A Prospective, Multicenter, Randomized Evaluation of Refractive Predictability in Patients With or Without Corneal Astigmatism (Maximum Allowable up to 1.25D) When Using the Cataract Refractive Suite and Standard Manual Techniques
Phase: NA
Conditions: Cataracts
Sponsor: Alcon, a Novartis Company

Alcon - Business Use Only 
Document: TDOC-0052629 
Status: Effective 
Effective Date: 04-Apr-2017 
Protocol - Clinical 
Version: 3.0; Most-Recent; Effective; CURRENT 
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a Novartis company 
 
Clinical Trial Protocol 
 
A prospective, multicenter, randomized evaluation of refractive 
predictability in patients with or without corneal astigmatism (maximum 
allowable up to 1.25 D) when using the Cataract Refractive Suite and 
standard manual techniques 
Protocol Number: 
Sponsor Name & 
Address: 
CTK246-P001 / NCT02974140 
Alcon Research, Ltd. and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
Project Name / Number: 
Cataract Refractive Suite/A02835 
Test Articles / Products: 
Cataract Refractive Suite (CRS) composed of the following: 
1. VERIONTM Image Guided System 
2. LenSx® Femtosecond Laser 
3. ORATM (Optiwave Refractive Analysis) with 
VerifEye+TM (with or without the VerifEye Lynk) 
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: 
Telephone: 
 
 
Signature 
Date 
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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Alcon -  Business  Use Only Protocol -  Clinical 
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D ocu m en t: TDOC- 00526 29 
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Status: Ef f e c t i ve 
Page 2 of 68 
 
1 
PROTOCOL SYNOPSIS 
 
Financial Disclosure 
for US FDA 
Submission Required? Q 
es E] No 
Test Article/ Product: Cataract Refractive Suite (CRS) composed of the following: 
1. Verion Image Guided System 
2. LenSx Femtosecond laser 
3. Optiwave Refractive Analysis (ORA) with VerifEye+ (with or 
without the VerifEye Lynk) 
Objectives: 
Effectiveness Objectives 
rimary: 
• 
To compare the refractive predictability (prediction enor) 
between the CRS and standard manual technique at 1 month 
postoperative. 
econdary: 
• 
To compare the amount of cumulative dissipated energy (CDE) 
expended in the eye between the CRS and standard manual 
technique. 
• 
To assess the average estimated aspiration fluid used during 
surge1y between the CRS and standard manual technique. 
• 
To assess the average aspiration time spent during surge1y 
between the CRS and standard manual technique. 

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Clinical Study Design: This is a prospective, multi-center, observer masked, randomized, 
active control (standard manual technique), contralateral design 
study. 
No. of Subjects: 
This study will enroll approximately 350 subjects to initially 
randomize and treat 300 subjects (that could potentially increase to 
approximately 580 subjects enrolled and 500 subjects randomized). 
An interim analysis will be performed once 200 subjects have been 
randomized, treated and completed 1-month follow-up visits. An 
additional 200 subjects may be randomized and treated beyond the 
initially planned 300 subjects. It is planned that the study will 
randomize and treat between 300 and 500 subjects. 
Regions: 
US and EU 
Clinical Study 
Duration: 
Total expected duration of the clinical investigation: 
a) Total expected duration of the clinical investigation- up to 
11 months 
b) Expected duration of each subject’s participation – up to 154 days 
c) Planned follow-up duration – 3.5 months 
d) Estimated time needed to select the number of subjects 
(enrollment period) - 6 months 
Clinical Study 
Population: 
Adult subjects with bilateral cataracts who are candidates to receive 
ReSTOR +2.5 D multifocal IOL 
Treatments: 
Test Article: 
The CRS is composed of the following: 
1. Verion Image Guided System 
2. LenSx Femtosecond laser 
3. ORA with VerifEye+ (with or without the 
VerifEye Lynk) 
Administration: 
Intervention during preoperative planning and 
during cataract surgery. 
General Description: The CRS is composed of a series of devices 
that address the pre-planning stages of IOL 
calculation and integrates this information 
into the operative stage up to postoperative 
follow-up. 

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Control Article: 
Active: Standard manual technique 
Administration: 
Intervention during surgery 
General Description: Standard phacoemulsification technique 
Inclusion & Exclusion 
Criteria: 
Inclusion Criteria: 
1. Adults (≥ 22 years of age at the time of surgery), diagnosed with 
bilateral cataracts. 
2. Planned cataract surgery and implantation of ReSTOR +2.5 D 
multifocal IOL in both eyes. 
3. Target is emmetropia (+0.50 to -0.50). 
4. Clear intraocular media other than cataract in study eye(s). 
5. Willing and able to complete all required postoperative visits. 
6. Able to comprehend and sign a statement of informed consent. 
7. Potential postoperative visual acuity of 0.2 logarithm of the 
minimum angle of resolution (LogMAR) or better. 
8. Preoperative keratometry reading between 40.0 D to 49.0 D in 
the primary meridians. 
9. Preoperative axial length between 21.5 mm to 27.0 mm. 
10. Preoperative/Baseline corneal with-the-rule (WTR), against-the- 
rule (ATR) or oblique astigmatism ≤ 1.25 D. 
Exclusion Criteria: 
1. Significant irregular corneal astigmatism as assessed by the 
index relevant to the corneal topographer and investigator 
judgement of the topography maps 
2. History of or current severe dry eyes. 
3. Tear breakup time (TBUT) < 10 secs prior to randomization. 
4. Retinal/uveal pathology or concurrent ocular disease including 
age-related macular degeneration (AMD), choroidal 
neovascularization (CNV), glaucoma, diabetic retinopathy, 
retinitis pigmentosa, optic nerve pathology. 
5. Previous intraocular or corneal refractive surgery. 
6. Any inflammation or edema (swelling) of the cornea, including 
but not limited to the following: keratitis, keratoconjunctivitis, 
and keratouveitis. 
7. Amblyopia. 
8. Previous corneal transplant. 

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9. Previous retinal detachment. 
10. Recunent severe anterior or posterior segment inflammation of 
unknown etiology. 
11. Pregnancy at time of Screening. 
12. Pa1ticipation in another concmTent clinica l study. 
13. Any other ocular condition or systemic co-morbidity that the 
Investigator determines would confound the results of this study 
or would prohibit completion of the study assessments. 
Effectiveness 
EndpointsNariables 
Primary 
• 
Percentageof eyes in which the MRSE at 1 month is :S 0 .5 0 D 
relative to predicted MRSE. 
Secondary 
• 
Cumulative dissipated energy (CDE) 
• 
Estimated aspiration fluid used 
• 
Phacoemulsification aspiration time 
Safety Variables 
• 
Adverse events 
• 
Slit-lamp examination 
• 
lntraocular pressure (IOP) 
• 
Surgical problems 
• 
Dilated fundus examination 
• 
Device deficiencies 

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Planned Analyses 
The prima1y effectiveness objective is to demonstrate superiority 
of the Cataract Refractive Suite (CRS) compared to standard 
manual techniques with respect to refractive predictability 
(predictive eITor) at 1 mon th. 
The null and alternative hypotheses for the primruy analysis are: 
Ho: Pc:S Ps 
Hi: Pc> Ps 
where Pc and Psare the percentage of eyes with manifest refraction 
spherical equivalentwithin 0.5 D of predicted postoperative 
spherical equivalent at 1 month in the CRS and standard manual 
technique aims respectively. The prima1yeffectiveness analysis 
will be analyzed using a one-sided McNemar 's test at the a,=0.05 
level. 
The secondruy endpoints ru·e: 
• 
The mean CDE expended in the eye during surge1y. 
• 
The mean estimated aspiration fluid used during surge1y. 
• 
The mean aspiration time spent during surge1y. 
The null and alternative hypotheses are the same for all secondary 
anal ysis and can be presented as: 
Ho: Le 2: µ s 
H i: Le < µs 
where µc denotes the mean value in the CRS group and µ5  denotes 
the mean value in the standard manual technique group for each of 
the respective secondruy endpoints. The secondary hypotheses will 
only be tested if the pri ma1y objective is met and each of the null 
hypotheses will be tested using a one-sided paired t-test. 
 
The safety outcomes will be summru·ized with appropr iate 
summa1ystatistics and also listed. The study will employ an 
adaptive design with potential sample size adjustment based on the 
propo1tion of discordance in the prima1y effectiveness outcome 
between the study eyes. An interim anal ysis to assess the need for 
sample size re-estimationwill be perfo1med when the first 
200 subjects who are randomized, treated and completed their 
assessment for the primruy effectiveness at Month 1. 

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Sample Size 
Justification 
Based on recent clinical experience, the rates of success for the 
primary endpoint are assumed to be 83% and 75% for the CRS 
and standard manual technique arms, respectively. 
An estimate of the discordance in outcome between eyes is not 
known; however, based on the assumed rates of 83% and 75% for 
the primary endpoint, the rate of discordance must be between 8% 
and 33%. For an initial sample size calculation, the midpoint value 
of this range, 21%, is assumed. Based on these assumptions, 
267 subjects, treated contralaterally, are required to provide 
90% power to reject the null hypothesis. If the proportion of 
discordance is 33% and all other assumptions stay the same a 
sample of 433 subjects is needed to provide 90% power. 
The two samples (267 and 433) are inflated to account for up to 
10% subject drop-out in the full analysis set (FAS) so the subject 
range increases to 300 to 500. 

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2 
TABLE OF CONTENTS 
1 
PROTOCOL SYNOPSIS ........................................................................................ 2 
2 
TABLE OF CONTENTS ........................................................................................ 8 
List of Tables....................................................................................................................................... 10 
List of Figures .......................................................................................................................... 10 
3 
ABBREVIATIONS................................................................................................... 12 
4 
GLOSSARY OF TERMS ..................................................................................... 14 
5 
AMENDMENTS .................................................................................................. 17 
5.1 
Amendment 2 ................................................................................................... 17 
5.2 
Amendment 1 ................................................................................................... 19 
6 
SCHEDULE OF VISITS ...................................................................................... 24 
7 
INTRODUCTION ................................................................................................ 27 
7.1 
Background ....................................................................................................... 27 
7.2 
Clinical Study Design ....................................................................................... 28 
8 
CLINICAL STUDY OBJECTIVES ..................................................................... 30 
8.1 
Primary Objective ............................................................................................. 30 
8.2 
Secondary Objectives ....................................................................................... 30 
30 
8.4 
Study Endpoints ................................................................................................ 31 
8.4.1 
Effectiveness Endpoints ............................................................................... 31 
8.4.2 
Safety Endpoints ........................................................................................... 32 
9 
INVESTIGATIONAL PLAN ................................................................................ 32 
9.1 
Outline of Clinical Study .................................................................................. 32 
9.2 
Rationale for Study Design ............................................................................... 32 
9.3 
Procedures Conducted at each Study Visit ......................................................... 33 
9.4 
Risk Benefit Assessment .................................................................................. 33 
9.4.1 
Potential Risks .............................................................................................. 33 
9.4.2 
Potential Benefits .......................................................................................... 35 
9.4.3 
Risk benefit Assessment ............................................................................... 37 
10 
SUBJECT POPULATION ........................................................................................... 37 
10.1 
Inclusion Criteria .............................................................................................. 37 

