Post-Approval Study of the Tecnis® Toric IOL, Models ZCT300 and ZCT400
Phase: NA
Conditions: Cataract
Sponsor: Abbott Medical Optics

 
 
Study Protocol 
 
POST-APPROVAL STUDY OF THE TECNIS® 
TORIC IOL,  
MODELS ZCT300 AND ZCT400  
 
 
 
NCT Number:  NCT02566083 
Version 3.0 
Document date: 21 May 2018 
 
 
 
 
 
 

ABBOTT MEDICAL OPTICS INC. 
CONFIDENTIAL 
Version 3.0 
 
 
PR/TIOL-202-TPAS 
CONFIDENTIAL 
The following contains confidential, proprietary information  
that is the property of Abbott Medical Optics Inc. 
 
POST-APPROVAL STUDY OF THE TECNIS® TORIC IOL,  
MODELS ZCT300 AND ZCT400  
 
PROTOCOL NUMBER:  TIOL-202-TPAS 
 
 
SPONSOR: Abbott Medical Optics Inc. 
 
 
1700 E. Saint Andrew Place 
 
 
Santa Ana, CA 92705 USA 
 
 
(714) 247-8200 
Investigator Agreement: 
As an Investigator, I agree to: 
 
Implement and conduct this study diligently and in strict compliance with this 
agreement; the protocol; Good Clinical Practices; 21CFR812 and all other 
applicable FDA regulations; conditions of approval imposed by the reviewing 
Institutional Review Board (IRB) or FDA; and all other applicable laws and 
regulations. 
 
Supervise all testing of the device where human subjects are involved. 
 
Ensure that the requirements for obtaining informed consent are met. 
 
Obtain authorization for use/disclosure of health information (HIPAA 
authorization). 
 
Maintain all information supplied by Abbott Medical Optics in confidence and, 
when this information is submitted to an independent IRB or any other group, 
it will be submitted with a designation that the material is confidential. 
I have read this protocol in its entirety and I agree to all aspects. 
 
________________________ 
_______________________ 
_______________ 
Investigator Printed Name 
Signature 
Date 
 
________________________ 
_______________________ 
_______________ 
Sub-Investigator Printed Name 
Signature 
Date 
 
________________________ 
_______________________ 
_______________ 
Sub-Investigator Printed Name 
Signature 
Date 
 
Acknowledged By: 
______________________________ 
_______________ 
Signature of Sponsor’s Representative 
Date 
 
_____________________________________________________________________ 
Printed Name and Title

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PR/TIOL-202-TPAS 
 
TABLE OF CONTENTS 
SECTION 
 
 
 
     TITLE 
 
 
 
 
PAGE 
PERSONNEL AND FACILITIES .................................................................................... 3 
PROTOCOL CHANGE HISTORY .................................................................................. 4 
1.0 
SYNOPSIS ......................................................................................................... 5 
2.0 
BACKGROUND AND PURPOSE OF STUDY ...................................................10 
3.0 
STUDY OBJECTIVE .........................................................................................11 
4.0 
STUDY DESIGN ................................................................................................11 
5.0 
CLINICAL HYPOTHESIS ..................................................................................11 
6.0 
STUDY ENDPOINTS .........................................................................................11 
7.0 
STUDY PRODUCTS ..........................................................................................12 
7.1 
INTRAOCULAR LENSES ..............................................................................12 
7.2 
IMPLANTATION SYSTEMS ..........................................................................14 
8.0 
STUDY POPULATION ......................................................................................15 
8.1 
SUBJECT RECRUITMENT ...........................................................................15 
8.2 
INCLUSION CRITERIA: ................................................................................15 
8.3 
EXCLUSION CRITERIA: ...............................................................................16 
9.0 
INVESTIGATOR/SITE SELECTION ..................................................................16 
9.1 
INVESTIGATOR QUALIFICATIONS .............................................................17 
9.2 
INVESTIGATOR OBLIGATIONS ...................................................................17 
9.3 
INVESTIGATOR APPROVAL ........................................................................18 
10.0 
STUDY TIMELINE .............................................................................................19 
11.0 
EXPERIMENTAL PLAN ....................................................................................19 
11.1   OVERVIEW ...................................................................................................19 
11.2 
VISIT SCHEDULE .........................................................................................21 
11.3 
PREOPERATIVE PROCEDURES .................................................................21 
11.4 
OPERATIVE PROCEDURES ........................................................................24 
11.5 
POSTOPERATIVE PROCEDURES ..............................................................25 
11.6 
UNSCHEDULED VISIT(S) FOR ADVERSE EVENT OR SPONTANEOUS 
REPORT OF VISUAL DISTORTION(S) .....................................................................27 
11.7 
SUBJECT FOLLOW-UP AND DISCONTINUATION ......................................28 
12.0 
ADVERSE EVENTS AND PRODUCT COMPLAINTS .......................................30 
12.1  
ADVERSE EVENT AND COMPLAINT DEFINITIONS ...................................30 
12.2  
ADVERSE EVENT REPORTING REQUIREMENTS .....................................32 
12.3  
ADVERSE EVENT FOLLOW-UP ..................................................................33 
12.4  
RELATIONSHIP TO STUDY DEVICES .........................................................33 
13.0 
PROTOCOL CHANGES AND PROCEDURES .................................................34 
14.0 
ETHICS REVIEW AND PATIENT WELFARE ...................................................34 
14.1 
INSTITUTIONAL REVIEW BOARD (IRB) ......................................................34 
14.2 
INFORMED CONSENT .................................................................................35 
15.0 
DOCUMENTATION ...........................................................................................35 
15.1 
SOURCE DOCUMENTS ...............................................................................35 
15.2 
SUBJECT CONFIDENTIALITY ......................................................................36 
15.3 
CASE REPORT FORM COMPLETION .........................................................36 
16.0 
MONITORING PROCEDURES ..........................................................................37 
16.1 
DATA MONITORING .....................................................................................37 

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16.2 
ADMINISTRATIVE MONITORING .................................................................37 
16.3 
MEDICAL OVERSIGHT .................................................................................38 
17.0 
PUBLICATIONS ................................................................................................39 
18.0 
RECORDS RETENTION ...................................................................................39 
19.0 
TERMINATION OF THE STUDY .......................................................................39 
20.0 
DATA ANALYSIS AND REPORTING ...............................................................40 
20.1 
ANALYSIS POPULATIONS ...........................................................................41 
20.2 
PRIMARY ENDPOINT ANALYSIS .................................................................41 
20.3 
OTHER VISUAL DISTORTION ENDPOINT ANALYSES ...............................42 
20.4 
OTHER ENDPOINT ANALYSES ...................................................................42 
20.5 
ADDITIONAL ANALYSES AND DATA CONVENTIONS ................................43 
20.6 
SAMPLE SIZE ...............................................................................................43 
20.7 
DATA REPORTING REQUIREMENTS .........................................................43 
21.0 
REFERENCES ..................................................................................................44 
APPENDIX A SUMMARY OF EXAMINATIONS ...........................................................45 
APPENDIX B STUDY QUESTIONNAIRE .....................................................................46 
APPENDIX C ................................................................................................................54 
TORIC IOL AXIS MEASUREMENT AT SLIT LAMP .....................................................54 
APPENDIX D SLIT-LAMP EXAM RATINGS .................................................................55 
APPENDIX E ADVERSE EVENT REPORTING INSTRUCTIONS ................................57 
ATTACHMENT A  SAMPLE STUDY INFORMED CONSENT ......................................58 
ATTACHMENT B ..........................................................................................................68 
SAMPLE AUTHORIZATION FOR USE/DISCLOSURE OF HEALTH INFORMATION 
FORM ................................................................................................................68 
 

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PR/TIOL-202-TPAS 
PERSONNEL AND FACILITIES 
 
MEDICAL MONITOR: 
Joy Domingo, MD 
 
Global Medical Director 
 
Abbott Medical Optics Inc. 
 
Santa Ana, CA 92705 
 
Office Number: 714-247-8992 
 
SPONSOR: 
Abbott Medical Optics Inc. 
 
1700 E. Saint Andrew Place 
 
Santa Ana, CA 92705 
 
Main Number:  714-247-8200 
 
Fax:  714-247-8784 
 
SPONSOR PERSONNEL: 
 
 
Director Clinical Research,  
Debbie Trentacost 
Cataract  
Office:  714-247-8625 
 
Study Manager: 
Rosangela Nolasco, DMD, MPH 
 
Clinical Research Manager 
 
Office:  714-247-8624 
 
 
 
EMERGENCY TELEPHONE NUMBERS: 
Rosangela Nolasco 
Office:  714-247-8624 
Cell:  949-280-0620 

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Protocol Change History 
Version 
Section(s) 
Page(s) 
Description of Change(s)  
Rationale for Change(s) 
1.0 (31 AUG15/F(A1) 
N/A 
N/A 
Original 
N/A 
2.0 
 
 
 
 
 
1.0 Synopsis 
8.0 Study Population 
Attachment A: Informed Consent 
5 
15 
59 
Changed number of subject to be 
enrolled from 435 to 475 
 Current screen failure rate is 14%; the 
increase in subject enrollment will ensure 
the ability to achieve bilateral implantation of 
385 subjects. 
10.0 Study Timelines, Table 3 
19 
Changed expected timelines 
Dates were modified to extend enrollment 
from August 2017 until April 2018. This is 
necessary to allow time to enroll 40 more 
subjects due to higher-than-anticipated 
Screen Failure Rate. All other analyses and 
reporting dates were modified as well.  
11.3 Preoperative Procedures 
21 
Removed note for 20/30 or better 
predicted best-corrected distance 
visual acuity 
Although recommended, there is not an 
inclusion criteria for potential visual acuity 
and this note was included in error. 
Footer: Changed footer to comply with 
current standards 
All 
Removed dates and placed 
version number 
Improved tracking of versions 

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3.0 
Personnel and Facilities 
3 
Updated medical monitor 
information. 
Removed Dr. David Tanzer and replaced 
with current medical monitor, Dr. Joy 
Domingo. 
1.0 Synopsis 
8.0 Study Population 
6, 7 
15 
Changed number of subjects to be 
enrolled and treated. 
The number of subjects required to prove 
the hypothesis is much smaller than 
originally calculated. 
20.6 Sample Size 
43 
Changed sample size calculations 
A revised sample size calculation was made 
following an interim analysis using current 
rates of severe visual distortions. 
 
Attachment A: Informed Consent 
61 
Changed number of subjects 
enrolled and treated. 
Modified to keep consistent with protocol 
wording, 
 
 
 

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1.0 
SYNOPSIS  
STUDY TITLE: 
Post-Approval Study of the TECNIS® Toric IOL, 
Models ZCT300 and ZCT400 
 
Protocol: TIOL-202-TPAS 
STUDY TREATMENTS: 
Toric Study Lenses:  
 
• TECNIS Toric 1-Piece IOL, Model ZCT300 (and 
PCT300) 
• TECNIS Toric 1-Piece IOL, Model ZCT400 (and 
PCT400) 
The ZCT300 and ZCT400 lens models (as well as 
PCT300 and PCT400) are intended for cataract 
patients with pre-existing corneal astigmatism that, 
when surgically induced astigmatism (SIA) is taken 
into account, have approximately 2.00 D to 3.62 D of 
predicted corneal astigmatism to be corrected.  
Note: The PCT models (PCT300 and PCT400) are 
the same IOLs as the ZCT models with the exception 
that they are provided preloaded in the TECNIS iTec 
Delivery System.  For reference in this protocol, PCT 
is the same as ZCT.   
Control Lens:  
• TECNIS Monofocal 1-Piece IOL, Model ZCB00 
(and PCB00) 
Note: Model PCB00 is the Model ZCB00 IOL 
preloaded into the TECNIS iTec Delivery System and 
may also be used as the control lens.  For reference 
in this protocol, PCB00 is the same as ZCB00. 
STUDY OBJECTIVE: 
The purpose of this post-approval study is to 
evaluate the rates of visual distortions for the 
TECNIS Toric IOLs with >2.0 D of cylinder correction 
at the corneal plane (Models ZCT300 and ZCT400) 
in a larger population in clinical practice compared to 

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a non-toric control IOL and to ensure the continued 
safety of the approved devices.  
CLINICAL HYPOTHESIS: 
The rate of severe visual distortions for the TECNIS 
Toric IOL Models ZCT300 and ZCT400 will be less 
than 10 percentage points above that for a non-toric 
control group with the same level of preoperative 
corneal astigmatism.   
OVERALL STUDY DESIGN: 
 
Structure: 
Prospective, multi-center, bilateral, non-randomized, 
open-label, comparative clinical study 
Number of Sites: 
Up to 80 sites in the USA 
Duration: 
Six months; however, any subjects that undergo a 
lens repositioning procedure due to IOL misalignment 
or that report a severe visual distortion at six months, 
will be followed through 1 year postoperatively.   
Administration: 
Emmetropia will be targeted for both eyes.  Surgeons 
will perform routine small-incision, 
phacoemulsification cataract surgery and use the 
AMO-recommended implantation systems for lens 
implantation. 
Visit Schedule: 
Subjects will be bilaterally implanted; the second eye 
is to be implanted within approximately one month 
after the first eye surgery.   
 
