Post-Approval Study of the Visian Toric Implantable Collamer Lens
Phase: NA
Conditions: Myopic Astigmatism
Sponsor: Staar Surgical Company

TITLE PAGE 
 
 
 
 
Post-Approval Study of the Visian Toric Implantable Collamer Lens 
 
PROTOCOL 
 
STUDY #CP18-02 
 
SPONSOR: 
STAAR Surgical Company 
1911 Walker Avenue 
Monrovia, California 91016 
Telephone USA: 626-303-7902 
 
 
 
This clinical investigation is being conducted in accordance with 21CFR Parts 11, 50, 54, 56, 803, 
814.82(a)(2), 820; 42 USC 282(j), FDA GCPs and with the ethical principles laid down in the Declaration of 
Helsinki. 
Revision Chronology:  
Revision #1  
- 
2018.Dec.19 
Revision #2  
 
2019.June.10 
 
The confidential information in the following document is provided to you, as an Investigator or consultant, 
for review by you, your study personnel, and the applicable IRB. By accepting this document, you agree that 
the information contained herein will not be disclosed to others without written authorization from STAAR 
Surgical Company, except to the extent necessary to obtain consent from those persons who participate in 
this study.  
 
Visian® Collamer® and MicroSTAAR® are registered trademarks of STAAR Surgical Company.  

Study #CP18-02 - Protocol 
 
Rev #2, 2019.June.10 
 
Page 3 of 39 
INVESTIGATOR STATEMENT OF APPROVAL 
 
Post-Approval Study of the Visian Toric Implantable Collamer Lens 
 
PROTOCOL 
 
STUDY #CP18-02 
 
 
I have read the attached document, concur that it contains all information necessary to 
conduct the study, and agree to abide by all provisions set forth therein.  
I agree to conduct this study in accordance with the relevant, current version of this 
protocol, 21CFR Parts 11, 50, 54, 56, 803, 814.82(a)(2), 820, 42 USC 282(j), FDA GCPs 
and with the ethical principles laid down in the Declaration of Helsinki. I will not initiate 
the study until I have obtained written approval by the appropriate IRB/EC and have 
complied with all financial and administrative requirements of the governing body of the 
clinical institution and the Sponsor. I will obtain written informed consent from each study 
subject prior to performing any study specific procedures.  
I understand that my signature on a case report form indicates that the data therein has been 
reviewed and accepted by me. 
I understand that this document and related information is subject to confidentiality terms 
found in my signed Confidentiality or Clinical Services Agreement. I agree to protect the 
confidentiality of my patients when allowing the Sponsor of this clinical investigation, 
and/or relevant regulatory authorities and IRB, direct access to my medical records for 
study subjects. 
 
 
 
Principal Investigator, Printed Name 
 
 
 
 
 
Principal Investigator, Signature 
Date 
 
Upon signing, provide a copy of this page to STAAR Surgical Company and retain a copy for your 
files.  

Study #CP18-02 - Protocol 
 
Rev #2, 2019.June.10 
 
Page 4 of 39 
PERSONNEL AND FACILITIES 
NOTE: The information on this page is subject to change. All changes will be provided under separate 
cover. 
Sponsor  
STAAR Surgical Company 
1911 Walker Avenue 
Monrovia, California 91016 
Telephone: 626-303-7902 
 
Study Manager (Primary Study Contact) and 
Contact for Reporting Serious Adverse Events 
and Product Complaints 
 
 
 
 
 
Scientific & Clinical Affairs 
  
  
 
 
Medical Monitor 
 
 
 
 
 
Clinical Investigator(s) 
(Provided under separate cover.) 
 
 

Study #CP18-02 - Protocol 
 
Rev #2, 2019.June.10 
 
Page 5 of 39 
TABLE OF CONTENTS 
PAGE 
TITLE PAGE ................................................................................................................................................ 1 
SPONSOR APPROVAL PAGE .................................................................................................................. 2 
INVESTIGATOR STATEMENT OF APPROVAL.................................................................................. 3 
PERSONNEL AND FACILITIES .............................................................................................................. 4 
TABLE OF CONTENTS ............................................................................................................................. 5 
LIST OF ABBREVIATIONS ...................................................................................................................... 7 
SYNOPSIS .................................................................................................................................................... 9 
1.0  INTRODUCTION ............................................................................................................................. 14 
2.0  OBJECTIVE ...................................................................................................................................... 14 
3.0  STUDY DESIGN ................................................................................................................................ 14 
3.1  DESCRIPTION OF STUDY DESIGN...................................................................................................... 14 
3.2  SELECTION OF STUDY POPULATION ................................................................................................. 15 
3.2.1 
Eligibility .............................................................................................................................. 15 
3.2.2 
Subject Completion .............................................................................................................. 17 
3.2.3 
Subject Discontinuation ........................................................................................................ 17 
3.2.4 
Lost to Follow-up ................................................................................................................. 17 
3.3  INVESTIGATORS ............................................................................................................................... 17 
3.4  STUDY DURATION ........................................................................................................................... 18 
4.0  STUDY MATERIALS ....................................................................................................................... 18 
4.1  DESCRIPTION OF INVESTIGATIONAL DEVICE .................................................................................... 18 
4.2  INSTRUCTIONS FOR USE AND ADMINISTRATION .............................................................................. 19 
4.2.1 
Storage Requirements ........................................................................................................... 19 
4.3  OTHER MATERIALS .......................................................................................................................... 19 
4.4  PACKAGING AND LABELING ............................................................................................................ 19 
4.5  ACCOUNTABILITY ............................................................................................................................ 20 
5.0  STUDY CONDUCT ........................................................................................................................... 20 
5.1  STUDY VISITS .................................................................................................................................. 20 
5.1.1 
Preoperative Visit – Days -120 to Day 0 .............................................................................. 21 
5.1.2 
Operative Visit – Day 0 ........................................................................................................ 21 
5.1.3 
Postoperative Visit 1 – Operative Day (1 – 6 hours after surgery) ....................................... 21 
5.1.4 
Postoperative Visits – Day 1 to Month 24 ............................................................................ 21 
5.1.5 
Unscheduled Visits ............................................................................................................... 21 
5.1.6 
Missed Visits ........................................................................................................................ 21 
5.2  STUDY COMPLETION ........................................................................................................................ 21 
5.2.1 
Early Study Termination ....................................................................................................... 22 
5.2.2 
Post-study Follow-up ............................................................................................................ 22 
5.3  CONCOMITANT MEDICATIONS/THERAPY ......................................................................................... 22 
5.4  PROTOCOL DEVIATIONS ................................................................................................................... 22 
6.0  ADVERSE EVENT REPORTING ................................................................................................... 22 
6.1  DEFINITIONS .................................................................................................................................... 23 
6.1.1 
Adverse Event....................................................................................................................... 23 
6.1.2 
Adverse Device Effects ........................................................................................................ 24 
6.1.3 
Device Deficiency ................................................................................................................ 24 
6.2  EVALUATION ................................................................................................................................... 24 
6.3  REPORTING ...................................................................................................................................... 25 

Study #CP18-02 - Protocol 
 
Rev #2, 2019.June.10 
 
Page 6 of 39 
6.3.1 
On-Site Expedited Reporting ................................................................................................ 25 
6.3.2 
Off-Site SAE Reporting ........................................................................................................ 26 
6.3.3 
Reporting of Complaints for STAAR Surgical Products ...................................................... 26 
6.3.4 
Adverse Events and SAEs at Subject Exit ............................................................................ 26 
7.0  STATISTICAL METHODS ............................................................................................................. 26 
7.1  HYPOTHESIS .................................................................................................................................... 26 
7.2  STUDY ENDPOINTS .......................................................................................................................... 26 
7.2.1 
Primary Effectiveness Endpoint ........................................................................................... 26 
7.2.2 
Secondary Endpoints ............................................................................................................ 27 
7.3  ANALYSIS POPULATIONS ................................................................................................................. 27 
7.4  SAMPLE SIZE ................................................................................................................................... 27 
7.5  STATISTICAL ANALYSIS ................................................................................................................... 27 
7.6  MISSING DATA IMPUTATION ............................................................................................................ 28 
7.7  MULTIPLICITY ADJUSTMENT ........................................................................................................... 28 
8.0  DATA QUALITY ASSURANCE ..................................................................................................... 28 
8.1  STUDY MONITORING ....................................................................................................................... 28 
8.2  SOURCE DOCUMENTATION .............................................................................................................. 29 
8.3  CASE REPORT FORMS AND DATA VERIFICATION ............................................................................. 29 
8.4  RECORDING OF DATA AND RETENTION OF DOCUMENTS.................................................................. 29 
8.5  AUDITING PROCEDURES .................................................................................................................. 30 
8.6  INSTITUTIONAL REVIEW BOARD APPROVAL .................................................................................... 30 
8.7  PUBLICATION OF RESULTS ............................................................................................................... 30 
 