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10.2 
Exclusion Criteria ............................................................................................. 38 
11 
TREATMENT ................................................................................................................ 38 
11.1 
Investigational Products ................................................................................... 39 
11.2 
Usage ................................................................................................................ 43 
12 
CLINICAL STUDY PROCEDURES ................................................................... 44 
12.1 
Clinical Study Assessments .............................................................................. 44 
12.1.1 
Screening Visit (Visit 0) ................................................................................ 44 
12.1.2 
Surgery Visit (Visit 00 and Visit 00A) .......................................................... 46 
12.1.3 
Visit 1 (Day 1 for Eye 1) .............................................................................. 47 
12.1.4 
Post-Surgery Visit (Visit 1A, 2A, 3A and Visit 4A) ..................................... 48 
12.2 
Unscheduled Visits ............................................................................................... 49 
12.3 
Missed Visit .......................................................................................................... 50 
12.4 
Discontinued Subjects ...................................................................................... 50 
12.5 
Clinical Study Termination ............................................................................... 50 
13 
DEVICE DEFICIENCIES AND ADVERSE EVENTS ....................................... 51 
13.1 
General Information ......................................................................................... 51 
13.2 
Monitoring for Adverse Events ........................................................................ 52 
13.3 
Procedures for Recording and Reporting ......................................................... 53 
13.4 
Return product analysis .................................................................................... 55 
13.5 
Protocol Masking Requirements ...................................................................... 55 
13.6 
Follow-Up of Subjects with Adverse Events .................................................... 55 
13.7 
Pregnancy in the Clinical Study ....................................................................... 56 
14 
DATA REVIEW AND HANDLING .................................................................... 56 
14.1 
Completion of Source Documents and Case Report Forms ............................. 56 
14.2 
Data Review and Clarifications ........................................................................ 57 
15 
ANALYSIS PLAN ................................................................................................ 58 
15.1 
Subject Evaluability .......................................................................................... 58 
15.2 
Analysis Data Sets ............................................................................................ 58 
15.3 
Demographics and Baseline Characteristics..................................................... 58 
15.4 
Effectiveness Analyses ..................................................................................... 58 
15.4.1 
Primary Effectiveness ................................................................................... 58 
15.4.1.1 
Statistical Hypotheses ............................................................................... 58 
15.4.1.2 
Analysis Methods ..................................................................................... 59 

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15.4.2 
Secondary Effectiveness ............................................................................... 59 
15.4.2.1 
Statistical Hypotheses ............................................................................... 59 
15.4.2.2 
Analysis Methods ..................................................................................... 59 
59 
15.4.3.1 
Statistical Hypotheses and Model ............................................................. 59 
15.4.3.2 
Analysis Methods ..................................................................................... 59 
15.5 
Handling of Missing Data................................................................................. 60 
15.6 
Multiplicity ....................................................................................................... 60 
15.7 
Safety Analysis ................................................................................................. 60 
15.8 
Interim Analyses ............................................................................................... 61 
15.9 
Adaptive Study Design ..................................................................................... 61 
15.10 
Sample Size Justification .................................................................................. 61 
16 
ADMINISTRATIVE PROCEDURES .................................................................. 62 
16.1 
Regulatory and Ethical Compliance ................................................................. 62 
16.2 
Informed Consent Procedures .......................................................................... 62 
16.3 
Responsibilities of the Investigator and IRB/IEC ............................................ 63 
16.4 
Sponsor and Monitoring Responsibilities ........................................................ 63 
16.5 
Regulatory Documentation and Records Retention ......................................... 64 
16.6 
Confidentiality and Publication of the Clinical Study ...................................... 64 
17 
REFERENCES ..................................................................................................... 66 
18 
APPENDICES ...................................................................................................... 68 
 
 
List of Tables 
Table 6–1 
Schedule of Visits ................................................................................................ 24 
 
Table 11–1 
Treatments........................................................................................................ 39 
Table 12–1 
Minimum time to stop wearing contact lens before Screening visit ................ 44 
 
 
List of Figures 
Figure 7–1 
Study Design .................................................................................................... 29 
 
Figure 11–1 
Test Article1: Verion Image Guided System (Verion Reference Unit) ............. 40 

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Figure 11-2 
Test Article2: Verion digital marker L ............................................................. 41 
Figure 11–3 
Test Article3: LenSx Femtosecond Laser ........................................................ 41 
Figure 11–4 
Test Article4: Verion Digital Marker M ........................................................... 42 
Figure 11–5 
Test Article5: ORA with Verifeye+ ........................................................................ 42 
Figure 13–1 
Categorization of All Adverse Events .............................................................. 51 
Figure 13–2 
Categorization of All Serious Adverse Events ................................................. 52 

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3 
ABBREVIATIONS 
 
Abbreviation 
Definition 
ADE 
Adverse device effect 
AE 
Adverse event 
AMD 
Age-related macular degeneration 
ATR 
Against-the-rule 
CDE 
Cumulative dissipated energy 
CFR 
Code of Federal Regulations 
CIM 
Corneal irregularity measurements 
CJD 
Creutzfeldt-Jacob Disease 
cm 
Centimeter 
CNV 
Choroidal neovascularization 
CRS 
Cataract Refractive Suite 
CSM 
Clinical site manager 
CTM 
Clinical Trial Management 
D 
Diopter 
EBMD 
Epithelial basement membrane dystrophy 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
ETDRS 
Early Treatment Diabetic Retinopathy Study 
EU 
European Union 
FAS 
Full analysis set 
FDA 
US Food and Drug Administration 
GCP 
Good clinical practice 
GPCMS 
Global Product Complaint Management System 
h 
Hour 
HIV 
Human immunodeficiency virus 
ICF 
Informed consent form 
IEC 
Independent ethics committee 
IOL 
Intraocular lens 
IOP 
Intraocular pressure 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
LCD 
Liquid crystal displays 
LCSM 
Lead clinical site manager 
LogMAR 
Logarithm of the minimum angle of resolution 
LRI 
Limbal relaxing incision 
MedDRA 
Medical Dictionary for Regulatory Activities 
mm 
Millimeter 
MOP 
Manual of procedures 
MRSE 
Manifest refractive spherical equivalent 

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Abbreviation 
Definition 
N/A 
Not applicable 
nm 
Nanometer 
ORA 
Optiwave Refractive Analysis 
PMMA 
Polymethyl methacrylate 
PT 
Preferred term 
RGP 
Rigid gas permeable 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SE 
Spherical equivalent 
SOC 
System organ class 
SOP 
Standard Operating Procedure 
TBUT 
Tear break up time 
US/USA 
United States of America 
USV 
Unscheduled study visit 
WHO 
World Health Organization 
WTR 
With-the-rule 

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4 
GLOSSARY OF TERMS 
 
Adverse Event (AE) 
Any untoward medical occunence, unintended disease or injmy, or 
untoward clinical signs (including abnonnal laboratmy findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device (test ariicle). 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. 
Adverse Device 
Effect (ADE) 
Adverse event related to the use of an investigational medical device 
(test ariicle) or control article. Note: This definition includes adverse 
events resulting/ram 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. 
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. 
Malfunction 
Failure of a medical device to meet its performance specifications or 
otherwise perform as intended. Performance spec ificat ions include 
all claims made in the labeling of the device. The intended 
performance of the device refers to the intended use for which the 
device is labeled or marketed. 
Product Complaint 
Any oral, electronic, or written communication that alleges 
deficiencies related to the identity (labeling), quality, durability, 
reliability, safety, effectiveness, or performance of a mar·keted 
produ ct, including failure of the product, labeling or packaging to 
meet specifications, whether or not the product is related to or 
caused the alleged deficiency. A complaint may allege that an 
adverse event or medical device malfunction has occmTed. 
Non-se riou s A d verse 
Event 
AE that does not meet the criteria for a serious adverse event (SAE). 
Serious Adverse 
Event 
Adverse event that led to any of the following: 
• 
Death. 

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• A serious deterioration in the health of the subject that either 
resulted in: 
a) a life-threatening illness or injmy. 
Note: Life-threatening means that the individual was at 
immediate risk of death from the event as it occurred, ie, it 
does not include an event which hypothetically might have 
caused death had it occurred in a more severe fon n. 
b) any potentially sight-threatening event or pe1manent 
impai1ment to a body stmcture 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 considereda 
serious adverse event. In general, hospitalizationsignifies 
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) orb). 
e) any indirectha1m as a consequence of incon ect diagno stic 
test results when used within manufacturer's instmctions for 
use. 
• Fetal distress, fetal death, or a congenital abnmmality or bitih 
defect. 
Refer to Section 13 for additional SAEs. 
Serious Adverse 
Device Effect 
(SADE) 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
Serious Public Health 
Threat 
Any event type which results in imminent risk of death, serious 
deterioration in state of health, or serious illness that requires prompt 
remedial action. This would include: events that are of significant 
and unexpected nature such that they become ala1ming as a potential 
public health hazard, eg, human immunodeficiency vitus (HIV) or 
Creutzfeldt-Jacob Disease (CJD). 
Use Enor 
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 

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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. 
 
5.1 
Amendment 2 
Purpose of Amendment: To revise an inclusion criterion, address omissions from the text and 
remove text about secondary surgical interventions 
 
Rationale: The corneal irregularity inclusion criterion is too specific. Additionally, the other 
items are needed for clarification 
 
Current Study Status: Enrolling 
 
4 subjects have been enrolled in the study at 1 site 
 
Case Report Form Revision Required: 
Yes 
X No 
Informed Consent Modifications Required: 
Yes 
X No 
Applicable Investigators: 
X All 
Selected (list below) 
Itemized Changes: 
 
Section 
Item 
Rationale 
Sections 1 
and 10 
Changed the exclusion criterion 1: 
From 
Significant irregular corneal astigmatism 
where the corneal irregularity 
measurements (CIM) index is above 1.0 as 
measured by the corneal topographer. 
To align the criterion with how 
corneal irregularity is 
evaluated in a standard clinic 
setting 

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To 
Significant irregular corneal astigmatism as 
assessed by the index relevant to the 
corneal topographer and investigator 
judgement of the topography maps 
Sections 1 
and 10 
Added condition to the exclusion criterion 
13: 
Any other ocular condition or systemic co- 
morbidity that the Investigator determines 
would confound the results of this study or 
would prohibit completion of the study 
assessments. 
To clarify the text 
Sections 3, 4 
and 15 
Removed any reference to secondary 
surgical intervention 
Collection of secondary 
surgical intervention is not 
applicable since this is not a 
registration trial 
Section 6 
Added an “X” under the Screening Visit 
Column of the Schedule of Visits table for 
Keratometric measurements 
To address an omission 
Section 12 
Revised text from: 
Perform Verion (measurement module and 
vision planner). 
To 
Use the Verion Vision Planner for IOL 
power calculation. 
To clarify that only the vision 
planner portion is to be used 
and that it’s used for IOL 
power calculation 
Section 6 
Revised text from: 
Verion (Measurement Module and Vision 
Planner) IOL calculation will only be used 
on the test eyes. 
To clarify that only the vision 
planner portion is to be used 
and that it will be used on both 
eyes 

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X 
X 
X 
 
To 
Verion Vision Planner IOL calculation will 
only be used on both eyes. 
Section 12 
Added LenStar 
Perform Keratometry with LenStar 
To clarify that the LenStar will 
be used for keratometry 
Section 12 
Added below text: 
Assess for irregular corneal astigmatism by 
evaluating the relevant irregularity index 
and the appearance of the topography 
maps. Document on the printed maps 
whether or not there is significant irregular 
corneal astigmatism and provide a 
justification for the assessment. 
To elaborate on the corneal 
topography assessment that 
will be used for the relevant 
exclusion criterion 
5.2 
Amendment 1 
Purpose of Amendment: To implement revisions based on the change in IOL platform from 
monofocal to multifocal (ReSTOR +2.5 IOL) 
 
Rationale: To align with business/reimbursement strategy 
Current Study Status: Planning 
 
 
Case Report Form Revision Required: 
Yes 
No 
 
 
Informed Consent Modifications Required: 
Yes 
No 
 
 
 