Subjects will undergo two postoperative visits at 
1 month and 6 months for both eyes together.  If a 
subject experiences a lens repositioning procedure 
for IOL misalignment or if a subject reports a severe 
visual distortion at 6 months, the subject will also 
undergo a final visit at 1 year. 
STUDY POPULATION: 
Condition: 
Bilateral cataracts with corneal astigmatism of 
approximately 2.00 D to 3.62 D based on the 
combination of preoperative keratometric cylinder 
and the expected effect of SIA. 
Number of subjects: 
A minimum of 396 subjects will be enrolled to 
achieve bilateral implantation in approximately 294 

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subjects:  169 TECNIS Toric ZCT300 and ZCT400 
subjects (including a minimum of approximately 30%, 
or 51,  ZCT400 subjects) and 125 control subjects 
(assumes a 10% drop-out rate for a minimum of 152 
toric and 112 control subjects available for evaluation 
at 6 months).  Subjects will choose to be implanted 
with the same lens in both eyes, either the toric IOLs 
or the non-toric control IOL.   
Inclusion Criteria:  
• 
Minimum 22 years of age 
• 
Bilateral cataracts for which phacoemulsification extraction and posterior 
chamber IOL implantation have been planned 
• 
Preoperative keratometric cylinder in both eyes that, when taking surgically 
induced astigmatism into account, have approximately 2.00 D to 3.62 D of 
predicted corneal astigmatism to be corrected and qualify for implantation of 
ZCT300 and/or ZCT400 IOLs as determined by the web-based AMO Toric IOL 
Calculator 
o Most appropriate toric IOL model choice (ZCT300 or ZCT400) 
based on the associated residual refractive cylinder (lowest) and 
axis  
o Predicted residual refractive cylinder, based on the AMO Toric IOL 
Calculator,  must be: 
 
≤0.69 D for a ZCT300 IOL 
 
≤0.88 D for a ZCT400 IOL 
• 
Clear intraocular media other than cataract in each eye 
• 
Availability, willingness, ability and sufficient cognitive awareness to comply with 
examination procedures and study visits 
• 
Ability to understand, read and write English in order to consent to study 
participation and complete a study questionnaire 
• 
Signed informed consent and HIPAA authorization  
 
Exclusion Criteria:  
• 
Irregular corneal astigmatism 
• 
Any corneal pathology/abnormality other than regular corneal astigmatism 
• 
Previous corneal surgery 
• 
Recent ocular trauma or intraocular surgery that is not resolved/stable or may 
affect visual outcomes 
• 
Any pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) 

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• 
Subjects with conditions associated with increased risk of zonular rupture, 
including capsular or zonular abnormalities that may lead to IOL decentration, 
including pseudoexfoliation, trauma, or posterior capsule defects 
• 
Known ocular disease or pathology that may affect visual acuity or that may 
require surgical intervention during the course of the study (macular 
degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled 
glaucoma, etc.) 
• 
Concurrent participation or participation during 30 days prior to preoperative visit 
in any other clinical study 
• 
Planned monovision correction 
• 
Patient is pregnant, plans to become pregnant, is lactating or has another 
condition associated with the fluctuation of hormones that could lead to refractive 
changes 
STUDY ENDPOINTS: 
Study endpoints will be evaluated at 6 months postoperatively. 
Primary Endpoint: 
Rate of severe visual distortions; defined as the percentage of subjects who report a 
severe visual distortion under overall circumstances at 6 months postoperative for any of 
the following 5 visual distortion items of interest: 
 
o lines that slant, tilt, split or separate   
o flat surfaces appearing curved 
o objects appearing further away or closer than they actually are 
o objects appearing to have a different size or shape 
o physical discomfort related to vision 
 
 
Other Endpoints: 
• 
Ratings of individual items included on the visual distortion questionnaire 
• 
Rates of IOL repositioning procedures (secondary surgical intervention) due to 
IOL misalignment 
• 
Rates of other adverse events  
 
VISITS AND PROCEDURES:   
All subjects enrolled in the study will sign the IRB-approved informed consent prior to 
any study-specific testing or administration of the questionnaire.  Each subject will 
choose to receive the same lens type in both eyes, either the TECNIS Toric IOLs 
(Models ZCT300 and/or ZCT400), or the non-toric control IOL (TECNIS Model ZCB00).   
VISIT SCHEDULE:  All subjects are intended to have bilateral cataract surgery with the 
second-eye surgery occurring within approximately 1 month of the first-eye surgery 
(≤60 days).  Two postoperative study visits will be conducted; at 1 month  

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(30-60 days after the second-eye surgery) and at 6 months (120-180 days after the 
second-eye surgery) for both eyes together.  However, subjects who underwent an IOL 
repositioning procedure due to IOL misalignment or who reported a severe visual 
distortion at 6 months will return for a final visit at 1 year (330-420 days after the  
second-eye surgery) postoperatively.  
PREOPERATIVE PROCEDURES:  Following informed consent, a subject questionnaire 
for determination of visual distortions will be administered (Patient Reported Visual 
Distortion Questionnaire; PRVDQ).  Demographic, general preoperative and operative 
information will be collected from routine cataract evaluation examinations and surgical 
reports.   
POSTOPERATIVE PROCEDURES:  At the 1-month visit, a spectacle and/or contact 
lens prescription will be offered to each subject.  If the subject has a spontaneous report 
of any of the 5 defined visual distortion items of interest or of blurred or hazy vision, the 
questionnaire will be administered and, for subjects with toric IOLs, keratometry and toric 
IOL axis measurements will be performed. 
At the 6-month visit, the postoperative procedures will include a subject questionnaire 
(Patient Reported Visual Distortion Questionnaire; PRVDQ) for determination of visual 
distortions, biomicroscopic slit-lamp examination for any adverse events and, for 
subjects with toric IOLs, determination of toric IOL axis position and keratometry.  
If outside of a scheduled study visit, a subject has a spontaneous report of; 1) any of the 
5 defined visual distortion items of interest or 2) blurred or hazy vision at 1 month 
postoperatively or later, the PRVDQ questionnaire will be administered and, for subjects 
with toric IOLs, keratometry and toric IOL axis measurements will be performed.  Exam 
details will be documented on an unscheduled visit form.   
If a subject reported a severe visual distortion in the questionnaire or experienced an 
ocular adverse event at any scheduled or unscheduled study visit, uncorrected distance 
visual acuity, best corrected distance visual acuity, manifest refraction, slit-lamp 
examination and intraocular pressure measurements will also be performed.   
A 1-year examination will be required only if the subject reports a severe visual distortion 
at the 6-month examination or experienced an IOL repositioning procedure (due to IOL 
misalignment during the study).   
If a serious or device-related adverse event occurs at or prior to the 6-month visit, details 
of the event will be collected at the time of the event using an adverse event form.  If the 
adverse event is an IOL misalignment resulting in an IOL repositioning procedure, the 
questionnaire is to be administered prior to the repositioning procedure to collect 
information regarding visual distortions, and, for subjects with toric IOLs, keratometry 
and toric IOL axis measurements will be performed prior to the repositioning procedure 
to collect data regarding the IOL misalignment.   

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DATA ANALYSIS:   
The rate of severe visual distortions as defined by the 5 items listed under primary 
endpoint will be compared between bilaterally-implanted toric IOL subjects and 
bilaterally-implanted non-toric control IOL subjects at 6 months. The frequency and 
proportion of toric and non-toric control subjects with severe visual distortions will be 
reported.  Results between the toric IOL and the non-toric control IOL groups will be 
evaluated using a non-inferiority approach with a non-inferiority margin of 10%.  
Assessment of toric IOL axis misalignment will be compared to reports of visual 
distortions. 
The frequency and proportion of secondary surgical interventions due to IOL 
misalignment, as well as rates for other adverse events or medical and lens findings, will 
be reported by treatment group.  Evaluation at 6 months will include reporting by 
treatment groups the incidence of all adverse events, including severity for serious 
adverse events and adverse device effects.  
Visual distortion findings, adverse events and medical/lens findings at one year will be 
reported for subjects who experienced a repositioning procedure during the study or for 
subjects who were reported with severe visual distortions at the 6-month visit. 
2.0 
BACKGROUND AND PURPOSE OF STUDY 
It is estimated that 35% of cataract patients have ≥1.00 diopter of corneal astigmatism1 
with 15%-20% having ≥1.5 D of corneal astigmatism.1,2  Although there are various 
modalities to reduce the amount of astigmatism during cataract surgery (e.g., limbal 
relaxing incisions, etc.), toric IOLs are now commonly used for correction of aphakia and 
pre-existing ocular astigmatism.  On April 15, 2013, Abbott Medical Optics (AMO) 
received USA FDA approval (P980040/S039) for the TECNIS 1-Piece Toric IOL, Models 
ZCT150, ZCT225, ZCT300 and ZCT400 for the visual correction of aphakia and pre-
existing corneal astigmatism of one diopter or greater.    
In the IDE registration trial of the TECNIS 1-Piece Toric IOL (G090251), rotational 
stability was demonstrated and there were minimal subject complaints of visual 
distortions; however, there is the potential, particularly in the case of toric IOLs that 
correct for higher amounts of corneal astigmatism, that patients may experience spatial 
distortions related to axis misalignment, e.g., whether objects appear tilted or 
misshapen, etc.  As a condition of approval, this post-approval study will be conducted to 

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evaluate visual distortions of the TECNIS Toric 1-Piece IOLs with ≥2.00 D of cylinder 
correction at the corneal plane (Models ZCT300 and ZCT400) and to ensure the 
continued safety of the approved devices.   
3.0 
STUDY OBJECTIVE 
The objective of this post-approval study is to evaluate the rates of severe visual 
distortions for the TECNIS 1-Piece Toric IOLs with ≥2.0 D of cylinder correction at the 
corneal plane (Models ZCT300 and ZCT400) in a larger population in clinical practice 
compared to a non-toric, control IOL, and to ensure the continued safety of the approved 
devices.  
4.0 
STUDY DESIGN 
This study is a prospective, multicenter, bilateral, non-randomized, open-label,  
comparative clinical study conducted at up to 80 sites in the USA.  Subjects will choose 
to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 
and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, 
according to subject preference. 
5.0 
CLINICAL HYPOTHESIS 
The rate of severe visual distortions for the TECNIS 1-Piece Toric IOL Models ZCT300 
and ZCT400 will be less than 10 percentage points above that for the non-toric control 
IOL group with the same level of preoperative corneal astigmatism.     
6.0 
STUDY ENDPOINTS 
Study endpoints will be evaluated at 6 months postoperatively.   
PRIMARY ENDPOINT 
The primary endpoint is the rate of severe visual distortions based on data collected 
from a self-administered subject questionnaire (PRVDQ). 
 
 

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The rate of severe visual distortions is defined as the percentage of subjects who report 
a severe visual distortion under overall circumstances at 6 months postoperative for any 
of the following 5 visual distortion items of interest: 
o lines that slant, tilt, split or separate   
o flat surfaces appearing curved 
o objects appearing further away or closer than they actually are 
o objects appearing to have a different size or shape 
o physical discomfort related to vision 
 
Distortions will be assessed using the overall circumstance reply at the 
6-month visit.  The frequency and proportion of subjects reporting one or 
more of these items as severe will be used to determine the rate of 
severe visual distortions. 
Success criteria:   Rates of severe visual distortions for the TECNIS 1-Piece 
Toric IOL group will be less than 10 percentage points above 
rates for the non-toric control IOL group. 
OTHER ENDPOINTS 
• 
Ratings of individual items included on the visual distortion questionnaire 
• 
Rates of IOL repositioning procedures (secondary surgical intervention) due to 
IOL misalignment 
• 
Rates of other adverse events  
 
7.0 
STUDY PRODUCTS 
7.1 
INTRAOCULAR LENSES 
The TECNIS 1-Piece Toric IOL, Models ZCT300 and ZCT400, and the TECNIS 1-Piece 
Model ZCB00 non-toric control IOL are posterior chamber, 1-piece, aspheric, 
hydrophobic acrylic foldable IOLs and are to be implanted in the capsular bag following 
cataract extraction.  Both the TECNIS 1-Piece Toric IOLs and the TECNIS 1-Piece 
monofocal non-toric IOL, Model ZCB00, have an anterior aspheric optic surface and a 
spherical posterior optic surface; however, the TECNIS 1-Piece Toric IOLS have an 
additional toric feature on the anterior optic surface to correct for ocular astigmatism.   
The TECNIS 1-Piece Toric IOLs are indicated for the visual correction of aphakia and  
pre-existing corneal astigmatism of one diopter or greater in adult patients with and 
without presbyopia in whom a cataractous lens has been removed by extracapsular 
cataract extraction, and who desire improved uncorrected distance vision, reduction in 
residual refractive cylinder, and increased spectacle independence for distance.  The 

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ZCT300 and ZCT400 lens models, in particular, are intended for cataract patients with 
pre-existing corneal astigmatism that, when taking surgically induced astigmatism into 
account, have approximately 2.00 D to 3.62 D of predicted corneal astigmatism to be 
corrected (Table 1). 
Note: The PCT models (PCT300 and PCT400) are the same IOLs as the ZCT models 
with the exception that they are provided preloaded in the TECNIS iTec Delivery 
System.  Similarly, Model PCB00 is the Model ZCB00 IOL preloaded into the TECNIS 
iTec Delivery System and may also be used as the control lens.  For reference in this 
protocol, PCB00 is the same as ZCB00, and the PCT models are the same as the ZCT 
models. 
TABLE 1 
TECNIS Toric Models ZCT300 and ZCT400 IOL Astigmatism Correction Range 
ZCT IOL 
Model 
Cylinder Power (D) 
Correction  Range Based on 
Combined Corneal Astigmatism  
(Preoperative Kcyla + SIAb) 
IOL Plane 
Corneal Plane 
ZCT300 
3.00 
2.06 
2.00 – 2.75 D 
ZCT400 
4.00 
2.74 
2.75 – 3.62 D 
a Keratometric cylinder 
b Surgically induced astigmatism 
 
 
The TECNIS 1-Piece Toric IOLs have two sets of four axis orientation marks 180o apart 
in the outer periphery of the anterior optic surface (Figure 1) to indicate the meridian of 
the lowest power (flat meridian).  These axis orientation marks are for proper alignment 
of the flat meridian of the IOL with the steep meridian of the corneal curvature. 
 
 
 
                                                 
FIGURE 1 
TECNIS Toric IOL Illustration of Axis Orientation Marks 
 
 
 

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Table 2 lists the general design characteristics of the non-toric control IOL and the 
TECNIS 1-Piece Toric IOLs: 
TABLE 2 
Lens Characteristics of the TECNIS Model ZCB00 and  
TECNIS Toric Models ZCT300 and ZCT400 
CHARACTERISTICS 
TECNIS® 1-Piece IOL 
Model ZCB00 (Control) 
TECNIS® Toric 1-Piece IOL 
Models ZCT300 and ZCT400 
 
Lens Design 
 
1-piece acrylic monofocal with an 
aspheric anterior surface 
1-piece acrylic monofocal with an 
aspheric anterior surface and a 
maximum and a minimum radii of 
curvature perpendicular to each 
other 
Lens Model 
Surface-treated SENSAR®  soft 
acrylic (acrylic with covalently bound 
UV absorber) 
Same as Model ZCB00 
DIMENSIONAL FEATURES 
Overall Diameter 
13.0 mm 
Same as Model ZCB00 
Optical Center Thickness 
0.722 mm (20.0 D Lens) 
Same as Model ZCB00 
Haptic Angle 
No angulation, but offset from the 
optic body 
Same as Model ZCB00 
Optic Body Diameter 
6.0 mm 
Same as Model ZCB00 
Haptic Material 
Same as optic 
Same as Model ZCB00 
Haptic Width 
0.39 mm 
Same as Model ZCB00 
Haptic Thickness 
0.46 mm 
Same as Model ZCB00 
Haptic Style 
TRI-FIX Design Modified C, integral 
with optic 
Same as Model ZCB00 
Other Features 
N/A 
Axis orientation marks 
OPTICAL FEATURES 
Optic Shape 
Biconvex 
Same as Model ZCB00 
Anterior Optic Profile 
Aspheric 
Aspheric with a maximum and a 
minimum radii of curvature 
perpendicular to each other 
Posterior Optic Profile 
Spherical 
Same as Model ZCB00 
Optic Edge Design 
PROTEC™ squared edge 
Same as Model ZCB00 
Dioptric Power Range 
+5.0 to +34.0 D in 0.50 D increments 
Same as Model ZCB00 
Cylinder Power Range 
N/A 
3.00 D, 4.00 D (at the IOL plane) 
Refractive Index 
1.470 (35° C) 
Same as Model ZCB00 
Theoretical A-constanta 
118.8 for ultrasound biometry 
119.3 for optical biometry 
Same as Model ZCB00 
a  For lens power calculations, the investigator’s personalized A-Constant for the TECNIS non-toric ZCB00 
IOL is to be used for both the ZCB00 and ZCT IOLs. 
   