APPENDICES 
APPENDIX A: 
SCHEDULE OF VISITS AND PARAMETERS .................................................. A-1 
APPENDIX B: 
METHODS OF CLINICAL EVALUATION ........................................................B-1 
REFERENCES ..........................................................................................................................................B-7 
 

Study #CP18-02 - Protocol 
 
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Page 7 of 39 
LIST OF ABBREVIATIONS 
Abbreviation 
/Acronym  Term  
ACD Anterior Chamber Depth 
ADE Adverse Device Effect 
AE  Adverse Event 
AREDS Age-Related Eye Disease Study 
BSS Balanced Salt Solution 
CDVA Corrected Distance Visual Acuity 
CECC Corneal Endothelial Cell Count 
CFR Code of Federal Regulations 
CRF Case Report Form 
D Diopters 
DFU Directions For Use 
DIA Device Investigator Agreement 
DOA Delegation of Authority 
EC Ethics Committee 
ECD Endothelial Cell Density 
eQMS Electronic Quality Management System 
ETDRS Early Treatment of Diabetic Retinopathy Study 
FDA United States Food and Drug Administration 
FTP Foam Tip Plunger 
GCPs Good Clinical Practices 
HEMA Hydroxyethyl Methacrylate 
HIPAA Health Insurance Portability and Accountability Act 
ICF Informed Consent Form  
ICH International Conference on Harmonisation 
ICL Implantable Collamer Lens 
IOL Intraocular Lens 
IOP Intraocular Pressure 
IRB Institutional Review Board 
ISO International Organization for Standardization 
ITT Intent to Treat 
LogMAR Logarithm of Minimal Angle of Resolution 
PAS Post-approval Study 
PI Principal Investigator 
PP Per Protocol 
SAE Serious Adverse Event 
SE Spherical Equivalent 
SOP Standard Operating Procedure 
TICL Visan Toric Implantable Collamer Lens for Myopia 

Study #CP18-02 - Protocol 
 
Rev #2, 2019.June.10 
 
Page 8 of 39 
Abbreviation 
/Acronym  Term  
UCVA Uncorrected Visual Acuity 
US United States 
UV Ultraviolet 
VA Visual Acuity 
YAG Yttrium Aluminum Garnet 
NOTE: The first occurrence of some abbreviations is not spelled out in the document (e.g., units of 
measure). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study #CP18-02 - Protocol 
 
Rev #2, 2019.June.10 
 
Page 9 of 39 
SYNOPSIS  
STAAR Surgical Company Study #CP18-02 
Revision chronology: 
Rev #2, 2019.June.10 
Title: 
Post-Approval Study of the Visian Toric Implantable Collamer Lens 
Type of study: 
Post-approval study (PAS) 
Number of study centers 
and subjects: 
The study will enroll and implant at least 124 eligible subjects (up to 248 
eyes, with 124 being primary) at 6-8 clinical sites in the US, to ensure 
that at least 100 subjects (assuming an overall attrition of 10% per year) 
will be available for evaluation at 24 months after implantation. 
Objective(s): 
The objective of this PAS is to evaluate the long term (i.e. 24 months) 
clinical performance of the Visian® Toric Implantable Collamer® Lens 
(ICL) for Myopia (TICL) with respect to rotational stability, refractive and 
visual outcomes, and ocular adverse event (AE) rates.  
Study design 
This is a prospective, multicenter, open-label, single arm, post approval 
study. Up to 124 subjects who meet all eligibility criteria will be offered 
consecutive enrollment in the study.  
It is intended that each enrolled subject will undergo bilateral 
implantation with the TICL. If only one eye of a given subject meets all 
of the inclusion and exclusion criteria, or the subject desires surgery in 
only one eye and that eye meets all of the inclusion and exclusion 
criteria, then that eye will be the primary eye.  If both eyes of a given 
subject meet all of the inclusion and exclusion criteria, and the subject 
desires surgery in both eyes, then the eye with the greater magnitude of 
manifest refraction cylinder will be designated as the primary eye. If both 
eyes of a given subject meet all of the inclusion and exclusion criteria 
and the refractive cylinder of the eyes are equal, then the right eye will 
be designated as the primary eye.   
A minimum of 14 subjects requiring a Toric ICL cylinder power of 3.5 
or 4.0 diopters will be enrolled.   
Postoperatively, subjects will return for visits at regularly scheduled 
intervals through 24 months after surgery (see App A). 
Subject Population 
Investigators will all have prior clinical experience with the STAAR 
Surgical Implantable Collamer Lens.  Subjects will be selected from each 
clinical site’s patient population.  Patients meeting all of the following 
criteria will be considered suitable study subjects.  All subjects enrolled 
in this clinical study will meet the requirements under the indications for 
use outlined in the package insert directions for use (DFU) for the FDA 
approved lenses and additional eligibility criteria. (refer below)  
 

Study #CP18-02 - Protocol 
 
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Inclusion Criteria (each eye to be implanted) 
1. 
Subjects 21 through 45 years old at time of surgery. 
2. 
Moderate to high myopia with spherical equivalent ranging from   
-3.0 D to ≤ -15.0 D (in the spectacle plane) and cylinder in the range 
of 1.0 D to 4.0 D (in the spectacle plane). 
3. 
Stable refractive history within 0.5 D for both spherical equivalent 
and cylinder for 1 year prior to implantation. 
4. 
Anterior chamber depth (ACD) 3.0 mm or greater, when measured 
from the corneal endothelium to the anterior surface of the crystalline 
lens. 
5. 
Meet minimum endothelial cell density (ECD) requirements for age 
and ACD (refer to the “Minimum Endothelial Cell Density for Age 
and True ACD*” table below).  
6. 
Correctable (CDVA) to at least 20/40 in the eye to be treated; and 
absent of ocular pathology (except that myopic degeneration is 
allowed). 
7. 
Subjects must be able to achieve a minimum dilated pupil size of 7 
mm (via use of mydriatic and/or cycloplegic eye drops) in each eye 
to be treated. 
8.     Able to read, understand and provide written informed consent on the 
Institutional Review Board (IRB) approved Informed Consent Form 
(ICF). 
9.      Able and willing to return for scheduled follow-up examinations after 
surgery. 
Exclusion Criteria (each eye to be implanted) 
1. 
Younger than 21 or older than 45 years of age. 
2. 
With true ACD < 3.00 mm*. 
3. 
Anterior chamber angle less than Grade III as determined by 
gonioscopic examination. 
4. 
Do not meet the minimum ECD as defined in the “Minimum 
Endothelial Cell Density for Age and True ACD*” table below. 
5. 
Unstable or worsening nearsightedness. 
6. 
History or clinical signs of iritis/uveitis. 
7. 
Diabetic retinopathy. 
8. 
Glaucoma. 
9. 
History of previous eye surgery. 
10. Serious (i.e., life threatening), acute, chronic or systemic, non-
ophthalmic disease or illness that would increase the operative risk, 
confound the outcome(s) of the study or which may preclude study 
completion. 

Study #CP18-02 - Protocol 
 
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Page 11 of 39 
11. Progressive sight threatening disease or other previous or current 
ocular conditions, other than myopia, that may predispose for future 
complication.  
12. Diagnosis of ocular hypertension (high eye pressure). 
13. Insulin-dependent diabetes. 
14. Pseudoexfoliation. 
15. Pigment dispersion. 
16. Spherical equivalent less than -3.0 D or greater than -15.0 D (in the 
spectacle plane) of nearsightedness; cylinder (spectacle plane) less 
than 1.0 D and greater than 4.0 D. 
17. Pregnant or nursing women, or those who plan to become pregnant 
over the course of this clinical study or has another condition with 
associated fluctuation of hormones that could lead to refractive 
changes. 
18. Involved in another clinical study or who may have been involved in 
a different clinical study within 30 days prior to this clinical study or 
will be involved in a different clinical study within 30 days of 
beginning this study. 
Minimum Endothelial Cell Density for Age and True ACD*
Age 
Minimum 
ECD 
ACD ≥ 
3.0mm 
Minimum 
ECD 
ACD ≥ 
3.2mm 
Minimum 
ECD 
ACD ≥ 
3.5mm 
21-25 
3875 
cells/mm2 
3800 
cells/mm2 
3250 
cells/mm2 
26-30 
3425 
cells/mm2 
3375 
cells/mm2 
2900 
cells/mm2 
31-35 
3025 
cells/mm2 
2975 
cells/mm2 
2625 
cells/mm2 
36-40 
2675 
cells/mm2 
2625 
cells/mm2 
2350 
cells/mm2 
41-45 
2350 
cells/mm2 
2325 
cells/mm2 
2100 
cells/mm2 
>45 
2075 
cells/mm2 
2050 
cells/mm2 
1900 
cells/mm2 
*The true ACD is defined as the distance from the apex of the posterior 
corneal surface to the apex of the anterior crystalline lens surface.  Many 
measuring devices provide an ACD measurement defined as the distance 
from the apex of the anterior corneal surface to the apex of the anterior 
crystalline lens surface. If the surgeon is using an instrument that measures 
from the anterior corneal surface, the thickness of the cornea must be 
subtracted to get the true ACD. 
Duration of treatment 
Eligible subjects who are enrolled in the study will be seen for 11 study 
visits over the course of approximately 27 months. 

