Post-Market Evaluation of the EVO ICL
Phase: NA
Conditions: Myopia, Myopic Astigmatism
Sponsor: Staar Surgical Company

 TITLE PAGE 
Post-Market Evaluation of the EVO ICL 
PROTOCOL 
STUDY #CP22-01 
Sponsor: 
STAAR Surgical Company 
1911 Walker Avenue 
Monrovia, California 91016 
Telephone USA: 626-303-7902 
This clinical study is being conducted in accordance with 21 CFR Parts 11, 50, 54, 56, 803, 814.82(a)(2), 
820; 42 USC 282(j), FDA GCPs and the with the ethical principles laid down in the Declaration of 
Helsinki. 
Revision Chronology:  
Revision 2  
- 
25Apr2023  
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 MicroSTAARTM are registered trademarks of STAAR Surgical Company. 
All other brand names/product names are trademarks of their respective owners.

2023-04-26

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                                          
 Page 3 of 45                                    
INVESTIGATOR STATEMENT OF APPROVAL 
 
Post-Market Evaluation of the EVO ICL 
 
PROTOCOL 
STUDY #CP22-01 
 
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, 21 CFR 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 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 IRBs, 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 #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 4 of 45 
 
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 
Jennifer Lynch MSc 
 
Director, Clinical Operations 
Email: jlynch@staar.com 
 
Clinical Affairs 
Joanne Egamino PhD 
Vice President, Global Clinical Affairs 
Email: jegamino@staar.com  
 
 
Medical Monitor 
Mark Packer MD 
Mark Packer MD Consulting, Inc. 
1400 Bluebell Ave. 
Boulder, CO 80302 
Tel: +1 541 915 0291 
Email: mark@markpackerconsulting.com 
Clinical Investigator(s) 
(Provided under separate cover.) 
 
 
 
 
 
 
 
 
 
 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 5 of 45 
 
TABLE OF CONTENTS 
PAGE 
 
TITLE PAGE ..................................................................................................................................................  
SPONSOR APPROVAL PAGE .................................................................................................................. 2 
INVESTIGATOR STATEMENT OF APPROVAL.................................................................................. 3 
PERSONNEL AND FACILITIES .............................................................................................................. 4 
TABLE OF CONTENTS ............................................................................................................................. 5 
LIST OF ABBREVIATIONS ...................................................................................................................... 7 
SYNOPSIS .................................................................................................................................................... 9 
  INTRODUCTION ............................................................................................................................. 14 
  OBJECTIVE ...................................................................................................................................... 15 
  STUDY DESIGN ................................................................................................................................ 15 
3.1  DESCRIPTION OF STUDY DESIGN...................................................................................................... 15 
3.2  SELECTION OF STUDY POPULATION ................................................................................................. 15 
3.2.1 
Eligibility .............................................................................................................................. 15 
3.2.2 
Subject Completion .............................................................................................................. 18 
3.2.3 
Subject Discontinuation ........................................................................................................ 18 
3.2.4 
Lost to Follow-up ................................................................................................................. 18 
3.3  INVESTIGATORS ............................................................................................................................... 19 
3.4  STUDY DURATION ........................................................................................................................... 19 
  STUDY MATERIALS ....................................................................................................................... 20 
4.1  DESCRIPTION OF INVESTIGATIONAL DEVICE .................................................................................... 20 
4.2  STUDY LENS SUPPLY ....................................................................................................................... 22 
4.2.1 
Instructions for Use and Administration ............................................................................... 22 
  STUDY CONDUCT ........................................................................................................................... 22 
5.1  STUDY VISITS .................................................................................................................................. 22 
5.1.1 
Preoperative Visit – Days -180 to Day -1 ............................................................................. 23 
5.1.2 
Operative Visit – Day 0 ........................................................................................................ 23 
5.1.3 
Postoperative Visits .............................................................................................................. 24 
5.1.4 
Postoperative Visits Day 1 – 18 ............................................................................................ 24 
5.1.5 
Unscheduled Visits ............................................................................................................... 24 
5.1.6 
Missed Visits ........................................................................................................................ 24 
5.2  STUDY COMPLETION ........................................................................................................................ 24 
5.2.1 
Early Study Termination ....................................................................................................... 24 
5.2.2 
Post-study Follow-up ............................................................................................................ 25 
5.3  CONCOMITANT MEDICATIONS/THERAPY ......................................................................................... 25 
5.4  PROTOCOL DEVIATIONS ................................................................................................................... 25 
  ADVERSE EVENT REPORTING ................................................................................................... 26 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 6 of 45 
 