7.2 
IMPLANTATION SYSTEMS 
All lenses are to be implanted using either the UNFOLDER Platinum 1 Series 
Implantation System (DK7796 handpiece with the Platinum 1 Series cartridge,  
Model 1MTEC30) or the ONE SERIES Ultra Implantation System (DK7786 [plunger] or 
the DK7791 [twist] handpieces in combination with the ONE SERIES Ultra cartridge, 
Model 1VIPR30).  Other AMO implantation systems may be used with the lenses if 
validated for use by AMO. 

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8.0 
STUDY POPULATION 
Minimum of  396 subjects will be enrolled to achieve approximately 294 
bilaterally-implanted subjects in the study as follows: 
o 
169 TECNIS Toric ZCT300 and ZCT400 subjects 
 
Approximately 30% (51 subjects) to be ZCT400 subjects 
o 
125 TECNIS Monofocal Model ZCB00 control subjects 
Each investigative site is anticipated to treat approximately 10 subjects.   
 
8.1 
SUBJECT RECRUITMENT 
All subjects will be enrolled from the normal surgical cataract population at the 
investigative sites.  This study will include only subjects intended to undergo bilateral 
primary phacoemulsification cataract extraction and IOL implantation who have 
approximately 2.00 D to 3.62 D of corneal astigmatism requiring correction in each eye 
based on the combination of preoperative keratometric cylinder and the expected effect 
of SIA.  All patients who sign informed consent will be enrolled in the study and subjects 
that meet the inclusion and exclusion criteria (Section 8.2 and 8.3) in both eyes will be 
offered treatment in the study.  Eligibility criteria may not be waived by the investigator.  
Any questions regarding patient eligibility are to be discussed with AMO prior to subject 
treatment.  Those subjects who meet the criteria and agree to participate will choose the 
lens model of their preference for implantation.  Subjects will be treated sequentially at 
each site until the total recruitment goals for each lens model are met.  In the case of 
slower than anticipated enrollment, the use of physician referral networks and IRB-
approved advertising may be implemented.  
8.2 
INCLUSION CRITERIA: 
• 
Minimum 22 years of age 
• 
Bilateral cataracts for which phacoemulsification extraction and posterior 
chamber IOL implantation have been planned 
• 
Preoperative keratometric cylinder in both eyes that, when taking surgically 
induced astigmatism into account, have approximately 2.00 D to 3.62 D of 
predicted corneal astigmatism to be corrected and qualify for implantation of 
ZCT300 and/or ZCT400 IOLs as determined by the web-based AMO Toric IOL 
Calculator 
o Most appropriate toric IOL model choice (ZCT300 or ZCT400) 
based on the associated residual refractive cylinder (lowest) and 
axis  

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o Predicted residual refractive cylinder, based on the AMO Toric IOL 
Calculator, must be: 
 
≤0.69 D for a ZCT300 IOL 
 
≤0.88 D for a ZCT400 IOL 
• 
Clear intraocular media other than cataract in each eye 
• 
Availability, willingness, ability and sufficient cognitive awareness to comply with 
examination procedures and study visits 
• 
Ability to understand, read and write English in order to consent to study 
participation and complete a study questionnaire 
• 
Signed informed consent and HIPAA authorization 
 
 
8.3 
EXCLUSION CRITERIA:  
• 
Irregular corneal astigmatism 
• 
Any corneal pathology/abnormality other than regular corneal astigmatism 
• 
Previous corneal surgery 
• 
Recent ocular trauma or intraocular surgery that is not resolved/stable or may 
affect visual outcomes 
• 
Any pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) 
• 
Subjects with conditions associated with increased risk of zonular rupture, 
including capsular or zonular abnormalities that may lead to IOL decentration, 
including pseudoexfoliation, trauma, or posterior capsule defects 
• 
Known ocular disease or pathology that may affect visual acuity or that may 
require surgical intervention during the course of the study (macular 
degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled 
glaucoma, etc.) 
• 
Concurrent participation or participation during 30 days prior to preoperative visit 
in any other clinical study 
• 
Planned monovision correction 
• 
Patient is pregnant, plans to become pregnant, is lactating or has another 
condition associated with the fluctuation of hormones that could lead to refractive 
changes 
 
9.0 
INVESTIGATOR/SITE SELECTION  
The study will be conducted at up to 80 investigative sites in the USA.  Initially, 
30-40 sites will be targeted; additional sites may be added as necessary to meet 
enrollment goals.  In general, investigative sites will be selected for study participation 
based on investigator experience with the TECNIS Monofocal Model ZCB00 IOL (having 
an established personalized A-constant) and toric IOLs, volume of cataract procedures, 

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and experience conducting clinical studies in accordance with good clinical practices 
(GCPs) and FDA regulations.    
9.1 
INVESTIGATOR QUALIFICATIONS 
AMO will select ophthalmic surgeons who have completed a residency in ophthalmology 
and are licensed to practice medicine and perform surgery in the state where the 
investigator conducts the study.  Each site will have one principal investigator; some 
sites may have additional implanting sub-investigators.   
Investigators for this clinical study will be selected from surgeons who are experienced in 
small incision, phacoemulsification and toric IOL implantation in cataract patients.  
Additionally, investigators should have established their personalized A-Constant for the 
TECNIS Monofocal Model ZCB00 IOL.  It is preferable that the investigator have 
experience with the TECNIS Toric ZCT IOLs.  Surgical cataract volume will be evaluated 
to ensure the ability to adequately enroll subjects.  It is preferable that sites also have 
experience conducting clinical studies in accordance with GCPs and FDA regulations.  
All sites will be required to have adequate staff support for reporting and subject  
follow-up. 
9.2 
INVESTIGATOR OBLIGATIONS 
Investigators are required to fulfill the following obligations: 
• 
Conduct the study in accordance with the relevant and current protocol.  
Investigator will only make changes to a protocol after notifying and obtaining 
approval from AMO, the FDA, and the Institutional Review Board (IRB), except 
when necessary to protect the safety, rights or welfare of subjects 
• 
Personally conduct and supervise the study 
• 
Maintain a list of appropriately qualified persons to whom the investigator has 
delegated significant study-related duties 
• 
Be responsible for protecting the rights, safety and welfare of subjects under the 
investigator’s care  
• 
Maintain confidentiality as required by HIPAA or similar laws and regulations 
• 
Shall not obtain written informed consent of any subject to participate or allow 
any subject to participate before obtaining IRB approval and approval from the 
FDA 
• 
Document in each subject’s case history that informed consent was obtained 
prior to participation in the study as required by 21CFR812 

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• 
Report to AMO any adverse experiences and/or device defects or malfunctions 
that occur during the course of the study in accordance with applicable laws and 
regulations 
• 
Maintain adequate and accurate records in accordance with applicable laws and 
regulations and make available all study documents and subject medical records 
for inspection by either AMO, duly authorized regulatory agencies (e.g., FDA) 
and/or the IRB 
• 
Submit progress reports on the study to AMO and the reviewing IRB at regular 
intervals, but no less often than yearly as required by 21CFR812.150  
• 
Ensure the IRB that is responsible for initial and continuing review of the study 
complies with applicable laws and regulations 
• 
Report all changes in research activity and all unanticipated problems involving 
risks to patients to the IRB and AMO 
• 
Submit a final report to AMO and reviewing IRB within 3 months after termination 
or completion of the study or the investigator’s part of the study 
• 
Provide sufficient accurate financial information to AMO to allow AMO to submit 
complete and accurate certification or disclosure statements as required by 
21CFR54.  Promptly update this information if any relevant changes occur during 
the course of the study or for up to one year following completion of the study 
• 
Comply with all other obligations of clinical investigators and requirements 
according to all applicable FDA regulations (e.g., 21CFR812), all other applicable 
laws and regulations and all conditions of approval imposed by the reviewing IRB 
and FDA  
• 
Ensure that all associates, colleagues and employees assisting in the conduct of 
the study are adequately informed about the protocol, the study devices, their 
study-related duties and functions and agree to fulfill their obligations in meeting 
the above commitments. 
9.3 
INVESTIGATOR APPROVAL  
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Study Files/Notebook.  Copies of IRB approvals should be 
forwarded to AMO. 
The investigator is required to report to AMO within five working days any withdrawal of 
approval by the reviewing IRB for his/her participation in the study. 
Study sites will obtain IRB approval and fulfill any other site-specific regulatory 
requirements.  Prior to the start of subject enrollment, the following documents must be 
signed and returned to AMO: 

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• 
Confidentiality Agreement 
• 
Clinical Trial Agreement 
• 
Investigator Agreement/Protocol Signature Page 
• 
Financial Disclosure Form 
• 
Signed and dated copy of investigator’s current curriculum vitae 
• 
Copy of the investigator’s current medical license 
By signing the study documents, the investigator agrees to conduct this study according 
to the obligations above and all other applicable regulatory and legal requirements. 
10.0 STUDY TIMELINE 
This study will be initiated following the validation activities of the subjective study 
questionnaire (estimated time of 9 months) and FDA approval of both the questionnaire 
and this protocol.  Initially, 30-40 sites will be targeted for study participation; however, 
up to 80 sites may be included as needed to meet enrollment goals.  The expected study 
timeline is presented in Table 3 
TABLE 3 
Expected Study Timeline 
Study Activity 
Expected Timing 
Begin IRB approvals, site initiations and 
subject enrollment 
AUG 2015:  Following FDA approval of the study 
questionnaire    
Complete Site IRB approvals and 
initiations (30-40 sites) 
APR 2016:  8 months (~5 sites/month)  
Complete subject enrollment 
APR 2018:  30 months from study start  
(1 subject/site/~3 months) 
Complete subject follow-up 
OCT 2018:  6 months  
APR 2019:  12 monthsa  
Complete primary-analysis, 6-month 
clinical study report 
JAN 2019:  3 months following completion of 
6-month exams 
Complete 1-year clinical study report 
JUL 2019:  3 months following completion of 
1-year exams 
a  An additional 6 months may be necessary depending upon the number and timing of subjects returning 
for 1 year visits (due to reports of severe visual distortions at 6 months or the occurrence of an IOL 
repositioning procedure) 
 
 
11.0 
EXPERIMENTAL PLAN 
11.1   OVERVIEW 
This study will be conducted in accordance with U.S. Code of Federal Regulations, the 
Declaration of Helsinki and all other applicable laws and regulations.  

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This study is a prospective, multicenter, bilateral, non-randomized, open-label, 
comparative clinical study conducted at up to 80 sites.  Subjects will choose to be 
implanted with the same lens type in both eyes, either the toric IOLs or the non-toric 
control IOL.  Second-eye surgeries are to be performed within approximately 1 month 
(no more than 60 days) of the first-eye surgery, as second-eye cataract surgeries are 
typically performed within 2 months of the first-eye surgery.  Subjects will be examined 
postoperatively at 1 and 6 months following the second-eye surgery.  If a subject 
requires a lens repositioning procedure due to IOL misalignment or if a subject reports a 
severe visual distortion at 6 months, the subject will undergo a final visit at 1 year.  
Additional visit schedule details are provided in Section 11.2 Visit Schedule. 
At the 1-month visit, a spectacle and/or contact lens prescription will be offered to each 
subject.  If the subject has a spontaneous report of any of the 5 defined visual distortion 
items of interest or of blurred or hazy vision, the questionnaire will be administered and, 
for subjects with toric IOLs, keratometry and toric IOL axis measurements will be 
performed.  
At the 6-month visit, the postoperative procedures will include a subject questionnaire for 
determination of visual distortions, biomicroscopic slit-lamp examination for any adverse 
events and, for subjects with toric IOLs, determination of toric IOL axis position and 
keratometry. 
If outside of a scheduled study visit, a subject has a spontaneous report of; 1) any of the 
5 defined visual distortion items of interest or 2) blurred or hazy vision at one month 
postoperatively or later, the PRVDQ questionnaire will be administered and, for subjects 
with toric IOLs, keratometry and toric IOL axis measurements will be performed.  Exam 
details will be documented on an unscheduled visit form.   
If a subject reported a severe visual distortion in the questionnaire or experienced an 
ocular adverse event at any scheduled or unscheduled study visit, uncorrected distance 
visual acuity, best corrected distance visual acuity, manifest refraction, slit-lamp 
examination and intraocular pressure measurements will also be performed. 
A 1-year examination will be required only if the subject reports a severe visual distortion 
at the 6-month examination or experienced an IOL repositioning procedure (due to IOL 
misalignment during the study).  The PRVDQ will be administered at this visit, followed 
by uncorrected distance visual acuity, best corrected distance visual acuity, manifest 

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refraction, slit-lamp examination and intraocular pressure measurements.  For subjects 
with toric IOLs, keratometry and toric IOL axis measurements will also be performed. 
If a serious or device-related adverse event occurs at or prior to the 6-month visit, details 
of the event will be collected at the time of the event using an adverse event form.  If the 
adverse event results in an IOL repositioning procedure due to misalignment, the 
questionnaire should be administered prior to the procedure to collect information 
regarding visual distortions, and for subjects with toric IOLs, keratometry and toric IOL 
axis measurements will be performed prior to the repositioning procedure to collect data 
regarding the IOL misalignment.   
A chart summary of all examination procedures required at each study visit is provided in 
Appendix A.   
11.2 
VISIT SCHEDULE 
The study visit schedule for all study subjects is outlined below in Table 4.  Additional 
visits may be conducted at the discretion of the investigator; however routine follow-up 
visits without reports of ocular adverse event(s) or spontaneous reports of visual 
distortion(s) are not considered study visits.  Note that second-eye surgeries are 
intended to be performed within approximately 1 month (≤60 days) of the first-eye 
surgery.   
TABLE 4 
Study Visit Schedule 
Visit 
Eyes 
Evaluated 
Exam 
Visit Window 
1 
Both Eyes 
Preoperative Exam 
N/A 
First Eye Surgery 
N/A 
Second Eye Surgery   
Within approximately 1 month (≤60 days)  
of 1st eye surgery  
2 
Both Eyes 
1 month 
30-60 days postoperative from 2nd implant 
3 
Both Eyes 
6 months 
120-180 days postoperative from 2nd implant 
4a 
Both Eyes 
1 yeara 
330-420 days postoperative from 2nd implant 
a  The 1-year exam is only required if a severe visual distortion was reported by the subject at the 6-month 
visit or if the subject underwent an IOL repositioning procedure during the study as a result of axis 
misalignment. 
11.3 
PREOPERATIVE PROCEDURES 
All subjects enrolled in the study must sign the current IRB-approved informed consent 
document.  The informed consent must be signed and dated before any study-specific 
testing is performed and this must be documented in the source documents.  An 