Applicable Investigators: 
All 
Selected (list below) 
 
 
Itemized Changes: 
 
Objectives (Protocol Section 1 and Section 8) 

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Eligibility Criteria (Protocol Section 1 and Section 10) 
 
Criterion 
Rationale 
Added an inclusion criterion, “target is 
emmetropia (+0.50 to -0.50) 
To ensure no monovision treatments are 
planned 
Changed minimum age from 21 to 22 
To be consistent with age defined as adult for 
other trials executed in US 
Replaced monofocal IOL implantation with 
ReSTOR +2.5 D IOL 
To align with business/reimbursement strategy 

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Statistics (Protocol Section 1 and Section 15) 
 
Item 
Rationale 
Changed assumptions for control vs test rates 
from 70% vs 80% to 75% vs 83% 
Changed the range of required sample size 
from 202 - 318 to 267 – 433 
Changed the range of the number of eyes to 
be randomized from 225 – 375 to 300 – 500 
New assumptions for control and test rates 
based on recently available data from the 
AnalyzOR Retrospective Data Exploration 
Study 
 
 
Other 
 
Added the following: 
 
Item 
Rationale 
Create a 4.8 to 5.5 mm anterior capsulotomy 
centered on the line of sight using the manual 
technique (Section 12.1.2) 
For consistency between eyes, subjects and 
sites 
LenSx arcuate incisions may be refined based 
on ORA recommendations (Table 6-1 
To maximize the value of ORA and 
Relevant changes made in Section 12 as well. 
To exclude eyes with an unstable tear film 
which could impact visual acuity and manifest 
refraction outcomes. TBUT may improve with 
warm compresses and this treatment will be 
initiated in those subjects with TBUT 
< 10 secs at the screening visit and the TBUT 
will be checked prior to randomization to 
determine if it is ≥ 10 secs prior to 
randomization. 
Added Exclusion criterion: 
TBUT < 10 secs prior to randomization 
NOTE: If either eye has a TBUT < 10 secs 
at the Screening Visit, start treatment with 
warm compresses if all other eligibility 
criteria are met. The TBUT must be checked 
prior to randomization and if the TBUT is 
< 10 secs in either eye, the subject must be 
discontinued from the study 

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footnote) 
consequently the CRS 
Added note 'o' as 'If subject did not meet 
TBUT at screening visit and waim compress 
therapy is staiied. TBUT must be reassessed 
prior to ensure subject meets criteria prior to 
randomization' (Table 6-1 footnote) 
For evaluation of the teaT fi hn 
Added details of manufacturer for Test 
a1iiicle: CRS (Table 11-1) 
To comply with ISO14155:201l guidance 
 
 
Updated the following: 
 
Updated screening visit 
From: Day -30 to 0 Screening for both eyes 
To: Day -30 to -1 Screening for both eyes 
(Table 6-1) 
To ensure randomization 1 day prior to 
surge1y. 
Randomization was shifted From Visit 00 To 
Visit 0 (Table 6-1) 
To ensure randomization 1 day prior to 
surge1y. 
Clin ical study duration (Protocol Section 1): 
To clarify study timing 
• 
Total expected duration of the clinical 
investigation- up to 5 months updated to 
11 months. 
• 
Estimated time needed to select the 
number of subjects (emollment period) - 
5 months updated to 6 months. 

Page 24 of 68 
 
 
6 
SCHEDULE OF VISITS 
 
Table 6–1 
Schedule of Visits 
 
Nominal Time ± Visit Window Limits 
Visit 0 
Visit 00 
Visit 1 
Visit 00A 
Visit 1A 
Visit 2A 
Visit 3A 
Visit 4A 
USVn 
Both eyes 
assessed 
Both eyes 
assessed 
Both eyes 
assessed 
Both eyes 
assessed 
Procedure/Assessment 
Day -30 to -1 
Screening for 
both eyes 
Day 0 
Implant for 
Eye 1 
Day 1 
for 
Eye 1 
Day 7-14 
Implant for 
Eye 2 
(7-14 days 
after V00) 
Day 1 
for Eye 2; 
Days 8-15 
for Eye 1 
Day 7-10 
post 2nd eye 
surgery 
Month 1 
(Days 20-40 
post 2nd eye 
surgery) 
Month 3 
(Days 70- 
110 post 2nd 
eye surgery) 
N/A 
Informed consenta 
X 
Demographics 
X 
Medical history 
X 
Concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Inclusion/exclusion criteria 
X 
Pregnancy testb 
X 
Randomizationc 
X 
IOPd 
X 
X 
X 
X 
X 
Corneal topography 
X 
Manifest refraction 
X 
X 
X 
X 
X 
X 
Predicted post-op spherical 
equivalent (SE) 
X 
Slit-lamp examination 
X 
X 
X 
X 
X 
X 
X 
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Nominal Time ± Visit Window Limits 
Procedure/Assessment 
Visit 0 
Both eyes 
assessed 
Visit 00 
Visit 1 
Visit 00A 
Visit 1A 
Both eyes 
assessed 
Visit 2A 
Visit 3A 
Both eyes 
assessed 
Visit 4A 
Both eyes 
assessed 
USVn 
Day -30 to -1 
Screening for 
both eyes 
Day 0 
Implant for 
Eye 1 
Day 1 
for 
Eye 1 
Day 7-14 
Implant for 
Eye 2 
(7-14 days 
after V00) 
Day 1 
for Eye 2; 
Days 8-15 
for Eye 1 
Day 7-10 
post 2nd eye 
surgery 
Month 1 
(Days 20-40 
post 2nd eye 
surgery) 
Month 3 
(Days 70- 
110 post 2nd 
eye surgery) 
N/A 
Tear Break Up Time 
(TBUT) 
Xo 
Dilated fundus examination 
X 
X 
Biometry (LenStar) 
X 
Keratometric 
measurements 
X 
X 
X 
Use Verion Vision Planner 
for IOL power calculation)f 
X 
Verion (digital marker L, 
digital marker M)g 
X 
X 
LenSx arcuate incisionsh 
X 
X 
CDE 
X 
X 
Estimated aspiration fluid 
X 
X 
Phaco aspiration time 
X 
X 
VerifyEye+ measurement 
with or without VerifyEye 
Lynkg, i 
X 
X 
Problems during surgeryj 
X 
X 
Manual LRIk 
X 
X 
Device deficiencies 
X 
X 
X 
X 
X 
X 
X 
X 
X 
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Nominal Time ± Visit Window Limits 
Procedure/Assessment 
Visit 0 
Both eyes 
assessed 
Visit 00 
Visit 1 
Visit 00A 
Visit 1A 
Both eyes 
assessed 
Visit 2A 
Visit 3A 
Both eyes 
assessed 
Visit 4A 
Both eyes 
assessed 
USVn 
Day -30 to -1 
Screening for 
both eyes 
Day 0 
Implant for 
Eye 1 
Day 1 
for 
Eye 1 
Day 7-14 
Implant for 
Eye 2 
(7-14 days 
after V00) 
Day 1 
for Eye 2; 
Days 8-15 
for Eye 1 
Day 7-10 
post 2nd eye 
surgery 
Month 1 
(Days 20-40 
post 2nd eye 
surgery) 
Month 3 
(Days 70- 
110 post 2nd 
eye surgery) 
N/A 
Adverse events (both 
volunteered and elicited)l 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Exit 
X 
X 
aAll subjects must consent to bilateral treatment; both eyes are to be treated. 
bWomen of child-bearing potential only. 
cRandomization must be completed following all Screening procedures and confirmation of subject eligibility at least 1 day prior to surgery 
dIOP should be measured only after all biometric and topographic measurements are performed. 
fVerion Vision Planner IOL calculation will only be used on both eyes. 
gVerion (Digital Marker L, Digital Marker M) VerifEye+ with or without VerifEye Lynk will only be performed on the test eyes. 
hLenSx arcuate incisions will only be performed according to the Verion plan on the test eye as described in the MOP. Incisions may be refined based on ORA 
recommendation 
iIOL power recommended by ORA with VerifEye+ will only be used on the test eyes. 
jIncludes intraoperative complications. 
kManual LRI will only be performed on astigmatism of > 0.50 D, including any known surgically induced astigmatism. 
lAEs should be collected from time of consent 
mAssessments will be performed at the Week 1 visit for eye 1 only. 
nThe assessments captured at the USV are dictated by the Investigator per his/her medical judgment. Dilated fundus examination may also be performed, based 
on Investigator’s judgment. 
oIf subject did not meet TBUT at screening visit and warm compress therapy is started, TBUT must be reassessed to ensure subject meets criteria prior to 
randomization. 
CDE=cumulative dissipated energy, IOP=intraocular pressure, LRI=limbal relaxing incision, 
USV=unscheduled study visit. 
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7 
INTRODUCTION 
7.1 
Background 
Cataract is the leading cause of blindness in the world, and cataract surgery is one of the most 
commonly performed operations in the Western world. Preferred surgical techniques have 
changed dramatically over the past half century with associated improvements in outcomes 
and safety. Femtosecond laser platforms that can accurately and reproducibly perform key 
steps in cataract surgery, including corneal incisions, capsulotomy and lens fragmentation, are 
now available (Day 2016). According to the World Health Organization (WHO), an estimated 
20 million people worldwide are blind due to bilateral cataracts (Baltussen 2004). 
 
Over the past decades, the safety and effectiveness of cataract surgery has improved, but 
cataract patients continue to have high expectations when it comes to their postoperative 
refractive outcomes. Modern cataract surgery is becoming a refractive procedure, and 
surgeons not only aim to remove the cataractous lens successfully but also to reduce or 
eliminate pre-existing refractive errors. Published literature reports 71% and 47% of post 
cataract removal patients are within ±0.5 D and ±0.25 D respectively of the biometry 
prediction error. It is interesting to note that only two thirds of the study population planned 
for emmetropia became emmetropic (Behndig 2012). Although there are reports on 
preoperative biometry prediction and astigmatism management (Behndig 2012, Hatch 2015), 
it is necessary to address the role of other variables such as posterior corneal curvature to 
total astigmatism and standard intraocular lens (IOL) calculation. 
 
Although there are published results regarding the individual devices of the Cataract 
Refractive Suite (CRS) (Hatch 2015, Nemeth 2015, Woodcock 2016, and Ianchulev 2014) 
and retrospective study of the use of the major components of the CRS (AnalyzOR 
Retrospective Data Exploration Study, data on file), there is no prospective study that reports 
the refractive outcomes produced by using the major components of the CRS together. 
 
The aim of this study is to assess the refractive accuracy when using the combined CRS for 
surgical planning and lens removal and to compare these results with those obtained using the 
standard manual technique. 
 
The CRS is composed of a series of devices that address the pre-planning stages of IOL 
calculation and integrates this information into the operative stage up to postoperative 
follow-up. In this study, the major components of the CRS are identified as Verion Image 
Guided System, LenSx femtosecond laser and Optiwave Refractive Analysis (ORA) with 
VerifEye+ with or without VerifEye Lynk. Verion takes a preoperative image of the eye and 

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the information captured is automatically transferred and used for IOL calculation. This 
information is then linked to LenSx laser where the customized treatment is automatically 
integrated. Intraoperatively, phacoemulsification is performed to remove the cataractous lens. 
After which, the ORA with VerifEye+ refracts the eye in the aphakic state and can confirm 
the IOL power selected or recommend a different IOL power and IOL positioning if using a 
toric IOL. All of this information is stored in the system and can be used to track 
postoperative results and eventually help the surgeon personalize and optimize their surgeries 
to achieve reproducible and consistent refractive outcomes. 
 