6.1  DEFINITIONS .................................................................................................................................... 26 
6.1.1 
Adverse Event....................................................................................................................... 26 
6.1.2 
Adverse Device Effects ........................................................................................................ 29 
6.2  EVALUATION ................................................................................................................................... 29 
6.3  REPORTING ...................................................................................................................................... 30 
6.3.1 
On-Site Expedited Reporting ................................................................................................ 30 
6.3.2 
Off-Site SAE Reporting ........................................................................................................ 31 
6.3.3 
Reporting of Complaints for Ancillary Marketed STAAR Surgical Products ...................... 31 
6.3.4 
Adverse Events and SAEs at Subject Exit ............................................................................ 32 
  STATISTICAL METHODS ............................................................................................................. 32 
7.1  HYPOTHESIS .................................................................................................................................... 32 
7.2  STUDY ENDPOINTS AND STATISTICAL ANALYSIS ............................................................................ 33 
7.3  SAMPLE SIZE ................................................................................................................................... 34 
  DATA QUALITY ASSURANCE ..................................................................................................... 35 
8.1  STUDY MONITORING ....................................................................................................................... 35 
8.2  SOURCE DOCUMENTATION .............................................................................................................. 35 
8.3  CASE REPORT FORMS AND DATA VERIFICATION ............................................................................. 36 
8.4  RECORDING OF DATA AND RETENTION OF DOCUMENTS.................................................................. 36 
8.5  AUDITING PROCEDURES .................................................................................................................. 37 
8.6  INSTITUTIONAL REVIEW BOARD APPROVAL .................................................................................... 37 
8.7  PUBLICATION OF RESULTS ............................................................................................................... 37 
  REFERENCES ................................................................................................................................... 38 
 
APPENDIX A:  SCHEDULE OF VISITS AND PARAMETERS ......................................................... 38 
APPENDIX B:  METHODS OF CLINICAL EVALUATION ............................................................... 40 
 
 
 
 
 
 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 7 of 45 
 
LIST OF ABBREVIATIONS 
Abbreviation 
/Acronym  
Term  
AC Anterior Chamber 
ACD Anterior Chamber Depth 
ADE Adverse Device Effect 
AE  Adverse Event 
AS-OCT Anterior Segment Optical Coherence Tomography 
BID Twice a Day 
CDVA Corrected Distance Visual Acuity 
CFR Code of Federal Regulations 
CME Cystoid Macular Edema 
CRF Case Report Form 
CRSE Cycloplegic Refraction Spherical Equivalent 
CV Curriculum Vitae 
D Diopters 
DFU/eDFU Directions for Use/electronic Directions for Use 
DIA Device Investigator Agreement 
DOA Delegation of Authority 
EC Ethics Committee 
ECD Endothelial Cell Density 
EVO ICL Brand name for VICMO and VTICMO lens models 
EVO+ ICL Brand name for VICM5 and VTICM5 models 
FDA United States Food and Drug Administration 
GCPs Good Clinical Practices 
HEMA Hydroxyethyl Methacrylate 
HIPAA Health Insurance Portability and Accountability Act 
HPMC Hydroxypropylmethylcellulose 
ICF Informed Consent Form  
ICH International Conference on Harmonisation 
ICL Implantable Collamer Lens 
IOL Intraocular Lens 
IOP Intraocular pressure 
IRB Institutional Review Board 
MRSE Manifest Refraction Spherical Equivalent 
NSAID Non-steroidal Topical Anti-inflammatory Drug 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 8 of 45 
 
Abbreviation 
/Acronym  
Term  
OCT Ocular Coherence Topography 
OVD Ophthalmic Viscoelastic Device 
PAS Post Approval Study/Peripheral Anterior Synechiae 
PI Principal Investigator 
PIB Patient Information Booklet 
PMA Premarket Approval Application 
QD Once a day 
QID Four times a day 
RD Retinal Detachment 
SAE Serious Adverse Event 
SE Spherical Equivalent 
SOP Standard Operating Procedure 
SSI Secondary Surgical Intervention 
STAAR STAAR Surgical Company 
SUN Standardization of Uveitis Nomenclature 
TASS Toxic Anterior Segment Syndrome 
US United States 
UV Ultraviolet 
VA Visual Acuity 
NOTE: The first occurrence of some abbreviations is not spelled out in the document (e.g., units of 
measure). 
 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 9 of 45 
 
