-180d postoperative) 
The null and alternative hypotheses for the first secondary analysis are: 
H0: µDFT015VA  µSN60WFVA 
HA: µDFT015VA < µSN60WFVA 
where µDFT015VA and µSN60WFVA refer to the mean monocular photopic DCNVA at 
40 cm for the test and control lenses, respectively, in the first implanted eye. Second 
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The statistical hypothesis in support of the second secondary effectiveness objective is: 
 
• ACRYSOF IQ EDF IOL is superior to ACRYSOF IQ Monofocal IOL with respect 
to proportion of subjects who respond “Never” to Q1 of the IOLSAT 
questionnaire (Overall, in the past 7 days, how often did you need to wear 
eyeglasses to see?) at Visit 4A (120-180d postoperative). 
The null and alternative hypotheses for the second secondary analysis are: 
H0: πDFT015Q1  πSN60WFQ1 
HA: πDFT015Q1 > πSN60WFQ1 
where πDFT015Q1 and πSN60WFQ1 refer to the proportion of subjects who responded 
“Never” for the test and control lenses. 
There are no hypothesis tests associated with the third and the fourth secondary effectiveness 
endpoints (UCIVA and UCDVA, respectively). 
 
15.4.2.2 
Analysis Methods 
Analysis of first secondary effectiveness endpoint (DCNVA) will be based on a two-sample t- 
test, with a type I error rate of 2.5%, 1-sided. The difference in means (ACRYSOF IQ EDF 
IOL minus ACRYSOF IQ Monofocal IOL) and the associated two-sided 95% confidence 
interval will be presented. 
 
Two performance targets in support of the first secondary effectiveness objective are: 
 
• At least 50% of eyes with ACRYSOF IQ EDF IOL achieve a monocular DCNVA 
of 0.3 logMAR or better 
• The percentage of eyes with DCNVA of 0.3 logMAR or better in ACRYSOF IQ 
EDF IOL group is at least 25 percentage points higher than in ACRYSOF IQ 
Monofocal IOL group. 
For the first performance target, the percentage of eyes achieving distance corrected near 
visual acuity of 0.3 logMAR or better in ACRYSOF IQ EDF IOL group will be presented and 
compared against the performance target of 50%. For the second performance target, the 
percentage of eyes achieving distance corrected near visual acuity of 0.3 logMAR or better in 
each IOL group will be presented and the difference between the IOL groups (ACRYSOF IQ 
EDF IOL – ACRYSOF IQ Monofocal IOL) will be compared against the performance target 
of 25%. 

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A success on the first secondary effectiveness endpoint will be indicated by successful 
outcomes on the hypothesis test and two performance targets. A hypothesis test on the second 
secondary effectiveness endpoint will be conducted only after successful outcomes on the 
first secondary endpoint are demonstrated. 
 
For the second secondary effectiveness endpoint, a two-sided 95% confidence interval for the 
difference in proportions (ACRYSOF IQ EDF IOL – ACRYSOF IQ Monofocal IOL) will be 
calculated using the Miettinen-Nurminen method (1985), and ACRYSOF IQ EDF IOL will 
be determined to be superior to ACRYSOF IQ Monofocal IOL if the lower boundary of the 
confidence interval is greater than zero. This is equivalent to using a type I error rate of 2.5%, 
1-sided. 
 
If IOLSAT questionnaire generates scores, the cumulative distribution curves showing the 
percentage of subjects with a given change in their score compared to baseline by IOL group 
will be presented to help determine whether any observed differences are meaningful. 
 
In addition, the frequencies of each item in IOLSAT will be summarized by visit with counts 
and percentages. 
 
For the third and the fourth secondary effectiveness endpoints (UCIVA and UCDVA, 
respectively), the following descriptive statistics will be provided for each IOL group: 
 
• The number and percentage of eyes with visual acuity of 
o 0.0 logMAR or better: ≤0.00 logMAR 
o 0.1 logMAR or better: ≤0.10 logMAR 
o 0.2 logMAR or better: ≤0.20 logMAR 
o 0.3 logMAR or better: ≤0.30 logMAR 
• Descriptive statistics including mean, median, standard deviation, number of eyes, 
minimum, maximum and (two-sided) 95% confidence interval will be presented 
for overall, by preoperative corneal cylinder (≤ 0.5 D vs. > 0.5 D), and by residual 
corneal cylinder (≤ 0.5 D vs. > 0.5 D). 
In addition, the difference in means (ACRYSOF IQ EDF IOL minus ACRYSOF IQ 
Monofocal IOL) and the associated two-sided 95% confidence interval will be presented. 
 