7.2 
Clinical Study Design 
This is a prospective, multi-center, observer-masked, randomized, active control (standard 
manual technique), contralateral design study to evaluate refractive predictability between 
CRS and standard manual technique. All products under investigation are commercially 
available in the countries where the study is being conducted. 
 
The eye with the worse preoperative best-corrected distance visual acuity (BCDVA) will 
undergo cataract surgery with IOL implantation first. If the preoperative BCDVA is equal in 
both eyes, then the right eye will undergo the surgery and IOL implantation first. The first eye 
will be randomized to receive the test or control treatment; the fellow eye will receive the 
opposite assignment. Subjects are required to attend 8 study visits, during which assessments 
will be scheduled separately for the first study eye, the second study eye and both study eyes. 
 
Subjects will attend the Screening visit from Day -30 to Day -1 (Surgery Eye 1, Visit 00), 
followed by Visit 1 (Day 1 post surgery for Eye 1), Visit 00A (Surgery Eye 2 [7-14 days after 
that for Eye 1]), Visit 1A for both eyes (Day 1 for Eye 2; Day 8-15 for Eye 1), Visit 2A 
(Day 7-10 post Eye 2 surgery), Visit 3A (Month 1 [Day 20-40 post Eye 2 surgery]), Visit 4A 
(Month 3 [Day 70-110 post Eye 2 surgery]). Total expected clinical study duration will be 
approximately 5 months after being screened for study eligibility. 
 
This study will employ an adaptive design with a potential sample size adjustment based on 
interim analysis (Section 15.8). It is planned that the study will enroll approximately 
350 subjects to initially randomize and treat 300 subjects (that could potentially increase to 
approximately 580 subjects enrolled and 500 subjects randomized). An interim analysis will 
be performed once 200 subjects have been randomized, treated and completed 1-month 
follow-up visits. An additional 200 subjects may be randomized and treated beyond the 
initially planned 300 subjects. Thus the study will randomize and treat between 300 and 
500 subjects. 

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An overview of the study design is presented in Figure 7–1. 
 
Figure 7–1 
Study Design 
 
 
In order to reduce bias, the observer (ie, study technician assessing primary endpoint data) 
will remain masked to the treatment assignment. The masked observer will be collecting and 
recording the required data at all the follow up visits. Alcon and other site personnel [eg, 
surgeons, nurses and technicians involved with the surgery, site personnel entering data in the 
electronic case report forms (eCRF), site personnel administering other study related 
procedures] must not reveal the treatment assignment to masked site personnel at any time 
during the study. 

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8 
CLINICAL STUDY OBJECTIVES 
8.1 
Primary Objective 
The prima1y objective of the study is: 
 
• 
To compare the refractive predictability(prediction enor) between the CRS and standard 
manual technique at 1 month postoperative. 
8.2 
Secondary Objectives 
The seconda1y objectives of the study are: 
 
• 
To compare the amount of cumulative dissipated energy expended in the eye between the 
CRS and standard manual technique. 
• 
To assess the average estimated aspiration fluid used during surge1ybetween the CRS and 
standard manual technique. 
• 
To assess the average aspiration time spent during surge1y between the CRS and standard 
manual technique. 

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8.4 
Study Endpoints 
8.4.1 
Effectiveness Endpoints 
 
The prima1y effectiveness endpoint is: 
 
• 
Percentage of eyes in which the MRSE at 1 month is 
0.50 D relative to predicted 
MRSE. 
Seconda1y effectiveness endpoints are as follows: 
 
• 
Mean cumulative dissipated energy (CDE) expended in the eye during surge1y. 
• 
Mean estimated aspiration fluid used during surgery. 
• 
Mean aspiration time spent during surge1y. 
 

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8.4.2 
Safety Endpoints 
Safety endpoints are as follows: 
 
• 
Adverse events 
• 
Slit-lamp examination 
• 
Intraocular pressure (IOP) 
• 
Surgical problems 
• 
Dilated fundus examination 
• 
Device deficiencies 
9 
INVESTIGATIONAL  PLAN 
9.1 
Outline of Clinical Study 
In this prospective, multi-center, observer masked, randomized, active control, post market 
clinical study, approximate ly 350 to 580 subjects with bilateral cataracts will be emolled at 
approximately 12 investigational sites and undergo cataract  surgery. An estimated  300 to 
500 subjects will be randomly assigned to receive either CRS or standard manual technique 
first, and the other eye will undergo opposite technique. Subjects participating in this study 
will attend a total of 8 study visits over a period of up to 154 days: a Screening visit (Visit 0), 
a surgery/implantation visit (Eye I-Visit 00; Eye 2-Visit 00A), and up to Visit 4A(124 days 
from first eye implantation) as post-surgery follow-up visits. Refer to Figure 7- 1 for a study 
outline diagram. Additional subjects may be emolled based on the interim analys is. 
 
9.2 
Rationale for Study Design 
The study is being perform ed to assess the refractive predictability when using CRS and to 
compare the results with those assessed using standard manual technique. There are several 
factors that can affect accuracy to target such as variability in keratometiy readings, IOL 
calculation, surgeon factors, pre-existing and induced astigmatism and type of IOL implanted 
among others. This study is designed to mitigate these factors by ensuring appropriate target 
population with the inclusion/exclusion criteria; and using standard integrated measurement 
devices in order to implant and confirm the IOL that will be closest to target refraction. 

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9.3 
Procedures Conducted at each Study Visit 
Procedures required by the protocol to be conducted at each study visit are listed in the 
Table 6-1 and detailed in Section 12 and in the manual of procedures (MOP) that 
accompanies this protocol. A brief summa1yof the main procedures perfo1med by visit is 
provided here. 
 
• 
At the Screening visit (Visit 0) the subject will sign infmmed consent. Standard 
procedures will be perfo1med to deternline subject eligibility. 
• 
Following confam ation of eligibility, the surge1y visit will be scheduled for the first study 
eye. The subject will be randomized (via the Medidata RAVE) prior to the first surge1y 
visit to a technique sequence. The technique sequence will be randomly assigned as 
either: CRS then standard manual technique or standard manual technique then CRS. 
• 
At the surge1yvisit (Visit 00), if subjects are randomized to CRS, the test devices to be 
used on the first eye during surge1y will be: Verion (digital marker L, digital marker M), 
LenSx device, VerifyEye+ measurement with or without VerifyEye Lynk. The estimated 
aspiration fluid, phacoemulsification aspiration time, and CDE will be recorded for both 
arms of the study. The subject will then undergo surge1y in the other eye using a standard 
manual technique and perfo1m manual LRI as needed as indicated on the MOP 
(Visit 00A). 
• 
At the post-surge1y follow-up visits, ie, Visit 1 (for the first study eye), Visit l A (for both 
study eyes), Visit 2A (for the second study eye), Visit 3A and Visit 4A (for both eyes), the 
following assessments will be perfmmed: concomitant medications, 
 
 manifest refract ion, slit-lamp examination, AEs and device 
deficiencies will be recorded in all post-surge1y follow-up visits. 
o IOP measurements will be perfmmed at Visit lA and Visit 4A. 
o Dilated fundus examination will be perfmmed at Visit 4A. 
o Keratometric measurements will be perfmmed at Visit 3A and Visit 4A. 
9.4 
Risk Benefit Assessment 
9.4.1 
Potential Risks 
VERION®  Image Guided System: The following conditions may affect the accuracy of 
surgical plans prepared with the Verion reference unit: a pseudophakic eye, eye fixation 
problems, a non-intact cornea or an ilTegular cornea and severe diy eyes. In addition, subjects 
should refrain from wearing contact lenses during the reference measurement as this may 

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interfere with the accuracy of the measurements (refer to Table 12-1 fordetails). The 
following conditions may affect the proper functioning of the Verion digital marker: changes 
in a subject's eye between preoperative measurement and surge1y, an inegular elliptic limbus 
(eg, due to eye fixation during surge1y, and bleeding or bloated conjunctiva due to 
anesthesia). In addition, the use of eye drops that constrict sclera vessels before or during 
surge1y should be avoided. 
 
LenSx® laser : The following complications may occur with the use of LenSx laser: 
 
• 
Incomplete or intenupted capsulotomy 
 
• 
Capsular tear 
 
• 
Corneal abrasion or defect 
 
• 
Infection 
 
• 
Damage to intraocular structures 
 
• 
Anterior chamber fluid leakage 
 
• 
Anterior chamber collapse 
 
• 
Suction failure 
 
• 
Elevated pressure to the eye 
 
The following conditions may affect the functioning of LenSx laser: corneal disease that 
precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength, 
descemetocele with impending corneal rupture, presence of blood or other material in the 
anterior chamber, poorly dilating pupil, such that the iris is not peripheral to the intended 
diameter for the capsulotomy, conditio ns which would cause inadequate clearance between 
the intended capsulotomy depth and the endothelium (applicable to capsulotomy only), 
previous corneal incisions that might provide a potential space into which the gas produced 
by the procedure can escape, corneal thickness requirements that are beyond the range of the 
system, corneal opacity that would interfere with the laser beam, hypotony or the presence of 
a corneal implant, residual, recun ent, active ocular or eyelid disease, including any corneal 
abno1mality (for example, recun ent corneal erosion, severe basement membrane disease), 
hist01y of lens or zonular instability and any other contraindication to cataract or keratoplasty. 

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VeritEye+: The following cond itions may affect the accuracy of measurements taken by 
VerifEye+. Progressive retinal pathology such as diabetic retinopathy, macular degeneration, 
or any other pathology that the physician deems would interfere with patient fixation. 
Corneal pathology such as Fuchs', epithelial basement membrane dystrophy (EBMD), 
keratoconus, advanced pte1ygium impairing the cornea, or any other pathology that the 
physician deems would interfere with the measurement process. Residual viscous substances 
left on the corneal surface such as lidocaine gel or viscoelastics. Visually significant media 
opacity, such as prominent floaters or asteroid hyalosis. Retro or peribulbar block, or any 
other treatment that impairs a patient's ability to visualize the fixation light. Utilization of iris 
hooks during surge1y.Pupil dilation less than 4.5 mm. 
 
Stand31'd manual technique: The following complications may occur with the standard 
manual technique. 
 
• 
Incomplete or intenupted capsulotomy 
• 
Capsular tear 
• 
Corneal abrasion or defect 
• 
Infection 
• 
Damage to intraocular strnctures 
• 
Anterior chamber fluid leakage 
• 
Anterior chamber collapse 
Another risk associated with phacoemulsification is rise in IOP. The response in IOP to 
phacoemulsification is biphasic, with a transient immediate rise followed by a modest 
long-te1mdecrease. Postoperative IOP usually peaks 5- 7 h after surge1y and returns to 
n01mal levels in 1- 3 days. Although transient, the elevated IOP can cause ocular pain, may 
increase the risk of sight threateningcomplications such as retinal vascular occlusion, 
progressive field loss in advanced glaucoma, and anterior ischemic optic neuropathy in 
susceptible patients (Karatas 2013). 
 
9.4.2 
Potential Benefits 
VERION® Ima ge Guid e d Sys te m : The Verion reference unit is a preoperative measurement 
device that captures and utilizes a high-resolution reference image of a subject's eye. It 
provides preoperative surgical planning functions to assist the surgeon with planning cataract 
surgical procedures that takes into account variables not typically considered when doing 
standard IOL calculation such as rotational eye movementsand surgical induced astigmatism. 

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The Verion reference unit also suppmis the expmi of captured images of the eye (ie, scleral 
vessels, undilated pupil), preoperative measurement data, and surgical plans for use with the 
Verion digital marker and other compatible devices. These features enable automatic 
positioning and cent:ration of the capsulotomy and IOL as well as placement of corneal 
incisions in the right location taking into account cyclorotation of the eye which would 
othe1wise be unidentifiable without physically marking the eye pre-op. 
 