SYNOPSIS  
STAAR Surgical Company Study #CP22-01: Post-Market Evaluation of the EVO ICL 
Revision 
chronology: 
Rev 1, 06May2022 
Title: 
Post-Market Evaluation of the EVO ICL 
Type of study:  
Post-approval study (PAS)  
Objective(s): 
To assess the rate of early intraocular pressure (IOP) increases following 
implantation of EVO/EVO+ICL lenses (EVO ICL). 
Study design: 
This new enrollment, prospective, multi-center, single arm PAS will be 
conducted at up to 10 clinical sites in the United States (US). The study is 
designed to evaluate the success of the EVO Physician Certification Program in 
reducing the rate of early IOP increases at 1 – 6 hours after implantation of EVO 
ICL lenses by surgeons who have been trained and certified under the EVO 
Physician Certification Program.  
This PAS will enroll a minimum of 200 subjects (i.e., 200 primary eyes and 200 
fellow eyes) who are eligible for EVO ICL surgery in both eyes. All subjects are 
intended to undergo bilateral implantation with the second-eye surgery 
occurring from 1 – 14 days (1≤14 days) following the day of first eye surgery. 
Surgeons will use 2% HPMC OVD for EVO ICL surgery as recommended in 
the EVO ICL Directions for Use (DFU). 
Subjects will be seen for 4 postoperative visits at the following timepoints:  
 
1 – 6 hours postoperatively 
 
1 day postoperatively 
 
5 – 9 days postoperatively 
 
10 – 18 days postoperatively 
Study duration: 
This study is expected to require approximately 28 months following initiation, 
including approximately 24 months for enrollment, approximately 2 – 3 weeks 
for follow-up of each eye and approximately 3 months for data analysis and 
reporting. 
Eligibility criteria: 
Subjects aged 21 to 45 years implanted with EVO ICLs in both eyes, in 
accordance with the product labeling and the following eligibility criteria: 
Inclusion Criteria 
1. Subjects 21 through 45 years old at time of surgery. 
2. For EVO ICL for Myopia: 
 
Moderate to high myopia ranging from -3.00 D to ≤ -20.00 D spherical 
equivalent (SE) in the spectacle plane with less than or equal to 2.50 D 
of astigmatism (in the spectacle plane). 
For EVO Toric ICL for Myopia with Astigmatism: 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 10 of 45 
 
STAAR Surgical Company Study #CP22-01: Post-Market Evaluation of the EVO ICL 
 
Moderate to high myopic astigmatism with spherical equivalent 
ranging from -3.00 D to ≤ -20.00 D (in the spectacle plane) and 
cylinder in the range of 1.00 D to 4.00 D (in the spectacle plane). 
 
Stable refractive history within 0.50 D cylinder for 1 year prior to 
implantation as determined by the Investigator. 
3. Stable refractive history within 0.50 D for spherical equivalent 1 year prior 
to implantation as determined by the Investigator. 
4. Anterior chamber depth (ACD) 3.00 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 ECD for Age and True ACD*” table below).  
6. Correctable distance visual acuity (CDVA) of at least 20/40 in the eye(s) to 
be treated; and absence of ocular pathology (except that myopic degeneration 
is allowed). 
7. Difference between cycloplegic refraction spherical equivalent (CRSE) and 
manifest refraction spherical equivalent (MRSE) of < 0.75 D. 
8. Able and willing to return for scheduled follow-up examinations after 
surgery. 
9. 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. 
Exclusion Criteria 
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 ECD for Age 
and True ACD*” table below. 
5. Unstable or worsening nearsightedness. 
6. Ocular hypertension or glaucoma. 
7. Pseudoexfoliation. 
8. Pigment dispersion. 
9. History or clinical signs of iritis/uveitis. 
10. Insulin-dependent diabetes or diabetic retinopathy.  
11. History of previous ocular surgery. 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 11 of 45 
 
