Postmarket Study of ORA With VerifEye+ and Barrett Toric Calculator Used for the Implantation of AcrySof Toric
Phase: NA
Conditions: Cataract
Sponsor: Alcon Research



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Table of Contents
Table of Contents .......................................................................................................................2
List of Tables..............................................................................................................................5
List of Figures............................................................................................................................5
1
GLOSSARY OF TERMS ....................................................................................................6
2
LIST OF ACRONYMS AND ABBREVIATIONS ...........................................................11
3
PROTOCOL SUMMARY.................................................................................................13
4
PROTOCOL AMENDMENTS .........................................................................................24
4.1
Amendment 4 ....................................................................................................24
4.2
Amendment 3 ....................................................................................................26
4.3
Amendment 2 ....................................................................................................28
4.4
Amendment 1 ....................................................................................................29
5
INTRODUCTION.............................................................................................................31
5.1
Background........................................................................................................31
5.2
Purpose of the Study..........................................................................................32
5.3
Risks and Benefits.............................................................................................32
5.3.1
ORA System with VerifEye+.............................................................32
5.3.2
Alcon Toric Calculator (Barrett)........................................................34
6
STUDY OBJECTIVES......................................................................................................35
6.1
Primary Objective(s) .........................................................................................35
6.2
Secondary Objective(s) .....................................................................................35
6.4
Safety Objective(s)............................................................................................36
7
INVESTIGATIONAL PLAN ............................................................................................36
7.1
Study Design .....................................................................................................36
7.2
Rationale for Study Design ...............................................................................39
7.3
Rationale for Duration of Treatment/Follow-Up...............................................39
7.4
Rationale for Choice of Control Product...........................................................39
7.5
Data Monitoring Committee..............................................................................39
8
STUDY POPULATION ....................................................................................................39
8.1
Inclusion Criteria...............................................................................................40
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8.2
Exclusion Criteria..............................................................................................40
8.3
Rescreening of Subjects ....................................................................................41
9
TREATMENTS ADMINISTERED...................................................................................41
9.1
Investigational Product(s)..................................................................................41
9.2
Other Medical Device or Medication Specified for Use During the Study ......43
9.3
Treatment Assignment / Randomization ...........................................................44
9.3.1
IRT.....................................................................................................44
9.4
Treatment masking ............................................................................................44
9.5
Accountability Procedures.................................................................................44
9.6
Changes to concomitant medications, treatments/ procedures..........................44
10 STUDY PROCEDURES AND ASSESSMENTS.............................................................45
10.1
Informed Consent and Screening ......................................................................45
10.2
Description of Study Procedures and Assessments...........................................45
10.2.1
Demographics....................................................................................45
10.2.2
Medical History.................................................................................45
10.2.3
Adverse Event Collection: Safety Assessment..................................45
10.2.4
Device Deficiencies: Safety Assessment...........................................46
10.2.8
Visual Acuity: Effectiveness..............................................................46
10.3
Study Visit Procedures.......................................................................................47
10.3.1
Visit 0: Day -30 to Day 0 (for both eyes) ..........................................47
10.3.2
Surgery Visit (Visit 00 and Visit 00A)...............................................48
10.3.3
Visit 1/1A (Day 1 for Eye 1/2) ..........................................................50
10.3.4
Post-Surgery Visit (Visits 2, 2A, 3A, 4A and 5A).............................50
10.4
Unscheduled Visits ............................................................................................51
10.5
Discontinued Subjects .......................................................................................51
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10.5.1
Screen Failures ..................................................................................51
10.5.2
Discontinuations................................................................................51
10.5.3
Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product .............................................................52
10.6
Clinical Study Termination................................................................................52
10.6.1
Follow-up of subjects after study participation has ended ................53
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................53
11.1
General Information ..........................................................................................53
11.1.1
Specific Events Relevant to this Protocol .........................................54
11.1.2
Device Deficiencies...........................................................................54
11.2
Monitoring for Adverse Events .........................................................................54
11.3
Procedures for Recording and Reporting ..........................................................55
11.3.1
Intensity and Causality Assessments.................................................56
11.4
Return product analysis .....................................................................................57
11.5
Unmasking of the Study Treatment...................................................................58
11.6
Follow-Up of Subjects with Adverse Events.....................................................58
11.7
Pregnancy in the Clinical Study........................................................................58
12 ANALYSIS PLAN ............................................................................................................58
12.1
Subject Evaluability...........................................................................................58
12.2
Analysis Sets .....................................................................................................59
12.3
Demographic and Baseline Characteristics.......................................................59
12.4
Effectiveness Analyses ......................................................................................59
12.4.1
Analysis of Primary Effectiveness Endpoint(s).................................59
12.4.1.1
Statistical Hypotheses........................................................59
12.4.1.2
Analysis Methods ..............................................................59
12.5
Handling of Missing Data .................................................................................61
12.6
Safety Analyses .................................................................................................61
12.7
Interim Analyses and Reporting........................................................................63
12.8
Sample Size Justification...................................................................................63
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................64
13.1
Subject Confidentiality......................................................................................64
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13.2
Completion of Source Documents and Case Report Forms..............................64
13.3
Data Review and Clarifications.........................................................................65
13.4
Sponsor and Monitoring Responsibilities .........................................................65
13.5
Regulatory Documentation and Records Retention ..........................................66
13.6
Quality Assurance and Quality Control.............................................................66
14 ETHICS .............................................................................................................................67
15 REFERENCES ..................................................................................................................68
15.1
References applicable for all clinical studies ....................................................68
15.1.1
US references applicable for clinical studies.....................................68
15.2
References for this clinical study ......................................................................69
List of Tables
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol ...........................11
Table 3–1
Schedule of Study Procedures and Assessments .............................................21
Table 6–1
Primary Objective(s)........................................................................................35
Table 6–3
Safety Objective(s)...........................................................................................36
Table 9–1
Test Product .....................................................................................................42
Table 9–2
Test Product .....................................................................................................43
Table 12-1
95% Confidence Interval and Width per Binomial Distribution .....................63
List of Figures
Figure 7–1
Study Flow Chart .............................................................................................38
Figure 11–1
Categorization of All Adverse Event ...............................................................53
Figure 11–2
Categorization of All Serious Adverse Events.................................................54
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1
GLOSSARY OF TERMS
Name of Test product(s)
ORA System with VerifEye+ 
Name of Test Product(s)
Alcon Toric Calculator (Barrett)
Adverse Device Effect
Adverse event related to the use of an investigational 
medical device (test product) or control product. Note: This 
definition includes adverse events resulting from insufficient 
or inadequate instructions for use, deployment, 
implantation, installation, or operation; any malfunction; 
and use error or intentional misuse of the test product or 
control product.
Adverse Event
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 product). Note: For subjects, this definition includes 
events related to the test product, the control product, or the 
procedures involved. For users or other persons, this 
definition is restricted to events related to the test product.
Requirements for reporting Adverse Events in the study can 
be found in Section 11.
Anticipated Serious 
Adverse Device Effect
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has been identified in the risk 
management file.
Device Deficiency
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety, or performance. Note: 
This definition includes malfunctions, use errors, and 
inadequate labeling.
Requirements for reporting Device Deficiencies in the study 
can be found in Section 11.
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Enrolled Subject
Any subject who signs an informed consent form for 
participation in the study.
Interventional Clinical Trial
A research trial that prospectively assigns, whether 
randomly or not, human participants or groups of humans to 
one or more health-related interventions to evaluate the 
effects on health outcomes, and/or a research trial in which 
diagnostic or monitoring procedures beyond standard of care 
are conducted and generate outcomes for use in analysis of
data.
Investigational Product
Is defined as a preventative (vaccine), a therapeutic (drug or 
biologic), device, diagnostic, or palliative used as a test or 
control product in a clinical trial, including a product with a 
marketing authorization when used or assembled 
(formulated or packaged) in a way different from the 
authorized form, or when used for an unauthorized 
indication, or when used to gain further information about 
the authorized form.
Malfunction
Failure of a medical device to perform in accordance with its 
intended purpose when used in accordance with the 
instructions for use or clinical investigation plan.
Non-serious Adverse Event
Adverse event that does not meet the criteria for a serious 
adverse event.
Postmarketing/Post-
authorization study
Any study conducted within the conditions laid down in 
product labelling and other conditions laid down for the 
marketing of the product or under normal conditions of use. 
A postmarketing study falls either within the definitions of 
an interventional or a non- interventional study and may also 
fall within the definition of a post-approval study.
Product Complaints
Any oral, electronic, or written communication that alleges 
deficiencies related to the identity (labeling), quality, 
durability, reliability, safety, effectiveness, or performance 
of a marketed product, including failure of the product, 
labeling or packaging to meet specifications, whether or not 
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the product is related to or caused the alleged deficiency. A 
complaint may allege that an adverse event or medical 
device malfunction has occurred.
Randomized Subjects
Any subject who is assigned a randomized treatment.
Serious Adverse Device 
Effect (SADE)
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event.
Serious Adverse Event 
(SAE)
Adverse event that led to any of the following:

Death.