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Authorization for Use/Disclosure of Health Information Form (HIPAA authorization) must 
also be signed for study enrollment.   
Study-specific preoperative testing for this protocol includes the administration of the 
subject questionnaire assessing visual distortions (Appendix B), as well as any other 
preoperative procedures that are not already performed during the investigator’s routine 
cataract evaluation for astigmatic patients (e.g., potential visual acuity).  To ensure 
subjects in both lens groups meet eligibility criteria, documentation via the AMO Toric 
IOL Calculator options of ZCT300 and/or ZCT400 for each eye of each subject is 
required.  As toric IOL calculations are not generally performed for non-toric IOL 
surgeries, the use of the AMO Toric IOL Calculator may be considered study-specific for 
subjects who choose to be implanted with the control, non-toric IOL.    
Preoperative data will be collected on the preoperative case report form (CRF) and 
includes the following: 
 
Informed consent documentation (including subject lens selection) 
 
Subject demographic information  
 
Ocular history, including presence of ocular pathology for each eye  
 
Potential best-corrected distance visual acuity for each eye Uncorrected 
distance visual acuity (Snellen) for each eye 
 
Best corrected distance visual acuity (Snellen) for each eye 
 
Manifest refraction (Snellen) for each eye 
 
Keratometry for each eye  
 
Intraocular pressure for each eye 
 
Ocular medications 
 
Cataract type and density for each eye 
 
Dilated fundus exam results for each eye (recommended) 
 
Medical and lens findings from a biomicroscopic slit-lamp exam for each eye 
 
Axial length, spherical equivalent IOL power and spherical equivalent 
targeted refraction (emmetropia, within ±0.50 D) for each eye using the 
investigators preferred biometry method 
 
A-constant used for spherical equivalent IOL power determination  
 
Surgeon-estimated surgically induced astigmatism (SIA) and planned 
incision location 

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 
Documentation of the AMO Toric IOL Calculator choice of ZCT300 and/or 
ZCT400 for each eye and corresponding residual refractive cylinder and axis 
for each eye (including control eyes) 
o Investigator to determine the most appropriate toric IOL model (ZCT300 
or ZCT400) based on the associated residual refractive cylinder (lowest) 
and axis  
o Predicted residual refractive cylinder, based on the AMO Toric IOL 
Calculator,  must be: 
 
≤0.69 D to receive a ZCT300 IOL 
 
≤0.88 D to receive a ZCT400 IOL 
 
Subject Questionnaire (Appendix B) 
 
LENS POWER CALCULATIONS AND IOL SELECTION:   
For lens power calculations, the investigator’s personalized A-Constant for the TECNIS 
monofocal ZCB00 lens is to be used for both the ZCB00 and Toric ZCT IOLs.  The 
spherical equivalent lens power, as determined by the investigator’s standard biometry 
methods, should be calculated to achieve emmetropia (± 0.50 D) at distance for all eyes.  
Intentional overcorrection or under-correction (i.e., monovision or outside ± 0.50 D) 
should NOT be planned for either eye; however, surgeons may adjust the targeted 
refraction as necessary to achieve emmetropia based on their surgeon factor, study 
subject experience and/or subject first-eye outcomes.     
In order to verify subject eligibility and to optimize toric IOL selection and axis placement, 
investigators will use the web-based AMO Toric IOL Calculator 
(www.TecnisToricCalc.com) to determine the appropriate TECNIS Toric IOL model 
(ZCT300 and/or ZCT400 for this study) for each eye.  Note that the AMO Toric IOL 
calculator provides toric IOL options based on predicted astigmatism, i.e., the vector 
sum of pre-existing corneal astigmatism and the expected effect of SIA.  For this study, 
subjects are to have corneal astigmatism that, when taking SIA into account, have 
approximately 2.00 D to 3.62 D of predicted corneal astigmatism to be corrected and 
qualify for implantation of a ZCT300 and/or ZCT400 IOL in both eyes by the web-based 
AMO Toric IOL Calculator.  Therefore, toric IOL calculations are to be performed for all 
subjects in this study, regardless of whether they choose to be implanted with the 
TECNIS Toric IOLs (Models ZCT300/ZCT400) or the TECNIS non-toric control IOL, 
Model ZCB00.  The investigator will determine the toric lens model that is most 
appropriate for each eye (based on associated residual refractive cylinder and axis) 
regardless of the choice of IOL type by the subject.  For all subjects, the toric IOL model 

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selections chosen by the investigator via the AMO Toric IOL Calculator are to be printed 
and maintained as source documentation.   
Note: Because lenticular astigmatism in the crystalline lens may influence the 
determination of the amount of astigmatism to be corrected, it is vital that corneal 
astigmatism (keratometry readings) and not refractive cylinder data be used for toric IOL 
calculations. 
11.4 
OPERATIVE PROCEDURES 
The investigator should use his or her standard, small-incision, phacoemulsification 
cataract extraction surgical technique.  All lenses should be folded for implantation and 
inserted into the capsular bag using one of the insertion systems indicated in the 
labeling.  No additional refractive procedures are to be performed on any study 
eyes during the initial surgeries or prior to completion of the 6-month study exam 
(e.g., LRI, AK, OCCI, etc.). 
TECNIS TORIC IOLS ONLY: 
Using the reference marks made prior to surgery with the subject sitting upright, an axis 
marker is to be used immediately prior to or during surgery to mark the intended axis of 
lens placement (post-incision steep corneal meridian) as indicated by the AMO Toric IOL 
Calculator.  
Following lens insertion, the TECNIS 1-Piece Toric ZCT IOL is to be precisely aligned 
with the intended axis of placement using the imaginary line formed by the axis 
orientation marks at each of the haptic/optic junctions of the IOL, identifying the flat 
meridian of the optic.  Carefully remove all viscoelastic from the capsular bag.  Special 
care should be taken to ensure proper positioning of the TECNIS  1-Piece Toric IOL at 
the intended axis following viscoelastic removal and/or inflation of the capsular bag at 
the end of the surgical case.  Residual viscoelastic and/or over-inflation of the bag may 
allow the lens to rotate, causing misalignment of the TECNIS 1-Piece Toric IOL from the 
intended axis.    
Operative case report forms will collect the following information: 
 
Date of surgery 
 
Operative eye 
 
IOL model, power and serial number 
 
Incision location  

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 
Surgical complications  
 
Other surgical procedures 
 
IOL placement (e.g., within capsular bag, proper alignment, etc.) 
 
Wound closure (e.g., suture required) 
 
Adverse events 
 
11.5 
POSTOPERATIVE PROCEDURES 
Postoperatively, all subjects will be examined at the 1- and 6-month study visits.  If a 
subject requires a lens repositioning procedure due to IOL misalignment or if a subject 
reports a severe visual distortion at 6 months, the subject will also undergo a final visit at 
1 year.    
At the 1-month visit, a spectacle and/or contact lens prescription will be offered to each 
subject.  If the subject has a spontaneous report of any of the 5 defined visual distortion 
items of interest or of blurred or hazy vision, the questionnaire will be administered and, 
for subjects with toric IOLs, keratometry and toric IOL axis measurements will be 
performed.  
Primary 6-month postoperative data collection consists of administration of a subject 
questionnaire for determination of visual distortion reports, biomicroscopic slit-lamp 
examination for any adverse events, and for subjects with toric IOLs, determination of 
toric IOL axis position and keratometry.  
If outside of a scheduled study visit, a subject has a spontaneous report of; 1) any of the 
5 defined visual distortion items of interest or 2) blurred or hazy vision at one month 
postoperatively or later, the PRVDQ questionnaire will be administered and, for subjects 
with toric IOLs, keratometry and toric IOL axis measurements will be performed.  Exam 
details will be documented on an unscheduled visit form.  
If a subject reports a severe visual distortion or has experienced an ocular adverse event 
at any scheduled or unscheduled study visit, uncorrected distance visual acuity, best 
corrected distance visual acuity, manifest refraction, slit-lamp examination and 
intraocular pressure measurements will be performed.   
If a serious or device-related adverse event occurs at or prior to the 6-month visit, details 
of the event will be collected at the time of the event using an adverse event form.  If the 

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adverse event results in an IOL repositioning procedure due to misalignment, the 
questionnaire should be administered prior to the procedure to collect information 
regarding visual distortions, and, for subjects with toric IOLs, keratometry and toric IOL 
axis measurements will be performed prior to the repositioning procedure to collect data 
regarding the IOL misalignment.   
If correction is required during the study postoperatively, spectacles or contact lenses 
will be prescribed; however, no additional refractive procedures (LRI, AK, etc.) are 
allowed until after completion of the 6-month study visit.  This is particularly important for 
non-toric control subjects who will likely have residual refractive cylinder for which they 
may need to wear correction until completion of the 6-month study exam.  If a subject is 
required to return for a 1-year exam (due to a severe visual distortion at 6 months or an 
IOL repositioning procedure during the study), a refractive enhancement (LRI, AK, etc.) 
may be performed prior to the 1-year exam but must be reported on the 1-year CRF. 
The postoperative case report form will collect the following information (Appendix A): 
 
Confirmation of offering of spectacle and/or contact lens prescription: 1-
month visit only 
 
Questionnaire (Appendix B):  6-month and 1-year visits; also at 1-month or 
unscheduled visits only if there is a spontaneous report of visual distortion or 
prior to an IOL repositioning procedure at that visit.   
 
Keratometry, for toric IOLs only: 6-month and 1-year visits; also at 1-month 
and unscheduled visits if there is a spontaneous report of visual distortion or 
prior to an IOL repositioning procedure at that visit.  
 
Toric IOL axis measurement by dilated slit-lamp examination ,for toric IOLs 
only (Refer to Appendix C for measurement instructions): 6-month and 1-year 
visits; also at 1-month and unscheduled visits if there is a spontaneous report 
of visual distortion or prior to an IOL repositioning procedure at that visit. 
 
Medical and lens findings from biomicroscopic slit-lamp exam: 6-month and 
1-year visits and may be performed at the 1-month and/or unscheduled visits 
if an ocular adverse event occurred at such visit or if a severe visual distortion 
is noted.  Findings of aqueous cells and flare, corneal edema, posterior 
capsule striae, posterior capsular opacification and IOL glistenings are to be 
rated using the standardized grading scales provided in Appendix D.   
 
Ocular medications  

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 
Dilated fundus exam, if medically indicated  
 
Occurrence of Nd:YAG capsulotomy(ies) 
 
Occurrence of any adverse events  
 
If an ocular adverse event or a severe visual distortion is noted at any 
postoperative study visit, the following additional information should be collected: 
o Monocular uncorrected distance visual acuity (Snellen) 
o Binocular uncorrected distance visual acuity (Snellen), 6-month and 
1-year visits only 
o Manifest refraction (Snellen) for each eye 
o Monocular best corrected distance visual acuity (Snellen) 
o Binocular best corrected distance visual acuity (Snellen), 6-month and 
1-year visits only 
o Intraocular pressure 
 
11.6 
UNSCHEDULED VISIT(S) FOR ADVERSE EVENT OR SPONTANEOUS 
REPORT OF VISUAL DISTORTION(S)  
A visit is considered an unscheduled study visit when it occurs other than at the 
specified 1- or 6-month study visits AND at which an ocular adverse event is reported 
OR if the subject has a spontaneous report of any of the 5 defined visual distortion items 
of interest (lines that slant, tilt or separate, flat surfaces appearing curved, objects 
appearing further away or closer than they actually are, objects appearing to have a 
different size or shape or physical discomfort related to vision as defined in Section 6.0) 
or of blurred or hazy vision at 1 month postoperatively or later.  For example, if the 
subject is seen for a routine (non-study) 3-month follow-up visit and there are no ocular 
adverse events or any spontaneous reports of visual distortion(s) of interest or of blurred 
or hazy vision at 1 month postoperatively or later, this would NOT be captured on an 
unscheduled visit form.  If however, the subject commented on a visual distortion as 
listed above or an ocular adverse event was noted at this visit, this visit would be 
captured on an unscheduled visit form.   
During the study period, if a serious or device-related adverse event occurs, per Section 
12.0, details of the event are to be captured on an adverse event CRF and the exam 
details are to be captured on the appropriate visit CRF (i.e., 1-month, 6-month, 1-year or 
unscheduled).  The event will be followed up as necessary and details captured on 
adverse event follow-up CRFs until resolution.   

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If the event results in an IOL repositioning procedure (secondary surgical procedure), the 
PRVDQ questionnaire is to be administered and, for subjects with toric IOLs, 
keratometry and toric IOL axis measurements are to be performed PRIOR to the IOL 
repositioning procedure for evaluation of visual distortions arising from IOL 
misalignment.  
If a subject reports a visual distortion at an unscheduled visit, the PRVDQ questionnaire 
is to be administered, and, for subjects with toric IOLs, keratometry and toric IOL axis 
measurements are to be performed.   
Data to be collected on adverse event and/or unscheduled visit forms (due to ocular 
adverse event or spontaneous report of visual distortion) include, as applicable: 
 
Adverse event, date of onset and classification  
 
Prognosis and treatment 
 
Questionnaire - in the event of a spontaneous report of visual distortion or prior to 
an IOL repositioning procedure 
 
Manifest refraction (Snellen),if performed 
 
Uncorrected and best-corrected distance visual acuity (Snellen), if performed 
 
Keratometry, for toric IOLs only- in the event of a spontaneous report of visual 
distortion or prior to an IOL repositioning procedure 
 
Intraocular pressure, if performed 
 
Toric IOL axis measurement by dilated slit-lamp examination, for toric IOLs only 
(Refer to Appendix C for measurement instructions) - in the event of a 
spontaneous report of visual distortion or prior to an IOL repositioning procedure 
 
Slit-lamp examination for medical and/or lens findings (e.g., IOL rotation), if 
performed 
 
Dilated fundus exam, if performed 
 
Ocular medications  
 
11.7 
SUBJECT FOLLOW-UP AND DISCONTINUATION  
Every attempt will be made to gather complete follow-up data for all treated subjects.  If 
a subject has a confirmed report of severe visual distortion(s) per the questionnaire, prior 
to the 6-month exam, every effort is to be made to ensure that subject returns for the  
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(phone calls/emails and/or letters) to locate missing subjects.  It is the responsibility of 
the investigator to provide complete follow-up data to AMO for each subject.   
SUBJECT FOLLOW-UP 
To minimize subjects lost to follow-up, subjects will be provided compensation for their 
time and participation in the study at the 1- and 6-month postoperative exams.  
Additionally, sites will be compensated for completion of the 1- and 6-month exams and 
will be provided frequent listings of upcoming 1- and 6-month subject examinations as 
well as follow-up reminder cards to send to the subjects.  It is anticipated that at least 
90% of subjects will be available for the 6-month study visit (i.e., no more than a 10% 
lost-to-follow-up rate at 6 months postoperatively).  
SUBJECT DISCONTINUATION 
The investigator should notify AMO prior to discontinuing a subject from the study.  If a 
subject is discontinued from the study, the investigator will, if at all possible, have the 
subject return for a final study visit.  An Exit CRF is to be completed for each subject 
exiting the study indicating the reason for early termination.  
Subjects should be discontinued from the study only if irretrievably lost to follow-up or for 
unavoidable reasons such as subject moved/unable to locate, subject 
uncooperative/refuses to return, subject died, subject ill/unable to travel, subject 
institutionalized.  The site shall document at least three attempts (phone calls/emails 
and/or letters) to locate lost-to-follow-up subjects.  Patients who would be traveling, 
relocating or otherwise unavailable for postoperative follow-up visits should not be 
chosen for this clinical study.  In the event of unplanned subject relocation, efforts must 
be made by the investigator to secure follow-up information (i.e., slit-lamp examination, 
etc.) from the subject’s new physician.  
A subject may be discontinued from the study if complications occur during the first-eye 
surgery and the planned study lens is not implanted; however, the eye will be followed 
until the resolution of the complication prior to discontinuing the subject from the study.  
If a complication occurs during the second-eye surgery and the planned study lens is not 
implanted in the second eye, the subject is to be followed according to the protocol for 
the first eye (although data may be analyzed separately), and the second eye will be 
followed for safety until resolution of the complication.      