STAAR Surgical Company Study #CP22-01: Post-Market Evaluation of the EVO ICL 
12. Progressive sight threatening disease or other previous or current ocular 
conditions, other than myopia or myopic degeneration, which may 
predispose for future complication in either eye.  
13. Serious 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 (e.g., immunocompromised, 
connective tissue disease, clinically significant atopic disease, uncontrolled 
diabetes, etc.). 
14. Monocular subjects. 
15. For EVO ICL for myopia: myopia less than -3.00 D SE (in the spectacle 
plane) or greater than -20.00 D SE (in the spectacle plane) and/or with greater 
than 2.50 D of astigmatism (in the spectacle plane). 
16. For EVO Toric ICL for myopia with astigmatism: myopia less than -3.00 D 
or greater than -20.00 D SE (in the spectacle plane) and/or refractive cylinder 
(in the spectacle plane) less than 1.00 D and greater than 4.00 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 while participating in this study. 
19. Subjects who, in the judgment of the Investigator, present any emotional, 
physiologic, or anatomical condition which may preclude participation in this 
study or provide an inappropriate landscape for the intended study treatment. 
Minimum Endothelial Cell Density for Age and True ACD* 
Age 
Minimum ECD 
ACD ≥ 3.0 mm 
Minimum ECD 
ACD ≥ 3.2 mm 
Minimum ECD 
ACD ≥ 3.5 mm 
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 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 12 of 45 
 
STAAR Surgical Company Study #CP22-01: Post-Market Evaluation of the EVO ICL 
from the anterior corneal surface, the thickness of the cornea must be 
subtracted to get the true ACD. 
Device description: 
The EVO/EVO+ lenses approved under PMA P030016/S035 include a refractive 
optic and features a single piece lens design with a convex/concave optic zone of 
4.9 to 6.1 mm diameter (according to model and power) and a 0.36 mm diameter 
central port. The lens is manufactured from Collamer, a proprietary hydroxyethyl 
methacrylate (HEMA)/porcine-collagen biocompatible polymer material with an 
ultraviolet (UV) absorber. The lens is manufactured in four overall diameters: 
12.1, 12.6, 13.2, and 13.7 mm to accommodate different eye sizes and feature a 
plate-haptic design with a central convex/concave optical zone and incorporate a 
forward vault to minimize contact with the central anterior capsule. The lens is 
supplied with a delivery system for implantation through an incision of 3.5 mm 
or less.  
EVO/EVO+ lenses have orientation markings on the footplates to ensure they are 
implanted in the correct orientation. When correctly oriented the orientation 
markings will be on the leading right/trailing left footplates.  
The EVO/EVO+ Toric lenses are labeled using a plus cylinder axis format and 
have two engraved lines, one on each side of the optic to aid with the axis 
alignment of the lens. The following EVO/EVO+ Models will be included in this 
study: 
 
EVO/EVO+ Visian Implantable Collamer Lens for Myopia: 
VICMO 12.1, VICMO 12.6, VICMO 13.2, VICMO 13.7, VICM5 12.1, 
VICM5 12.6, VICM5 13.2, VICM5 13.7 
 
EVO/EVO+ Visian Toric Implantable Collamer Lens for Myopia with 
Astigmatism: 
VTICMO 12.1, VTICMO 12.6, VTICMO 13.2, VTICMO 13.7, 
VTICM5 12.1, VTICM5 12.6, VTICM5 13.2, VTICM5 13.7 
All lenses are available in -3.00 D to -16.00 D SE dioptric powers. The 
EVO/EVO+ Visian Toric ICLs are also available in cylinder dioptric power of 
1.00 D to 4.00 D. 
Indications for Use: 
(EVO/EVO+ Sphere Lenses) 
The EVO ICL lens is indicated for use in patients 21-45 years of age: 
1. for the correction of myopia with spherical equivalent ranging from -3.0 D 
to ≤ -15.0 D with less than or equal to 2.5 D of astigmatism at the spectacle 
plane; 
2. for the reduction of myopia with spherical equivalent ranging from greater 
than -15.0 D to -20.0 D with less than or equal to 2.5 D of astigmatism at the 
spectacle plane; 
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 1 year prior 
to implantation). 
4. The EVO ICL lens is intended for placement in the posterior chamber 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 13 of 45 
 