LenSx laser: The LenSx laser is indicated for use in subjects undergoing cataract surgery for 
removal of the c1ystalline lens. It pre-cuts the anterior capsule, lens and creates the corneal 
incisions for easier removal of the cataractous lens in the operating room. The LenSx 
femtosecond laser can create corneal incisions that are single plane or multi-plane allowing 
for customization of the cuts. Since the LenSx device pre-cuts the eye prior to surge1y, this 
will require less phacoemulsification power and time to remove the cataractous lens. Reduced 
time in the eye has been associated with less risk for potential complications such as corneal 
bums and others. 
 
With the integrationof the Verion to the LenSx femtosecond laser, the pre-op data collected 
from the Ve1ion refe rence unit is transfeITed to the Verion Digital Marker L allowing 
automatic positioning and placement of the cuts. This automatic feature can decrease any 
e1rnr that may come from manual transcription. 
ORA with Verifeye+: The ORATM System is designed to be used during ophthalmic surge1y. 
Wavefront data is obtained, analyzed, and presented to the user via a ca1i mounted liquid 
c1ystal displays (LCD) touchscreen, within a period that does not impede the surgical 
procedure. The ORA System is intended for use in the measurement and analysis of the 
refractive power of the eye (ie, sphere, cylinder, and axis measurements) and can obtain 
measurements in the phakic, aphakic and pseudophakic state. It uses proprieta1y IOL power 
calculations that aim to assist the surgeon in IOL power (sphere, and in the case of toric IOLs, 
cylinder power and axis of placement) selection intraoperatively. The predicted IOL power is 
calculated at the reference unit po1i ion of the Verion, but then confiim ed or an alternate plan 
suggested by ORA following the aphakic measurements. In this study, due to the type of IOL 
specified SV25T0, only the aphakic application will be used. The pseudophakic function of 
the system is typically only used in toric IOL cases to refine axis of placement. 
 
Standardmanual technique: The poten tial benefits of standard manual techniques include: 
 
• 
Removal of the cataractous lens. 
• 
No additional equipment required and therefore has less associated cost. 

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• 
No extra learning curve for the surgeon that comes with using a new device. 
9.4.3 
Risk benefit Assessment 
Surgical devices for both the techniques are commercially available and the safety and 
effectiveness of these surgeries have been established in clinical trials prior to approval of 
these devices. 
 
Overall, the benefits of the CRS and manual technique are considered to outweigh the risks. 
 
Phacoemulsification cataract surgery is considered a safe procedure; however, introduction of 
new technologies allows the surgeon to improve preoperative  planning  and optimize 
refractive outcomes (Solomon 2016). 
 
10 
SUBJECT POPULATION 
Subjects 2 22 years age, diagnosed with bilateral cataracts and fulfilling all other eligibility 
criteria in Section 10.1 and Section 10.2, will be emolled into the study. This study will emoll 
approximately 350 subjects to initially randomize and treat 300 subjects (that could 
potentially increase to approximately 580 subjects emolled and 500 subjects randomized) to 
be emolled at approximately 12 sites. 
 
10.1 
Inclusion Criteria 
Subjects should fulfill the below criteria to be eligible for this study. 
 
1. Adults (2 22 years of age at the time of surge1y), diagnosedwith bilateral cataracts. 
2. Planned cataract surge1y and implantation of of ReSTOR +2.5 D multifocal IOL in both 
eyes. 
3. Target is emmetropia (+0.50 to -0.50). 
4. Clear intraocular media other than cataract in study eye(s). 
5. Willing and able to complete all required postoperative visits. 
6. Able to comprehend and sign a statement of info1m ed consent. 
7. Potential postoperative visual acuity of 0.2 logarithm of the minimum angle of resolution 
(LogMAR) or better. 
8. Preoperative keratometiy reading between 40.0 D to 49.0 Din the prima1ymeridians. 
9. Preoperative axial length between 21.5 mm to 27.0 mm. 

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10. Preoperative/Baseline corneal with-the-rule (WTR), against-the-rule (ATR) or oblique 
astigmatism ≤ 1.25 D. 
10.2 
Exclusion Criteria 
1. Significant irregular corneal astigmatism as assessed by the index relevant to the corneal 
topographer and investigator judgement of the topography maps 
2. History of or current severe dry eyes. 
3. Tear breakup time (TBUT) < 10 secs prior to randomization. 
4. Retinal/uveal pathology or concurrent ocular disease including age-related macular 
degeneration (AMD), choroidal neovascularization (CNV), glaucoma, diabetic 
retinopathy, retinitis pigmentosa, and optic nerve pathology. 
5. Previous intraocular or corneal refractive surgery. 
6. Any inflammation or edema (swelling) of the cornea, including but not limited to the 
following: keratitis, keratoconjunctivitis, and keratouveitis. 
7. Amblyopia. 
8. Previous corneal transplant. 
9. Previous retinal detachment. 
10. Recurrent severe anterior or posterior segment inflammation of unknown etiology. 
11. Pregnancy at time of Screening. 
12. Participation in another concurrent clinical study. 
13. Any other ocular condition or systemic co-morbidity that the Investigator determines 
would confound the results of this study or would prohibit completion of the study 
assessments. 
11 
TREATMENT 
Throughout the clinical study, the Investigator will be responsible for the ensuring that the 
clinical study products are not used in any unauthorized manner. 

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Table 11-1 
Treatments 
 
Test article: CRS 
Control articles: Standa1·d m a nu al 
tec hniqu e 
Ad ministration 
Intervention during 
preope rative planning and 
during cataract surge1y 
Intervention during surge1y 
Man ufacturer 
Alcon Laboratories, Ft. Worth, 
TX, USA 
-- 
 
11.1 
Investigational Products 
Test Article: CRS composed of the following: 
 
1. Verion Image Guided System which comprises of the following: 
• Verion measurement module 
• Verion vision planner 
• Verion digital marker 
2. LenSx femtosecond laser 
3. ORA with VerifEye+ (with or without the VerifEye Lynk) 
The CRS is a collection of advanced technologies that is designed to guide inf01med surgical 
decisions, minimize potential sources of en or, and may allow surgeons to be more consistent 
in delivering the desired refractive outcomes. The cmTent focus in cataract surge1y is toward 
achieving better refractive outcomes, and the CRS helps to achieve this goal because each 
component enhances accuracy in the many steps of the surgical procedure. The CRS may 
improve refractive outcomes by integrating the different technologies that is used from the 
planning stage to surge1y to postoperative follow-up. It gives the surgeon the capability to 
access, review and analyze their postoperative data all in one location and personalize 
surgeon factors to fmt her optimize their results. 

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The Verion Image Guided system performs 3 functions: diagnostic imaging, surgical 
planning, and surgical guidance. The Verion Reference Unit is comprised of the Verion 
measurement module and the vision planner. The measurement module obtains a digital 
image of the eye and performs keratometry and pupillometry measurements. The Verion 
vision planner—performs IOL power selection and astigmatism management—uses the data 
from the measurement module. The reference image and the surgical plan are then exported 
to the Verion digital marker L and digital marker M that creates a computer-generated 
tracking overlay for the LenSx laser and the surgical microscope respectively. The image and 
overlay support eye tracking and registration while providing a real-time guide for accurate 
capsulotomy creation, corneal incisions, and IOL positioning. 
The Verion measurement module is used for performing pre- and post-op measurements and 
the Verion vision planner is used to plan the surgery steps (including lens calculation) and to 
record the surgery and postoperative measurement data (Figure 11–1). 
 
Figure 11–1 
Test Article1: Verion Image Guided System (Verion Reference 
Unit) 
 
 
 
 
Verion digital marker is the link of the diagnostic and surgery context information to the eye 
coordinate system. It provides the integrated image guidance throughout the diagnostic and 
surgery process and the per-subject documentation of the surgery workflow (Figure 11-2 and 
Figure 11–4). 

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Figure 11-2 
Test Article2: Verion digital marker L 
 
The LenSx laser creates incisions through tightly focused femtosecond laser pulses that cut 
tissue with micron-scale precision. The incision is achieved by contiguously placed 
microphotodisruptions scanned by a computer-controlled delivery system. The LenSx laser is 
indicated for use in subjects undergoing cataract surgery for removal of the crystalline lens. 
Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the 
creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may 
be performed either individually or consecutively during the same procedure (Figure 11–3). 
 
Figure 11–3 
Test Article3: LenSx Femtosecond Laser 

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Figure 11–4 
Test Article4: Verion Digital Marker M 
 
 
ORA with VerifEye + is an intraoperative aberrometer that is capable of calculating the IOL 
power based on the aphakic refraction and the subject’s preoperatively measured axial length 
and keratometry readings and white to white measurements. In this study, IOL power 
recommended by ORA with VerifEye+ will be used on the test eyes. 
 
Figure 11–5 
Test Article5: ORA with Verifeye+ 
 
 
ORA with VerifEye Lynk is an intraoperative aberrometer which contains a data interface 
with Verion. It is used in conjunction with Verion digital marker M (Version 3.0) to combine 
intraoperative refraction with integrated image guidance. ORA System AnalyzOR in the 
VerifEye Lynk system receives all required preoperative data from the Verion vision planner 
(Version 3.0). 

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Control Articles: Standard manual technique and manual limbal relaxing incisions as 
necessary. If a manual limbal relaxing incision is needed, the calculation will be based on the 
output of the Verion measurement module and Vision planner taken at Screening. The control 
procedure is standard biometry for IOL calculation and cataract removal using 
phacoemulsification technique. 
 
11.2 
Usage 
Verion reference unit and Verion digital marker: 
 
Plausibility of measurement: Ensure the cornea is in natural condition before performing a 
Verion measurement. Normal conditions might be violated after direct cornea contact. Do not 
perform more than 15 measurements per session per eye. 
 
The user should check all measurement readings for plausibility. Ensure that the subject is not 
wearing contact lenses during the time of reference measurement. Dry eyes might impact the 
accuracy and robustness of the keratometry measurement. It may not be possible to carry out 
measurements on subjects with fixation problems. Reference measurements results for 
subjects with a non-intact cornea (eg, due to cornea implants, corneal transplants, corneal 
scarring, keratorefractive surgery, or irregular cornea) or pathologies that influence the 
appearance of limbus, pupil and/or iris may be incorrect. In such cases, a cross-check with 
other alternative diagnostic devices/methods is mandatory. Always check status for 
plausibility. Reference measurements on such subjects may be incorrect. Measurements of 
pseudophakic subjects may be incorrect or not possible due to the reflexes of the IOL. 
 
The user should check all measurement readings for plausibility. This involves verifying the 
registration proposals of the Verion digital marker between reference and microscope image, 
as well as verifying limbus detection during live tracking. An irregular elliptic limbus may 
not be detected correctly during the surgery. 
 
Refer to the user manuals for the Verion reference unit and the Verion digital marker for a 
complete description of proper use and maintenance of these devices, as well as a complete 
list of contraindications, warnings and precautions. 
 
Refer to the LenSx laser operator’s manual for a complete listing of indications, warnings and 
precautions. 
 
Refer to the ORA VerifEye+ operator’s manual for a complete description of proper use and 
maintenance of these devices, as well as a complete list of warnings and precautions. 

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The control procedure (standard manual technique) is standard biometry for IOL calculation 
and cataract removal using phacoemulsification technique. 
 
12 
CLINICAL STUDY PROCEDURES 
12.1 
Clinical Study Assessments 
The following section outlines the assessments to be performed in this clinical study. 
Assessments are described in detail in the MOP, and are outlined in tabular format in 
Section 6 of this protocol. 
 