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In the event of a lens removal or other serious adverse event, the subject may be exited 
from the study; however, efforts must be made by the investigator to follow the subject 
until resolution of the adverse event. 
12.0 ADVERSE EVENTS AND PRODUCT COMPLAINTS 
12.1  ADVERSE EVENT AND COMPLAINT DEFINITIONS 
ADVERSE EVENT (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical 
signs (including abnormal laboratory findings) in subjects, users or other persons, 
whether or not related to the IOL or the implantation procedure. 
All adverse events will be recorded in the subject’s case report forms.  An adverse event 
form will be completed by the investigative site for any adverse device effect (ADE) or 
serious adverse event (SAE). 
NOTE: Findings typical of early postoperative healing (e.g., corneal edema, cells and 
flare, elevated intraocular pressure, etc.) will not be considered an ocular adverse event 
in the first postoperative month.   
ADVERSE DEVICE EFFECT (ADE) 
An adverse event that is believed to be, probably  or possibly related to the IOL or the 
use of the IOL.   
PRODUCT COMPLAINT/DEVICE DEFICIENCY 
Any alleged deficiency related to the identity, quality, durability, reliability, safety, 
effectiveness, or performance of a device after it is released for distribution. Product 
complaints can pertain to any marketed AMO device being used in the study as well as 
the study device, if marketed in another region.  The investigator is to assess whether 
the deficiency could have led to a serious adverse event without suitable action or 
intervention or under less fortunate circumstances. 
SERIOUS ADVERSE EVENT (SAE) 
A serious adverse event is any (ocular or non-ocular) untoward occurrence which may or 
may not be related to the use of the study device that: 
 
results in death 
 
is sight- or life-threatening 

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 
requires in-patient hospitalization or prolongation of existing hospitalization (a 
planned hospitalization for a pre-existing condition is not considered an SAE) 
 
results in permanent impairment of a body structure or body function, or 
 
necessitates medical or surgical intervention to prevent permanent 
impairment to a body structure or function 
 
led to fetal distress, fetal death, congenital abnormality or birth defect  
STUDY-SPECIFIC ANTICIPATED SERIOUS ADVERSE EVENTS 
The following is a list including, but not limited to, ocular adverse events that are 
anticipated and must be reported to AMO for this study.  Any events that are unlikely but 
anticipated (i.e. endophthalmitis) will be reported to the FDA. 
 
Endophthalmitis/Intraocular infection 
 
Hypopyon 
 
Hyphema 
 
Lens dislocation 
 
Cystoid macular edema  
 
Pupillary block 
 
Retinal detachment/tear 
 
Persistent corneal edema  
 
Persistent iritis  
 
Persistent elevated IOP requiring treatment  
 
Tilt, decentration or axis misalignment resulting in secondary surgical 
intervention (e.g. repositioning) 
 
Visual symptoms requiring secondary surgical intervention  
 
Residual refractive error resulting in a secondary surgical intervention 
 
Residual lens remnants resulting in a secondary surgical intervention 
 
NOTE 1:  Conditions resulting in anterior chamber taps in the first postoperative 
week, suture removal and/or Nd:YAG capsulotomy are not considered 
adverse events for this study.   
NOTE 2:  For those subjects who are required to return for the 1-year study 
exam, conditions resulting in refractive enhancements performed after 
the 6-month postoperative exam are also not considered adverse 
events for this study and are to be reported as non-adverse event 
secondary surgical procedures.   
NOTE 3:  Raised IOP requiring treatment, corneal edema and iritis will only be 
considered serious if persistent at the final study visit (120-180 days 
postoperative or 330-420 days postoperative if 1-year visit is required) 
or sight-threatening at the time of occurrence.  Treatment merely to 
hasten the resolution of such conditions (and not intended to prevent 
permanent damage to the eye) will not be reported.   

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UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) 
An unanticipated adverse device effect is defined as any serious adverse device effect 
on health or safety or any life-threatening problem or death caused by, or associated 
with, a device, if that effect, problem or death was not previously identified in nature, 
severity or degree of incidence in the study protocol, risk management file or existing 
product labeling; or any other unanticipated serious problem associated with a device 
that relates to the rights, safety or welfare of subjects.  
12.2  ADVERSE EVENT REPORTING REQUIREMENTS 
All adverse events, regardless of severity and whether or not attributed to the IOLs, are 
to be reported to AMO and recorded on the CRFs supplied.  All serious adverse events, 
whether anticipated or unanticipated, and all adverse device effects shall be reported 
using an adverse event case report form and forwarded to AMO.  Adverse events are 
also to be reported to the reviewing IRB as per their reporting requirements.  If required, 
adverse events will be reported to the appropriate regulatory agencies (e.g., FDA, etc.) 
according to all applicable laws and regulations.  Specific instructions on notification 
procedures to AMO are included in Appendix E, Adverse Event Reporting.   
In addition to adverse event reporting, Investigators are required to notify AMO of a 
product complaint, device defect or malfunction within a timely manner.  Any device 
deficiency that could have led to a serious adverse event without suitable action or 
intervention, or under less fortunate circumstances, must be reported to the sponsor 
immediately (no later than 48 hours after detection).  Device deficiencies that could have 
let to a serious adverse event should also be reported to the investigators IRB as per 
their reporting requirements.  
ADVERSE DEVICE EFFECT (ADE) 
An adverse device effect is to be reported to AMO in a timely manner by submitting a 
completed Adverse Event CRF.  The investigator must report the ADE to the 
investigator’s IRB as per their reporting requirements. 
SERIOUS ADVERSE EVENT (SAE) 
In the event of a serious adverse event, which may or may not be related to use of the 
study device, the investigator must notify AMO immediately (within 48 hours after 
detection) by phone and by submitting a completed Adverse Event CRF.  The 

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investigator must report serious adverse events to the investigator’s IRB as per their 
reporting requirements. 
UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) 
If during the study a serious adverse event occurs that may reasonably be regarded as 
product related and was not previously identified in nature, severity, or degree of 
incidence in the study protocol, risk management file, or existing product labeling, the 
investigator is to report the UADE to AMO within 48 hours, and to the investigator’s IRB 
as soon as possible (and no later than 10 working days after learning of the event). 
12.3  ADVERSE EVENT FOLLOW-UP 
For every serious or device-related adverse event, i.e., ADE, SAE and UADE, 
appropriate measures should be undertaken to treat and/or monitor the subject until 
resolution occurs.  The investigator should keep AMO closely informed as to the 
outcome, thereby allowing AMO to comply with the appropriate regulatory reporting 
requirements.  An Adverse Event Update CRF should be completed each time the 
subject returns for follow-up until resolution of the event, i.e., of an ADE, SAE or UADE.  
Additionally, the investigator may need to supply to AMO written reports (e.g., from 
outside specialist evaluations) related to these adverse events until resolution of the 
adverse event.  Any subject who is withdrawn from the study due to an adverse event 
will be followed until the outcome is determined. 
12.4  RELATIONSHIP TO STUDY DEVICES 
The investigator should be alert to adverse events that may be related to the study 
devices; in this case, the TECNIS Toric IOLs, Models ZCT300 or ZCT400, and the 
control TECNIS 1-piece monofocal IOL, Model ZCB00.  An attempt should be made in 
every case to determine if the event may be device-related.  The following definitions are 
to be used as guidelines to determine the relationship between the event and the study 
devices or use of the device (implantation procedure):   
Definitely related: 
There is a definite causal relationship between the study 
device or implantation procedure and the adverse event. 
Probably related:   
There is a reasonable possibility of a causal relationship 
between the study device or implantation procedure and 
the adverse event. 

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Possibly related:   
The adverse event has not been determined to be related 
to the study device or implantation procedure, but no other 
cause has been definitively identified and the device 
cannot be ruled out as a possible cause. 
Unlikely to be related: The possibility of a potential causal relationship between 
the adverse event and the study device or implantation 
procedure could exist but the adverse event is most likely 
explained by causes other than the study device or 
implantation procedure.  
Not related:           
There is no possibility of a causal relationship between the 
adverse event and the study device or implantation 
procedure.  
If an adverse event is believed to be definitively, probably or possible related to the study 
device, the event will be considered device-related.  The investigator’s determination of 
causal relationship between the adverse event and the IOLs and/the implantation 
procedure will be recorded on the  Adverse Event case report form.   
13.0 PROTOCOL CHANGES AND PROCEDURES 
Any deviation from the protocol done to protect the life or physical well-being of a subject 
in an emergency must be reported to AMO and the reviewing IRB as soon as possible, 
but no later than five working days after the deviation occurred.  A Protocol Deviation 
form is to be completed by the investigator for each protocol deviation, defined as any 
deviation from the study plan and/or procedures (e.g., an exception to the 
inclusion/exclusion criteria).  Unless it is an emergency, if the investigator desires to 
modify any procedure and/or deviate from the design of the study, he or she must 
contact and obtain consent from AMO regarding the proposed changes prior to 
implementation.  Any modifications (including additional data collection) require approval 
by the FDA as well as approval by the IRB. 
14.0 ETHICS REVIEW AND PATIENT WELFARE 
14.1 
INSTITUTIONAL REVIEW BOARD (IRB) 
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Notebook.  Copies of IRB approvals should be forwarded 
to AMO. 

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The investigator is responsible for notifying the IRB of reportable adverse events as well 
as any other circumstance in which additional procedures outside the protocol were 
conducted to eliminate apparent hazards to subjects. 
14.2 
INFORMED CONSENT 
The current version of the IRB-approved study informed consent must be signed and 
dated by each study subject prior to any study-specific examinations being performed.  
The approved informed consent is to be signed and dated by the subject as well as by 
the person who conducted the informed consent discussion.  The signed informed 
consent will be maintained by the investigator as a permanent part of the subject’s 
medical records.  A signed and dated copy is to be provided to the subject.  The 
investigator will provide AMO written acknowledgement on the preoperative case report 
form that a signed agreement of informed consent has been obtained and is in the 
investigator’s possession for each subject.  As required by 21CFR812 Part G, the site 
shall document in the source documents that informed consent was obtained prior to 
participation in the study for each subject enrolled.  A sample informed consent form is 
provided in Attachment A. 
NOTE:  The informed consent process also includes obtaining the subject’s signature on 
an Authorization for Use/Disclosure of Health Information for Research Form.  A sample 
Authorization for Use/Disclosure of Health Information for Research Form is provided in 
Attachment B. 
15.0 DOCUMENTATION 
15.1 
SOURCE DOCUMENTS 
Source documents must be kept for all study subjects.  Source documents may include 
a subject’s medical records, hospital charts, clinic charts, the investigator’s subject study 
files (including original subject case report forms), as well as results of any diagnostic 
tests or procedures, photographs or instrument printouts. 
Each site is expected to adhere to the clinic’s own standard documentation requirements 
for medical charts/clinic notes.  However, for the purposes of this clinical study, the 
medical charts/clinic notes must also include, at a minimum, the following data that will 
be considered source data and will be reviewed by AMO: 

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 
Subject’s name and study identification number 
 
Subject’s contact information 
 
Study title and/or protocol number of the study and the sponsor name, Abbott 
Medical Optics (AMO) 
 
Document in each subject’s case history that informed consent was obtained 
prior to participation in the study as required by 21CFR812 
 
Dates of all subject visits and surgeries throughout the duration of the study 
 
Concomitant medications 
 
Corrected and uncorrected distance visual acuities 
 
Manifest refraction 
 
Keratometry (e.g., IOL master or topography printouts) 
 
Toric IOL Calculator output for each eye 
 
Occurrence and status of any operative complications, postoperative medical or 
lens findings and adverse events 
 
The date the subject completed the study; or if the subject was discontinued prior 
to completing the study, the date the subject exited the study and the reason for 
discontinuation 
 
If the subject was lost to follow-up, documentation of a minimum of three 
attempts to locate subject (phone, email and/or letter) 
The study protocol should be used as a guide for the points of data that are required for 
the study.   
15.2 
SUBJECT CONFIDENTIALITY 
Subjects will be assigned a unique subject number and code at the time of enrollment as 
a means of identification on study documents.  Subject confidentiality will be maintained 
by recording only the subject number and code (e.g., subject initials) on case report 
forms.  Subject names may possibly be disclosed to AMO, the IRB or regulatory 
agencies during inspection of study records.  All reasonable precautions will be taken to 
maintain confidentiality of medical records and personal information to the extent 
permitted by applicable laws and regulations. 
15.3 
CASE REPORT FORM COMPLETION 
An electronic data capture system using electronic case report forms will be used for this 
study.  Case report forms are to be completed in accordance with instructions provided 
to the site prior to study start. 