First implanted eyes and second implanted eyes assessments will be in separate tables. 

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. 

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Visual Acuity Endpoints 
 
In general, for visual acuity endpoints, the following descriptive statistics will be provided for 
each IOL group: 
 
• The number and percentage of eyes with visual acuity of 
o 0.0 logMAR or better: ≤0.00 logMAR 
o 0.1 logMAR or better: ≤0.10 logMAR 
o 0.2 logMAR or better: ≤0.20 logMAR 
o 0.3 logMAR or better: ≤0.30 logMAR 
• Descriptive statistics including sample size, mean, median, standard deviation, 
number of eyes, minimum, maximum and the confidence interval will be 
presented. 
Additionally, these descriptive statistics will be provided for the first two co-primary and the 
first secondary visual acuity endpoints, for first eye and second eye, by age categories (<65 
years vs. ≥65 years), by investigative site, by adverse event (study eyes with ocular adverse 
events vs. study eyes without ocular adverse events) and by preoperative ocular pathology 
(study eyes with vs. study eyes without) for both the AAS and BAS. Listings of these visual 
acuity endpoints at every visit for each eye will also be provided. 
 
In addition, the difference in means (ACRYSOF IQ EDF IOL minus ACRYSOF IQ 
Monofocal IOL) and the associated two-sided 95% confidence interval will be presented. 
 
First implanted eyes, second implanted eyes 
tables. 
 
Defocus curve evaluation at Visit 4A (120-180d postoperative) 
will be in separate 
 
Descriptive statistics (mean, median, standard deviation, number of eyes/subjects, minimum, 
maximum, and two-sided 95% confidence intervals) will be provided for the logMAR VA 
measured on the ETDRS chart at each defocus level for all eyes/subjects. The mean logMAR 
VA measured on the ETDRS chart at each defocus value will be displayed graphically for all 
eyes/subjects, separately for first implanted eye, second implanted eye and binocular 
assessments. Mean logMAR visual acuity will be plotted versus defocus value, including 
two-sided 95% confidence intervals and standard deviations, with the amount of defocus 
along the x-axis and logMAR VA at each defocus point along the y-axis. The defocus tables 
and plots will be generated overall and by site. 

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In addition, monocular defocus curves for the first implanted eye and second implanted eye 
will be presented, by treatment group, for the following photopic pupil ranges: 
[3.0 mm (small), 3.0 mm to 4.0 mm (medium), and 4.0 mm (large)] and three axial 
length ranges [21.0 mm (short), 21.0 mm to 26.0 mm (medium), and 26.0 mm (long)]. 
 
Manifest refraction 
 
Descriptive statistics (number of eyes, mean, median, standard deviation, minimum, and 
maximum) on manifest refraction spherical equivalent (MRSE= sphere + ½ cylinder) will be 
provided by IOL group. 
 
First implanted eyes and second implanted eyes will be in separate tables. 
 
 
 
 
 
 
 
 
 
 
 

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15.5 
Handling of Missing Data 
The AAS and BAS do not include any imputed values. Although missing data will occur, the 
influence of missing data is expected to be minimal. The following sensitivity analyses will 
be conducted to address missing values for the first two co-primary effectiveness endpoints 
and first secondary effectiveness endpoint. 
 
1. Multiple imputation with a fully conditional specification method will be used to 
impute and estimate the treatment effect. 

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2. The sensitivity of inferences to departures from the MAR assumption will be 
examined using a pattern-mixture model approach with a control-based pattern 
imputation (Ratitch 2011). 
The details will be described in the Statistical Analysis Plan. 
 
15.6 
Multiplicity 
Overall type I error will be maintained at 5% level using the sequential testing approach 
summarized in the figure below. 
 