Study #CP18-02 - Protocol 
 
Rev #2, 2019.June.10 
 
Page 13 of 39 
 
A sample of 100 eyes provides 94.9% power to reject the null 
hypothesis that >10% of eyes will exhibit >5 rotation.  The two-sided 
95.0% upper confidence limit of the proportion of eyes with >5 
absolute rotation is ≤ 0.1. The null hypothesis will be rejected if the 
two-sided 95.0% upper confidence limit of the proportion of eyes with 
>5 absolute rotation between 18 and 24 months is ≤0.1. To allow for 
losses of 10% per year, a total of up to 124 primary eyes of 124 subjects 
will be enrolled. 

Study #CP18-02 - Protocol 
 
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Page 14 of 39 
1.0 
INTRODUCTION  
The STAAR Visian® Toric Implantable Collamer® Lens (ICL) for Myopia (TICL) 
received FDA approval on September 13, 2018. The STAAR TICL is indicated for use in 
patients 21 – 45 years of age: 
1. for the correction of myopic astigmatism with spherical equivalent ranging from   
-3.0 diopters (D) to ≤ -15.0 D (in the spectacle plane) with cylinder (spectacle 
plane) of 1.0 D to 4.0 D. 
2. for the reduction of myopic astigmatism with spherical equivalent ranging from 
greater than -15.0 D to -20.0 D (in the spectacle plane) with cylinder (spectacle 
plane) 1.0 D to 4.0 D. 
3. with an anterior chamber depth (ACD) of 3.00 mm or greater, when measured 
from the corneal endothelium to the anterior surface of the crystalline lens and a 
stable refractive history (within 0.5 D for both spherical equivalent and cylinder 
for 1 year prior to implantation). 
4. The Visian TICL is intended for placement in the posterior chamber (ciliary 
sulcus) of the phakic eye. 
As a condition of FDA approval, STAAR is conducting a new enrollment post-approval 
study (PAS) in order to provide continued reasonable assurance of the safety and 
effectiveness of the TICL. 
2.0 
OBJECTIVE 
The objective of this PAS is to evaluate the long term (i.e., 24 months) clinical performance 
of the TICL with respect to rotational stability, refractive and visual outcomes, and ocular 
adverse event (AE) rates.  
3.0 
STUDY DESIGN 
3.1 
Description of Study Design   
This is a prospective, multicenter, open-label, single arm, post-approval study. A total of 
124 subjects (up to 248 eyes, with 124 being primary) who meet all eligibility criteria will 
be enrolled at 6-8 clinical sites in the United States (US).  
It is intended that each enrolled subject will undergo bilateral implantation with the 
TICL. If only one eye of a given subject meets all of the inclusion and exclusion 
criteria, or the subject desires surgery in only one eye and that eye meets all of the 
inclusion and exclusion criteria, then that eye will be the primary eye.  If both eyes of a 
given subject meet all of the inclusion and exclusion criteria, and the subject desires 
surgery in both eyes, then the eye with the greater magnitude of manifest refraction 
cylinder will be designated as the primary eye. If both eyes of a given subject meet all 
of the inclusion and exclusion criteria and the refractive cylinder of the eyes are equal, 
then the right eye will be designated as the primary eye.   
A minimum of 14 subjects requiring a Toric ICL cylinder power of 3.5 or 4.0 D will be 
enrolled.   

Study #CP18-02 - Protocol 
 
Rev #2, 2019.June.10 
 
Page 15 of 39 
Study subjects will be followed at Day 0, Day 1, Week 1, Month 1, 3, 6, 12, 18, and 24 
postoperatively (Refer to Appendix A).  
STAAR will submit periodic study reports to FDA every six (6) months during the first 
two (2) years of the study and annually thereafter, unless otherwise specified by FDA. The 
first report will be submitted 6 months after the initial approval of this study protocol. 
3.2 
Selection of Study Population  
Investigators will all have prior clinical experience with the STAAR Surgical Implantable 
Collamer Lens.  Subjects will be selected from each clinical site’s patient population.  
Patients meeting all of the following criteria will be considered suitable study subjects.  All 
subjects enrolled in this clinical study will meet the requirements under the indications for 
use outlined in the package insert directions for use (DFU) for the FDA approved lenses 
and the additional eligibility criteria described below.  
3.2.1 
Eligibility 
 
Inclusion Criteria  
1. Subjects must be able to read, understand and provide written informed consent on the 
Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide 
authorization as appropriate for local privacy regulations. 
2. Subjects must be of the ages of 21 through 45 at the time of surgery.  
3. Moderate to high myopia with spherical equivalent ranging from -3.0 D to ≤ -15.0 D 
(in the spectacle plane) and cylinder in the range of 1.0 D to 4.0 D (in the spectacle 
plane). 
4. Stable refractive history within ± 0.5 D for both spherical equivalent and cylinder for 
1 year prior to implantation. 
5. ACD 3.0 mm or greater, when measured from the corneal endothelium to the anterior 
surface of the crystalline. 
6. Meet minimum endothelial cell density (ECD) requirements for age and ACD (refer to 
the “Minimum Endothelial Cell Density for Age and True ACD*” table below).  
7. Subjects must be able to achieve a minimum dilated pupil size of 7 mm (via mydriatic 
and/or cycloplegic eye drops) in each eye to be treated. 
8. Correctable (CDVA) to at least 20/40 in the eye to be treated; and absent of ocular 
pathology (except that myopic degeneration is allowed). 
9. Able to read, understand and provide written informed consent on the IRB approved 
ICF. 
10. Subjects must be able and willing to comply with all treatment and follow-up study 
procedures. 
 
Exclusion Criteria 
This study will include subjects who do not meet the following criteria: 
1. Younger than 21 or older than 45 years of age. 

Study #CP18-02 - Protocol 
 
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Page 16 of 39 
2. With true ACD < 3.00 mm*. 
3. Anterior chamber angle less than Grade III as determined by gonioscopic examination. 
4. Do not meet the minimum ECD as defined in the “Minimum Endothelial Cell Density 
for Age and True ACD*” table below. 
5. Unstable or worsening nearsightedness. 
6. History or clinical signs of iritis/uveitis. 
7. Diabetic retinopathy. 
8. Glaucoma. 
9. History of previous eye surgery. 
10. Serious (i.e., life threatening), acute, chronic or systemic, non-ophthalmic disease or 
illness that would increase the operative risk, confound the outcome(s) of the study or 
which may preclude study completion.   
11. Progressive sight threatening disease or other previous or current ocular conditions, 
other than myopia, that may predispose for future complication.  
12. Diagnosis of ocular hypertension (high eye pressure). 
13. Insulin-dependent diabetes. 
14. Pseudoexfoliation. 
15. Pigment dispersion. 
16. Spherical equivalent less than -3.0 D or greater than -15.0 D (in the spectacle plane) of 
nearsightedness; cylinder (spectacle plane) less than 1.0 D and greater than 4.0 D. 
17. Pregnant or nursing women, or those who plan to become pregnant over the course of 
this clinical study or has another condition with associated fluctuation of hormones that 
could lead to refractive changes. 
18. Involved in another clinical study or who may have been involved in a different clinical 
study within 30 days prior to this clinical study or will be involved in a different clinical 
study within 30 days of beginning this study. 
Minimum Endothelial Cell Density for Age and True ACD* 
Age 
Minimum ECD 
ACD ≥ 3.0mm 
Minimum ECD 
ACD ≥ 3.2mm 
Minimum ECD 
ACD ≥ 3.5mm 
21-25 
3875 cells/mm2 
3800 cells/mm2 
3250 cells/mm2 
26-30 
3425 cells/mm2 
3375 cells/mm2 
2900 cells/mm2 
31-35 
3025 cells/mm2 
2975 cells/mm2 
2625 cells/mm2 
36-40 
2675 cells/mm2 
2625 cells/mm2 
2350 cells/mm2 
41-45 
2350 cells/mm2 
2325 cells/mm2 
2100 cells/mm2 
>45 
2075 cells/mm2 
2050 cells/mm2 
1900 cells/mm2 
*The true ACD is defined as the distance from the apex of the posterior corneal surface to the apex of the 
anterior crystalline lens surface.  Many measuring devices provide an ACD measurement defined as the 
distance from the apex of the anterior corneal surface to the apex of the anterior crystalline lens surface. If 