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The investigator is responsible for ensuring that data are properly recorded on each 
subject’s case report forms and related documents.  Prior to database lock, the 
investigator will verify completeness and accuracy of data submitted to AMO.  
16.0 MONITORING PROCEDURES 
AMO will perform three types of monitoring to ensure compliance with regulations: data 
monitoring, administrative monitoring and medical oversight. 
16.1 
DATA MONITORING 
In order to ensure a well-controlled clinical trial, AMO will follow specific data monitoring 
procedures.   
Subject data will be transmitted via case report forms from the investigative site to AMO.  
Requests for data clarification will be handled through this same data management 
system.   
To minimize data omissions and inconsistencies on clinical reports and to ensure that 
data are accurately transcribed to computer data files, AMO will follow internal data 
processing procedures that include automated and manual quality control checks to 
identify any data discrepancies.  Any such items will be resolved and documented as 
needed on the case report forms at the investigative site and entered into the data 
management system at AMO. 
16.2 
ADMINISTRATIVE MONITORING 
Administrative monitoring procedures will ensure that subjects, study product, including 
IOLs, and forms can be traced and will allow monitoring of investigator progress and 
compliance. 
LENS ACCOUNTABILITY 
As both study lens types, the TECNIS Toric ZCT300 and ZCT400 IOLs and the TECNIS 
Model ZCB00, are commercially available, supply records for study lenses will solely be 
the responsibility of the site and managed by their customary methods.  However, 
documentation of the lenses that are implanted in study subjects will be maintained.  
AMO will periodically monitor IOL implant logs to ensure compliance and traceability. 

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SITE MONITORING  
Prior to performing any study implants, the requirements of the study and reporting 
mechanisms will be explained to each investigator either personally at the investigative 
site or at a group investigator meeting.  When necessary, a pre-study site qualification 
visit may also be performed to assess the adequacy of the site to perform the study for 
sites that have not previously worked with AMO or have undergone significant changes, 
or have not been visited in the past year.  At a minimum, a study initiation visit will be 
performed at all sites.  
Throughout the duration of the study, site visits to monitor compliance to the protocol will 
be made at each investigative site by an AMO representative.  Sites will be visited at 
least once a year during the study or more often if needed, depending upon site 
enrollment progress, data collection and case report form completion, study exam visit 
compliance, occurrence of adverse events, etc.  During a routine site visit, AMO will 
review informed consent documents and eligibility, and the data on study case report 
forms against subject charts and other source documents to ensure complete and 
accurate reporting.  The subject files will also be reviewed to ensure that all adverse 
events have been reported in a timely manner.  Additionally, AMO will review documents 
to verify that the minimum items for source documentation have been documented in the 
subject medical charts.  Refer to Section 15.1 Source Documents for a list of items that 
are required for source documentation.  Subject records will be reviewed at each site in 
accordance with an approved monitoring plan.  Training on study-specific procedures 
may also be conducted during or outside of monitoring visits.  Upon study completion, a 
final close-out visit to each site will be conducted to monitor the last of the subject data 
records and finalize any outstanding study issues.  
16.3 
MEDICAL OVERSIGHT 
The medical monitor will be available throughout the clinical study to review study results 
and to answer any questions from investigators.  The specific responsibilities of the 
medical monitor are to review and assess any reports of serious or device-related 
adverse events and, if necessary, to discuss these with the reporting investigator(s).  
The medical monitor, as well as any other qualified personnel designated by AMO, shall 
also review any reports on the progress of the study.   

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17.0 PUBLICATIONS 
Refer to the Clinical Trial Agreement for information regarding AMO publication policies. 
18.0 RECORDS RETENTION 
All study-related correspondence, subject records, consent forms, Authorization for 
Use/Disclosure of Health Information Forms, records of use of study products and 
original case report forms should be maintained on file by the investigative site.   
The investigator must maintain and have access to the following essential documents for 
a minimum of two years from the date of study completion or five years from the date of 
regulatory submission, whichever is longer, or until AMO informs the site as to when 
these documents no longer need to be retained: 
 
All case report forms 
 
All adverse event information (adverse event forms, follow-up letters, etc.) 
 
IRB and regulatory approval documentation 
 
Study agreements 
 
Study correspondence  
 
Site visit documentation 
 
Protocol(s) and the reason for any deviations from the protocol 
 
Subject log(s) 
 
Study lens implantation logs 
 
Completed subject informed consent forms and Authorization for Use/Disclosure 
of Health Information forms 
 
Subject medical chart/clinic notes 
 
AMO requires written notification from the site if the investigator wishes to relinquish 
ownership of the study documents so that mutually agreed-upon arrangements can be 
made for transfer of ownership to a suitably-qualified, responsible person. 
19.0 TERMINATION OF THE STUDY 
The clinical study will be suspended in the event of unexpected high levels of 
complications and/or the occurrence of adverse events that are unexpected in nature 
and/or severity.  The clinical study will be suspended by AMO if any of the following 
conditions occur: 
 
In the event of severe and alarming adverse events that have not been 
previously anticipated in nature and/or severity. 

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 
The Medical Monitor, upon review and evaluation of the clinical data and/or 
adverse event reports, finds the level of single or total complications and/or 
adverse events unacceptable for continuation of the study. 
 
The FDA or IRBs, upon review of clinical study data and/or adverse event 
reports, find the level of complications and/or adverse events unacceptable for 
continuation of the study. 
 
Unacceptable clinical performance of the study lens(es) (i.e., unacceptable 
incidence, bother or intensity of subjective visual distortions, etc.) as deemed by 
AMO and/or the Medical Monitor. 
If the study is suspended, an evaluation of causality will be made to determine the 
relationship to the study lens(es).  If causality is shown not to be related to the study 
lens(es), the study may be resumed in accordance with the IRB and FDA.  The study will 
be terminated if causality is shown to be related to the study lens(es). 
The investigator or AMO may stop a subject’s participation at any time.  Additionally, 
AMO may stop the study at any time for reasons it determines appropriate.  However, no 
suspension of the study will be made to disadvantage the study subjects.  Following 
suspension of the study for any reason, all study subjects who have already received at 
least one study lens will continue to be followed through completion of the study visit 
schedule.   
20.0 DATA ANALYSIS AND REPORTING  
Outcomes for subjects implanted with the TECNIS Toric IOLs, Models ZCT300 and 
ZCT400, will be compared to those implanted with the TECNIS Model ZCB00 control 
IOL at 6 months postoperatively.  The number and proportion of subjects who did and 
did not have 6-month data available will be presented for toric and non-toric control IOL 
groups.  Demographic data (age, sex, gender) will also be presented for both groups.   
Visual distortion findings, adverse events and medical/lens findings at one year will be 
reported for subjects who experienced a repositioning procedure during the study or for 
subjects who were reported with severe visual distortions at the 6-month visit.  The 
primary endpoint is the rate of severe visual distortions defined as the proportion of 
subjects who report a severe visual distortion under overall circumstances at 6 months 
for any of the 5 visual distortion items of interest. The frequency and proportion of 
subjects reporting one or more of these items as severe will be used to determine the 
rate of severe visual distortions.   

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20.1 
ANALYSIS POPULATIONS 
For the primary endpoint of the rate of severe visual distortions (under overall 
circumstances) and for most visual distortion endpoints, the primary analysis population 
will be subjects bilaterally implanted with either the toric IOLs or the control lenses.  An 
additional analysis for the rate of severe visual distortions based on the 5 items used for 
the primary endpoint will be performed that includes all bilateral subjects and those with 
only one eye implanted (i.e., having a phakic or cataractous fellow eye or having another 
IOL in the fellow eye due to surgical complications prior to lens implantation).  The rates 
of severe visual distortions (based on the 5-item evaluation), will also be stratified by 
subjects in the lower-cylinder group (those eligible for the ZCT300) and the higher-
cylinder group (those eligible for the ZCT400).  Control subjects will be included in the 
lower- or higher-cylinder group based on the toric lens they would have required if they 
had chosen a toric IOL.  Subjects who are eligible for the ZCT300 in one eye and the 
ZCT400 in the fellow eye will be placed in the ZCT400 group for analysis. .  
For other safety endpoints, the primary analysis will consist of the safety population of all 
eyes implanted with either a toric or control IOL and with available data at the time of 
analysis.  Any operative complications or additional procedures will also be presented for 
first and second eyes of toric and control subjects.  Reporting of cumulative 
complications (occurring at any time postoperatively) will include data from all study eyes 
(first and second) implanted.   
20.2 
PRIMARY ENDPOINT ANALYSIS 
The primary endpoint is the rate of severe visual distortions (under overall 
circumstances) as measured by the 5 defined visual distortion items at 6 months 
postoperative.  The frequency and proportion of bilateral subjects with severe visual 
distortions will be presented for toric IOL and control IOL subjects.  Any subject with 
missing data for visual distortion symptoms at the 6-month visit will have the last 
reported value carried forward, if the subject had an earlier visit.  Results for severe 
visual distortions will be evaluated using a non-inferiority approach with a non-inferiority 
margin of 10%.  The upper limit of the 90% confidence interval of the difference in 
severe visual distortion rates (toric minus control) will be used to evaluate this endpoint.  
The null hypothesis, H0, is:  pToric – pControl ≥ 0.10 
The alternate hypothesis, H1, is:  pToric – pControl < 0.10  

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With p=proportion reporting severe visual distortions 
A logistic regression analysis for severe visual distortions will be performed with age, 
sex, race, and cylinder subgroup as well as age by IOL group and sex by IOL group as 
covariates to evaluate the influence of these variables. 
To evaluate if toric IOL axis misalignment relative to keratometry are associated with 
severe visual distortions, descriptive statistics for IOL axis misalignment will be reported 
for toric subjects with and without severe visual distortions.  In this study, axis 
misalignment is defined as the difference between the toric IOL axis marker location 
from the slit-lamp evaluation and the steep meridian from the postoperative keratometry 
measurement.  This measurement is intended to evaluate toric IOL misalignment as a 
possible reason for severe visual distortions experienced by a subject at a specific 
postoperative time point.  This axis misalignment measurement is not a measure of toric 
IOL rotational stability, but a measure of toric IOL alignment relative to post-surgical 
keratometry steep meridian, as it is known that cataract surgery can induce changes in 
the cornea. 
The frequency and proportion for the rate of severe visual distortions will also be 
presented for those in the low- and high-cylinder subgroups for toric and control 
subjects.   
20.3 
OTHER VISUAL DISTORTION ENDPOINT ANALYSES   
In addition, the number and percent of subjects with each response will be reported for 
the individual visual distortion items from the questionnaire and will also be reported by 
IOL group.  
20.4 
OTHER ENDPOINT ANALYSES   
The frequency and proportion of medical and lens findings and adverse events will be 
presented for first and second eyes of toric and control subjects.  The severity of all 
serious adverse events and adverse device effects, such as IOL repositioning 
procedures, through 6 months postoperatively will also be presented.   

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20.5 
ADDITIONAL ANALYSES AND DATA CONVENTIONS  
For categorical data, frequencies and proportions will be computed.  Descriptive 
statistics will include sample size (N), mean, standard deviation (SD), minimum (Min) 
and maximum (Max) as appropriate.   
20.6 
SAMPLE SIZE  
A sample size of a minimum of 396 enrolled subjects to achieve bilateral 
implantation of approximately 294 subjects: 169 TECNIS Toric ZCT300 and 
ZCT400 and 125 control subjects is reflective of the number of subjects enrolled 
on the date of this protocol revision (3.0).  
A two-group large-sample normal approximately test of proportions with a one-
sided 0.05 signficance level using only 37 evaluable toric subjects and 27 
evaluable control subjects will have a greater than 90% power to detect a rate of 
severe visual distortions for toric subjects as being 10 percentage points or 
greater than that for control subjects. This assumes severe visual distortion rates 
of 1% for both the toric and control subjects. Therefore, the sample size 
proposed for a minimum of 396 enrolled subjects, assuming a 10% drop out rate 
for a minimum of 152 toric and 112 control subjects available for evaluation at 6 
months, is sufficient to demonstrate non-inferiority in the rate of severe visual 
distortions (the primary endpoint of this study) between the two study groups in a 
larger population in clinical practice and thereby demonstrate the continued 
safety of the toric IOLs.  
20.7 
DATA REPORTING REQUIREMENTS  
Interim status study reports will be provided to FDA every 6 months from the date of 
study initiation for the first 2 years and annually thereafter according to the guidance 
document entitled “Procedures for Handling Post-Approval Studies Imposed by PMA 
Order,” dated June 15, 2009. 
A primary-analysis, complete 6-month study report will be provided to FDA 
approximately 3 months following completion of the last 6-month study visit.  Any 1-year 
data collected to date will be included.   

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A final study report will be provided to FDA approximately 3 months following completion 
of the last 1-year study visit.  Note that the primary-analysis, 6-month report and the final 
report may be submitted at the same time depending upon when the last 6-month and 1-
year exams are completed. 
Interim and final study reports will include general enrollment and accountability items 
including the number of active sites, the number of subjects enrolled, implanted and 
discontinued and the number of postoperative examinations completed.  Enrollment 
rates and subject follow-up will be compared to anticipated, target study timelines 
(Section 10.0 Study Timeline).   
21.0 REFERENCES 
1. 
Ferrer-Blasco, T. et al. Prevalence of corneal astigmatism before cataract 
surgery. J Cataract Refract Surg 2009; 35: 70-75 
2. 
Hoffer KJ. Biometry of 7,500 cataractous eyes. Am J Ophthalmol 1980;90:360-
368

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APPENDIX A 
SUMMARY OF EXAMINATIONS FOR EACH VISIT 
Examination 
X= To be performed 
A= To be performed if a subject reports a severe 
visual distortion or experienced an ocular 
adverse event at this visit  
B= To be performed if a visual distortion is 
spontaneously reported prior to 6 month exam 
or prior to a required IOL repositioning 
(adverse event) 
O = Only if medically indicated 
Preoperative 
Both eyes 
Op 1 
1st eye 
Op 2 
2nd eye 
Unscheduled 
Visit  
1 Month 
Both eyes 
6 Months 
Both eyes 
1 Yeara 
Both eyes  
Ocular history, inclusion/exclusion criteria 
X 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
Potential visual acuity  
X 
 
 
 
 
 
 
Targeted refraction/IOL power calculationsb/axial 
length  
X 
 
 
 
 
 
 
Lens power/serial number/operative procedures 
 
X 
X 
 
 
 
 
Manifest refraction (Snellen) 
X 
 
 
A 
A 
A 
X 
UCDVA-photopic, monocular (Snellen) 
X 
 
 
A 
A 
A 
X 
UCDVA-photopic, binocular (Snellen) 
 
 
 
 
  
A 
X 
BCDVA-photopic, monocular (Snellen) 
X 
 
 
A 
A 
A 
X 
BCDVA-photopic, binocular (Snellen) 
 
 
 
 
  
A 
X 
Offer spectacle and/or contact lens prescription        
 
 
 
 
X 
 
 
Keratometry 
X 
 
 
Bd 
Bd 
Xd 
Xd 
Intraocular pressure 
X 
 
 
A 
A 
A 
X 
Biomicroscopic slit-lamp examc   
X 
 
 
A 
A 
X 
X 
Toric IOL axis measurement at dilated slit-lamp 
examd,  
 
 
 
Bd 
Bd 
Xd 
Xd 
Dilated fundus exam  
X 
 
 
O 
O 
O 
O 
Adverse events 
 
X 
X 
X 
X 
X 
X 
Ocular medications 
X 
 
 
X 
X 
X 
X 
Subject questionnaire  
X 
 
 
B  
B 
X 
X 
a  Examination at 1 year is to be conducted ONLY if a subject reported a severe visual distortion at 6 months or if the subject experienced an IOL repositioning procedure (due to 
IOL misalignment) during the study.   
b   Includes documentation of toric IOL calculations showing ZCT300 and/or ZCT400 IOLs as toric choices for each eye 
c  Includes determination of medical and lens findings/complications, including lens rotation 
d  For Toric IOLs only 
 

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APPENDIX B 
STUDY QUESTIONNAIRE 
 
 
 
 

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Patient Reported 
Visual Distortions Questionnaire 
(PRVDQ) 
 
This questionnaire asks about the severity of visual distortions OVER THE 
LAST 7 DAYS. If your vision is different between eyes, please respond with 
how you see with both eyes in general. For each question, please indicate if 
you have experienced the “visual distortion” under these 3 circumstances: 
 
A. When NOT wearing corrective glasses (including reading 
glasses) or contacts  
 
B. When WEARING corrective glasses (including reading glasses) 
or contacts.  
 
C. Overall (taking all things into account) 
Please read each question carefully and answer as honestly as you can 
without the help of anyone. There are no right or wrong answers. 
 