A serious deterioration in the health of the subject 
that either resulted in:
a. a life-threatening illness or injury.
Note: Life-threatening means that the 
individual was at immediate risk of death from 
the event as it occurred, ie, it does not include 
an event which hypothetically might have 
caused death had it occurred in a more severe 
form.
b. any potentially sight-threatening event or 
permanent impairment to a body structure or a 
body function.
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c. in-patient hospitalization or prolonged 
hospitalization.
Note: Planned hospitalization for a pre-
existing condition, without serious 
deterioration in health, is not considered a 
serious adverse event. In general, 
hospitalization signifies that the individual 
remained at the hospital or emergency ward 
for observation and/or treatment (usually 
involving an overnight stay) that would not 
have been appropriate in the physician's office 
or an out-patient setting. Complications that 
occur during hospitalization are adverse 
events. If a complication prolongs 
hospitalization or fulfills any other serious 
criteria, the event is serious. When in doubt as 
to whether “hospitalization” occurred, the 
event should be considered serious.
d. a medical or surgical intervention to prevent 
a) or b).
e. any indirect harm as a consequence of
incorrect diagnostic test results when used 
within manufacturer’s instructions for use.

Fetal distress, fetal death, or a congenital 
abnormality or birth defect.
Refer to Section 11 for additional SAEs.
Serious Public Health 
Threat
Any event type which results in imminent risk of death, 
serious deterioration in state of health, or serious illness that 
requires prompt remedial action. This would include: Events 
that are of significant and unexpected nature such that they 
become alarming as a potential public health hazard, eg, 
human immunodeficiency virus (HIV) or Bird Flu.
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Unanticipated Serious 
Adverse Device Effect 
(USADE)
Serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the risk 
management file.
Use Error
Act or omission of an act that results in a different medical 
device response than intended by manufacturer or expected 
by user. Note: This definition includes slips, lapses, and 
mistakes. An unexpected physiological response of the 
subject does not in itself constitute a use error.
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2
LIST OF ACRONYMS AND ABBREVIATIONS
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol
Abbreviation
Definition
AAS
All-Implanted Analysis Set
ADE
Adverse device effect
AE
Adverse Event
BCDVA
Best Corrected Distance Visual Acuity
BSS
Balanced salt solution
CFR
Code of Federal Regulations
CRF
Case Report Form
D
Diopter
DEP
Deviations and Evaluability Plan
DEQ
Defocus equivalent
DFU
Directions for use
EBMD
Epithelial basement membrane dystrophy
eCRF
Electronic case report form
EDC
Electronic data capture
EN
European Standard
ETDRS
Early Treatment Diabetic Retinopathy Study
FDA
Food and Drug Administration
GCP
Good Clinical Practice
GPCMS
Global Product Complaint Management System
HIV
Human immunodeficiency virus
ICF
Informed consent form
ICH
International Council for Harmonisation of Technical Requirements 
for Pharmaceuticals for Human Use
IEC
Independent ethics committee
IOL
Intraocular Lens
IP
Investigational product
IRB
Institutional review board
ISO
International Organization for Standardization
LCD
Liquid crystal display
LogMAR
Logarithm of the minimum angle of resolution
mm
Millimeter
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Abbreviation
Definition
mmHg
Millimeter of mercury
MOP
Manual of procedures
N/A
Not applicable
ORA
Optiwave Refractive Analysis
OVD
Ophthalmic viscosurgical device
PI
Principal Investigator
PPS
Per Protocol Analysis Set
SADE
Serious adverse device effect
SAE
Serious Adverse Event
SD
Standard Deviation
SIA
Surgically induced astigmatism
SOP
Standard operating procedure
SS
Safety Analysis Set
SSI
Secondary surgical intervention
US
United States
USADE
Unanticipated serious adverse device effect
VA
Visual acuity
YAG
Yttrium-aluminum-garnet
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3
PROTOCOL SUMMARY
Investigational 
product type
Devices
Study type
Interventional
Investigational 
products
Investigational Products:
The ORA System with VerifEye + is made up of the following 
components:
The ORA System Aberrometer is mounted on a compatible 
surgical microscope. It measures optical aberrations which 
are converted to wavefront data to generate refraction data. 
The refraction data is used for selecting the power of an 
intraocular lens (IOL). Once a toric IOL is placed in the 
eye, the aberrometer indicates when the toric marks of the 
IOL are aligned with the intended axis. A key feature of 
ORA with VerifEye + is that surgical information is 
displayed through the microscope oculars.
The Cart provides control and power to, and receives and 
processes data from, the aberrometer. The portable cart is 
tethered to the ORA System via a cable.
The LCD Touchscreen is mounted on the cart and displays 
operating screens for user input, option selections, and data 
output. It can also display wavefront analyses.
The Alcon Toric IOL Calculator (Barrett) is a tool to assist the 
treating ophthalmic surgeon in selecting a Toric IOL for adult 
patients with corneal astigmatism undergoing cataract removal. 
Accurate keratometry and biometry measurements are required to 
achieve optimal visual outcomes.
The calculator offers two options with the manufacturer’s model 
specific A-constant for IOL calculation:
1. Barrett Toric Calculator algorithm which calculates a 
patient-specific effective lens position and also 
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estimates the effect of posterior corneal astigmatism. 
Optimum outcomes are achieved with a centroid 
Surgically Induced Astigmatism (SIA) value.
2. Holladay I Vergence formula which calculates a 
patient-specific effective lens position, but does not 
consider posterior corneal astigmatism.
The Calculator combines patient specific biometry data and the 
planned surgery information to recommend a Toric IOL model 
with the optimal alignment axis within the capsular bag.
Purpose and 
rationale
The Alcon Toric Calculator (Barrett) is a modern IOL calculator 
that includes estimates of the posterior corneal astigmatism in the 
selection of the IOL power.
The ORA System with VerifEye + is an intraoperative device that 
measures the total corneal astigmatism in the aphakic condition 
which is used for IOL power selection. Also, in the pseudophakic 
condition, ORA provides guidance for alignment of the Toric axis 
mark.
These modern technologies account for the posterior corneal 
astigmatism in the IOL power selection and this study is intended 
to evaluate the visual acuity outcomes when they are used for 
implantation of a Toric IOL.
Objective(s)
Primary Effectiveness: 
To evaluate the percentage of eyes with best corrected distance 
visual acuity (BCDVA) of 20/20 or better in eyes implanted with 
AcrySof® Toric selected by ORA with VerifEye + and Barrett 
Toric Calculator
 
 
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Safety: 
To evaluate adverse events including secondary surgical 
interventions related to the investigational device.
Endpoint(s)
Primary Effectiveness: 
Percentage of eyes with BCDVA of 20/20 or better at 
6 months
 
 
 
 
 
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Safety:
1. Adverse events including secondary surgical 
interventions related to the investigational device
2. Device deficiencies
Assessment(s) 
Effectiveness