NOTE: AEs are collected and reported for both the study eyes (refer to Section 13). 
 
12.1.1 
Screening Visit (Visit 0) 
Visit 0: Day -30 to Day -1 (for both eyes) 
Upon signing informed consent, subjects are considered enrolled. Subjects will be assigned a 
single subject identifier at the Screening visit. The subject identifier consists of a combination 
of a 4-digit Investigator number and a 5 digit subject number. The number is automatically 
generated sequentially by the electronic data capture (EDC) system. As an example: 
“4584.00001” (the Investigator number and subject number are separated by a “.” character). 
 
Eligible subjects who currently wear contact lenses must discontinue their use before 
undergoing Screening procedures in the study for the appropriate amount of time as indicated 
in Table 12–1. 
 
Table 12–1 
Minimum time to stop wearing contact lens before Screening visit 
 
Type of Contact Lens 
Minimum Time to Stop Wearing 
before Preoperative Visita 
Hard (PMMA) lenses 
3 weeks 
RGP lenses 
3 weeks 
Soft Toric lenses 
2 weeks 
Soft lenses 
3 days 
aThese guidelines are estimations only. Preoperative measurements should not be taken until stability of the 
keratometry reading has been established. 
PMMA= polymethyl methacrylate, RGP=rigid gas permeable. 
 
Below is a list of study procedures to be undertaken at Visit 0. Procedures should be 
performed in the order presented below unless otherwise stated. All assessments must be 
documented in the source documentation and eCRFs (if applicable). 

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1. For a potential subject meeting all entry criteria via pre-screening, invite him/her to 
participate in the study, and carry out the informed consent process if he/she is interested. 
Refer to Section 16.2 Informed Consent Procedures. 
NOTE: Subjects must formally consent to participate in the study prior to undergoing any 
study specific testing. 
2. Document demographics, ocular and nonocular medical history, ocular and nonocular 
concomitant medications. 
3. Perform a urine pregnancy test, if the subject is a woman of childbearing potential. 
4. 
 
5. Perform manifest refraction (refer to MOP for details). 
6. 
 
7. Perform slit-lamp evaluation. 
8. Measure the TBUT. Record time in source document. 
NOTE: If either eye has a TBUT < 10 secs at the Screening Visit, start treatment with warm 
compresses if all other eligibility criteria are met. 
9. Perform corneal topography. Assess for irregular corneal astigmatism by evaluating the 
relevant irregularity index and the appearance of the topography maps. Document on the 
printed maps whether or not there is significant irregular corneal astigmatism and provide 
a justification for the assessment. 
10. Perform Keratometry measurement with LenStar 
11. Use the Verion Vision Planner for IOL power calculation.(refer to MOP for details). 
12. Perform biometry (LenStar) (refer to MOP for details). 
13. Identify target refraction. 
14. Perform intraocular pressure measurement. IOP should be measured only after all 
biometric and topographic measurements are performed (refer to MOP for details). 
15. Conduct dilated fundus examination (refer to MOP for details). 
16. Record any device deficiency and AEs. 
17. Randomize the subject. 

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12.1.2 
Surgery Visit (Visit 00 and Visit 00A) 
Visit 00: Day 0 (implant for Eye 1) 
Visit 00A: 7-14 days after surgery for Eye 1 (implant for Eye 2) 
Below is a list of study procedures to be undertaken at surgery visit. Procedures should be 
performed in the order presented below. Activities involving multiple delegated staff 
members may be performed in parallel. All assessments must be recorded in source 
documentation and eCRFs (if applicable). 
 
Procedures to be performed in the CRS eye: 
 
NOTE: Randomization must be completed following all Screening procedures and 
confirmation of subject eligibility prior to surgery (this includes TBUT*). 
*If subject starts warm compresses after the screening visit, the subject must return prior to 
surgery day (Visit 00: Day 0) to have TBUT reassessed. If the TBUT is < 10 secs in either 
eye, the subject must be discontinued from the study as a screen fail. If the TBUT is ≥ 10 secs 
in each eye, the subject may be randomized and continue in the study. The warm compresses 
regimen must be maintained for the duration of the study. Record TBUT in source. 
1. Document any changes to ocular and nonocular concomitant medications. 
2. Prepare subject /operative eye for surgery in accordance with site specific 
operating procedures. 
3. Create a 4.8 to 5.5 mm anterior capsulotomy centered on the line of sight using the LenSx 
femtosecond laser. 
4. Remove the cataract by phacoemulsification using Centurion. 
5. Record use of CDE. 
6. Record estimated aspiration fluid. 
7. Record phacoemulsification aspiration time. 
8. Record aphakic refraction and aphakic spherical equivalent (SE). 
9. Record IOL power recommended by VerifEye+ (or Lynk) and predicted post-op SE. 

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Procedures to be performed in the Standard Manual Technique eye: 
 
1. Ensure IOL power calculation was performed. 
2. Document any changes to ocular and nonocular concomitant medications. 
3. Prepare subject /operative eye for surgery in accordance with site specific operating 
procedures. 
4. Create a 4.8 to 5.5 mm anterior capsulotomy centered on the line of sight using the 
manual technique. 
5. Remove the cataract by phacoemulsification using the Centurion. 
6. Record use of CDE. 
7. Record estimated aspiration fluid. 
8. Record phacoemulsification aspiration time. 
9. Perform manual limbal relaxing incision (LRI). Manual LRI will only be performed on 
astigmatism of > 0.50 D, including any known surgically induced astigmatism, according 
to the Verion measurements obtained at Screening. 
10. Record implanted IOL power and predicted post-op SE. 
11. Record surgical problems, complications, or other events that occur during surgery. 
12. Record any device deficiencies and AEs. Refer to Section 13 for further detail. 
 
12.1.3 
Visit 1 (Day 1 for Eye 1) 
 
10. Record implanted IOL power and predicted post-op SE. 
11. Record surgical problems, complications, or other events that occur during surgery. 
12. Record any device deficiencies and AEs. Refer to Section 13 for further detail. 
1. Document any changes to ocular and nonocular concomitant medications. 
2. 
3. Perform slit-lamp examination. 

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12.1.4 
Post-Surgery Visit (Visit 1A, 2A, 3A and Visit 4A) 
Below is a list of study procedures to be undertaken at post-surgery visits. Procedures should 
be performed in the order presented below. All assessments must be recorded in source 
documents and eCRFs (if applicable). 
 
Ocular assessments are to be performed in the study eye only. 
 
4. Perform IOP measurement. 
5. Record any device deficiencies and AEs. Refer to Section 13 for further detail. 
1. Document changes in ocular and nonocular concomitant medications at Visit 1A, 2A, 3A, 
and Visit 4A. 
2. 
3. 
4. 
5. 
6. Perform manifest refraction assessment at Visit 1A, 2A, 3A, and Visit 4A. However, at 
Visit 1A, assessments will be performed at the Week 1 visit for eye 1 only (Refer to MOP 
for details). 
7. 
8. Perform slit-lamp examination at Visit 1A, 2A, 3A, and Visit 4A. Refer to MOP for 
details. 
9. 
10. 
11. Perform Keratometric measurements at Visit 3A and Visit 4A. 
12. Perform IOP at Visit 1A and 4A only. IOP should be measured after all VAs, corneal 

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12.2 
Unscheduled Visits 
An unscheduled study visit (USV) is defined as one that meets all of the following: 
 
• 
Examination that is not standard of care and not required by the protocol. 
• 
Examination conducted by the study staff. 
• 
New finding, continuation of an existing finding, or a change to a previous finding is 
noted. 
An USV may or may not result in the caphire of an AE. Likewise, an AE may be captured 
without the report of an USV (eg, AE identified subsequent to study eye examination by non­ 
study personnel). 
 
The assessments captured at the USV are dictated by the Investigator per his/her medical 
judgment. The following assessments/documentations are recommended. 
 
• 
Concomitant medications 
 
• 
IOP 
• 
• 
• 
Manifest refraction 
• 
Slit-lamp examination 
• 
Dilated fundus examination, as necessary 
• 
Device deficiencies 
 
• 
AEs 
NOTE: Assessments/documentation are not limited to the above list. 
 
For safety purposes, if an USV is required after the final study visit, the visit should be 
documented. Refer to Section 13.6 for further detail. 
measurements and refractive findings have been obtained. Refer to MOP for details. 
13. Perform dilated fundus exam at Visit 4A only. Refer to MOP for details. 
14. Record any device deficiencies and AEs. Refer to Section 13 for further detail. 
15. Document subject exit from study at Visit 4A. 

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12.3 
Missed Visit 
If a subject misses a scheduled visit, reschedule the subject within the same visit period. 
Diligence should be shown in trying to schedule the subject for all visits, and all attempts to 
contact the subject documented in the subject's chart. In doc umentation, include dates, times, 
method of contact, etc. If attempts to contact the subject are unsuccessful, the date the subject 
is considered lost to follow-up should be documented. 
 
If a subject is unable to return for the final study visit, complete the Exit case rep01i form 
with the appropriate reason for discontinuation indicating the subject is lost to follow-up. 
 
12.4 
Discontinued Subjects 
Discontinued subjects withdraw, or are withdrawn from the study after signing informed 
consent and prior to completing all study visits. Subjects signing consent, but withdrawing or 
withdrawn prior to randomization will be considered discontinued due to screen failure and 
the failed entry criterion will be documented (refer to Section 10). 
 
Subjects may discontinue study pariicipation at any time and for any reason. Subjects may be 
discontinued from the study at any tin1e if, in the medi ca l opinion of the Principal 
Investigator or designated, qualified medical personnel, continued pariicipation poses a 
health risk to the subject. Subject numbers from discontinued subjects will not be reissued. 
Discontinued subjects will not be replaced. 
 
12.5 
Clinical Study Termination 
The Sponsor reserves the right to close the investigational site or terminate the study in its 
entirety at any time, for any reasonable cause. The Investigator may also terminate the study 
at his/her site for reasonable cause. Reasons for the closure of an investigational site or 
termi nation of a study may include: 
 
• 
The Investigator fails to comply with the protocol or good clinical practice (GCP) 
guidelines. 
• 
Safety concerns. 
• 
Inadequate recrnitment of subjects by the Investigator. 
If the clinical study is prematurely terminated or suspended, the Sponsor will inform the 
Investigator and the regulat01y authorities (where applicable) of the termination/suspension 
and the reason for the termination/suspension. The Investigator should promptly notify the 
IRB/IEC of the termination or suspension and of the reasons. 

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If the Sponsor terminates the study for safety reasons, the Sponsor will immediately notify 
the Investigator(s), and provide written instructions for study termination and applicable 
subject follow-up. 
 
13 
DEVICE DEFICIENCIES AND ADVERSE EVENTS 
13.1 
General Information 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, 
whether or not related to the investigational medical device (test article). Refer to the 
Section 4 (Glossary of Terms) for definitions of all categories of AEs and SAEs. 
 
Figure 13–1 
Categorization of All Adverse Events 
 

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Figure 13-2 
Categorization of All Serious Adverse Events 
 
 
All SAEs 
 
 
 
 
 
Device/ 
procedure 
related? 
 
 
 
 
SADE 
 
SAE 
 
 
 
 
 
 
Device Deficiencies 
 
A device deficiency may or may not be associated with subject haim (ie, ADE or SADE); 
however, not all ADEs or SADEs are due to a device deficiency. The Investigator should 
dete1mine the applicable category for the identified or suspect device deficiency and repmt 
any subject ha1m separa tely. For definitions of device deficiency, malfunction and use en or, 
refer to Section 4. 
 