STAAR Surgical Company Study #CP22-01: Post-Market Evaluation of the EVO ICL 
(ciliary sulcus) of the phakic eye. 
(EVO/EVO+ Toric Lenses) 
The EVO 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 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 EVO TICL lens is intended for placement in the posterior chamber 
(ciliary sulcus) of the phakic eye. 
Study endpoints: 
Primary: The proportion of primary (i.e., first implanted) eyes that have IOP ≥ 
30 mmHg and IOP ≥ 40 mmHg at 1 – 6 hours postoperatively.  
Secondary: The proportion of fellow eyes that have IOP ≥ 30 mmHg and IOP ≥ 
40 mmHg at 1 – 6 hours postoperatively.  
Statistical methods: 
Analysis of the superiority of the proportion of primary eyes that have IOP ≥ 30 
mmHg and IOP ≥ 40 mmHg at 1 – 6 hours postoperatively compared with the 
outcomes of Premarket Approval Application (PMA) Study CP19-01, i.e., 
15.3% (50/327) primary eyes with IOP ≥ 30 mmHg, and 7.0% (23/327) primary 
eyes with IOP ≥ 40 mmHg. Analysis of fellow eye rates will be used to support 
the findings of the two primary eye analyses. 
Summaries for continuous variables will include the sample size, mean, standard 
deviation, median, minimum, and maximum. Summaries for discrete variables 
will include the tabulation of frequencies and percentages. 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 14 of 45 
 
 
 
INTRODUCTION  
The EVO Visian Implantable Collamer Lenses (ICLs) were approved by the US Food 
and Drug Administration (FDA) in March 20221 for the following indications: 
(EVO/EVO+ Sphere Lenses) 
The EVO ICL lens is indicated for use in patients 21-45 years of age: 
1. for the correction of myopia with spherical equivalent ranging from -3.0 D to ≤ -
15.0 D with less than or equal to 2.5 D of astigmatism at the spectacle plane; 
2. for the reduction of myopia with spherical equivalent ranging from greater than -
15.0 D to -20.0 D with less than or equal to 2.5 D of astigmatism at the spectacle 
plane; 
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 1 year prior to implantation). 
4. The EVO ICL lens is intended for placement in the posterior chamber (ciliary 
sulcus) of the phakic eye. 
(EVO/EVO+ Toric Lenses) 
The EVO 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 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 EVO TICL lens is intended for placement in the posterior chamber (ciliary 
sulcus) of the phakic eye. 
All surgeons are required to be certified by STAAR Surgical Company (STAAR) prior to 
being granted access to order STAAR ICLs for their patients. The EVO Physician 
Certification Program has been revised to align with the device labeling approved by the 
FDA.2 STAAR is conducting a Post-Approval Study (PAS) designed to evaluate the 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 15 of 45 
 
effectiveness of the EVO certification training program in reducing the risks of early 
postoperative Intraocular Pressure (IOP) increases due to incomplete removal of 2% 
hydroxypropylmethylcellulose (HPMC) ophthalmic viscoelastic device (OVD). 
 
OBJECTIVE 
The objective of this PAS is to assess the rate of early IOP increases following 
implantation of EVO ICL lenses. 
 
STUDY DESIGN 
3.1 
Description of Study Design  
This prospective, multi-center, single arm PAS will enroll subjects who are eligible for 
EVO ICL surgery at up to 10 clinical sites in the US. A minimum of 200 subjects (i.e., 
200 primary eyes and 200 fellow eyes) will be enrolled in the study. All subjects are 
intended to undergo bilateral implantation with the second-eye surgery occurring from 1 
– 14 days (1≤14 days) following the day of first eye surgery. 
Enrolled subjects will have EVO ICL surgery performed by an Investigator surgeon who 
has been trained and certified under the STAAR EVO Certification Program. A total of 
four postoperative visits will be conducted after surgery for each eye (OP Visit); at 1– 6 
hours after surgery (Day 0), at 1 day after surgery (Day 1), at approximately 1 week 
(Week 1, days 5 – 9) and at approximately 2 weeks after surgery (Week 2, Days 10 – 18). 
3.2 
Selection of Study Population  
Subjects will be selected from each clinical site’s patient population. Patients meeting all 
of the eligibility criteria will be considered suitable study subjects and will be offered 
consecutive enrollment into this study. 
3.2.1 
Eligibility 
 Inclusion Criteria  
1. Subjects must be between the ages of 21 and 45 at the time of surgery.  
2. For EVO ICL for Myopia: 
 Moderate to high myopia ranging from -3.00 D to ≤ -20.00 D spherical 
equivalent (SE) in the spectacle plane, with less than or equal to 2.50 D of 
astigmatism (in the spectacle plane). 
For EVO Toric ICL for Myopia with Astigmatism: 
 Moderate to high myopic astigmatism with spherical equivalent ranging from 
-3.00 D to ≤ -20.00 D (in the spectacle plane) and cylinder in the range of 1.00 
D to 4.00 D (in the spectacle plane) 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 16 of 45 
 