Monocular Best Corrected Distance Visual Acuity in 
logMAR
 
Safety

Adverse Events

Device Deficiencies
Study Design
This is a prospective, randomized, contralateral, multicenter, 
postmarket study. A total of 115 subjects will be enrolled to 
achieve 90 evaluable subjects. Treatments will be randomized 
between eyes and the eye with the more visually significant 
cataract, as measured by best corrected distance visual acuity 
(BCDVA), will undergo surgery first. If the BCDVA is equal 
between eyes, the right eye will undergo surgery first.
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The Barrett Toric Calculator via the Alcon Toric Calculator will be 
used for IOL power selection preoperatively. Sites that have LenSx 
will use it for primary and secondary incisions, capsulorhexis, and 
phacofragmentation consistently in both eyes for all subjects. Sites 
that don’t have LenSx will use standard manual procedures.
For the eyes in the ORA with VerifEye + study group, the IOL 
power and axis and axis mark alignment will be provided by ORA. 
For eyes in the Barrett Toric study group, the IOL power and axis 
will be provided by the Barrett Toric Calculator and axis alignment 
will be done manually (ie, without ORA guidance).
The study will be conducted at up to 10 sites in the US. Surgery 
will be done on each eye on different days 7 to 14 days apart. Total 
follow-up duration is 6 months. There will be 10 visits in total. 
Refer to the Overview of Study Procedures Table for an overview 
of the visit schedule and the assessments to be performed at each 
visit.
Subject population
Subjects who require cataract surgery and a Toric IOL in both 
eyes. Subjects will be required to have preoperative keratometric 
astigmatism of 0.75 D to 3.00 D and require the AcrySof IQ®
Toric SN6AT3 – 6 as determined by Alcon Toric Calculator.
 
 
 
 
 
Key inclusion 
criteria
(See Section 8.1 for a 
complete list of 
inclusion criteria)
Inclusion Criteria:
1. 22 years of age or older
2. Preoperative keratometric astigmatism of 0.75 to 3.00 D
3. Planned implantation of AcrySof IQ Toric SN6AT3 – T6 
as determined by the Alcon Toric Calculator
4. Potential postoperative visual acuity of 0.04 logMAR 
(20/20) or better
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5. Willing and able to complete all required postoperative 
visits
6. Able to comprehend and sign the informed consent form
Key exclusion 
criteria
(See Section 8.2 for a 
complete list of 
exclusion criteria)
Exclusion Criteria:
1. Unclear intraocular media other than cataract
2. Axial length < 21.5 and > 27.0 mm
3. Significant irregular corneal astigmatism as measured by a 
corneal topographer
4. Unstable tear film per Investigator judgement
5. Significant anterior or posterior segment disease
6. Prior intraocular or corneal surgery
7. Prior retinal detachment
8. Pregnancy or lactation, current or planned, during the 
course of the study.
9. Participation in another concurrent clinical trial per the PI 
judgement
10. Presence or history of any condition or finding that makes 
the subject unsuitable as a candidate for cataract surgery or 
study participation or may confound the outcome of the 
study, in the opinion of the Investigator.
Exclusion Criteria During Surgery
11. Intra-op complications such as but not limited to posterior 
capsular tear, wound burn and need to place a suture
12. ORA or Alcon Toric Calculator recommends an IOL other 
than AcrySof IQ Toric SN6AT3-T6
Data analysis and 
sample size 
justification
No formal statistical hypothesis testing is planned in support of the 
primary objective. Rather the data will be summarized using 
descriptive statistics by treatment group.
There will be two effectiveness analysis sets. The All Implanted 
Analysis Set (AAS) includes all eyes with successful IOL 
implantation, T3-T6 and recommended by ORA. The Per Protocol 
Analysis Set (PPS) includes all eyes with successful IOL 
implantation, T3-T6 and recommended by ORA and with no major 
protocol deviations. The primary analysis set for effectiveness is 
the PPS.
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Safety Analysis Set (SS) will include all eyes with attempted 
implantation with any IOL (successful or aborted after contact 
with the eye) and will be used for the safety analyses.
 
 
 
In general, descriptive statistics generated for effectiveness and 
safety parameters will be based upon the type of parameter (ie, 
whether the data were categorical or continuous) being analyzed. 
For categorical parameters, the statistics used to summarize the 
data descriptively included sample size, number in the category, 
and percent in the category. For continuous parameters, sample 
size, mean, median, standard deviation, minimum, and maximum 
will be presented.
For visual acuity endpoints, the number and percentage of the 
logMAR categories and Snellen categories will be provided 
respectively.

logMAR categories: the number and percentage of eyes 
with visual acuity of

0.00 logMAR or better: ≤0.00 logMAR

0.10 logMAR or better: ≤0.10 logMAR

0.20 logMAR or better: ≤0.20 logMAR

0.30 logMAR or better: ≤0.30 logMAR

Snellen categories: the number and percentage of eyes 
with visual acuity of

20/20 Snellen or better: ≤0.04 logMAR

20/25 Snellen or better: ≤0.14 logMAR
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
20/32 Snellen or better: ≤0.24 logMAR

20/40 Snellen or better: ≤0.34 logMAR
In addition, descriptive statistics including sample size, mean, 
median, standard deviation, number of subjects/eyes, minimum, 
maximum and (two-sided) 95% confidence interval will be 
presented.
Descriptive statistics for adverse events (including SSIs) will be 
presented for study eyes. The rates of all adverse events will be 
provided with counts and percentages, and these rates will be 
accompanied by two-sided exact 95% confidence intervals.
In order to estimate the percent of eyes with BCDVA of 20/20 or 
better (ie, ≤ 0.04 logMAR) at 6 months postop, the 95% 
confidence interval for the percent of eyes with BCDVA of 20/20 
or better at 6 months postop will be calculated based on the 
binomial distribution. With a sample size of 90 eyes, per the 
binomial distribution, the width of the 95% confidence interval 
ranges from 4.0% to 21.5%. As an example, for an observed 
outcome of 70%, the 95% confidence interval per binomial 
distribution is (59.4%, 79.2%) with a width of 19.8%.
Key words
ORA, Verifeye+, Barrett, Toric, IOL
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4
PROTOCOL AMENDMENTS
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments must be created by the Study Sponsor and must be 
approved by the IRB/IEC and global and regional Health Authorities, as applicable, prior to 
implementation except when required to mitigate immediate safety risks or when the changes 
involve only logistical or administrative revisions.
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study must sign 
the approved, revised informed consent (re-consent), as required by the IRB/IEC.
 
 
 
 
 
 
 
 
 
 
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Table 6-2
 
 
 
 
 
 
 
 
 
 
 
 
 
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
Pre-existing corneal astigmatism (reported to exceed 1.00 D in approximately one-
third of cataract patients) and imprecise preoperative measurement of corneal 
astigmatism (Ferrer-Blasco 2009, Lekhanont 2011).

Surgical variations in the size and central position of the capsulorhexis which may 
influence the final position of the IOL inside the bag and are surgeon-dependent, 
and surgically induced astigmatism (SIA; McIntyre 2012).

Healing process, such as anterior movement of the IOL resulting from 
postoperative capsular bag fibrosis and contraction (McIntyre 2012).
When spectacle or contact lens correction is not adequate or desired, secondary surgical 
procedures currently available to address residual refractive error include excimer laser 
corneal surgery, astigmatic keratotomy, piggyback (second) IOL placement and IOL 
exchange. Incorrect lens power remains one of the major causes cited for the removal of 
intraocular lenses (Steinert 1999, Connors 2002, Mamalis 2001).
5.2
Purpose of the Study
The purpose of the study is to evaluate the visual acuity outcomes when two modern 
technologies (Barrett Toric Calculator and ORA with VerifEye+) are used for implantation of 
a Toric IOL. There are also exploratory measurements which will be used to determine the 
effectiveness of each device.
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards.
There are no immediate plans to submit the results of this study for publication; however, the 
results may be offered for publication if they are of scientific interest, or if the results relate to 
a product that is subsequently approved or cleared for marketing.
5.3
Risks and Benefits
5.3.1
ORA System with VerifEye+
The ORA System with VerifEye+ is designed to provide intraoperative measurement of the 
refractive power of eyes during cataract removal and IOL implantation. The ORA System 
provides real time confirmation to ophthalmic surgeons with respect to the correctness of the 
IOL selection for the patient during the surgical procedure potentially reducing the frequency 
of revision surgery and possibly refractive surprises. In addition, the ORA system helps with 
the following:
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
Judging the axis placement of the Toric IOL.