Study #CP18-02 - Protocol 
 
Rev #2, 2019.June.10 
 
Page 17 of 39 
the surgeon is using an instrument that measures from the anterior corneal surface, the thickness of the cornea 
must be subtracted to get the true ACD. 
3.2.2 
Subject Completion 
The subject has completed the entire study when the 24 month follow-up visit is concluded.   
Subjects who require further follow-up for an AE will be followed according to Section 
6.0. 
A Study Exit CRF for each eye must be completed for all subjects who complete the study.  
3.2.3 
Subject Discontinuation 
A subject may be discontinued (at the discretion of the Investigator, the Sponsor and/or the 
IRB) prior to the final study visit for several reasons, including, but not limited to:  
 
voluntary withdrawal 
 
death 
 
surgical complication preventing implantation of the study lens in any eye 
 
explant of the study lenses  
 
If both TICL lenses are explanted, a minimum of one post-explant visit should be 
completed to record safety measures for the subject (e.g., CDVA, cataract/lens evaluation, 
endothelial cell count, etc.) prior to subject discontinuation. 
Prior to discontinuing a subject, every effort should be made to contact the subject, 
schedule a final study visit, and obtain as much follow-up data as possible.  
Adverse events will be followed as described in Section 6.0. Subject withdrawals will be 
documented clearly on the source document and applicable CRF. 
Only subjects who do not receive any study lenses MAY be replaced. Subjects who are 
discontinued from the study following treatment will not be replaced. 
Discontinued subjects should be followed outside of the study protocol according to the 
Investigator’s normal postoperative standard of care.  
3.2.4 
Lost to Follow-up 
Subjects who do not return for the final study visit, as defined by the visit window and 
cannot be contacted, will be considered lost to follow-up. All follow-up attempts will be 
documented in the subject’s source documentation, and the applicable CRFs will be 
completed. 
3.3 
Investigators 
 
The study will be conducted at approximately 6-8 clinical site(s) located in the US.  
 
The study will be conducted by Investigators who have prior clinical experience with 
the STAAR Surgical ICL and are determined by STAAR Surgical to be suitably 
qualified by training and experience to conduct this study in compliance with all 
applicable GCPs and FDA Federal Regulations. Sub-Investigators will be identified on 
the Device Investigator Agreement (DIA)/DOA (Delegation of Authority Log). 

Study #CP18-02 - Protocol 
 
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 
Each clinical site will enroll approximately 20 subjects (40 eyes). In the event that 
selected sites do not meet full enrollment, the Sponsor may decide to increase 
enrollment as needed at other currently active sites and additional site(s) may be added 
to satisfy the enrollment requirements of the study.  
3.4 
Study Duration  
The duration of the study, including the time to recruit all subjects, will be approximately 
42 months. Eligible subjects who are enrolled in the study will be seen for 11 scheduled 
study visits (per eye) over the course of approximately 27 months. 
4.0 
STUDY MATERIALS 
4.1 
Description of Investigational Device  
The Visian® Toric ICL (Implantable Collamer® Lens) for myopia and astigmatism (TICL), 
is an intraocular implant manufactured from Collamer®, a proprietary hydroxyethyl 
methacrylate (HEMA)/porcine-collagen based biocompatible polymer material. The 
Visian TICL contains a UV absorber made from a UV absorbing material. The TICL lens 
features a plate-haptic design with a central convex/concave optical zone and incorporates 
a forward vault to minimize contact of the Visian TICL with the central anterior capsule. 
The Visian TICL features an optic diameter that varies with the dioptric power; the smallest 
optic diameter being 4.9 mm and the largest 5.8 mm. All descriptions of optic diameter, 
overall diameter or power refer to measurements in BSS unless otherwise noted. The 
Visian TICL is capable of being folded and inserted into the posterior chamber through an 
incision of 3.5 mm or less. The Visian TICL is intended to be placed entirely within the 
posterior chamber directly behind the iris and in front of the anterior capsule of the human 
crystalline lens. When correctly positioned, the Visian TICL functions as a refractive 
element to optically reduce moderate to high myopic astigmatism. 
Study lenses will be available in the following powers and sizes:  
 
The Visian TICL is labeled using a plus cylinder axis format. The lenses are labeled to the 
nearest degree and as such lenses of any axis between 1°to 180° may be held in inventory.  
The Visian TICL is designed to be rotated up to 22.5° clockwise or counterclockwise in 
order to align the lens axis at the preoperative plus cylinder axis. The lens has two diamond 
shaped markings, one on each side of the optic, these are to aid with the alignment of the 
lens. The markings indicate the meridian from which the cylinder axis is measured and do 
not indicate the cylinder axis of the lens.    
Model Number 
Spherical Equivalent 
Dioptric Power (D) 
Cylinder 
Dioptric 
Power (D) 
Overall 
Diameter 
(mm) 
Optic 
Diameter 
(mm) 
Haptic 
Design 
TICL 12.1 
-3.0 to -16.0 D 
1.0 to 4.0 
12.1 
4.9 – 5.8 
Flat, plate 
TICL 12.6 
-3.0 to -16.0 D 
1.0 to 4.0 
12.6 
4.9 – 5.8 
Flat, plate 
TICL 13.2 
-3.0 to -16.0 D 
1.0 to 4.0 
13.2 
4.9 – 5.8 
Flat, plate 
TICL 13.7 
-3.0 to -16.0 D 
1.0 to 4.0 
13.7 
4.9 – 5.8 
Flat, plate 

Study #CP18-02 - Protocol 
 
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Page 19 of 39 
The Visian TICL has orientation markings on the footplates to ensure the lens is implanted 
right side up.  When correctly oriented the orientation markings will be on the leading 
right/trailing left footplates.  
The sphere component of the Visian TICL label indicates the spherical power and not 
the spherical equivalent power. 
 
 
4.2 
Instructions for Use and Administration  
Refer to current approved DFU for Visian Toric ICL for surgical instructions.1  
4.2.1 
Storage Requirements 
As instructed on the package labeling, the following storage instructions should be 
followed: 
 Store at room/ambient temperature. 
 Do not autoclave. 
 Do not expose to temperature greater than 40ºC. 
 Do not freeze.   
4.3 
Other Materials  
STAAR will provide the following materials: 
 a MICROSTAARº injector MSI-PF or MSI-TF reusable injector,  
 SFC-45, single use cartridge, and  
 Foam tip plunger (FTP) for each study lens ordered. 
4.4 
Packaging and Labeling  
All TICL lenses will be provided in commercial packaging, as approved by FDA on 13 
Sep 2018.  

Study #CP18-02 - Protocol 
 
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Page 20 of 39 
4.5 
Accountability 
The Investigator will be responsible for keeping current and accurate records of all study 
lenses ordered, received, dispensed, and returned to the Sponsor. The study lenses must be 
stored at room/ambient temperature as described on the package labeling.  
 
5.0 
STUDY CONDUCT 
5.1 
Study Visits  
All Subjects who meet the eligibility criteria will be seen according to the following 
schedule.  
 Preoperative Visit 
Days -120 to 0 
 Operative Visit 
Day 0 
 Postoperative Visit 1 
⁓ 1-6 hours after surgery  
 Postoperative Visit 2 
1 to 2 days postoperatively 
 Postoperative Visit 3 
1 week (5 – 9 days) 
 Postoperative Visit 4 
1 month (3 – 5 weeks) 
 Postoperative Visit 5 
3 months (10 -14 weeks) 
 Postoperative Visit 6 
6 months (21 – 26 weeks) 
 Postoperative Visit 7 
12 months (11 – 14 months) 
 Postoperative Visit 8  
18 months (17 – 21 months) 
 Postoperative Visit 9 
24 months (23 – 27 months) 
 
 
Refer to Appendix A for a schedule of visits and parameters and Appendix B for methods 
of clinical evaluation.  
Following identification of a potential subject, the Investigator (or designee) will explain 
the purpose of the study, procedures, risks/benefits, and subject responsibilities to the 
potential subject. The subject’s willingness and ability to meet the follow-up requirements 
of the study will be determined. If the subject chooses to participate in the investigation, 
written informed consent will be obtained. The subject and the person obtaining written 
consent, will sign and date the IRB approved ICF. The original signed document will be 
retained in the subject records, and a copy will be provided to the subject. In addition, the 
applicable privacy regulation requirements must be met. 