 Stable refractive history within 0.50 D cylinder for 1 year prior to 
implantation as determined by the Investigator. 
3. Stable refractive history within 0.50 D for spherical equivalent 1 year prior to 
implantation as determined by the Investigator. 
4. ACD 3.00 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 Table 1: Minimum Endothelial Cell Density for Age and True 
ACD*).  
6. Correctable distance visual acuity (CDVA) of at least 20/40 in the eye(s) to be 
treated; and absence of ocular pathology (except that myopic degeneration is 
allowed). 
7. Difference between cycloplegic refraction spherical equivalent (CRSE) and 
manifest refraction spherical equivalent (MRSE) of <0.75 D. 
8. Subjects must be able and willing to return for scheduled follow-up examinations 
after surgery. 
9. 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. 
 
 Exclusion Criteria 
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 Table 1: Minimum ECD for Age 
and True ACD. 
5. Unstable or worsening nearsightedness. 
6. Ocular hypertension or glaucoma. 
7. Pseudoexfoliation. 
8. Pigment dispersion. 
9. History or clinical signs of iritis/uveitis. 
10. Insulin-dependent diabetes or diabetic retinopathy. 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 17 of 45 
 
11. History of previous ocular surgery. 
12. Progressive sight threatening disease or other previous or current ocular 
conditions, other than myopia or myopic degeneration, which may predispose for 
future complication in either eye. 
13. Serious 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 (e.g., immunocompromised, connective tissue 
disease, clinically significant atopic disease, uncontrolled diabetes, etc.). 
14. Monocular subjects 
15. For EVO/EVO+ ICL for myopia: myopia less than -3.00 D SE (in the spectacle 
plane) or greater than -20.00 D SE (in the spectacle plane) and/or with greater 
than 2.50 D of astigmatism (in the spectacle plane). 
16. For EVO/EVO+ Toric ICL for myopia with astigmatism: myopia less than -3.00 
D or greater than -20.00 D SE (in the spectacle plane) and/or refractive cylinder 
(in the spectacle plane) less than 1.00 D and greater than 4.00 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 while participating in this study. 
19. Subjects who, in the judgment of the Investigator, present any emotional, 
physiologic, or anatomical condition which may preclude participation in this 
study or provide an inappropriate landscape for the intended study treatment. 
Table 1: 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 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 18 of 45 
 
Age 
Minimum ECD 
ACD ≥ 3.0mm 
Minimum ECD 
ACD ≥ 3.2mm 
Minimum ECD 
ACD ≥ 3.5mm 
>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. 
3.2.2 
Subject Completion 
The subject has completed the entire study when the study lenses have been implanted 
bilaterally and the Sponsor receives completed case report form (CRF) documentation for 
all visits. Subjects who require further follow-up for an adverse event (AE) will be 
followed according to Section 6.3.4. 
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(es) 
 explantation of the study lenses 
If the study lens is explanted, a minimum of one post-explant visit should be completed 
to record safety measures for the subject (e.g., CDVA, IOP, etc.). 
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 6.3.4. Subject withdrawals will 
be documented clearly on the source document and applicable CRF. 
Only subjects who do not receive successful bilateral implantation MAY be replaced. 
Subjects who are discontinued from the study following treatment will not be replaced. 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 19 of 45 
 
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 last 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 up to 10 clinical site(s) located in the US.  
The study will be conducted by Investigator surgeons who have been trained and certified 
under the STAAR EVO Certification Program and who have been determined to be 
suitably qualified by training and experience to conduct this study in compliance with all 
applicable Good Clinical Practices (GCPs) and FDA Federal Regulations.  
Sub-Investigators will be identified on the Device Investigator Agreement (DIA)/ 
Delegation of Authority Log (DOA).  
Each Investigator will enroll approximately 20 subjects (40 eyes) and no individual site 
may enroll more than 25% of the total enrollment.  
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 
28 months following study initiation (see Table 1). Eligible subjects who are enrolled in 
the study will be seen for 4 scheduled study visits (per eye) over the course of 
approximately 2 weeks after surgery.  
Table 1: Enrollment Milestones 
Milestone 
Date 
First Subject Enrolled 
Within 6 months of FDA approval of PAS protocol 
20% of Subjects Enrolled 
(40 subjects) 
Within 12 months of FDA approval of PAS protocol 
50% of Subjects Enrolled 
(100 subjects) 
Within 18 months of FDA approval of PAS protocol 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 20 of 45 
 