Measurement of refractive power of the eye intraoperatively

Confirmation of proper IOL selection
Harm is defined as physical injury or damage to the health of people, or damage to property 
or environment. The Risk Management File identifies harms, which are known as potential 
AEs associated with the ORA System with VerifEye. 
Below is a summary of the identified harms:

Temporary user discomfort (Blurred Vision)

Decreased vision

Visual Disturbance

Microbial Infection

Unexpected Postoperative Refraction Intervention Required

Injury Due To Interference With Other Equipment

Globe Rupture

Blindness
The following conditions may make it difficult to obtain accurate readings using the ORA 
System:

Patients having progressive retinal pathology such as diabetic retinopathy, macular 
degeneration, or any other pathology that the physician deems would interfere with 
patient fixation;

Patients having corneal pathology such as Fuchs’, EBMD, keratoconus, advanced 
pterygium impairing the cornea, or any other pathology that the physician deems 
would interfere with the measurement process;

Patients for whom the preoperative regimen includes 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, 
will either limit or prohibit the measurement process; 

Patients having received retro or peribulbar block or any other treatment that 
impairs their ability to visualize the fixation light; 
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
Use of iris hooks during an ORA system image capture will yield inaccurate 
measurements.
In addition:

Significant central corneal irregularities resulting in higher order aberrations might 
yield inaccurate refractive measurements.

Post refractive keratectomy eyes might yield inaccurate refractive measurement.

The safety and effectiveness of using the data from the ORA System have not been 
established for determining treatments involving higher order aberrations of the 
eye such as coma and spherical aberrations.
There may also be unknown risks to use of the ORA System with VerifEye+. Any risk to 
subjects in this clinical study will be minimized by compliance with the eligibility criteria 
and study procedures, clinical oversight and monitoring.
Refer to the ORA System DFU for additional information.
5.3.2
Alcon Toric Calculator (Barrett)
The Toric IOL Web-based Calculators, including the updated Alcon Online Toric IOL 
Calculator, provide clinically significant benefits in regard to assisting the ophthalmic 
surgeon in calculations related to IOL selection and placement. This benefit is substantiated 
by clinical evidence and published literature demonstrating an overall improvement in 
refractive status across the general population of patients following IOL implantation.
The key harm is unexpected postoperative refraction resulting in intervention, which was 
identified in a comprehensive review of the post-market clinical experience surveillance data 
incorporated in the RMF for existing Alcon Toric IOL Web-based IOL Calculators
(TDOC-0050559; Risk Management File for the Alcon Online Toric IOL Calculator). The 
affected population includes cataract patients implanted with an AcrySof Toric, AcrySof IQ 
Toric, AcrySof ReSTOR® Toric 3.0, AcrySof ReSTOR Toric 2.5 or AcrySof Cachet® IOL, 
previously calculated with existing Web-based IOL calculators.
Unexpected post-operative refraction errors may occur as a result of a combination of factors 
which may include the calculator algorithm (underestimation of the corneal plane equivalent 
power of the cylinder), steps between IOL cylinder powers, and other sources of surgical and 
measurement error. In addition, iatrogenic as well as inherent patient/subject dependent 
healing processes following surgery may also contribute to unexpected postoperative 
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refraction error as shown by Jeon, et al (2014) who reported a myopic shift in the refractive 
spherical equivalent.
Unexpected post-operative refraction has been identified as harm in the risk assessment of the 
Toric IOL Web-based Calculators; this risk has been further mitigated and reduced as far as 
possible for calculator-related factors through design risk control measures by implementing 
Holladay I formula and the Universal II (Barrett) formula in the updated Calculator and the 
provision of instructions for use.
Overall, the clinically significant benefits of the IOL Web-based Calculators, including the 
Alcon IOL Online Toric Calculator are considered to outweigh the overall risks.
Refer to the Alcon Toric Calculator DFU for additional information.
6
STUDY OBJECTIVES
6.1
Primary Objective(s)
Table 6–1
Primary Objective(s)
Objective(s)
Endpoint(s)
To evaluate the percentage of eyes with 
BCDVA of 20/20 or better in eyes implanted 
with AcrySof Toric selected by ORA with 
VerifEye + and Barrett Toric Calculator
Mean Monocular BCDVA in logMAR
6.2
Secondary Objective(s)
Not Applicable.
 
 
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QoV questionnaire
6.4
Safety Objective(s)
Table 6–3
Safety Objective(s)
Objective(s)
Endpoint(s)
Evaluation of adverse events including 
secondary surgical interventions related to 
the investigational device
Adverse events
Device deficiencies
Device deficiencies
7
INVESTIGATIONAL PLAN
7.1
Study Design
This is a prospective, randomized, contralateral, multicenter, postmarket study. A total of 
115 subjects will be enrolled to achieve 90 evaluable subjects. Treatments will be randomized 
between eyes and the eye with more visually significant cataract as measured by BCDVA will 
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undergo surgery first. If the BCDVA is equal between eyes, the right eye will undergo surgery 
first.
The Barrett Toric Calculator via the Alcon Toric Calculator will be used for IOL power 
selection preoperatively. Sites that have LenSx will use it for primary and secondary 
incisions, capsulorhexis, and phacofragmentation consistently in both eyes for all subjects. 
Sites that don’t have LenSx will use standard manual procedures.
For the eyes in the ORA with VerifEye + study group, the IOL power and axis and axis mark 
alignment will be provided by ORA. For eyes in the Barrett Toric study group, the IOL power 
and axis will be provided by the Barrett Toric Calculator and axis alignment will be done 
manually (ie, without ORA guidance). 
The study will be conducted at up to 10 sites in the US. Surgery will be done on each eye on 
different days 7 to14 days apart. Total follow-up duration is 6 months. There will be 10 visits 
in total. Refer to the Overview of Study Procedures Table for an overview of the visit 
schedule and the assessments to be performed at each visit.
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Figure 7–1
Study Flow Chart
Visit 0: Day -30 to Day 0
First eye surgery/Visit 00: Day 0
Visit 1: Day 1 – 2 Post Visit 00
Visit 2: Day 7 – 14 Post Visit 00
Visit 00A: Second eye surgery
Visit 1A: Day 1-2 Post Visit 00A
Visit 2A: Day 7-14 Post Visit 00A
Visit 3A: Day 30-60 Post Visit 00A
Visit 4A: Day 80 – 100 Post Visit 00A
Visit 5A: Day 120 – 180 Post Visit 00A
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7.2
Rationale for Study Design
This is a prospective, randomized, contralateral eye, multicenter postmarket study. 
Treatments will be randomized between eyes to mitigate bias. Contralateral design can 
control for environmental and patient specific factors. There is no masking in the study 
because it will be obvious to the surgeon which methodology is being used. Purpose and 
Timing of Interim Analyses and Resulting Design Adaptations
There will be an interim analysis performed using the 1-month follow up data. This will be 
performed after the last subject has completed their 1-month follow up visit. There are no 
expected design adaptations planned using the results of this analysis.
7.3
Rationale for Duration of Treatment/Follow-Up
A six month follow-up duration was chosen because it is expected that the visual acuity and 
refraction variables will be stabilized by then.
7.4
Rationale for Choice of Control Product

Not applicable.
7.5
Data Monitoring Committee

Not applicable
8
STUDY POPULATION
The study population consists of male and female subjects at least 22 years old who require 
cataract surgery and a Toric IOL in both eyes. It is aimed to enroll approximately 115 subjects 
at approximately 10 sites in the US. Site-specific targets may vary based upon individual site 
capabilities. Estimated time needed to recruit subjects for the study is approximately 
12 weeks.
Subjects will be required to have preoperative keratometric astigmatism of 0.75 to 3.00 D and 
require the AcrySof IQ Toric SN6AT3 – 6 as determined by Alcon Toric Calculator.
 