Study #CP18-02 - Protocol 
 
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Page 21 of 39 
5.1.1 
Preoperative Visit – Days -120 to Day 0 
Prospective subjects who have provided informed consent will be screened to determine 
eligibility for treatment in the study. Demographic information, relevant ocular medical 
history, and current ocular medication use will be collected. The preoperative clinical 
evaluation will consist of a complete ophthalmic examination conducted no more than 120 
days prior to surgery. 
Refer to Appendix A: Schedule of Visits and Parameters for assessments to be performed.  
5.1.2 
Operative Visit – Day 0 
Subjects will be reassessed to confirm eligibility. In addition, any changes in concomitant 
medications or AEs will be recorded. If the subject no longer meets eligibility criteria, 
he/she will be considered a screen failure. If the subject is eligible, he/she will be enrolled 
in the study and undergo surgery according to the Investigator’s standard practice for ICL 
surgery and in accordance with the surgical procedure described in the current DFU for the 
Visian Toric ICL1.  
5.1.3 
Postoperative Visit 1 – Operative Day (1 – 6 hours after surgery) 
At approximately 1 – 6 hours after surgery, an intraocular pressure (IOP) reading in the 
implanted eye(s) will be conducted. Any complications, AEs, or associated treatment given 
will be appropriately documented and reported. 
5.1.4 
Postoperative Visits – Day 1 to Month 24 
Each treated subject will be seen for 8 postoperative visits according to the schedule in 
Appendix A.  
5.1.5 
Unscheduled Visits 
Additional visits may be scheduled, as necessary, to ensure the safety and well-being of 
subjects. All additional exams should be fully documented in the source documents and on 
Unscheduled Visit CRFs, as appropriate. Visits intended to fulfill scheduled visit 
requirements that fall outside the designated scheduled visit range, will also be captured on 
Unscheduled Visit CRFs. In these cases, the intended visit will be identified on the 
Unscheduled Visit CRF. 
5.1.6 
Missed Visits  
Site personnel will make every effort to avoid missing data, for example, by scheduling 
visits early in each visit window, calling subjects to remind them of upcoming visits and 
promptly calling subjects who have missed a visit in order to reschedule their visit within 
the appropriate window.  If, despite best efforts, a missed visit cannot be rescheduled, the 
visit will be documented as missed in the source documents and CRFs.   
 
5.2 
Study Completion  
STAAR Surgical will notify the Investigator when to contact the IRB to inform them that 
the study is complete. 

Study #CP18-02 - Protocol 
 
Rev #2, 2019.June.10 
 
Page 22 of 39 
5.2.1 
Early Study Termination 
If during the study it becomes evident to the Sponsor that the study should be stopped 
prematurely, the study will be terminated and appropriate notification will be given to the 
Investigator(s), IRB, and FDA, as applicable. STAAR Surgical will instruct the 
Investigators to stop dispensing study materials/treatment, to assure appropriate follow-up 
for all enrolled subjects and arrange for study closeout at each site as appropriate. 
In addition, should the study be discontinued prior to bilateral implantation, STAAR 
surgical will provide an appropriate commercially available ICL or suitable alternative 
refractive procedure for the subject’s fellow eye. 
5.2.2 
Post-study Follow-up 
If a subject requires further follow-up of serious adverse events (SAEs) upon 
discontinuation or completion of the study, the Investigator should schedule post-study 
follow-up visits, as necessary. Refer to Section 6.3.4 for follow-up of SAEs following study 
exit. 
5.3 
Concomitant Medications/Therapy  
The Investigator may use any medical treatment that is judged appropriate and beneficial 
to the subject. All medications that are considered necessary for the subject’s welfare may 
be used at the Investigator’s discretion. Documentation of all medications used for ocular 
indications by the subject during this study will be recorded in the subject’s source 
document and applicable CRFs. 
5.4 
Protocol Deviations 
The date of and reason for deviations will be documented in all cases. Significant or major 
protocol deviations impacting the safety of the subject or the integrity of the study must be 
reported by the Investigator to the Sponsor and IRB immediately. Reporting of all other 
protocol deviations must adhere to the requirements of the governing IRB.  
Protocol assessments will continue until the end of the study, unless the protocol deviations 
put the subject at risk or the subject’s condition requires that he/she be discontinued from 
the study. 
6.0 
ADVERSE EVENT REPORTING 
Throughout the course of this study, all efforts will be made to remain alert to possible 
AEs. If an AE occurs, the first concern will be the safety of the subject, and appropriate 
medical intervention will be made. All ocular AEs and all SAEs (both ocular and non-
ocular) will be reported in this study. Non-serious non-ocular AEs will not be reported. 
The collection of AEs begins at the time the subject completes the informed consent 
process to participate in the study. 
Refer to Section 6.3.1 for instructions on events that require expedited reporting to the 
Sponsor. 

Study #CP18-02 - Protocol 
 
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Page 23 of 39 
6.1 
Definitions  
6.1.1 
Adverse Event 
An Adverse Event (AE) is any untoward medical occurrence in a subject that does not 
necessarily have a causal relationship to the study device and study protocol. Adverse 
events include Adverse Device Effects (ADEs). 
Complications during phakic IOL surgery of the study eye must be reported as AEs. A 
worsening of a pre-existing ocular condition during the study should be documented as an 
AE and evaluated according to the guidelines in Section 6.2.  
Adverse events that have been associated with the ICL (TICL and MICL) include: 
 anterior subcapsular opacities or clinically significant cataracts,  
 narrowing of the anterior chamber angle, 
 increased IOP, 
 pupillary block,  
 glaucoma, 
 corneal endothelial cell loss, 
 loss of CDVA, 
 increase in refractive astigmatism, 
 pigment dispersion  
 iris transillumination defects. 
As with implantation of other types of IOLs, potential AEs can also include, but are not 
limited to infection (endophthalmitis), hypopyon, corneal endothelial damage, IOL 
dislocation, cystoid macular edema, corneal edema, iritis, retinal detachment, transient or 
persistent glaucoma, vitritis, iris prolapse, and increased visual symptoms related to the 
optical characteristics of the IOL including halos, glare and/or double vision. 
Ocular AEs associated with phakic IOLs may require a secondary surgery in the implanted 
eye(s). The following surgeries have been associated with the ICL (TICL and MICL):  
 surgery to remove, replace or reposition the lens,  
 vitreous aspiration,  
 iridotomy/iridectomy for pupillary block,  
 wound leak repair,  
 retinal detachment repair,  
 corneal transplantation. 
 
Experience with intraocular surgery and the implantation of IOLs has shown that some 
AEs can be considered normal or expected events after these procedures. The following 

Study #CP18-02 - Protocol 
 
Rev #2, 2019.June.10 
 
Page 24 of 39 
may be considered normal or expected events after phakic IOL surgery and only need to 
be reported as AEs at the time frames specified below: 
 iritis/cells/flare (if at postoperative Visit 3 or later) 
 corneal edema (if at postoperative Visit 3 or later) 
 increased IOP if ≥ 30 mmHg or >10 mmHg above the preoperative measurement 
 any expected postoperative ocular event requiring a change in standard 
postoperative medication regimen 
6.1.2 
Adverse Device Effects 
Adverse Device Effects are any untoward or unintended responses to a medical device. 
This definition may include any event resulting from insufficiencies or inadequacies in the 
instructions for use or the deployment of the device or other device malfunctions. This 
definition includes any event that is a result of a user error. 
6.1.3 
Device Deficiency 
A Device Deficiency is any inadequacy of the medical device with respect to its identity, 
quality, durability, reliability, safety or performance. This includes malfunctions, use errors 
and inadequate labeling. A malfunction is any failure of a medical device to perform in 
accordance with its intended purpose when used in accordance with the instructions for use 
or clinical study protocol. All device deficiencies are classified as product complaints and 
are to be reported to the Sponsor as described in Section 6.3.3.   
6.2 
Evaluation 
Adverse events experienced in this study may be associated with the study device (i.e., 
ADE) or the study protocol.  
When evaluating AEs, the Investigator must determine if the event is serious, assess the 
severity of symptoms, and evaluate the relationship of the event to the study device and 
study protocol, using the following guidelines: 
A Serious Adverse Event (SAE) is any AE (ocular or non-ocular) that: 
 results in death 
 results in serious injury, defined as:  
- life-threatening 
- permanent impairment of a body structure or function (e.g., blindness) 
- necessitates medical or surgical intervention to prevent permanent 
impairment to a body structure or a body function, or 
- results in a potentially sight-threatening condition;  
 is a malfunction that might cause or contribute to a serious injury or death if it were 
to recur 
 requires in-patient hospitalization or prolongation of existing hospitalization1 
 leads to fetal distress, fetal death, a congenital abnormality, or birth defect 

Study #CP18-02 - Protocol 
 
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Page 25 of 39 
1Hospitalization is a criterion for assessment of seriousness. Hospitalization in the absence of a 
medical AE is not in itself an AE. For example, the following reports of hospitalization without a 
medical AE should not be considered either serious, or an AE: 
 
administrative admission (e.g., for yearly monitoring exam)  
 
optional admission not associated with a worsening of a pre-existing condition (e.g., 
scheduled repair of the rotator cuff) 
 
hospitalization for admission without a medical AE 
Severity 
 
Mild: Subject awareness of a sign or symptom that is easily tolerated, requires no 
treatment, and does not interfere with the subject’s daily activities 
 
Moderate: Subject awareness of a sign or symptom which may be a low level of 
concern to the subject and may interfere with daily activities, but can be relieved by 
simple therapeutic care 
 
Severe: A sign or symptom that interrupts the subject’s daily activity and requires 
systemic therapy or other treatment 
 
Relationship (Causality) to Study Device or Study Protocol 
 
Not Related: Adverse events which are clearly and incontrovertibly due to causes other 
than the study device or study protocol (e.g., concomitant disease, etc.) 
 