For ALL questions, please mark an 
 in the box that 
best describes your answer.  
 
 
 

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APPENDIX C 
TORIC IOL AXIS MEASUREMENT AT SLIT LAMP 
The following instructions are to be followed for the measurement of the toric IOL axis in 
both eyes. 
 
1. Dilate each eye with 2.5% phenylephrine prior to measurement.  Tropicamide (1%) 
may be used in addition, at the Investigator’s discretion.  
2. Allow sufficient time to achieve adequate pupillary dilation to facilitate direct 
visualization of alignment marks. 
3. At the slit lamp, adjust the slit-lamp beam to be as narrow as possible and align the 
beam with the four axis orientation marks (4.5, 5.0, 5.5 and 6.0 mm diameter) on 
one side of the toric IOL.  
a. It is important to align the beam with at least two of the four orientation 
marks for an accurate measurement. 
b. Ensure the subject’s head is oriented vertically in the slit lamp with proper 
head position and alignment of eye with the slit lamp.  
4. Read the angle of the toric IOL axis markers based on the narrowed slit-lamp 
beam from the angular scale on the slit lamp.  
5. Record this angle in degrees for each eye on the appropriate postoperative case 
report form. 

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APPENDIX D 
SLIT-LAMP EXAM RATINGS 
A.  RATINGS OF AQUEOUS CELLS AND FLARE 
For consistency across study sites, the SUN (Standardization of Uveitis Nomenclature) 
Working Group Grading Scheme is to be used for grading of anterior chamber cells and 
flare as reported in: Standardization of uveitis nomenclature for reporting clinical data.  
Results of the first international workshop; The standardization of uveitis nomenclature 
(SUN) working group.  Am J Ophthalmol 2005;140:509-516. 
CELLS 
Grade 
Cells in Field*                                                                    *Field is a 1x1 mm slit beam 
0 
<1                                                                             
0.5+ 
1-5                                                                            
1+ 
6-15 
2+ 
16-25  
3+ 
26-50 
4+ 
>50  
 
 
FLARE 
Grade 
Description 
0 
None 
1+ 
Faint 
2+ 
Moderate (iris and lens details clear) 
3+ 
Marked (iris and lens details hazy) 
4+ 
Intense (fibrin or plastic aqueous) 
B.  RATINGS OF CORNEAL EDEMA 
Corneal edema should be classified according to the haziness of the epithelium, the 
number of microcysts observed and the clouding of the stroma. 
None 
0 
Normal transparency: 
a. No epithelial or sub-epithelial haziness 
b. No microcysts 
c. No stromal cloudiness 
Trace 
+1 
a. Barely discernable localized epithelial or sub-epithelial 
haziness and/or 
b. 1 to 20 microcysts and/or 
c. Barely discernable localized stromal cloudiness 
Mild 
+2 
a. Faint but definite localized or generalized epithelial, sub-
epithelial or stromal haziness/cloudiness and/or 
b. 21-50 microcysts 
Moderate 
+3 
a. Significant localized or generalized epithelial, sub-epithelial or 
stromal haziness/cloudiness and/or 
b. 51-100 microcysts 
Severe 
+4 
a. Definite widespread epithelial or stromal cloudiness, giving 
dull glass appearance to cornea or numerous coalescent 
bullae (please note the number and location of bullae) and/or 
b. >100 microcysts or bullae and/or 
c. Numerous striae (please note the number and location of 
striae or folds) 
 

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APPENDIX D (CONTINUED) 
SLIT-LAMP EXAM RATINGS 
C.  POSTERIOR CAPSULE STRIAE GRADING SCALE 
The following five-point grading scale is to be used for rating striae in the posterior 
capsule: 
None 
0 
None 
Trace 
+1 
One detectable, barely noticeable striae 
Mild 
+2 
One or two prominent striae 
Moderate 
+3 
Three or more prominent striae, but visibility of retina is not impacted 
Severe 
+4 
Three or more prominent striae affecting visualization of retina 
D.  POSTERIOR CAPSULE OPACIFICATION (PCO) GRADING SCALE 
Below is the five-point grading scale to be used for PCO determination: 
None 
0 
Normal posterior capsule with no area of opacity.  Red reflex bright. 
Trace 
+1 
Some loss of transparency involving the posterior capsule.  Red 
reflex fairly bright 
Mild 
+2 
Mild loss of transparency with cloudiness extending through most of 
the posterior capsule.  There may be a few Elschnig’s pearls in the 
posterior capsule.  Red reflex mildly diminished. 
Moderate 
+3 
Moderate loss of transparency with difficulty visualizing the retina.  
There may be multiple Elschnig’s pearls in the posterior capsule.  
Red reflex markedly diminished. 
Severe 
+4 
Posterior capsule very opaque with inability to view the retina.  The 
posterior capsule may have confluent Elschnig’s pearls and fibrous 
scarring.  Red reflex barely visible. 
E. IOL GLISTENINGS  
Use the following scale to grade IOL glistenings using a slit beam 2.0 mm wide and     
10.0 mm long: 
None 
0 
No glistenings visible 
Rare 
+0.5 <10 glistenings visible 
Trace 
+1 
10-19 glistenings visible 
Mild 
+2 
20-29 glistenings visible 
Moderate 
+3 
30-39 glistenings visible 
Severe 
+4 
≥40 glistenings visible 
 

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APPENDIX E 
ADVERSE EVENT REPORTING INSTRUCTIONS 
 
Adverse Device Effect (ADE) 
In the event of an ADE, the investigator must notify AMO preferably within 48 hours and 
no later than 10 working days of first becoming aware of the event by completing the 
Adverse Event Form and submitting it to AMO.  
Serious Adverse Event (SAE) 
In the event of a sight- or life-threatening incident or serious adverse event, which may or 
may not be related to use of the study device, the investigator must notify AMO 
immediately (no later than 48 hours after detection) by phone and/or email and by 
submitting a completed Adverse Event Form as follows: 
a. Contact the following AMO personnel by phone: 
Rosangela Nolasco 
 
Clinical Research Manager 
 
Office: 714-247-8624 
 
Cell:  949-280-0620 
 
Email:  Rosangela.Nolasco@abbott.com  
 
AND 
 
b. Complete an Adverse Event Form and submit to AMO.  
 
 
Unanticipated Adverse Device Effect (UADE) 
For an adverse event that may reasonably be regarded as product related and was not 
previously expected in nature, severity, or degree of incidence in the study protocol, risk 
management file or existing product labeling, the investigator must report the event to 
AMO within 48 hours of detection after learning of the event using the same reporting 
method as for SAEs. 
 
Device Defect or Malfunction without an Adverse Event 
In the event of a complaint of study device defect or malfunction, the investigator must 
notify AMO preferably within 48 hours and no later than 10 working days of first becoming 
aware of the event by completing the information about the device on the Operative CRF 
and submitting it to AMO.  
  

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ATTACHMENT A 
 SAMPLE STUDY INFORMED CONSENT 
 
NOTE:  This sample informed consent is intended for submission to IRB upon FDA 
approval of protocol and is not to be used for participant enrollment.  Only a current  
IRB-approved consent is to be used for subject enrollment. 

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SAMPLE  
Informed consent 
Research Subject Information and Consent Form 
SPONSOR: 
 
 
 
 
Abbott Medical Optics Inc. 
 
 
 
 
 
 
1700 E. Saint Andrew Place 
 
 
 
 
 
 
Santa Ana, CA 92705 
 
STUDY TITLE: 
Post-approval study of the TECNIS® Toric 
1-Piece Intraocular Lens, Models ZCT300 
and ZCT400 
  
STUDY NUMBER: 
TIOL-202-TPAS 
 
STUDY DOCTOR: 
 
 
 
___________________________ 
 
Doctor’s Phone Number: 
 
 
___________________________ 
 
Subject Number: 
 
 
 
___________________________ 
 
 
 
 
 
INTRODUCTION 
You are being invited to participate in a clinical research study sponsored by Abbott 
Medical Optics Inc. (AMO).  This document describes the study and your role in it.  Your 
doctor has reviewed the study and has agreed to participate as an investigator.  He or she 
will answer any questions that you have about this study or this consent document.  
Please read this document carefully and ask any questions you have regarding the 
information that it contains. 
PURPOSE OF THIS RESEARCH STUDY 
The purpose of this study is to evaluate the rate of visual distortions and ongoing safety of 
the TECNIS Toric intraocular lenses (IOLs), Models ZCT300 and ZCT400.  You have 
been invited to participate in this research study because you have a certain level of 
astigmatism and are scheduled to undergo cataract surgery with IOL implantation in both 
of your eyes. 
Cataracts occur when the natural lens of the eye becomes cloudy and eventually can 
interfere with vision.  Cataract surgery involves the removal of the clouded lens by a 
surgical technique called phacoemulsification, and this must be performed before an IOL 
can be placed in your eye.  The IOLs will be implanted into your eyes to help restore vision 
and are intended to remain in your eyes permanently; however, the IOLs can be surgically 
repositioned, replaced or removed if necessary.  Standard or “monofocal, non-toric” IOLs 
provide predominantly far vision only and do not correct astigmatism. 
Astigmatism is a condition where the cornea (front surface) of the eye is not curved 
uniformly like a sphere, but is shaped more like a football.  With astigmatism, the light rays 
passing through the cornea do not focus on a single point of the retina.  This may cause 
objects both near and far away to appear blurred and even broadened or elongated.  An 
IOL designed to reduce astigmatism is called a “toric” IOL.   
In this study, you will have the option to choose which type of lens you would like to be 
implanted with in both of your eyes:  either toric IOLs or standard IOLs.  Both types of 

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IOLs in this study have been approved by the FDA and are made of the same acrylic 
material, the same 1-piece monofocal lens design and have the same TECNIS aspheric 
front surface for improved vision quality.  The only difference between the toric lenses and 
the standard lens is the toric surface to correct for astigmatism.  The toric IOLs in this 
study are designed for eyes with higher amounts of astigmatism and are called the 
TECNIS Toric IOLs, Models ZCT300 and ZCT400.  If you choose to be implanted with the 
toric lenses, the amount of astigmatism you have in your eyes will determine which toric 
IOL model is best for each of your eyes.  The standard IOL in this study is called the 
TECNIS 1-piece IOL, Model ZCB00.  The table below compares the three lenses in this 
study: 
Lens Model 
General Design 
Amount of  
Astigmatism Correction 
TECNIS 1-Piece 
Monofocal 
Model ZCB00 
(Standard) 
1-Piece, acrylic 
material 
None 
TECNIS Toric  
Model ZCT300 
1-Piece, acrylic 
material with toric 
feature 
2.00 to 2.75 diopters  
TECNIS Toric  
Model ZCT400 
1-Piece, acrylic 
material with toric 
feature 
2.75 to 3.62 diopters 
 
Approximately 396 enrolled and 294 treated from up to 80 investigative sites in the USA to 
participate in this study.  If you qualify for the study, you will be able to choose which lens 
type you prefer (“toric” or “standard”) and your Study Doctor will help you decide.   
The TECNIS Toric IOLs were previously studied for safety and effectiveness in a clinical 
study of 269 subjects.  In the previous study, 174 subjects were implanted with the 
TECNIS Toric IOLs and 55 of these were implanted with the TECNIS Toric IOL Models 
ZCT300 and ZCT400.  The TECNIS Toric IOLs are marketed in the US, Europe and other 
countries worldwide. 
INCLUSION CRITERIA 
To be considered for enrollment in this study, you must: 
• 
be at least 22 years old  
• 
have cataracts in both eyes  
• 
have a certain degree of astigmatism in both eyes 
• 
sign this written informed consent  
• 
be willing and able to comply with examination procedures 
• 
understand, read and write English to complete informed consent and 
questionnaires 
• 
be available for study follow-up visits 
EXCLUSION CRITERIA 
You will not be eligible to participate in the study if: 
• 
you are currently participating in any other clinical study or have participated in a 
clinical study during the last 30 days 

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• 
you have a certain disease/illness such as poorly-controlled diabetes 
• 
you have certain ocular conditions such as uncontrolled glaucoma 
• 
you are taking medication that may affect your vision 
• 
you are pregnant, plan to become pregnant during the study, or are breastfeeding 
Both of your eyes must qualify to be eligible to participate in this study.  Your Study Doctor 
will inform you if you do not meet the criteria to participate in this study. 
DURATION OF PARTICIPATION 
The duration of participation is approximately 6 months with a minimum of two study visits 
after the surgeries.  If you experience a secondary surgical procedure to reposition your 
IOL(s) or have certain visual distortions you will need to return at 1 year as well. Your 
personal doctor will be informed of your participation in this study only with your 
permission. 
STUDY PROCEDURES 
You will be screened preoperatively by your Study Doctor to ensure that you are a good 
candidate for this study.  If you are enrolled and qualify, you will be able to choose which 
lens type you prefer (the TECNIS Toric IOLs or the TECNIS standard IOL).  If you choose 
to be implanted with toric IOLs, your doctor will determine which lens model (ZCT300 or 
ZCT400) will be best for each of your eyes.  
During surgeries, the IOLs will be folded and inserted into your eyes, following routine 
cataract extraction.  Your second eye will undergo surgery within approximately 1 month 
after the surgery on your first eye.  Your estimated recovery time after surgery is expected 
to be the same regardless of which IOL type you receive. 
You will have a minimum of 2 postoperative study visits through approximately 6 months 
following the surgery for your second eye.  If you experience an ocular adverse event prior 
to the 6-month visit, you will be asked to return for evaluation(s) by your study doctor.  In 
certain cases, you may also be asked to return for a visit at 1 year if you experience a 
secondary surgical procedure to reposition your IOL(s) or have certain visual distortions.   
The study visits are outlined in the table below: 
Study 
Visit 
Exams 
Eyes Evaluated 
1 
Preoperative Exam 
Both Eyes 
 