 
15.7 
Safety Analysis 
15.7.1 
Primary Safety 
Co-primary safety endpoints are adverse events and monocular mesopic contrast sensitivity 
(with and without glare). 
 
15.7.1.1 
Adverse Events 
Descriptive summaries (counts and percentages) for specific AEs including SSIs will be 
presented by IOL group. The one-sided exact 95% lower confidence limit of incidence rates 
(proportion of eyes with events) observed for each IOL group will be compared to the 
cumulative and persistent adverse event SPE rates. In addition to SPE rates predefined in 
IS EN ISO 11979-7, the rate of adverse events that may be specifically related to ACRYSOF 
IQ EDF IOL design features; and any other significant events will be provided. These rates 
will be accompanied by two-sided exact 95% confidence intervals. 
 
The number and percentage of all adverse events will be tabulated with a breakdown by IOL 
group and implanted eye. A listing of all adverse events will also be provided. 

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The number and percentage of secondary surgical interventions (SSIs) that may be related to 
optical characteristics of the lens will be tabulated with a breakdown by IOL group and 
implanted eye. 
 
15.7.1.2 
Mesopic contrast sensitivity (with and without glare) 
All measured contrast sensitivity values will be converted to logarithmic form before 
performing statistical calculations. Analyses of log contrast sensitivity will be performed for 
each testing condition and spatial frequency. If a subject is unable to see a targeted spatial 
frequency at any available contrast (including the contrast of the reference patch), the lowest 
contrast score will be given, preceded by the appropriate inequality symbol (<) to indicate 
that the actual sensitivity is below the given value. Prior to any averaging or other statistical 
calculations, all contrast threshold values will be converted to log contrast sensitivity values. 
The number and percentage of subjects who cannot see any contrast will be recorded and 
tabulated for each spatial frequency to provide a qualitative extent of the bias. Descriptive 
statistics will include number of eyes, mean, standard deviation, median, minimum, 
maximum, and additional percentiles (10th, 25th, 75th, and 90th percentiles). Descriptive 
tables will include a note that the corresponding mean values are biased upward and 
variability values are biased downward (using < and > symbols). The 5th percentile of log 
contrast sensitivity values will be calculated for the control group, then the percentage of eyes 
in the test group that achieved a log contrast sensitivity lower than this value will be 
presented. 
 
In addition, for mesopic contrast sensitivity, descriptive summary statistics will be presented 
by IOL group and 3 mesopic pupil size ranges: 3.0 mm (small), 3.0 mm to 4.0 mm 
(medium), and 4.0 mm (large). 
15.7.2 
Secondary Safety 
Secondary safety endpoint is: 
 
• Rates of severe and most bothersome (separately) visual disturbances as reported 
by the subjects using the QUVID questionnaire 
For the secondary safety endpoint, descriptive summaries (counts and percentages) for the 
severe and most bothersome (separately) visual disturbances as reported by the subjects using 
the QUVID questionnaire will be presented by IOL group. These rates will be accompanied 
by two-sided exact 95% confidence intervals. 

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If QUVID questionnaire generates scores, the cumulative distribution curves showing the 
percentage of subjects with a given change in their score compared to baseline by IOL group 
will be presented to help determine whether any observed differences are meaningful. 
 
Counts and percentages of subjects who did not have a given visual disturbance at baseline 
but developed and present at Visit 4A (120-180d postoperative) will be presented. 
In addition, the presence and absence of these symptoms, and how frequent, severe, and 
bothersome they appear will be summarized by visit with counts and percentages. 
 
15.7.3 
Supportive Safety 
Intraocular pressure 
 
Descriptive statistics (mean, median, SD, number of eyes, minimum, and maximum) will be 
presented for IOP by IOL group and implanted eye. A listing of all eyes with an increase or 
decrease in IOP of more than 10 mmHg at any visit compared to the same eye at baseline will 
also be provided. 
 
Slit-lamp examination 
 
The number and percentage of all slit lamp examination findings will be tabulated by IOL 
group and implanted eye. A listing of abnormal slit lamp examination findings will also be 
provided. 
 
Dilated fundus exam 
 
The number and percentage of all dilated fundus examination findings will be tabulated by 
IOL group and implanted eye. A listing of abnormal dilated fundus examination findings will 
also be provided. 
 