Related: Adverse events which are felt with a reasonable degree of certainty to be 
related to the study device or study protocol 
 
Unknown: Adverse events for which a connection with the study device or study 
protocol cannot be ruled-out with certainty, or not enough information is available to 
assess the relationship 
6.3 
Reporting 
6.3.1 
On-Site Expedited Reporting 
The Investigator is obligated to report the following to the Sponsor within 24 hours of 
becoming aware of the event to ensure the safety of all participants in the study and to meet 
regulatory reporting requirements: 
 
all SAEs, regardless of relationship to study device or study protocol 
 
all non-serious AEs determined to be related to the study device (ADE) 
 
all device malfunctions that do not result in one of the above reportable events 
 
all secondary surgical interventions (removal, replacement or repositioning) involving 
the study lens 
When reporting these events to the Sponsor, the site should forward any supporting 
documents along with the appropriate reporting form and the corresponding CRF, if 
applicable. Refer to the Personnel and Facilities section for Sponsor contact information 
for reporting of SAEs/ADEs and device malfunctions. Sites must also report applicable 
events to the reviewing IRB per its established reporting procedures. 

Study #CP18-02 - Protocol 
 
Rev #2, 2019.June.10 
 
Page 26 of 39 
6.3.2 
Off-Site SAE Reporting 
When participating in multicenter clinical trials, Principal Investigators may receive “off-
site” reports (e.g., SAE Report). These are Sponsor reports of SAEs which occurred at 
other sites for the same trial, or in different trials using the same test article, that met the 
criteria for reporting to a regulatory agency. These should be reported to the reviewing IRB 
per their established reporting procedures. The IRB may require a revision to the ICF and 
re-consenting of subjects if the SAE provides new information regarding risk to the study 
subject.  
6.3.3 
Reporting of Complaints for STAAR Surgical Products 
All information collected on a CRF could potentially be identified as a product complaint, 
as defined in Section 6.1.3. During clinical monitoring by the Sponsor/designee, the 
information collected on the CRFs will be evaluated to determine if any of the information 
should be forwarded to the Sponsor for consideration as a complaint according to STAAR 
standard operating procedures for complaint handling. The Sponsor has the responsibility 
for evaluating and investigating potential complaints in accordance with STAAR’s internal 
complaint handling procedures. 
Any complaints, malfunctions or similar events related to ancillary STAAR Surgical 
marketed products used in this study should be reported by the Investigators in accordance 
with the reference information provided on the commercial packaging. 
6.3.4 
Adverse Events and SAEs at Subject Exit 
Ongoing ocular AEs at study exit will be documented as such in the CRFs and followed 
per the Investigator’s standard of care.  
Ongoing SAEs and ADEs will be followed until resolution or no further change in the 
condition is expected. Non-serious AEs that are ongoing at the study exit visit or upon 
discontinuation from the study will be followed per the Investigator’s standard of care. 
Documentation in the eCRF of this follow-up is not required although subject care should 
continue as appropriate. 
7.0 
STATISTICAL METHODS 
7.1 
Hypothesis 
Based on clinical experience with stabilization of lens rotation over time, it is assumed that 
between 18 and 24 months postoperative, no more than 2% of eyes will exhibit rotation 
>5º.  Our null and alternate hypotheses are as follows: 
H0 (null hypothesis): >10% of eyes with >5º rotation  
Ha (alternative hypothesis):  ≤10% of eyes with >5º rotation 
7.2 
Study Endpoints 
7.2.1 
Primary Effectiveness Endpoint 
The primary endpoint for this study is rotation of less than or equal to five degrees between 
18 and 24 months postoperative. The endpoint will be met if at least 90% of the treated 

Study #CP18-02 - Protocol 
 
Rev #2, 2019.June.10 
 
Page 27 of 39 
eyes rotate less than or equal to five degrees between 18 and 24 months postoperative (i.e., 
≤10% of eyes exhibit >5º rotation).  
7.2.2 
Secondary Endpoints 
The following additional endpoints will be evaluated: 
 
Absolute rotation between visits. 
 
Absolute rotation <5 degrees, <10 degrees, <20 degrees, and <30 degrees from 
the intended orientation at each visit. 
 
Absolute rotation from the intended orientation at each visit. 
 
Postoperative manifest refraction spherical equivalent and cylinder at each visit. 
 
Ocular AE rates assessed in implanted eyes. 
There are no pre-specified performance targets for the secondary endpoints.  
7.3 
Analysis Populations 
All subjects in whom surgery is attempted will be included in both the Intent to Treat (ITT) 
and in the Safety analysis populations.  Effectiveness will also be evaluated using a Per 
Protocol (PP) analysis set.  This set will include subjects with successful implantation, no 
major protocol deviations, and a non-missing primary effectiveness endpoint.  The PP 
analysis set will be supportive of the ITT findings. 
7.4 
Sample Size 
A sample of 100 eyes provides 94.9% power to reject the null hypothesis that >10% of 
eyes will exhibit >5º rotation. We assume that the rotational failure rate will be 2% or less. 
To allow for losses of 10% per year, a total of up to 124 primary eyes of 124 subjects will 
be enrolled. If a primary eye of an enrolled subject is explanted during the study, the 
enrolled fellow eye of that subject may be used in its place for the primary analysis. If the 
fellow eye was not enrolled or implanted, it may not be used in the primary analysis.  
7.5 
Statistical Analysis 
The two-sided 95.0% upper confidence limit of the proportion of eyes with >5º absolute 
rotation will be calculated. The null hypothesis will be rejected if the two-sided 95.0% 
upper confidence limit of the proportion of eyes with >5º absolute rotation between 18 and 
24 months is ≤0.1. An exact binomial confidence interval will be used. 
Secondary endpoints, degrees of rotation between visits and misalignment from the 
intended orientation will be analyzed using descriptive statistics. Rates of rotation of the 
TICL of <10, <20 and <30 degrees from the intended orientation will be reported.  
Evaluation of study endpoints will be conducted separately for study visits conducted 
within the protocol defined visit windows and separately for those outside of the visit 
windows. Out of window visits will be identified during analysis of study accountability. 
If separate evaluations of in-window and out-of-window data, including the distribution of 
times outside of the window that data were collected, justify poolability, then the endpoints 
will be analyzed using the pooled data. 

Study #CP18-02 - Protocol 
 
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Page 29 of 39 
 
the Investigator and site personnel remain qualified and able to conduct the study 
 
test article accountability 
During the course of the study, if the Sponsor determines that an Investigator is  
non-compliant with the study plan and/or applicable regulatory requirements, the Sponsor 
will take action to secure compliance. In addition, the Sponsor may terminate the 
Investigator’s participation in the study if appropriate, or if the Investigator remains  
non-compliant despite the Sponsor’s actions.  
8.2 
Source Documentation 
All medical information obtained at each study visit must be recorded in the subject’s 
record (source documentation) in real time as it is collected. Source documentation consists 
of original subject documents, as well as data and records with information relevant to the 
subject and his/her participation in the study.  
Examples of acceptable source documents include: hospital records, clinical and office 
charts, notes, or memoranda. The signed ICF, evaluation checklists, recorded data from 
automated instruments, and subject files. Source data also include information initially 
recorded in an electronic format (e.g., digital photographs, etc.). 
Source documentation worksheets may be provided by the Sponsor to record pertinent 
information. The completed worksheets can then be incorporated into the subject’s medical 
chart. If it is preferred to not use the worksheets in the subject’s permanent record, then the 
worksheets should be used as a reference to determine the type of study data to record in 
the subject’s permanent record.   
8.3 
Case Report Forms and Data Verification 
Subject data required by this protocol are to be recorded onto electronic CRFs. The 
Investigator and his/her study site personnel will be responsible for completing the CRFs. 
The Investigator is required to verify that all of the requested information is accurately 
recorded on the CRFs. All information requested on the CRFs needs to be supplied, 
including subject identification and initials, date(s), assessment values, etc., and any 
omission or discrepancy will require explanation. All information on CRFs must be 
traceable to source documents if not otherwise specified in the Monitoring Plan for the 
study.  
A STAAR Surgical designee will be responsible for reviewing and verifying the data 
recorded on the CRFs, utilizing the original source documentation and issuing queries as 
necessary for clarifications or discrepancies. The Investigator and study site personnel will 
be responsible for answering all queries. The CRFs will be submitted to STAAR Surgical 
via an electronic data capture system for quality assurance review and statistical analysis.  
A copy of the CRFs will be retained by the Investigator at the conclusion of the study, who 
must ensure that it is stored in a secure place. 
8.4 
Recording of Data and Retention of Documents 
Subject data recorded on CRFs during the study will be documented in a coded fashion. 
The subject will only be identified by the subject number, and by their initials/date of birth 
if also required. Confidentiality of subject records must be maintained to ensure adherence 
to applicable local privacy regulations. 