 
 
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8.1
Inclusion Criteria
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject is considered enrolled in the study.
Subjects eligible for inclusion in this study must fulfill all of the following criteria:
1.
Subject must be able to understand and sign an IRB/IEC approved Informed 
Consent form.
2.
Willing and able to attend all scheduled study visits as required per protocol.
3.
22 years of age or older
4.
Preoperative keratometric astigmatism of 0.75 to 3.00 D
5.
Planned implantation of AcrySof IQ Toric SN6AT3 – T6 as determined by the Alcon 
Toric Calculator
6.
Potential postoperative visual acuity of 0.04 logMAR (20/20) or better
8.2
Exclusion Criteria
Subjects fulfilling any of the following criteria are not eligible for participation in this study.
1.
Pregnancy:
a.
they are currently pregnant,
b. have a positive urine pregnancy test result at Screening,
c.
intend to become pregnant during the study period,
d. are breast-feeding.
Subjects who become pregnant during the study will not be discontinued; however, 
data will be excluded from the effectiveness analyses because pregnancy can alter 
refraction and visual acuity results.
2.
Unclear intraocular media other than cataract
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3.
Axial length < 21.5 and > 27.0 mm
4.
Significant irregular corneal astigmatism as measured by a corneal topographer
5.
Unstable tear film per Investigator judgement
6.
Significant anterior or posterior segment disease
7.
Prior intraocular or corneal surgery
8.
Prior retinal detachment
9.
Participation in another concurrent clinical trial per the PI judgement
10.
Presence or history of any condition or finding that makes the subject unsuitable as a 
candidate for cataract surgery or study participation or may confound the outcome of 
the study, in the opinion of the Investigator
Exclusion Criteria during Surgery
11.
Intra-operative complications such as, but not limited to, posterior capsular tear, wound 
burn and need to place a suture
12.
ORA or Alcon Toric Calculator recommends an IOL other than AcrySof IQ Toric 
SN6AT3-T6
8.3
Rescreening of Subjects
Rescreening of subjects is not allowed in this study.
9
TREATMENTS ADMINISTERED
9.1
Investigational Product(s)
Test Product(s):
ORA with VerifEye+
Alcon Toric Calculator
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Table 9–1
Test Product
Test Product
ORA System with VerifEye+
Manufacturer
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134-2099
USA
Indication for use 
and intended 
purpose in the 
current study 
The ORA System uses wavefront aberrometry data in the 
measurement and analysis of the refractive power of the eye (ie, 
sphere, cylinder, and axis measurements) to support cataract 
surgical procedures.
Product description 
and parameters 
available for this 
study
The ORA System uses wavefront aberrometry data in the 
measurement and analysis of the refractive properties of the eye. 
The ORA System method of determining the refractive state of the 
eye is performed intraoperatively during the aphakic state (after 
natural lens removal) during cataract surgery. This additional 
information provided by the ORA System can be collected only 
after the natural lens is removed and may contribute to the 
provider’s plan and patient’s outcome when seeking a refractive 
correction. Preoperatively, a patient who has been diagnosed with a 
treatable refractive condition could elect to have the ORA System 
utilized during cataract surgery to allow the surgeon to measure the 
total corneal impact on refraction, and variables that may impede 
the refractive goal.
Packaging 
description
N/A
Storage conditions
N/A
Supply
N/A
More information on this test product can be found in the Directions for Use.
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Table 9–2
Test Product
Test Product(s)
Alcon Toric Calculator
Manufacturer
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134-2099
USA
Indication for Use
The Alcon Online Toric IOL calculator is a tool intended to assist the 
ophthalmic surgeon in selecting a toric IOL and placement axis for 
adult patients with corneal astigmatism undergoing cataract removal.
Product description 
and parameters 
available for this 
study
IOL Web-based Calculators and the Alcon Online Toric IOL 
Calculator are a family of IOL accessories that use software-driven 
algorithms to assist the surgeon in necessary calculations and are 
intended to be displayed in the Microsoft® Internet Explorer® or 
similar browser. The IOL Web-based Calculators and the Alcon 
Online Toric IOL Calculator are accessories to AcrySof Toric IOLs. 
The family of Toric IOL Calculators help to predict the amount of 
postoperative corneal astigmatism that needs to be corrected in order 
to optimize IOL model selection and axis placement within the 
capsular bag. The Barrett Toric formulas will be used in this study.
Formulation
N/A
Storage conditions
N/A
Supply
N/A
More information on this test product can be found in the Directions for Use.
9.2
Other Medical Device or Medication Specified for Use During the 
Study
No other medical devices or medications outside of the standard of care are required to be 
used in conjunction with the treatments during the clinical study.
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9.3
Treatment Assignment / Randomization
Subjects will be randomized in a 1:1 ratio to receive treatment with ORA System with 
VerifEye+ or the Barrett Toric Calculator in the first treated eye, respectively. Since this is a 
contralateral study, each subject should have one eye treated with each technique.
Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system. 
A randomization list will be generated using a validated system that automates the random 
assignment of treatment arms to randomization numbers in the specified ratio. Subjects will 
be assigned to treatment according to the randomization list uploaded in the IRT system. The 
randomization list will be generated and maintained by the Study Sponsor.
9.3.1
IRT
At Visit 0, all eligible subject eyes will be randomized via the IRT system to one of the 
treatment arms. The Investigator or delegate will access the IRT system after confirming that 
the subject meets all the eligibility criteria. A randomization number will be automatically 
assigned to the subject according to the subject randomization list. The IRT system will 
inform the site user of the treatment assignment to be used for the subject eye.
9.4
Treatment masking
All members associated with the study (at the site and the Study Sponsor) are unmasked to 
the assigned treatment. 
9.5
Accountability Procedures
Not applicable.
9.6
Changes to concomitant medications, treatments/ procedures
After the subject is enrolled into the study, the Investigator must instruct the subject to notify 
the study site about:

Any new medications 

Alterations in dose or dose schedules for current medications 

Any medical procedure or hospitalization that occurred or is planned

Any non-drug therapies (including physical therapy and blood transfusions). 
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The Investigator must document this information in the subject’s case history source 
documents.
10 STUDY PROCEDURES AND ASSESSMENTS
10.1 Informed Consent and Screening
The Investigator or delegate must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IRB/IEC-approved informed consent document. The subject 
must sign the ICF BEFORE any study-specific procedures or assessments can be performed, 
including study-specific screening procedures.
The Investigator or delegate must provide a copy of the signed document to the subject and 
place the original signed document in the subject’s chart, or provide documentation as 
required by local regulations.
10.2 Description of Study Procedures and Assessments
Detailed descriptions of assessments and procedures are provided in the MOP. All devices are 
to be used per the standard of care and the DFU.  The Investigator is responsible for ensuring 
responsibilities for all procedures and assessments are delegated to appropriately qualified 
site personnel.
10.2.1 Demographics
Obtain demographic information including age, race, ethnicity, and sex.
10.2.2 Medical History
Collect medical history information, including information on all medications used within the 
past 30 days. Include herbal therapies, vitamins, and all over-the-counter as well as 
prescription medications. Throughout the subject’s participation, obtain information on any 
changes in medical health and/or the use of concomitant medications.
10.2.3 Adverse Event Collection: Safety Assessment
Assess and record any adverse events that are observed or reported, including those 
associated with changes in concomitant medication dosing since the previous visit.
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time of 
signature of informed consent, regardless of subject enrollment status (screen failure or 
randomized).
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10.2.4 Device Deficiencies: Safety Assessment
Assess and record any device deficiencies that are reported or observed, including those 
associated with changes in concomitant medication dosing since the previous visit.
Requirements for reporting device deficiencies in the study can be found in Section 11. 
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time of 
signature of informed consent, regardless of subject enrollment status (screen failure or 
randomized).
 
 
 
 
10.2.8 Visual Acuity: Effectiveness
Visual acuity testing for both eyes must be performed prior to any assessment requiring 
administration of eye drops to dilate the eyes, or any assessment requiring contact with the 
eye.
 