IOL observations 
 
The number and percentage of all IOL observations will be tabulated by IOL group and 
implanted eye. 
 
IOL tilt/decentration 
 
The number and percentage of all eyes with IOL tilt/decentration will be tabulated by IOL 
group and implanted eye. A listing of all IOL tilt/decentration assessments will also be 
provided. 

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Subjective posterior capsular opacification 
 
The number and percentage of eyes within each category of subjective posterior capsule 
opacification will be tabulated by IOL group and implanted eye. A frequency table of the 
“worst case” posterior capsule opacification (including capsulotomy) will be presented by 
IOL group and implanted eye. In addition, the difference in the rate (ACRYSOF IQ EDF IOL 
minus ACRYSOF IQ Monofocal IOL) and the associated two-sided 95% confidence interval 
will be presented. A listing of eyes with clinically significant posterior capsule opacification, 
clinically significant posterior capsule opacification requiring YAG or posterior capsulotomy 
will be presented. 
 
Posterior capsulotomy 
 
The number and percentage of eyes with PC will be tabulated by IOL group and implanted 
eye. In addition, the difference in the rate (ACRYSOF IQ EDF IOL minus ACRYSOF IQ 
Monofocal IOL) and the associated two-sided 95% confidence interval will be presented. 
 
Surgical problems 
 
The number and percentage of all surgical problems will be tabulated by IOL group and 
implanted eye. A listing of all surgical problems will also be provided. 
 
Other procedures at surgery 
 
A listing of all other procedures at surgery will be provided. 
 
Device Deficiencies 
 
The number and percentage of all device deficiencies will be tabulated with a breakdown by 
IOL group and implanted eye. A listing of all device deficiencies will also be provided. 
 
15.8 
Interim Analyses 
Not Applicable. 
 
15.9 
Adaptive Study Design 
Not Applicable. 

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16 
Ethics 
This clinical study must be conducted in accordance with the ethical principles contained 
within: 
 
• The Declaration of Helsinki (DoH), and in compliance with the International 
Conference on Harmonization (ICH) E6 GCP Consolidated Guideline 
• ISO 14155:2011 Clinical investigation of medical devices for human subjects – 
Good clinical practice 
• SOPs of the Study Sponsor and contract research organizations participating in the 
conduct of the clinical study and all other applicable regulations. 
The Investigator and all clinical study staff must conduct the clinical study in compliance 
with the protocol. The Investigator must ensure that all personnel involved in the conduct of 
the study are qualified to perform their assigned responsibilities through relevant education, 
training, and experience. 
 
Before clinical study initiation, this protocol, the ICF, any other written information given to 
subjects, and any advertisements planned for subject recruitment must be approved by an 
IEC/IRB. The Investigator must provide documentation of the IEC/IRB approval to the Study 
Sponsor. The approval must be dated and must identify the applicable protocol, amendments 
(if any), ICF, all applicable recruiting materials, written information for subject, and subject 
compensation programs. The IEC/IRB must be provided with a copy of the any periodic 
safety updates, and all other information as required by local regulation and/or the IEC/IRB. 
At the end of the study, the Investigator must notify the IEC/IRB about the study’s 
completion. The IEC/IRB also must be notified if the study is terminated prematurely. 
Finally, the Investigator must report to the IEC/IRB on the progress of the study at intervals 
stipulated by the IEC/IRB. 
 
Voluntary informed consent must be obtained from every subject prior to the initiation of any 
screening or other study-related procedures. The Investigator must have a defined process for 
obtaining consent. Specifically, the Investigator, or delegate, must explain the clinical study 
to each potential subject and the subject must indicate voluntary consent by signing and 
dating the approved ICF. The subject must be provided an opportunity to ask questions of the 
Investigator, and if required by local regulation, other qualified personnel. The Investigator 
must provide the subject with a copy of the consent form written in a language the subject 
understands. The consent document must meet all applicable local laws and provide subjects 
with information regarding the purpose, procedures, requirements, and restrictions of the 

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study, along with any known risks and potential benefits associated with the IP, the available 
compensation, and the established provisions for maintaining confidentiality of personal, 
protected health information. Subjects will be told about the voluntary nature of participation 
in the study and must be provided with contact information for the appropriate individuals 
should questions or concerns arise during the study. The subject also must be told that their 
records may be accessed by appropriate authorities and Sponsor-designated personnel. The 
Investigator must keep the original, signed copy of the consent and must provide a duplicate 
copy to each subject according to local regulations. 
 