Study #CP18-02 - Protocol 
 
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Page 30 of 39 
The Investigator must retain essential documents indefinitely after the completion of the 
study, unless otherwise notified by the Sponsor.   
Essential documents include but are not limited to the following: 
 study protocol/amendments 
 Protocol Signature Page signed and dated by Principal Investigator (PI) 
 IRB approved blank as well as copies of all signed subject ICFs 
 all IRB approvals, correspondence and reports (e.g., SAE reports, protocol 
deviations, and safety updates) 
 curriculum vitae and medical licenses for the PI and all sub-investigators (if 
applicable) 
 regulatory documents (e.g., financial disclosure and delegation of authority forms) 
 source documents 
 archive of CRFs 
 Device Investigator Agreement 
 investigational device accountability records 
 relevant correspondence from and to the Sponsor 
 any other documents relevant to the conduct of the study 
In the event that the Investigator withdraws from the study (e.g., retirement, relocation), 
study records will be transferred to a mutually agreed upon designee (e.g., another 
Investigator, site IRB). The Investigator will provide notice of such transfer in writing to 
STAAR Surgical. 
8.5 
Auditing Procedures 
Audits of clinical research activities in accordance with the Sponsor’s internal SOPs to 
evaluate compliance with the principles of GCP may take place. A regulatory authority 
may also wish to conduct an inspection (during the study or after its completion). If an 
inspection is requested by a regulatory authority and/or IRB, the Investigator must inform 
the Sponsor immediately that this request has been made. 
8.6 
Institutional Review Board Approval 
The Investigator should ensure that participation in the study, in addition to the protocol, 
subject recruitment materials and the ICF to be used in this study are approved by their 
institution IRB, or if not using their institution's IRB, approved by the reviewing central 
IRB prior to entering any subjects in the study. Documentation of IRB approval of the 
study protocol and informed consent must be provided to the Sponsor prior to initiation of 
the study and maintained during the course of the study. In addition, the Investigator must 
ensure that the reviewing IRB, and Sponsor have provided approval for any protocol 
amendments prior to implementation. If the amendment necessitates a revision to the ICF, 
the Investigator should ensure the revised form is also submitted to and approved by the 
Sponsor and the IRB prior to re-consenting study subjects.   
8.7 
Publication of Results 
All data generated as a result of this study will be regarded as confidential, until appropriate 
analysis and review by the Sponsor or its designee are completed. The results of the study 
may be published or presented by the Investigator(s) after the review by, and in 

Study #CP18-02 - Protocol 
 
Rev #2, 2019.June.10 
 
Page 31 of 39 
consultation and agreement with the Sponsor, and such that confidential or proprietary 
information is not disclosed. 
Prior to publication or presentation, a copy of the final text should be forwarded by the 
Investigator(s) to the Sponsor or its designee, for comment. Such comments shall aim to 
ensure the scientific integrity of the proposed publications and/or presentations and ensure 
that the data and material referring to STAAR Surgical products and activities receive fair, 
accurate, and reasonable presentation. 
  
 

Study #CP18-02 - Protocol 
Rev #2, 2019.June.10 
 
Page A-1  
APPENDIX A: SCHEDULE OF VISITS AND PARAMETERS  
All study tasks should be performed by qualified study site personnel as indicated on the delegation of authority log under the supervision of the 
Principal Investigator.  
Table 1: Preoperative, Surgical Assessments, and Postoperative Assessments  
PROCEDURE/ 
ASSESSMENTS 
 
PreOp 
Day -120 
to 
Day 0 
Op 
Day 0 
V1 
1-6 hrs 
postop 
V2 
Day 1-2 
V3 
Day 5 - 9 
V4 
Wk 3 – 5 
V5 
Wk 10 – 14 
V6 
Wk 21 – 26 
V7 
Mo 11- 14 
V8 
Mo 17- 21 
V9 
Mo 23- 27 
Informed Consent /HIPAA 
Authorization 
X 
 
 
 
 
 
 
 
 
 
 
Demographics/Relevant 
Ocular Med Hx  
X 
 
 
 
 
 
 
 
 
 
 
Uncorrected Visual Acuity 
(UCVA) 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
CDVA 
X 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Manifest Refraction 
X 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Keratometry 
X 
 
 
 
 
 
 
 
 
 
X 
Slit Lamp Exam 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Specular Microscopy 
(corneal endothelial cell 
count-CECC) 
X 
 
 
 
 
 
 
 
 
 
 
Axial length, White to White 
(W2W), corneal topography 
and ACD 
X 
 
 
 
 
 
 
 
 
 
 
Gonioscopy 
X 
 
 
 
 
 
 
 
 
 
 
IOP 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Cycloplegic refraction 
X 
 
 
 
 
 
 
 
 
 
 
Rotational stability 
assessment1 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
Con meds/AEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
1 Refer to Appendix B 

Study #CP18-02 - Protocol 
Rev #2, 2019.June.10 
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APPENDIX B: 
METHODS OF CLINICAL EVALUATION  
Any changes to the procedures described in this appendix will be provided under separate 
cover. 
Calculation of Lens Power and Size 
The lens power and size calculation will be performed by the surgeon using the STAAR 
Visian Toric ICL Calculation Software.  Alternatively, the power and size of the lens may 
be determined utilizing the surgeon’s standard of care method. 
Postoperative target will be emmetropia with an acceptable variation of ±0.50 D spherical 
equivalent (SE), at the Investigator’s discretion. 
It is recommended that preoperative and postoperative testing be completed in the same 
examination room by the same examiner. This will help to eliminate variability in testing 
equipment, methodology and environment. 
 
Manifest Refraction 
The refraction should be obtained by a qualified ophthalmologist, optometrist, or trained 
ophthalmic technician, in 0.25 D steps, in a calibrated refraction lane. If the subject has a 
current pair of glasses for distance vision, they can be measured with a lensometer and 
these measurements used as the beginning approximate refraction. If the subject does not 
have glasses for distance vision, retinoscopy should be performed by an examiner 
proficient in this procedure. 
AUTOREFRACTION ALONE IS NOT ALLOWED AT ANY POINT IN THIS STUDY. 
RESULTS MUST BE REFINED USING SUBJECTIVE TECHNIQUES. 
The manifest refraction (adjusted for optical infinity as necessary) will be carried out using 
a standard “push plus” procedure, in 0.25 D increments and utilizing Jackson Cross-
cylinder to assess toricity. The end result of the refraction must ensure the manifest 
refraction outcome reflects the very minimum “minus” power required to read the smallest 
line possible. If adding -0.25 does not result in an additional letter read, it must not be 
added. Further, if adding +0.25 does not result in a loss of letters read, it must be added.  
 