• 
Laser defect 
• 
Laser optic 
• 
Unable to calibrate laser 
• 
Suspect product contamination (patient interface) 
• 
Lack of effectiveness 
13.2 
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: 
 
• 
"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?" 
No 

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Changes in any protocol-specific parameters evaluated during the study are to be reviewed by 
the Investigator. Any untoward (unfavorable and unintended) change in a protocol-specific 
parameter that is clinically relevant, in the opinion of the Investigator, is to be repmied as an 
AE. These clinically relevant changes will be repo1ied regardless of causality. 
 
13.3 
Procedures for Recording and Reporting 
AEs are collected from the time of infmmed consent. Any pre-existing medical conditions or 
signs/symptoms present in a subject prior to the sta1i of the study (ie, before info1med 
consent is signed) are not considered AEs in the study and should be recorded in the Medical 
Histmy section of the eCRF. 
 
For each recorded event, the ADEs and SAEs documentation must include: date of 
occmTence , seve rity, 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 ruticles on the Device Deficiency eCRF. The site must submit 
all available info1mation on ADEs, SAEs, and device deficiencies to the Study Sponsor 
immediately as follows: 
 
• 
All SAEs must be repmted immediately (within 24 hours) of the Investigator's or site's 
awru·eness. 
• 
ADEs that do not meet seriousness criteria and device deficiencies must be reported 
within 10 calendar days of the Investigator 's or site's awareness. 
• 
A printed copy of the completed Serious Adverse Event and Adverse Device Effect 
and/or Device Deficiency eCRF must be included with product returns. 
• 
Additional relevant infmmation after initial repo1ting must be entered into the eCRF as 
soon as the data become available. 
• 
Document any changes to concomitant medications on the appropriate eCRFs. 
• 
Document all relevant info1mation from Discharge Summa1y, Autopsy Repo1i, Ce1tificate 
of Death etc, if applicable, in the nrurntive section of the ADE (for related AEs) and SAE 
eCRF. 
NOTE: Should the EDC system become non-operational, the site must complete the 
appropriate paper Serious Adverse Event and Adverse Device Effect and/or Device 
Deficiency Fmm. The completed fo1m is faxed or emailed to the Study Sponsor at ­ 
  according to the timelines outlined above; however, 
the repmied information must be entered into the EDC system once it becomes operational. 

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Any AEs and device deficiencies for non-study marketed devices/products will be considered 
and processed as spontaneous (following the post-market vigilance procedures) and should be 
communicated to the device’s/product’s manufacturer as per local requirements. 
 
Study Sponsor representatives may be contacted for any protocol related question and 
their contact information is provided in the MOP that accompanies this protocol. 
 
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC. 
 
Intensity and Causality Assessments 
 
Where appropriate, the Investigator must assess the intensity (severity) of the AE based on 
medical judgment with consideration of any subjective symptom(s), as defined below: 
 
Intensity (Severity) 
 
Mild 
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom. 
 
Moderate 
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities. 
 
Severe 
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 
 
For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below: 
 
Causality 
 
Related 
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study 
procedure has not been demonstrated but there is a reasonable possibility that 
the AE was caused by the medical device or study procedure. 
 
Not Related 
An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (ie, there are other more likely causes for the AE). 

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The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the Investigator of any AEs that 
are upgraded from non-serious to serious or from unrelated to related. 
 
13.4 
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/reported per manufacturer instructions and must include the Complaint # which will 
be provided by Study Sponsor after the case is entered in the Study Sponsor’s Global Product 
Complaint Management System (GPCMS). 
 
13.5 
Protocol Masking Requirements 
Masked information on the identity of the assigned medical device should not be disclosed to 
the observer during the study (see Section 7.2). The Study Sponsor must be informed of all 
cases in which unmasking of the observer occurs and of the circumstances involved. 
 
13.6 
Follow-Up of Subjects with Adverse Events 
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. 
 
The Investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock). 
 
All complaints received after 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. 

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13.7 
Pregnancy in the Clinical Study 
Pregnancy is not repo1iable as an AE; however, complications may be repo11able and will be 
decided on a case- by-case basis. An Alcon form will be utilized to capture all 
pregnancy-related infonnation until bili h of the child. 
 
14 
DATA REVIEW AND HANDLING 
14.1 
Completion of Source Documents and Case Report Forms 
The nature and location of all source documents must be identified to ensure that original 
data required to complete the eCRFs exist and are accessible for verification by the monitor. 
If electronic source records are maintained, these records will be reviewed for 21 Code of 
Federal Regulations (CFR) Paii 11 compliance and the method of verification will be 
dete1mined in advance of sta11ing the study. Data repo1i ed on the eCRF s must be derived 
from source doc umentation and be consistent with so urce documenta tion, and any 
discre pancies mu st be exp lained in writing. At a miniln um, so urce docum entation mu st 
incl ude the follow ing informa tion for eac h subject: 
 
• 
Subject ident ifi cation (nam e, sex) 
 
• 
Documentation of subject eligibility 
 
• 
Date of info1med consent, and a copy of signed inf01m ed co nsent f01m 
 
• 
Dates of visits 
 
• 
Docum entation tha t protoco l-specific proce dur es were performed 
 
• 
Results of study assessments, as required by the protocol 
 
• 
Documentation of AEs and other safety parameters (as applicable) 
 
• 
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study 
• 
Date of study completion and reason for early discontinuation (if applicable) 
It is required that the author of each entiy in the source documents be identifiable (eg, initials 
or signature and date). Any change or con ection to data reported in the source must be dated, 
initialed, and explained if necessaiy. Changes must not obscure the original entry (ie, an audit 
u-ail mu st be ma int ain e d). Dit·ec t 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. 

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The EDC system is designated for data collection and should be completed by designated 
individuals only. Required examinations must be recorded on the eCRFs. All data reported 
must have corresponding entries in the source documents. The Investigator will review the 
reported data and certify that the eCRFs are accurate and complete as indicated by signature. 
Subject identifiers must not be recorded on the eCRFs beyond subject number, demographics 
information, and/or other study identifiers. 
 
Deviations from this protocol, regulatory requirements, and GCP must be recorded in the 
study records. An explanation of the deviation should be included, as applicable. In addition, 
corrective and preventive action should be identified, implemented, and documented within 
the study records. 
 
14.2 
Data Review and Clarifications 
Upon completion of the eCRFs, the data will be reviewed by Alcon study personnel for 
accuracy and completeness. If corrections and/or any additions to the data are deemed 
necessary, queries will be generated by Alcon data management or the site management 
(study monitor) team and forwarded to the investigative site. Designated staff at each site are 
expected to respond to data queries in a timely manner and ensure that the corrections and 
changes made to the data in the EDC system are reflected in the subjects’ source 
documentation. In addition, prior to study start (first subject first visit) a plan for data 
validation will be completed by Alcon Clinical Data Management and agreed upon by 
members of the Clinical Trial Management (CTM) team. 
 
Concomitant medications entered into the database will be coded using the current version of 
the WHO Drug Reference List. Medical history and AEs will be coded using the medical 
dictionary for regulatory activities (MedDRA) terminology. 
 
Upon completion of the study and once the database is declared complete and accurate, the 
database will be locked and data will be available for data analysis. Any changes to the 
database after lock will be implemented upon agreement between Alcon’s clinical trial 
management and biostatistics department, and will be completed following Alcon’s 
procedures for changes to a database after database lock. 

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15 
ANALYSIS PLAN 
15.1 
Subject Evaluability 
All subjects who satisfy the inclusion and exclusion criteria, and who sign the informed 
consent form, will be considered evaluable. 
 
15.2 
Analysis Data Sets 
The full analysis set (FAS) will contain all eyes that are randomized and for which an IOL is 
successfully implanted; all eyes in the FAS will be assigned to the treatment actually received 
for analysis purposes. The FAS will be the primary analysis set for all effectiveness 
summaries and analyses, as well as all baseline and study summaries. 
 
The safety analysis set will contain all eyes for which LenSx is activated and laser cut is 
started for the test eyes and corneal incision is begun for the control eyes; all eyes in the 
safety analysis set will be assigned to the treatment actually received. The safety analysis set 
will be the primary analysis set for all summaries and analyses of safety data. 
 
Assignment of study eyes to the appropriate analysis set(s) will be determined prior to 
database lock. 
 
15.3 
Demographics and Baseline Characteristics 
Demographic and baseline characteristics will be summarized by treatment group and overall 
using frequency tables for qualitative variables and descriptive statistics for quantitative 
variables. 
 
Relevant medical history (ocular and nonocular) and current medical conditions will be 
tabulated by system organ class (SOC) and preferred term (PT) of the MedDRA dictionary. 
Other relevant baseline information will be listed and summarized as appropriate with 
descriptive statistics. 
 
15.4 
Effectiveness Analyses 
15.4.1 
Primary Effectiveness 
15.4.1.1 
Statistical Hypotheses 
The null and alternative hypotheses for the primary effectiveness analysis are: 
 
H0: pc ≤ ps 

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H1: pc > ps 
 
where pc and ps are the percentage of eyes with manifest refraction SE within 0.5 D of 
predicted postoperative SE at 1 month in the CRS and standard manual technique arms 
respectively. 
 
15.4.1.2 
Analysis Methods 
The primary effectiveness analysis will be analyzed using a one-sided McNemar’s test at the 
α=0.05 level. 
 
15.4.2 
Secondary Effectiveness 
15.4.2.1 
Statistical Hypotheses 
The null and alternative hypotheses are the same for all secondary analysis and can be 
presented as: 
 
H0: µc ≥ µs 
H1: µc < µs 
where µc denotes the mean value in the CRS group and µs denotes the mean value in the 
standard manual technique group for each of the respective secondary endpoints. 
 
15.4.2.2 
Analysis Methods 
Each of the null hypotheses will be tested using a paired t-test; the family-wise type-I-error of 
5% will be controlled using the Hochberg testing procedure outlined in Section 15.6. 
 
15.4.3.2 
Analysis Methods 
Continuous data will be presented using n, mean, standard deviation, median, minimum, and 
maximum values. Categorical data will be presented with the number and percent in each 
category. All other summaries will be outlined in the statistical analysis plan (SAP). 

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15.5 
Handling of Missing Data 
The FAS and safety analysis set will not include any imputed values. Although missing data 
will occur, the influence of missing data is expected to be minimal. 
 
15.6 
Multiplicity 
In order to control the overall type I error rate, the secondary effectiveness hypotheses will 
only be tested if the primary effectiveness null hypothesis is rejected at the 5% significance 
level (one-sided). 
 
If the null hypothesis of the primary effectiveness endpoint is rejected, then the secondary 
effectiveness endpoints will be tested using the Hochberg testing procedure (Hochberg 1988). 
The Hochberg procedure is a step-up method for multiple testing controlling for the type I 
error rate at the 5% significance level. 
 
15.7 
Safety Analysis 
Adverse Events 
 
All information obtained on AEs will be summarized for ocular and nonocular AEs 
separately. 
 
The number and percentage of all ocular AEs, including for either eye, will be tabulated by 
treatment and preferred term. An eye with multiple ocular AEs of the same preferred term is 
only counted once toward the total of this preferred term. A listing of nonocular AEs will be 
provided. 
 
Device Deficiencies 
 
The number and percentage of all device deficiencies will be tabulated by treatment. A listing 
of all device deficiencies will also be provided. 
 
Other Safety Assessments 
 
All other safety assessments (IOP, slit-lamp examination and dilated fundus examination) 
will be summarized. Number and percentage will be presented for categorical variables and 
descriptive statistics for continuous variables. 