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10.3 Study Visit Procedures
10.3.1 Visit 0: Day -30 to Day 0 (for both eyes)
Upon signing informed consent, patients 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).
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).
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. 
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NOTE: Subjects must formally consent to participate in the study prior to undergoing any 
study specific testing.


Document demographics, ocular and nonocular medical history, ocular and 
nonocular concomitant medications.

Perform a urine pregnancy test, if the subject is a woman of childbearing potential.

 

Measure and record BCDVA measurement (monocular) - (refer to MOP for 
details).


Identify target refraction.
 

Record any device deficiency and AEs.
10.3.2 Surgery Visit (Visit 00 and Visit 00A)
Visit 00: Day 0 (implant for first eye)
Visit 00A: 7-14 days after surgery for Eye 1 (implant for second eye)
Below is a list of study procedures to be undertaken at the 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).
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Procedures performed in ORA group:

Subjects will be randomized and undergo surgery using the ORA system. 

Document any changes to ocular and nonocular concomitant medications.

Prepare subject/operative eye for surgery in accordance with site-specific operating 
procedures.

Ensure that the subject was randomized to ORA and it is utilized for the surgery.

Perform the surgical procedure using standard of care.

Record aphakic refraction and aphakic SE.

Record IOL power recommended by ORA and predicted post-operative SE.

Record implanted IOL power and predicted post-operative SE.

Record any surgical problems, complications, or other procedures that occur 
during surgery.

Record any device deficiencies and adverse events. Refer to Section 11 for further 
detail.
Procedures performed in Barrett Toric Calculator group:

Subjects will be randomized and undergo surgery using the Barrett Toric 
Calculator.

Take preoperative measurements for IOL calculation.

Prepare subject/operative eye for surgery in accordance with site-specific operating 
procedures.

Document any changes to ocular and nonocular concomitant medications.

Ensure that the subject was randomized to Barrett Toric Calculator and it is 
utilized.

Perform surgical procedure using standard of care.

Record implanted IOL power and anticipated residual refractive astigmatism.

Record any surgical problems, complications, or other procedures that occur 
during surgery.

Record any device deficiencies and adverse events. Refer to Section 11 for further 
detail.
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10.3.3 Visit 1/1A (Day 1 for Eye 1/2)

Document any changes to ocular and nonocular concomitant medications.


Record any device deficiencies and adverse events. Refer to Section 11 for further 
detail.
10.3.4 Post-Surgery Visit (Visits 2, 2A, 3A, 4A and 5A)
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).


Document changes in ocular and nonocular concomitant medications at Visits 2, 
2A, 3A, 4A, and 5A.

 
 

Perform BCDVA (monocular) assessment at Visits 2, 2A, 3A, 4A, and 5A. Refer to 
MOP for details.

 
 
 
 
 
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

Record any device deficiencies and AEs. Refer to Section 11 for further detail.

Document subject exit from study at Visit 5A.
10.4 Unscheduled Visits
If a subject visit occurs between any regularly scheduled visits, this visit must be documented 
as an Unscheduled Visit. During all unscheduled visits, the Investigator must conduct the 
following procedures: 

Collect Adverse Event information

Record changes in medical condition or concomitant medication
The Investigator may perform additional procedures for proper diagnosis and treatment of the 
subject. The Investigator must document this information in the subject’s case history source 
documents.
If during an Unscheduled Visit the subject is discontinuing from the study, the Investigator 
must conduct Exit procedures according to Table 3-1 Schedule of Study Procedures and 
Assessments, as possible.
10.5 Discontinued Subjects
10.5.1 Screen Failures
Subjects who were excluded from the study after signing the informed consent and prior to
randomization/surgical procedure.
The Investigator must document the reason for screen failure in the subject’s case history 
source documents.
Subject numbers must not be re-used.
10.5.2 Discontinuations
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the Investigator after randomization/surgical procedure.
Subject numbers of discontinued subjects must not be re-used.
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Subjects may discontinue from study or study treatment at any time for any reason. Subjects 
may also be discontinued from study treatment at any time if, in the opinion of the 
Investigator, continued treatment poses a risk to their health.
If a subject discontinues from study treatment, every effort must be made to keep the subject 
in the study and to continue with the study assessments as specified in the schedule of study 
procedures and assessments until the final visit.
For subjects discontinuing from the study, the Investigator must complete all Exit procedures 
according to Table 3-1 Schedule of Study Procedures and Assessments, if the subject is 
willing and able, and if in the opinion of the Investigator it is safe for the subject to do so.
The Investigator must document the reason for study or treatment discontinuation in the 
subject’s case history source documents.
To ensure the safety of all subjects who discontinue early, Investigators must assess each 
subject and, if necessary, advise them of any therapies and/or medical procedures that may be 
needed to maintain their health.
10.5.3 Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product 
Not applicable.
10.6 Clinical Study Termination
The Study Sponsor reserves the right to close the investigational site or terminate the study in 
its entirety at any time.
If the clinical study is prematurely terminated or suspended by the Study Sponsor: 

The Study Sponsor must:

Immediately notify the Investigator(s) and subsequently provide 
instructions for study termination.

Inform the Investigator and the regulatory authorities of the
termination/suspension and the reason(s) for the termination/suspension. 

The Investigator must:

Promptly notify the IRB/IEC of the termination or suspension and of the 
reasons. 
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
Provide subjects with recommendations for post-study treatment options 
as needed.
The Investigator may terminate the site’s participation in the study for reasonable cause.
10.6.1 Follow-up of subjects after study participation has ended 
Following this study, the subject will return to their eye care professional for their routine eye 
care.
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES
11.1 General Information
An AE is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, 
whether or not related to the investigational medical device (test article). Refer to the 
Glossary of Terms for categories of AEs and SAEs.
Figure 11–1
Categorization of All Adverse Event
ADE
Device /
procedure-
related?
Meets 
seriousness 
criteria?
SAE
All AEs
AE
No
No
Yes
Yes
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
“Have there been any changes in the medicines you take since your last study 
visit?”
Changes in any protocol-specific parameters and/or questionnaires evaluated during the study 
are to be reviewed by the Investigator. Any untoward (unfavorable and unintended) change in 
a protocol-specific parameter or questionnaire response that is clinically relevant, in the 
opinion of the Investigator, is to be reported as an AE. These clinically relevant changes will 
be reported regardless of causality.
11.3 Procedures for Recording and Reporting
Adverse events are collected from the time of informed consent. Any pre-existing medical 
conditions or signs/symptoms present in a subject prior to the start of the study (ie, before 
informed consent is signed) are not considered AEs in the study and should be recorded in the 
Medical History section of the eCRF. 
In addition, aqueous cells and flare, corneal edema, raised IOP and superficial punctate 
keratitis are examples of early postoperative findings that are typically observed following 
ocular surgery. These are not considered AEs if they can be reasonably expected to resolve 
within a week and not result in any untoward long term visual outcome impact. 
For each recorded event, the ADE and SAE documentation must include the following: date 
of occurrence, severity, treatment (if applicable), outcome, and assessments of the 
seriousness, and causality. In addition, the Investigator must document all device deficiencies 
reported or observed with test articles on the Device Deficiency eCRF. The site must submit 
all available information on ADEs, SAEs, and device deficiencies to the Study Sponsor 
immediately as follows:

All SAEs must be reported immediately (within 24 hours) of the Investigator’s or 
site’s awareness. 

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 information after initial reporting must be entered into the eCRF as 
soon as the data become available.