Visual Acuity 
Corrected and uncorrected visual acuity at all scheduled visits will be measured using the 
Early Treatment of Diabetic Retinopathy Study (ETDRS) charts at 4 meters or an 
equivalent optotype-adjusted distance.  
The charts were designed according to the following principles described by Bailey and 
Lovie2 and the National Academy of Science-National Research Council (NAS-NRC) 
Committee on Vision 19803: 1) letters of equal legibility; 2) combine the letters so that 
each line is of approximately equal difficulty as described by Ferris et al4; 3) present five 
letters at each acuity level; 4) space rows by the height of the smaller letter; 5) space 
letters by the width of same-sized letters; and 6) use a logarithmic progression of letter 
size from LogMAR (Logarithm of Minimal Angle of Resolution) -0.3 (20/10) to 1.68 
(20/957).  This standard describes a single method for the measurement of VA (which is 

Study #CP18-02 - Protocol 
Rev #2, 2019.June.10 
 Page B-2  
strongly influenced by the methods used in the ETDRS and AREDS protocols) so that 
measurements obtained using the procedures listed below can be compared within and 
between sites.4  
The subject should attempt to read each letter, line-by-line, left to right, beginning with 
line 1 at the top of the chart. The subjects should be told that the chart has letters only, no 
numbers.  If the subject reads a number, he or she should be reminded that the chart 
contains no numbers, and the examiner should then request a letter in lieu of the number.  
The subject should be asked to read slowly, about one letter per second, so as to achieve 
the best identification of each letter.  He/she is not to proceed to the next letter until 
he/she has given a definite response. 
A maximum effort should be made to identify each letter on the chart.  When the subject 
says he/she cannot read a letter, the subject should be encouraged to guess.  If the subject 
identified two (2) letters (e.g., A or B), the subject should be asked to choose one letter 
and, if necessary, to guess. When it becomes evident that no further meaningful readings 
can be made despite encouragement to read or guess, the examiner should stop the testing 
for that eye.  However, all letters on the last line should be attempted as letter difficulties 
vary and the last letter may be the only one read correctly.  The number of letters missed 
or read incorrectly should be noted.   
In order to provide standardized and well-controlled assessment of visual acuity, all 
visual acuity assessments for a subject should be performed consistently (e.g., the same 
lighting conditions, viewing distance, etc.) at each visit. 
Illumination of the ETDRS Chart and Examination Room  
The ETDRS chart background luminance should be 85 cd/m2 (80 – 160 cd/m2 acceptable 
range) for photopic testing. Luminance should be identical for all study sites. The internal 
illumination of the ETDRS chart should be turned on. This will provide the nominal 
contrast for each of the charts. Room illumination should be turned off to ensure that the 
illumination is consistent for each measurement. Ambient sources of light in the room 
should be kept at a minimum. The room lighting and any ambient sources should be 
consistent in their use and placement at each subject visit throughout the course of this 
study.  
Scoring Visual Acuity logMAR Tests 
The examiner records each letter identified correctly by circling the corresponding letter 
on the Visual Acuity Worksheet.  Letters read incorrectly or not read at all are not 
marked on the form.  Each letter read correctly is recorded as one.  The total letters read 
is recorded on the source documents. The logMAR score will be calculated by the 
sponsor. 
During the course of the study, if the subject is unable to read any letters at 1 meter, they 
will be asked to count fingers at 0.5 meters (1 foot and 7 ⅝ inches).  If fingers cannot be 

Study #CP18-02 - Protocol 
Rev #2, 2019.June.10 
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counted at 0.5 meters, the vision will be considered hand motion.  Hand motion will be 
determined at 0.5 meters.  Light perception will be determined using an indirect 
ophthalmoscope. 
The ETDRS chart must be placed at a distance of 4.00 meters (13 feet and 1.5 inches, or 
157.5 inches) from cornea to chart surface, when using a 4-meter chart.  For testing at 1 
meter, the distance must be 1.00 (39 and 3/8 inches). A measuring tape or meter stick 
should always be available to verify the chart distance, even if the examining chair is 
supposed to be immovable or if reference marks are placed on the floor or walls.  
The 1-meter distance is measured from the eye of the participant, seated comfortably in a 
chair with his/her back firmly placed against the chair, to the center of the 2nd or 4th 
letter of the 3rd line of the chart. The measuring device can be home-made (e.g., a dowel 
rod accurately cut to a length of 1.00 m) or 1-meter ruler may be purchased. 
If it is necessary to refract at the 1-meter distance, remember to add +0.75 sphere to the 
trial frame. Subtract the +0.75 sphere from the final refraction obtained at the 1-meter 
distance before recording the refraction. 
Slit Lamp Examination 
This examination will be performed using a slit lamp biomicroscope. It is recommended to 
use a slit beam 1 mm wide by 1 mm high. The following information will be captured for 
this study: 
External and Cornea 
Lids 
Normal/Abnormal 
Conjunctiva 
Normal/Abnormal 
Cornea 
Superficial 
Punctate 
Keratitis (SPK) 
 
0 - None 
1 - Mild 
2 - Moderate 
3 - Severe 
4 - Very Severe 
Corneal Wound 
Edema 
 
0 - None 
1 - Mild 
2 - Moderate 
3 - Severe 
Corneal Edema 
 
0 - No evidence of corneal swelling with normal transparency  
1 - Mild corneal swelling 
2 - Moderate corneal swelling 
3 - Severe and definite widespread cloudiness or haziness giving dull ground glass 
appearance to cornea, or numerous coalescent bullae 

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Anterior Chamber 
For the cell and flare evaluation, use a slit lamp beam 0.3 mm wide and 1 mm high. 
Cells 
0 - No cells seen 
1 - Mild 1-5 cells seen 
2 - Moderate 6-15 cells seen 
3 - Severe 16-30 cells seen 
4 - Very severe >30 cells seen 
Flare 
0 - No Tyndall effect 
1 - Mild Tyndall effect barely discernible 
2 - Moderate Tyndall beam in anterior chamber is moderately intense 
3 - Severe Tyndall beam in anterior chamber is severely intense 
4 - Very severe Tyndall beam. The aqueous has a white and milky appearance 
Iris/Pupil 
Normal/Abnormal 
 
Rotational stability of the implanted TICL will be performed as described in this section.  
All other assessments for this study will be conducted using the Investigator’s standard of 
care methods for ICL surgery. 
 
 
 

Study #CP18-02 - Protocol 
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Photographic Method for Rotational Stability 
 
The aim of imaging the subject’s eye is to establish the rotational stability of the TICL5. In 
order to achieve this on all images, both toric markings on the TICL need to be identifiable. 
Also, the iris architecture and scleral/conjunctival blood vessels should be identifiable. 
A digital slit lamp, capable of 10x magnification and retroillumination photography will 
be used to capture images of the eye that visualize conjunctival vessels or iris features.   
Procedures 
1. Intraoperatively 
Surgical video will be recorded for each subject. Images should be acquired before 
any miotic agent is used to ensure that the axis markings on the TICL are visible 
in the image. 
2. Postoperative Imaging 
At follow-up visits the subject should be dilated (e.g., using phenylephrine 2.5% 
and tropicamide 1.0%) to ensure that the axis markings on the TICL are visible.  
The eye will be placed and imaged with the photo slit lamp as follows: 
 10x magnification 
 Retroilluminate the TICL with the illumination arm perpendicular to cornea 
 Use appropriate slit beam width and height to achieve optimal 
retroillumination and image quality 
Ensure that: 
 
TICL markings visible 
 
TICL edge visible 
 
Eye centered in image 
 
Scleral/conjunctival blood vessels / iris architecture clearly defined 
 A secondary light source should be used to optimize visibility of iris and 
scleral/conjunctival blood vessels. This secondary illumination system needs 
to be set high enough to provide general illumination of the entire eye in 
addition to where the slit beam is present. The secondary illumination system 
can be controlled by twisting the top of the slit lamp where the illumination 
system is. 
3. Images will be downloaded and submitted to an independent reading center for 
analysis of the rotation of the TICL for degrees of rotation between each visit and 
from intended axis placement.  
4. Image Analysis 
a) Determination of the intended TICL axis placement. 
On the intraoperative images, the axis markings on the TICL will be 
identified and a lens-marking-line will be drawn. Landmarks in the iris, 
sclera, or conjunctiva, such as blood vessels and iris features, will be 

Study #CP18-02 - Protocol 
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identified. A landmark-line connecting these landmarks will be drawn. 
The difference in degrees between the lens-marking-line and landmark-
line will be the intended TICL axis placement. 
b) Postoperative TICL Orientation Assessment  
On all images obtained at follow-up visits, a lens-marking-line will be 
drawn. The same landmarks used to determine the TICL axis placement 
on the intraoperative images will be marked and the landmark-line will be 
drawn.  
The TICL axis orientation will be calculated as the difference in degrees 
between the lens-marking-line and the landmark-line.  
Refer to section 7.2 Study Endpoints for the planned analyses. 
 
 
 
 

Study #CP18-02 - Protocol 
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REFERENCES   
1 Directions for Use, Visian® TORIC ICL (Implantable Collamer® Lens) for Myopia.   
 
2 Bailey IL, Lovie JE.  New design principles for visual acuity letter charts. Am J Optom 
Physiol Opt. 1976 Nov; 53(11):740-5. 
 
3 Recommended standard procedures for the clinical measurement and specification of 
visual acuity. Report of working group 39. Committee on vision. Assembly of Behavioral 
and Social Sciences, National Research Council, National Academy of Sciences, 
Washington, D.C. Adv Ophthalmol. 1980; 41:103-48. 
 
4 Ferris FL, Kassoff A, Bresnick GH, et al: New visual acuity charts for clinical research. 
Am J Ophthalmol 94:91-96, 1982. 
 
5 Wolffsohn, JS and Buckhurst, PJ. J Cataract Refract Surg 2010; 36:778–782.