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15.8 
Interim Analyses 
An interim analysis for the purposes of sample size re-estimation will be performed when the 
first 200 subjects who are randomized and treated complete their assessment for the primary 
effectiveness endpoint at Month 1 (Visit 3A). Alcon staff not involved with the conduct of the 
trial will re-estimate the sample size based on the data from the first 200 subjects. These staff 
will provide the re-estimated sample size and the predicted conditional power of the final test 
statistic based on that sample size. If the conditional power of the study is < 50% for the 
largest allowable sample size (500 subjects), no additional sample size beyond the originally 
planned 300 subjects will be added, and termination of the study may be considered. Because 
additional sample size will not be added if the conditional power of the study is < 50% at the 
maximum allowable sample size, any effect of the sample size modification on the type 1 
error should be minimal (Mehta 2011). 
 
15.9 
Adaptive Study Design 
The study will employ an adaptive design with potential sample size adjustment based on the 
proportion of discordance from the interim analysis. This study will enroll approximately 
350 subjects to initially randomize and treat 300 subjects (that could potentially increase to 
approximately 580 subjects enrolled and 500 subjects randomized). Based on the calculation 
from the interim analysis an additional 200 subjects may be randomized and treated thus the 
study will randomize and treat a total sample size in the range of 300 to 500 subjects. Any 
additional sample size will be added in blocks of 50 in order to prevent any back-calculation 
of the interim study results. For example in the event an additional 30 subjects are needed, a 
total of 50 will be added to the study. 
 
15.10 
Sample Size Justification 
The rates of success for the primary endpoint are assumed to be 83% and 75% for the CRS 
and standard manual technique arms respectively. These assumptions are based on data from 
the AnalyzOR Retrospective Data Exploration Study (Data on File). 
 
An estimate of the discordance in outcome between eyes is not known; however it’s 
estimated that discordance will be in the range 8% to 33%. For an initial sample size 
calculation, the midpoint value of this range, 21%, will be assumed. Based on these 
assumptions 267 subjects, treated contralaterally, are required to provide 90% power to reject 
the null hypothesis for a one sided McNemars test at the 5% level using the approximation 
from Miettinen (Miettinen 1968). If the proportion of discordance is 33% and all other 
assumptions stay the same a sample of 433 subjects is needed. 

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The initially planned sample size of 267 is inflated to allow for up to 10% drop out; this 
inflation yields a sample size of 300 subjects. Inflation of the sample size of 433 to allow for 
up to 10 % drop out yields a sample size of 485; the sample size of 500 is selected so that the 
maximum sample size will be divisible by the block size of 50. 
 
16 
ADMINISTRATIVE PROCEDURES 
16.1 
Regulatory and Ethical Compliance 
This clinical study will be conducted in accordance with the principles of the Declaration of 
Helsinki, and in compliance with International Organization for Standardization (ISO) 
14155:2011 Clinical investigation of medical devices for human subjects – GCP, CFR, and 
laws and regulations of foreign countries, whichever affords greater protection to subjects. 
The study will also be conducted in accordance with the Standard Operating Procedures 
(SOPs) of Alcon and Contract Research Organizations participating in the conduct of the 
clinical study, and all other applicable regulations. The Investigator and all clinical study staff 
will conduct the clinical study in compliance with this protocol. The Investigator will ensure 
that all personnel involved in the conduct of the clinical study are qualified to perform their 
assigned duties through relevant education, training, and experience. 
 
16.2 
Informed Consent Procedures 
Voluntary informed consent must be obtained from every subject prior to the initiation of any 
Screening or other clinical study-related procedures. The Investigator must have a defined 
process for obtaining consent. Specifically, the Investigator, or designee, must explain the 
clinical study to each potential subject and the subject must indicate voluntary consent by 
signing and dating the approved informed consent form. The subject must be provided an 
opportunity to ask questions of the Investigator, and if required by local regulation, other 
qualified personnel. The Investigator must provide the subject with a copy of the consent 
form written in a language the subject understands. The consent document must meet all 
applicable local laws and will provide subjects with information regarding the purpose, 
procedures, requirements, and restrictions of the clinical study, along with any known risks 
and potential benefits associated with the investigational product, the available compensation, 
and the established provisions for maintaining confidentiality of personal, protected health 
information. Subjects will be told about the voluntary nature of participation in the clinical 
study and will be provided with contact information for the appropriate individuals should 
questions or concerns arise during the clinical study. The subject will also be told that their 
records may be accessed by appropriate authorities and Sponsor-designated personnel. The 

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Investigator must keep the original, signed copy of the consent and must provide a duplicate 
copy to each subject. 
 
16.3 
Responsibilities of the Investigator and IRB/IEC 
Before clinical study initiation, this protocol, the informed consent form (ICF) (and assent 
form, if applicable), any other written information provided to subject, and any 
advertisements planned for subject recruitment must be approved by an IRB/IEC. A master 
list of IRBs/IECs for this clinical study can be found in the Trial Master File. The Investigator 
must provide documentation of IRB/IEC approval to the Sponsor. The approval must be 
dated and must identify the applicable protocol, amendments (if any), informed consent form, 
assent form (if any), all applicable recruiting materials, written information for subjects, and 
subject compensation programs. The IRB/IEC must be provided with a copy of the 
Directions for Use, any periodic safety updates, and all other information as required by local 
regulation and/or the IRB/IEC. At the end of the clinical study or in the case of early 
termination, the Investigator will notify the IRB/IEC of the clinical study’s final status. 
Finally, the Investigator will report to the IRB/IEC on the progress of the clinical study at 
intervals stipulated by the IRB/IEC. 
 
16.4 
Sponsor and Monitoring Responsibilities 
The Sponsor will designate a monitor to conduct the appropriate site visits at the appropriate 
intervals. The clinical study will be monitored to ensure that the rights and wellbeing of the 
subjects are protected; the reported data are accurate, complete, and verifiable from the 
source documents; the equipment used to assess variables in the clinical investigation is 
maintained and calibrated per manufacturer instructions and Sponsor requirements; and the 
study is conducted in compliance with the current approved protocol (and amendment[s], if 
applicable), with current GCP, and with applicable regulatory requirements. 
 
All investigative sites will have a site initiation. Monitoring will be conducted periodically 
while the clinical study is ongoing. Monitoring methods may include site visits, telephone, 
written, and fax correspondence. The assigned Clinical Site Manager (CSM) will contact 
each site at appropriate intervals. The Lead Clinical Site Manager (LCSM) will determine the 
frequency of site visits. Close-out visits will take place after the last visit of the last subject. 
 
Enrollment will be tracked and reported at regular intervals. Details regarding enrollment (eg, 
number of subjects pre-screened, screened, reasons for screen failures) may be requested of 
the investigative site and must be provided within a reasonable time period. 

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The Sponsor will be responsible for implementing and maintaining quality assurance and 
quality control systems to ensure the study is conducted and data are generated, documented 
and reported in compliance with the protocol, GCP and applicable regulatory requirements. 
The 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 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 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. 
 
16.5 
Regulatory Documentation and Records Retention 
The Investigator is accountable for the integrity, retention, and security of all study related 
data. The Investigator must maintain accurate, complete, and current records relating to the 
clinical study. The Investigator must maintain the required records during the investigation 
and for a period of time specified by local law or per the Clinical Study Agreement, 
whichever is longer. If the Investigator retires, relocates, or for any other reason withdraws 
from responsibility of keeping the study records, the Sponsor must be notified and suitable 
arrangements made for retention of study records and source documents needed to comply 
with national and international regulations. 
 
16.6 
Confidentiality and Publication of the Clinical Study 
Any information other than that which is disclosed upon registration should not be discussed 
with persons outside the study. The protocol, study data, and information related to the study 
or to Alcon’s products or research programs that is provided by Alcon (Confidential 
Information) is to be kept confidential and not disclosed directly or indirectly to any third 
party other than those involved in the study who have a need to know. All data and 
discoveries arising out of the study, patentable or non-patentable, shall be the sole property of 
Alcon, Inc. Alcon reserves the right of prior review of any publication or presentation of 
information related to the study. Alcon may use these data now and in the future for 
presentation or publication at Alcon’s discretion or for submission to government regulatory 
agencies. The existence of this clinical study is confidential and should not be discussed with 
persons outside of the study. You shall hold confidential, and not disclose directly or 
indirectly to any third party other than those persons involved in the study who have a need to 
know, the protocol, the data arising out of the study, and any other information related to the 
study or to Alcon’s products or a research program that is provided by Alcon to you (the 
“Confidential Information”). All such persons must be instructed not to further disseminate 

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this information to others. You shall not use the Confidential Information for any purpose 
other than the study. The foregoing obligations of confidence and non-use assumed by you 
shall not apply to: (a) information which at the time of disclosure is in the public domain; (b) 
information which thereafter lawfully becomes part of the public domain other than through 
disclosure by or through you; (c) information which, as evidenced by your written records, 
was known by you prior to Alcon’s disclosure; (d) information which is lawfully disclosed to 
you by a third party not under any obligation of confidence to Alcon; or (e) information 
which is required to be disclosed by law or government regulatory agency, provided 
reasonable advance notice of such disclosure is given to Alcon. 
 
In signing this protocol, you agree to the release of the data from this study and acknowledge 
the above confidentiality and publication policy. The provisions of this Statement shall 
survive the completion of the study. 

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17 
REFERENCES 
Baltussen R, Sylla M, Mariotti SP. Cost-effectiveness analysis of cataract surgery: a global 
and regional analysis. Bull World Health Organ. 2004;82:338–45. 
 
Behndig A, Montan P, Stenevi U, Kugelberg M, Zetterström C, Lundström M. Aiming for 
emmetropia after cataract surgery: Swedish National Cataract Register study. J Cataract 
Refract Surg. 2012;38(7):1181-6. 
 
Day AC, Gore DM, Bunce C, Evans JR. Laser-assisted cataract surgery versus standard 
ultrasound phacoemulsification cataract surgery. Cochrane Database Syst Rev. 
2016;7:CD010735. 
 
Hatch KM, Woodcock EC, Talamo JH. Intraocular lens power selection and positioning with 
and without intraoperative aberrometry. J Refract Surg. 2015;31(4):237-42. 
 
Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika. 
1988;75(4):800-2. 
 
Ianchulev T, Hoffer KJ, Yoo SH, Chang DF, Breen M, Padrick T, et al. Intraoperative 
refractive biometry for predicting intraocular lens power calculation after prior myopic 
refractive surgery. Ophthalmology. 2014;121(1):56-60. 
 
Karatas MC, Sizmaz S, Yaycioglu RA, Canan H, Akova YA. Risk factors for intraocular 
pressure rise following phacoemulsification. Indian J Ophthalmol. 2013;61(3):115–8. 
 
Mehta CR, Pocock SJ. Adaptive increase in sample size when interim results are promising: 
a practical guide with examples. Stat Med. 2011;30(28):3267-84. 
 
Miettinen OS. The matched pairs design in the case if all-or-none responses. Biometrics. 
1968;24:339–52. 
 
Nemeth G, Szalai E, Hassan Z, Lipecz A, Berta A, Modis L. Repeatability data and 
agreement of keratometry with the VERION system compared to the IOLMaster. J Refract 
Surg. 2015;31(5):333-7. 
 
Solomon KD, Lorente R, Fanney D, Cionni RJ. Clinical study using a new 
phacoemulsification system with surgical intraocular pressure control. J Cataract Refract 
Surg. 2016;42(4):542–9. 

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Woodcock MG, Lehmann R, Cionni RJ, Breen M, Scott MC. Intraoperative aberrometry vs 
standard preoperative biometry and a toric IOL calculator for bilateral toric IOL implantation 
with a femtosecond laser: one month results. J Cataract Refract Surg. 2016;42(6):817-25. 

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18 
APPENDICES 
Not Applicable 

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