Operative 
1st Eye 
 
Operative 
2nd Eye 
As 
needed 
Unscheduled visit(s) if an 
ocular adverse event 
occurs 
Either Eye 
2 
1 Month 
Both Eyes 
3 
6 Months 
Both Eyes 
4 
1 Year (possible) 
Both Eyes 
 
Each study visit will consist of routine procedures that are commonly performed during 
preoperative, operative and postoperative visits for this type of surgery.  Your doctor may 
also ask you to return for additional study or routine follow-up visits at his or her discretion.  
Prior to surgery and at the 6-month visit, you will be asked to complete a questionnaire 
related to the occurrence of any visual distortions.  If you experience certain visual 

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distortions or have had a secondary surgical procedure to reposition your IOL(s), you will 
be asked to return at 1 year to complete the questionnaire again.   
If you experience significant complications during the study in either of your eyes, 
regardless of which lens type you choose, the lens(es) may be surgically removed.  In this 
case, you will be asked to return for routine follow-up exams as needed. 
Please understand that missing study exams can have a negative effect on the integrity 
and reliability of the study and may reduce the scientific value of your contributions to the 
study.  You are therefore encouraged not to miss any scheduled visits. 
During the course of the study, no additional surgical procedures to enhance your vision 
(such as LASIK or limbal relaxing incisions) are to be performed on your eyes after IOL 
implantation.  If you require correction for your vision, you will be asked to wear glasses or 
contact lenses for the duration of the study.  A spectacle and/or contact lens prescription 
will be offered to you at the 1-month visit. 
Your Study Doctor or a member of the study staff will answer any questions you may have 
about the surgery, follow-up tests and procedures.   
REASONABLY FORESEEABLE RISKS OR DISCOMFORT TO THE PATIENT 
GENERAL CATARACT SURGERY AND IOL IMPLANTATION RISKS 
Regardless of which IOL type you receive, there are risks and possible complications for 
the basic procedure of cataract surgery and IOL implantation.  Some complications of this 
surgery in general, although rare, may include: 
• 
worsening of vision 
• 
hemorrhage (bleeding) 
• 
loss of corneal clarity 
• 
inflammation 
• 
infections 
• 
pupil size or shape changes 
• 
retinal detachment 
• 
glaucoma 
• 
swelling in the back of the eye  
• 
secondary surgical procedure to reposition, remove or replace the IOL(s) 
 
These complications may occur whether or not an IOL is implanted and may result in poor 
vision, total loss of vision, or loss of the eye.  Additionally, there may be other 
unforeseeable risks that may also be associated with cataract surgery and implantation of 
an IOL.   
TORIC IOL RISKS: Toric IOLs are primarily intended to provide far vision, and you will 
most likely need to wear glasses for near vision.  If the toric IOLs are not placed in your 
eyes in the correct position or rotate at a later time, you may possibly experience visual 
distortions such as:  
• 
objects appearing distorted in shape 
• 
objects appearing tilted 
• 
flat surfaces appearing curved 
• 
queasiness related to your vision 

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Additionally, you may need to undergo a second surgical procedure to reposition the toric 
IOL if it is no longer in the correct position.  
STANDARD IOL RISKS:  Standard (monofocal) IOLs are primarily intended to provide far 
vision, and you will most likely need to wear glasses for near vision.  The standard 
monofocal IOL is not designed to correct astigmatism.  If you choose to receive this IOL, 
you may need to wear spectacles (glasses) for the duration of the study to correct your 
astigmatism.  Following study completion, contacts may be worn or you may undergo a 
surgical procedure such as a Limbal Relaxing Incision (LRI) to correct the astigmatism if 
needed.  Additionally, some patients report optical visual symptoms with monofocal IOLs 
as well.  
TECNIS ASPHERIC SURFACE RISKS:  Both the TECNIS monofocal and TECNIS Toric 
IOLs have the TECNIS aspheric surface designed to improve vision in low-light conditions.  
However, there is a possibility you may not experience improved vision in low-light 
conditions as the surface was designed for the “average” eye and may not improve vision 
for all people and also depends on achieving complete correction postoperatively.   
MEDICAL BENEFITS 
You may or may not receive any direct medical benefit from being in this study.  Your 
condition may get better, it may get worse, or it may stay the same.  The information that 
is obtained during this study may be useful scientifically and thus be helpful to others 
requiring the same treatment 
 
ALTERNATIVE TREATMENTS 
You understand that you may decide not to have a cataract operation at all.  However, if 
you decide to participate in this study, you understand that there are alternative toric IOLs 
available for restoring useful vision and reducing astigmatism.  Additionally, other 
treatments and procedures to reduce astigmatism are available to you such as spectacles 
(glasses), contact lenses, and surgical procedures such as LRI and LASIK.  You should 
discuss the potential risks and benefits of the additional treatments and procedures 
available to you with your Study Doctor. 
CONFIDENTIALITY 
Information from this study will be given to AMO.  “AMO” includes any persons or 
companies that are contracted by AMO to have access to the research information during 
and after the study. 
The information will also be given to the U.S. Food and Drug Administration (FDA).  It may 
be given to governmental agencies in other countries as well.  Medical records that 
identify you and the consent form signed by you will be looked at and/or copied for 
research or regulatory purposes by AMO and may be looked at and/or copied for research 
or regulatory purposes by: 
• 
The U.S. Food and Drug Administration (FDA) 
• 
Department of Health and Human Services (DHHS) agencies 
• 
The governing Institutional Review Board (IRB) 
Absolute confidentiality cannot be guaranteed because of the potential need to give 
information to these parties.  The results of this research study may be presented at 
meetings or in publications, but your identity will not be disclosed.  All reasonable 

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precautions will be taken to keep your medical records and personal information private to 
the extent permitted by applicable laws and regulations.  
A description of this clinical study will be available at http://www.ClinicalTrials.gov, as 
required by U.S. Law.  This Web site will not include information that can identify you.  At 
most, the Web site will include a summary of the results.  You can search this Web site at 
any time; however, there may be some delay in posting study information. 
 
PHOTOGRAPHY RELEASE INFORMATION 
Photographs may be taken of your eye(s) during the study.  These photographs will be of 
your eye(s) only and will not show your face.  If you do not wish to have the photographs 
taken, you may still participate in the study.  AMO may use the photographs to evaluate 
results of the study and/or for general research, education, or informational purposes.     
As the photographs are part of the study records, they will also be available for review by 
health regulatory agencies (such as the Food and Drug Administration), or governing IRB, 
that is entitled to view study records. AMO may also use these photographs for 
advertising, publicity, and promotional purposes with your consent.   AMO will own the 
copyright of the photographs. When the photographs are used for any purposes indicated 
above, you release AMO from any claims or actions due to their publication or distribution. 
COST TO YOU 
You and/or your insurance company will be responsible for all usual and customary fees 
related to your cataract surgeries, the IOLs implanted and any glasses or contacts that 
may be needed postoperatively. 
PAYMENT FOR PARTICIPATION 
You will be compensated for your time and participation in this study.  Compensation will 
be provided to you by way of a Visa or American Express gift card at the completion of 
each of the study visits as follows: 
Exams 
Eyes 
Evaluated 
Compensation 
Preoperative Exam 
Both Eyes 
$50 
1-Month Postoperative Exam 
Both Eyes 
$50 
 6-Month Postoperative Exam 
Both Eyes 
$100 
Total Compensation 
$200 
 
Abbott Medical Optics (AMO), the company sponsoring the study, is paying for the 
compensation listed above.  The Study Doctor is being paid by AMO to conduct this study. 
 I 
N CASE OF RESEARCH INJURY 
If, during your participation in the study, you are injured as a direct result of the use of the 
study device(s) or study treatment, AMO agrees to pay reasonable medical expenses 
necessary to treat the injury; provided you have followed the direction of the study doctor 
and to the extent that these expenses are not covered by a third party, private or 
government insurance or programs.  AMO makes no commitment to provide 
compensation except as described above.”. 

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LEGAL RIGHTS 
You do not lose any legal rights by signing this consent form.   
WHOM TO CONTACT 
You may contact the Study Doctor or study staff at the phone number listed on the first 
page of this consent document: 
• 
for answers, questions, concerns or complaints about this research study,  
• 
to report a research-related injury, or 
• 
for information about the study procedure. 
If you need immediate medical attention, please go to the nearest emergency room. 
You may contact the Institutional Review Board if you: 
• 
would like to speak to someone not related to the research,  
• 
have questions, concerns, or complaints regarding the research study, or 
• 
have questions about your rights and welfare as a research subject. 
<IRB NAME> 
<ADDRESS> 
<PHONE NUMBER> 
<EMAIL> 
VOLUNTARY PARTICIPATION/WITHDRAWAL 
Your participation in this study is entirely voluntary.  You may refuse to participate or may 
withdraw from this study at any time without penalty or loss of any rights or benefits to 
which you are otherwise entitled.  Your Study Doctor or AMO may also stop your 
participation in the study at any time.  AMO may stop the study at any time for reasons 
they determine to be appropriate. 
If you decide to withdraw from the study, you should contact your Study Doctor 
immediately.  If you withdraw or are removed from the study, you may be asked to return 
for final tests and procedures to be done for your safety.  Please also understand that if 
you agree to participate in the study, you may not receive the study lens you chose if 
something happens during your first cataract procedure.  In this case, you will receive an 
alternate, marketed lens during your surgery and you will be withdrawn from the study.  
You may not be withdrawn from the study if something happens during your second 
cataract procedure. You may continue to be followed for your first study eye until study 
completion. 
NON-PREGNANCY 
Although there is no known risk to an unborn baby or infant, you should not participate in 
the study if you are pregnant, plan to become pregnant during the study or are 
breastfeeding because these conditions could change your vision.   
NEW INFORMATION 
Your Study Doctor will inform you of any new information about the study that may 
develop during the course of this research and may influence your willingness to 
participate in the study. 

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INFORMED CONSENT SIGNATURE PAGE 
STUDY TITLE: 
Post-approval study of the TECNIS Toric 1-Piece Intraocular Lens, 
Models ZCT300 and ZCT400  
STUDY NUMBER: 
TIOL-202-TPAS 
Study Participant Initials:____________    Study Participant ID Number:_________ 
You will be given a signed and dated copy of this consent form for your records prior to 
your participation in the study. 
BY SIGNING BELOW, YOU ACKNOWLEDGE THAT: 
1. You have read all sections of this Informed Consent Form.   
2. You are able to understand and complete a questionnaire in English. 
3. You have had your questions about the study and your participation in it answered. 
4. You voluntarily consent to participate in this research study and follow your Study 
Doctor’s instructions. 
5. Should you decide not to participate, discontinue or withdraw from the study at any 
time, there is no penalty to you. 
6. You authorize the release of your medical records for research or regulatory 
purposes to AMO, the Study Doctor, the FDA, DHHS agencies, and the governing 
Institutional Review Board (IRB). 
7. By signing this consent form, you have not waived any of the legal rights which you 
otherwise would have as a study participant in a research study. 
I choose to receive the following lens type in both of my eyes (choose one): 
 TECNIS Toric IOL (Models ZCT300 and/or ZCT400)  
 TECNIS Monofocal IOL Model ZCB00 (non-toric IOL) 
By placing your initials in the space provided below, you are also agreeing to the 
following use of the photographs by AMO: 
__________ for advertising, publicity, and promotional purposes. 
Study Participant’s Name (Please print) ______________________________________ 
Signature __________SAMPLE DOCUMENT DO NOT SIGN____ Date ____________ 
Legal Representative’s Name (Please print)___________________________________ 
Signature __________SAMPLE DOCUMENT DO NOT SIGN____ Date ____________ 
Name/Signature of person who conducted informed consent discussion: 
Name (Please print) _____________________________________________________ 
Signature _____________________________________________ Date ____________ 
 
 

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FEMALE PARTICIPANTS:  Please affirm by your signature below that either you are not 
pregnant at this time or are taking precautions not to become pregnant during this study. 
Affirmation of study participant regarding non-pregnancy: 
Signature_____________________________________________ Date ____________ 
 
 

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ATTACHMENT B 
SAMPLE AUTHORIZATION FOR USE/DISCLOSURE OF HEALTH 
INFORMATION FORM  

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Authorization for Use/Disclosure of Health Information 
Only minimal medical/health information may be collected for research-related 
purposes.  This disclosure form pertains to your release of such information to 
Abbott Medical Optics Inc.  
What is the purpose of this form?  You are being asked to sign this form so that we may 
use and release your health information for research.  Participation in research is 
voluntary.  If you choose to participate in the research, you must sign this form so that 
your health information may be used for the research. 
What health information do the researchers want to use?  They may use medical 
information and personal identifiers including past, present and future history, 
examinations, laboratory results, imaging studies and reports and treatments of whatever 
kind related to or collected for use in the research study. 
Why do the researchers want my health information?  The researchers want to use 
your health information as part of the research study described to you in the Informed 
Consent document. 
Who will disclose, use and/or receive my health information?  The technicians and 
staff working on this research study; the governing Institutional Review Board and its staff; 
the sponsor of this research, its employees and agents contracted by it to analyze study 
data; and outside regulatory agencies, such as the Food and Drug Administration. 
How will my health information be protected once it is given to others?  Your 
personal health information may no longer be protected by HIPAA (Health Insurance 
Portability and Accountability Act) once it is disclosed to the study sponsor (AMO) by the 
study doctor.  However, AMO will take reasonable measures to keep your personal health 
information confidential. 
How long will this Authorization last?  Unless withdrawn, your HIPAA authorization has 
no expiration date, since information collected for research purposes continues to be 
analyzed for many years. 
Can I cancel the Authorization?  You may cancel this Authorization at any time by 
notifying your doctor, in writing, at the address on the first page of the Informed Consent 
Document (please reference the research protocol number).  If you cancel this 
Authorization, the investigator and researchers will not collect any new health information 
for research.  However, researchers may continue to use the health information that was 
provided before you cancelled your authorization. 
Can I see my health information?  You have a right to request to see your health 
information.  However, to ensure scientific integrity of the research, you will not be able to 
review the research information until after the research study has been completed. 
Signature of Subject: ________________________ 
 
   Date: _______ 
 
Signature of Legal Representative: __________________                Date: ___________ 
Signature of Witness: ________________________ 
 
   Date: _____