The Study Sponsor assures that the key design elements of this protocol will be registered in 
www.clinicaltrials.gov as required by current regulations and, if applicable, other public 
databases as required by local country regulations. In addition, results of this study will be 
made publicly available in www.clinicaltrials.gov regardless of outcome as required by 
current regulations and, if applicable, in other public databases as required by local country 
regulations. 
 
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study must sign 
the approved, revised informed consent, as required by the IEC/IRB. 

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17 
REFERENCES 
Boettner EA, Wolter JR. Transmission of the ocular media. Invest Ophthalmol. 1962;1:776- 
83. 
 
ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical 
practice. 
 
Draft ANSI Z80.35 Extended Depth of Focus Intraocular Lenses, 2016 July. 
 
Masket S, Rorer E, Stark W, Holladay JT, MacRae S, Tarver ME, et al. Special Report: The 
American Academy of Ophthalmology Task Force Consensus Statement on Adverse Events 
with Intraocular Lenses. Ophthalmology. 2017; 124(1):142-144. 
 
MacRae S, Holladay JT, Glasser A, Calogero D, Hilmantel G, Masket S, et al. Special report: 
American Academy of Ophthalmology Task Force consensus statement for extended depth of 
focus intraocular lenses. Ophthalmology. 2017; 124(1):139-141. 
 
McCaffery M, Beebe A. Pain: Clinical manual for nursing practice. Mosby-Year Book; 1989. 
 
IS EN ISO 11979-7:2014 Ophthalmic implants – Intraocular lenses – Part 7: Clinical 
investigations. 
 
Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) 
Working Group. Standardization of Uveitis Nomenclature for Reporting Clinical Data. 
Results of the First International Workshop. Am J Ophthalmol. 2005; 140(3):509–516. 
 
Ratitch B, O’Kelly M. Implementation of pattern-mixture models using standard SAS/STAT 
procedures. Proceedings of PharmaSUG; 2011 May 8-11; Nashville, TN. 
 
Retzlaff JA, Sanders DR, Kraff MC. Development of SRK/T intraocular lens implant power 
calculation formula. J. Cataract Refract Surg. 1990;16(3):333-40. 
 
Simpson MJ, Charman WN. The effect of testing distance on intraocular lens power 
calculation. J Refract Surg. 2014;30(11):726.. 
 
Optical Design of Toric Extended Depth of Field IOL. Fort Worth (TX): Alcon Research, 
Ltd.; 2013 June. Technical Report No.: TDOC-0016353, 
 
Miettinen OS and Nurminen M. (1985). Comparative analysis of two rates. Statistics in 
Medicine, 4:213-226. 

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18 
APPENDICES 
18.1 
Adverse Event Tables 
Below are the tables referred to in Section 13 DEVICE DEFICIENCIES AND ADVERSE 
EVENTS. 
 
Table 18–1 
Additional Supportive Characterizations of Ocular Adverse 
Events 
Adverse Event 
Deﬁnition 
 
 
 
Anterior uveitis 
 
 
Clinically signiﬁcant cystoid 
macular edema 
Anterior segment inﬂammation characterized by grade 1+ cell or greater using SUN criteria 
that is persistent for greater than 3 months after surgery, or relapses in less than 3 months 
after discontinuation of therapy, or the subject is maintained on therapy for more than 3 
months to control inflammation. (Note that any iritis present at the final visit is considered 
significant and should be counted as a “persistent” ISO SPE event.). 
 
Macular edema diagnosed by clinical examination and adjunct testing (e.g., OCT, FA) 
resulting in BCDVA of  20/40 at ≥1 month 
 
 
Visually significant corneal edema 
Corneal swelling (stromal or epithelial) resulting in CDVA of 20/40 or worse at Form 3 
(Visit 3A) or later. (Note that any corneal stromal edema present at the final visit is 
considered significant and should be counted as a “persistent” ISO SPE event.). 
 