Document any changes to concomitant medications on the appropriate eCRFs.
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
Document all relevant information from Discharge Summary, Autopsy Report, 
Certificate of Death, etc, if applicable, in narrative section of the Adverse Device 
Effect (for related AEs) and Serious Adverse Event eCRF.
Note: Should the EDC system become non-operational, the site must complete the 
appropriate paper Serious Adverse Event and Adverse Device Effect and/or Device 
Deficiency Form. The completed form is emailed to the Study Sponsor to 
FTW.medical_safety@alcon.com according to the timelines outlined above; however, the 
reported information must be entered into the EDC system once it becomes operational.
Any AEs and device deficiencies for non-study marketed devices/products (ie, AcrySof IQ 
Toric IOL SN6AT3-6, Alcon OVDs and BSS and Alcon surgical systems) will be considered 
and processed as spontaneous (following the post-market vigilance procedures) and should be 
communicated to the device’s/product’s manufacturer as per local requirements.
Study Sponsor representatives may be contacted for any protocol related question and their 
contact information is provided in the Manual of Procedures that accompanies this protocol.
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC.
11.3.1 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.
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For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below:
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).
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 is 
upgraded from non-serious to serious or from unrelated to related.
11.4 Return product analysis
Study Sponsor representatives and their contact information are provided in the Manual of 
Procedures that accompanies this protocol. 
Alcon products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint # which will be provided by Study Sponsor after the 
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case is entered in the Study Sponsor’s Global Product Complaint Management System 
(GPCMS).
11.5 Unmasking of the Study Treatment
Not applicable; this study is open-label.
11.6 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 
11.7 Pregnancy in the Clinical Study
Women of childbearing potential are not excluded from participation. If a woman becomes 
pregnant during the study, the pregnancy is not reportable as an AE; however, complications 
may be reportable and will be decided on a case–by-case basis. An Alcon form will be 
utilized to capture all pregnancy-related information until birth of the child.
12 ANALYSIS PLAN
12.1 Subject Evaluability
The final subject evaluability will be determined using the Deviations and Evaluability Plan 
(DEP) prior to locking the database.
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12.2 Analysis Sets
There will be two effectiveness analysis sets. The All Implanted Analysis Set (AAS) includes 
all eyes with successful IOL implantation, T3-T6 and recommended by ORA. The Per 
Protocol Analysis Set (PPS) includes all eyes with successful IOL implantation, T3-T6 and 
recommended by ORA and with no major protocol deviations. The primary analysis set for 
effectiveness is the PPS.
Safety Analysis Set (SS) will include all eyes with attempted implantation with any IOL
(successful or aborted after contact with the eye) and will be used for the safety analyses.
12.3 Demographic and Baseline Characteristics
Summary statistics will be provided for demographic and baseline characteristics by 
treatment group. Number and percentage will be presented for categorical variables and 
descriptive statistics including mean, standard deviation (SD), minimum, and maximum will 
be presented for continuous variables.
12.4 Effectiveness Analyses
12.4.1 Analysis of Primary Effectiveness Endpoint(s)
The primary objective of this study is to evaluate the percentage of eyes with BCDVA of 
20/20 or better in eyes implanted with AcrySof Toric selected by ORA with VerifEye + and 
Barrett Toric Calculator. The primary endpoint is percentage of eyes with BCDVA of 20/20 or 
better at 6 months.
12.4.1.1 Statistical Hypotheses
No hypothesis testing of the primary effectiveness endpoint is planned.
12.4.1.2 Analysis Methods
The following descriptive statistics will be provided by treatment group:

logMAR categories: the number and percentage of eyes with visual acuity of

0.0 logMAR or better: ≤0.00 logMAR 

0.1 logMAR or better: ≤0.10 logMAR 

0.2 logMAR or better: ≤0.20 logMAR 

0.3 logMAR or better: ≤0.30 logMAR
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
Snellen categories: the number and percentage of eyes with visual acuity of

20/20 Snellen or better: ≤0.04 logMAR 

20/25 Snellen or better: ≤0.14 logMAR 

20/32 Snellen or better: ≤0.24 logMAR 

20/40 Snellen or better: ≤0.34 logMAR

Descriptive statistics including mean, median, standard deviation, number of eyes, 
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12.5 Handling of Missing Data
The AAS does not include any imputed values. Although missing data will occur, the 
influence of missing data is expected to be minimal.
12.6 Safety Analyses
There are no safety hypotheses planned in this study. The focus of the safety analysis will be 
a comprehensive descriptive assessment of occurrence of adverse events as well as the other 
listed parameters.
The safety endpoints are: 

Adverse events including SSIs

Device deficiencies
Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. 
Adverse events including SSIs
Descriptive summaries (counts and percentages) for AEs including SSIs will be presented by 
treatment group. Individual subject listings will be provided for AEs.
Device Deficiencies
The number and percentage of all device deficiencies will be tabulated with a breakdown by 
treatment group. A listing of all device deficiencies will also be provided.
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13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS
13.1 Subject Confidentiality
The Investigator must ensure that the subject’s anonymity is maintained throughout the 
course of the study. In particular, the Investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. At the end of the clinical study, the Study Sponsor will collect a copy 
of the enrollment log without any identifying subject information. All documents submitted 
to the Study Sponsor will identify the subjects exclusively by number and demographic 
information. No other personally identifying information will be transmitted to the Study 
Sponsor.
The Study Sponsor may release anonymized study data to external researchers for purposes 
of future research directly related to the study objectives, or future research that is beyond the 
scope of the current study objectives. The Informed Consent Form explains this to study 
subjects. Anonymization means that all identifiable information will be removed from the 
dataset and all links to the subjects in the study will be removed. Anonymization of the data 
will maintain confidentiality of the subjects who participate in the study so that they cannot 
be identified by external researchers. The anonymized data set will contain records from all 
of the subjects in the current study, but the anonymization process might change the data set 
in some ways, so external researchers will be informed that they might not be able to 
duplicate some of the results from this study.
13.2 Completion of Source Documents and Case Report Forms
The nature and location of all source documents will be identified to ensure that original data 
required to complete the CRFs exist and are accessible for verification by the site monitor, 
and all discrepancies shall be appropriately documented via the query resolution process. Site
monitors are appointed by the Study Sponsor and are independent of study site staff.
If electronic records are maintained, the method of verification must be determined in
advance of starting the study. 
At a minimum, source documents include the following information for each subject:

Subject identification (name, sex, race/ethnicity)

Documentation of subject eligibility
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
Date of informed consent

Dates of visits

Documentation that protocol specific procedures were performed

Results of study parameters, as required by the protocol

IP accountability records

Documentation of AEs and other safety parameters (if applicable)

Records regarding medical histories and the use of concomitant therapies prior to and 
during the study

Date of study completion and reason for early discontinuation, if applicable
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the CRF are consistent with the original source data.
Only designated individuals at the site will complete the CRFs. The CRFs must be completed 
at regular intervals following the clinical study visit schedule. It is expected that all data 
reported have corresponding entries in the source documents. The Principal Investigator is 
responsible for reviewing and certifying that the CRFs are accurate and complete. The only 
subject identifiers recorded on the CRFs will be subject number, and subject demographic 
information.
13.3 Data Review and Clarifications
A review of CRF data to the subject’s source data will be completed by the site monitor to 
ensure completeness and accuracy. After the CRFs have been completed, additional data 
clarifications, and/or additions may be needed as a result of the data cleaning process. Data 
clarifications are documented and are part of each subject’s CRF.
13.4 Sponsor and Monitoring Responsibilities
The Study Sponsor will designate a monitor to conduct the appropriate site visits at the 
appropriate intervals according to the study monitoring plan. The clinical investigation will 
be monitored to ensure that the rights and well-being of the subjects are protected, the 
reported data are accurate, complete, and verifiable from the source documents, and the study 
is conducted in compliance with the current approved protocol (and amendments[s], if 
applicable), with current GCP, and with applicable regulatory requirements.
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The site may not screen subjects or perform the informed consent process on any subject until 
it receives a notification from an appropriate Study Sponsor representative that the site may 
commence conducting study activities. Monitoring will be conducted periodically while the 
clinical study is ongoing. Monitoring methods may include site visits, telephone, written and 
fax correspondence. Close-out visits will take place after the last visit of the last subject at the 
site.
A Coordinating Investigator may be identified by the Study Sponsor to review and endorse 
the final study report. In cases where a Coordinating Investigator is engaged, the Study 
Sponsor will select the Coordinating Investigator based upon their experience, qualifications, 
active study participation, and their willingness and availability to take on this role.
Additionally,
Alcon may have an expert Sponsor Observer present during subject visits to make 
observations during the study visit. 
The Sponsor Observer must be supervised by the Investigator or designee to ensure the 
Sponsor Observer’s presence or activities do not bias the outcome of the study, affect 
the quality of the research data, and/or compromise the rights and welfare of the 
subject. The Sponsor Observer will not intervene with the standard of care provided to 
study subjects or make safety-related decisions or assessments. The activities of 
Sponsor Observers will be described in the Informed Consent.
13.5 Regulatory Documentation and Records Retention
The Investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the Study Sponsor and the Investigator’s files will be reviewed as part of the 
ongoing study monitoring. Financial information is to be kept separately. 
Additionally, the Investigator must keep study records and source documents consistent with 
the terms of the clinical study agreement with the Study Sponsor. If the Investigator retires, 
relocates, or for any other reason withdraws from responsibility of keeping the study records, 
then the Study Sponsor must be notified and suitable arrangements made for retention of 
study records and source documents needed to comply with national and international
regulations.
13.6 Quality Assurance and Quality Control
The Study Sponsor will secure agreement from all involved parties to ensure direct access to 
all study related sites, source data and documents, and reports for the purpose of monitoring 
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and auditing by the Study Sponsor, and inspection by domestic and foreign regulatory 
authorities. Quality control will be applied to each stage of data handling to ensure that all 
data are reliable and have been processed correctly. Agreements made by the Study Sponsor 
with the Investigator/Institution and any other parties involved in the clinical study will be 
provided in writing as part of the protocol or as a separate agreement.
14 ETHICS
This clinical study must be conducted in accordance with the ethical principles contained 
within: 