Endophthalmitis 
Intraocular inﬂammation requiring diagnostic vitreous tap and intraocular antibiotics 
 
 
Mechanical pupillary block 
Shallowing of anterior chamber due to obstruction of aqueous humor ﬂow from the 
posterior to anterior chamber through the pupil by the crystalline lens, vitreous face, or 
implanted device 
 
 
Increased IOP 
Elevation of IOP by ≥10 mmHg above baseline to a minimum of 25 mmHg. (Note that 
any “raised IOP requiring treatment” present at the final visit is considered significant and 
should be counted as a “persistent” ISO SPE event.). 
Rhegmatogenous RD 
Partial or complete RD associated with retinal tear 
 
 
Toxic anterior segment syndrome 
 
 
Secondary IOL intervention 
Exchange 
Removal 
 
Reposition 
Acute, noninfectious inﬂammation of the anterior segment that starts within 24 to 48 hrs 
after surgery, usually resulting in hypopyon and commonly presenting with corneal 
edema, that improves with steroid treatment 
 
 
The investigational device is replaced with the same lens model 
The investigational device is removed and replaced with a non-investigational lens or no 
lens is implanted 
The existing IOL is surgically moved to another location or rotated 
 
 
CDVA = corrected distance visual acuity; FA = ﬂuorescein angiography; IOL = intraocular lens; IOP = intraocular pressure; 
OCT = optical coherence tomography; RD = retinal detachment; SUN = Standardization of Uveitis Nomenclature 

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Table 18-2 
Definitions of Indications for Device Exchange, Removal, or 
Reposition 
Indication 
Deﬁnition 
 
Capsular block syndrome 
Hyper-distention of the lens capsular bag due to the IOL optic blocking egress of 
ﬂuid through the anterior capsulotomy typically inducing a myopic refractive error 
Cataract 
Any opaciﬁcation of the crystalline lens with or without reduced visual acuity 
Chronic anterior uveitis 
Persistent anterior segment inﬂammation characterized by grade ≥1+ cell  using 
SUN criteria 
Endothelial cell loss 
Chronic endothelial cell loss at a rate greater than that due to normal aging 
Incorrect IOL power 
Postoperative refractive error different from predicted and not due to a 
calculation or other user error 
New or worsening iris transillumination defects or increase in pigmented cells in 
the anterior chamber noted after the 1-wk visit when assessed before instillation 
Iris pigment epithelium loss 
 
 
 
 
 
Lens optic abnormality 
 
 
Malpositioned IOL 
Early 
Late 
 
Damaged IOL 
 
 
 
Pupil ovalization 
 
 
 
Pain 
of any dilating drops 
Note: If there is a transillumination defect preoperatively, then a photograph should be taken, and then at each 
subsequent visit, a photograph should be taken and compared with the preoperative photograph via a standardized 
photographic method 
Unanticipated visual outcome (e.g., acuity, contrast sensitivity, symptoms) 
associated with opaciﬁcation, vacuoles, microvacuoles, or subsurface 
nanoglistenings and not due to other causes 
Decentration, tilt, or rotation of IOL requiring reoperation 
If noted before 120 days postoperatively 
If noted at ≥120 days postoperatively 
Crack of lens optic, breakage, or deformity of haptic, or other damage to the 
IOL; may include changes induced by Nd:YAG laser anterior or posterior 
capsulotomy 
Progressive deformation of the pupil with elongation of the pupil in the meridian 
of the long axis of the IOL Documentation to be made under photopic conditions 
NOTE: A consensus statement regarding a proposed methodology for standardizing assessment of pupil ovalization 
is available (Appendix 1, Masket 2017). 
Graded as ≥4 on the standardized pain numeric rating scale of current pain 
intensity from 0 (no pain) to 10 (worst possible pain) 
Refer to the MOP for the standardized numeric pain scale (McCaffery 1989). 
 
Peripheral anterior synechiae 
Progressive closure of the anterior chamber angle due to propagation of anterior 
synechiae in the absence of obvious anterior uveitis 
Patient-reported undesirable 
optical phenomena 
Dysphotopsia (positive or negative or both), monocular diplopia, intolerable glare, 
halos, or other visual symptoms, not due to 1 of the indications listed 
 
 

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