The Declaration of Helsinki, and in compliance with the ICH E6 GCP Consolidated 
Guideline, ISO 14155:2011, and the applicable US FDA 21 CFR Regulations. 

SOPs of the Study Sponsor and contract research organizations participating in the 
conduct of the clinical study and all other applicable regulations. 

Notifications and timelines for reporting protocol deviations should be based upon
applicable Ethics Committee requirements
The Investigator must ensure that all personnel involved in the conduct of the study are 
qualified to perform their assigned responsibilities through relevant education, training, and 
experience. The Investigator and all clinical study staff must conduct the clinical study in 
compliance with the protocol. Deviations from this protocol, regulatory requirements and/or 
GCP must be recorded and reported to the Sponsor prior to database lock. If needed, 
corrective and preventive action should be identified, implemented, and documented within 
the study records. Use of waivers to deviate from the clinical protocol is prohibited.
Before clinical study initiation, this protocol, the informed consent form, any other written 
information given to subjects, and any advertisements planned for subject recruitment must 
be approved by an IRB/IEC. The Investigator must provide documentation of the IRB/IEC 
approval to the Study 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 subject, and subject compensation programs. The 
IRB/IEC must be provided with a copy of the Package Insert, any periodic safety updates, 
and all other information as required by local regulation and/or the IRB/IEC. At the end of 
the study, the Investigator must notify the IRB/IEC about the study’s completion. The 
IRB/IEC also must be notified if the study is terminated prematurely. Finally, the Investigator 
must report to the IRB/IEC on the progress of the study at intervals stipulated by the 
IRB/IEC.
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Voluntary informed consent must be obtained in writing from every subject and the process 
shall be documented before any procedure specific to the clinical investigation is applied to 
the subject. The Investigator must have a defined process for obtaining consent. Specifically, 
the Investigator, or their delegate, 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 provide subjects 
with information regarding the purpose, procedures, requirements, and restrictions of the 
study, along with any known risks and potential benefits associated with the IP and the study, 
the available compensation, and the established provisions for maintaining confidentiality of 
personal, protected health information. Subjects will be told about the voluntary nature of 
participation in the study and must be provided with contact information for the appropriate 
individuals should questions or concerns arise during the study. The subject also must be told 
that their records may be accessed by appropriate authorities and Sponsor-designated 
personnel. The Investigator must keep the original, signed copy of the consent (file in 
subject’s medical records) and must provide a duplicate copy to each subject according to 
local regulations. 
The Study Sponsor assures that the key design elements of this protocol will be registered on 
www.clinicaltrials.gov as required by current regulations and, if applicable, other public 
databases as required by local country regulations. In addition, results of this study will be 
made publicly available on www.clinicaltrials.gov regardless of outcome as required by 
current regulations and, if applicable, in other public databases as required by local country 
regulations.
15 REFERENCES
15.1 References applicable for all clinical studies

EN ISO 11979-7:2014 Ophthalmic implants – Intraocular lenses – Part 7: Clinical
Investigations

ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good 
clinical practice
15.1.1 US references applicable for clinical studies

21 CFR Part 11 - Electronic Records; Electronic Signatures
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
21 CFR Part 50 - Protection of Human Subjects

21 CFR Part 56 - Institutional Review Boards

21 CFR Part 812 - Investigational Device Exemptions

21 CFR Part 54 - Financial Disclosure by Clinical Investigators

The California Bill of Rights
15.2 References for this clinical study
Agresta B, Knorz MC, Donatti C, Jackson D. Visual acuity improvements after implantation 
of toric intraocular lenses in cataract patients with astigmatism: a systematic review. Graefes 
Arch Clin Exp Ophthal. 2012;12:41.
Brandser R, Haaskjold E, Drolsum L. Accuracy of IOL calculation in cataract surgery. Acta 
Ophthalmol Scan. 1997;75:162-5.
Connors R 3rd, Boseman P 3rd, Olson RJ. Accuracy and reproducibility of biometry using 
partial coherence interferometry. J Cataract Refract Surg. 2002;28(2):235-8.
Ferrer-Blasco T, Montes-Mico R, Peixoto-de-Matos SC, Gonzalez-Meijome JM, Cervino A. 
Prevalence of corneal astigmatism before cataract surgery. J Cataract Refract Surg.
2009;35:70–5.
Hirnschall N, Hoffmann PC, Draschl P, Maedel S, Findl O. Evaluation of factors influencing 
the remaining astigmatism after toric intraocular lens implantation. J Refract Surg.
2014;30(6):394-400.
Jeon JH, Hyung Taek Tyler R, Seo KY, Kim EK, Kim TI. Comparison of refractive stability 
after non-toric versus toric intraocular lens implantation during cataract surgery. Am J 
Ophthalmol. 2014;157(3):658-65.
Kirwan C, Nolan JM, Stack J, Moore TC, Beatty S. Determinants of patient satisfaction and 
function related to vision following cataract surgery in eyes with no visually consequential 
ocular co-morbidity. Graefes Arch Clin Exp Ophthalmol. 2015;253(10):1735-44.
Lekhanont K, Wuthisiri W, Chatchaipun P, Vongthongsri A. Prevalence of corneal 
astigmatism in cataract surgery candidates in Bangkok, Thailand. J Cataract Refract Surg.
2011;37(3):613–5.
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Mamalis N, Spencer TS. Complications of foldable intraocular lenses requiring explantation 
or secondary intervention – 2000 survey update. J Cataract Refract Surg. 2001;27(8):1310-7.
McIntyre JS, Werner L, Fuller SR, Kavoussi SC, Hill M, Mamalis N. Assessment of a single-
piece hydrophilic acrylic IOL for piggyback sulcus fixation in pseudophakic cadaver eyes. J 
Cataract Refract Surg. 2012;38:155–62.
Nordan LT. The surgical rehabilitation of vision. New York: Gower Medical; 1991.
Norrby S. Sources of error in intraocular lens power calculation. J Cataract Refract Surg.
2008;34(3):368–76.
Olsen T, Bargum R. Outcome monitoring in cataract surgery. Acta Ophthalmol Scand.
1995;73(5):433-7.
Steinert RF, Aker BL, Trentacost DJ, Smith PJ, Tarantino N. A prospective comparative study 
of the AMO ARRAY zonal-progressive multifocal silicone intraocular lens and a monofocal 
intraocular lens. Ophthalmology. 1999;106(7):1243-55.
Wegener M, Alsbirk PH, Hojgaard-Olsen K. Outcome of 1000 consecutive clinic- and 
hospital-based cataract surgeries in a Danish county. J Cataract Refract Surg.
1998;24(8):1152-60.
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