Milestone 
Date 
100% of Subjects Enrolled 
(200 subjects) 
Within 24 months of FDA approval of PAS protocol 
 
In addition, STAAR will provide interim study reports every 6 months from FDA 
approval of the PAS supplement, then every 6 months thereafter until subject enrollment 
has been completed, and then annually thereafter until completion of the post-approval 
study according to the schedule provided in Table 2.  
Table 2: Reporting Schedule Plan  
Milestone 
Date 
FDA Approval of Study 
Protocol  
TBD 
6 Month Status Report 
6 months after FDA approval of PAS protocol 
12 Month Status Report 
12 months after FDA approval of PAS protocol 
18 Month Status Report 
18 months after FDA approval of PAS protocol 
24 Month Status Report 
24 months after FDA approval of PAS Protocol  
Final Report 
Within 3 months of database lock following last 
subject exit from study.  
 
 
STUDY MATERIALS 
4.1 
Description of Investigational Device  
The EVO/EVO+ Visian Implantable Collamer Lens for Myopia (Figure 1), and 
EVO/EVO+ Visian Toric Implantable Collamer Lens for Myopia with Astigmatism 
(Figure 2) study lenses (EVO lenses), are sterile intraocular implants manufactured from 
Collamer, a proprietary hydroxyethyl methacrylate (HEMA)/porcine- collagen 
biocompatible polymer material. These lenses contain an Ultraviolet (UV) absorber made 
from a UV absorbing material. The lenses feature a plate-haptic design with a central 
convex/concave optical zone and incorporate a forward vault to minimize contact with 
the central anterior capsule. 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 21 of 45 
 
The EVO lenses feature a 0.36 mm central port, and an optic diameter that varies with the 
dioptric power; the smallest optic diameter being 4.9 mm and the largest 5.8 mm for 
EVO and 6.1 mm for EVO+. The implantable lenses are capable of being folded and 
inserted into the posterior chamber through an incision of 3.5 mm or less. The EVO 
lenses have orientation markings on the footplates to ensure the lenses are implanted in 
the correct orientation. When correctly oriented the orientation markings will be on the 
leading right/trailing left footplates.  
The EVO lenses are intended to be placed entirely within the posterior chamber (ciliary 
sulcus) directly behind the iris and in front of the anterior capsule of the human 
crystalline lens. When correctly positioned, the lenses function as a refractive element to 
optically reduce moderate to high myopia and myopic astigmatism (toric lens only). 
Figure 1: EVO/EVO+ Lens Models for Myopia 
 
 
The EVO Toric lenses are labeled using a plus cylinder axis format. The lens axis is 
labeled to the nearest degree and as such lenses of any axis between 1°to 180° may be 
held in inventory. The EVO Toric Lenses are 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 lenses have two engraved lines, one on each side of the optic. These 
are to aid with the axis 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.   

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 22 of 45 
 
Figure 2: EVO/EVO+ Toric Lens Models for Myopia with Astigmatism 
 
 
 
The following FDA-approved EVO Models are included in this study: 
 EVO/EVO+ Visian ICL for Myopia: 
VICMO 12.1, VICMO 12.6, VICMO 13.2, VICMO 13.7, VICM5 12.1, VICM5 
12.6, VICM5 13.2, VICM5 13.7 
 EVO/EVO+ Visian Toric ICL for Myopia with Astigmatism: 
VTICMO 12.1, VTICMO 12.6, VTICMO 13.2, VTICMO 13.7, VTICM5 12.1, 
VTICM5 12.6, VTICM5 13.2, VTICM5 13.7 
4.2 
Study Lens Supply 
The lens power and size calculation will be performed by the surgeon using the STAAR 
EVO ICL Online Calculation and Ordering Software. (www.ocos.STAAR.com). 
Alternatively, the power and size of the lens may be determined utilizing the surgeon’s 
standard of care method for ICL surgery. Postoperative target for all enrolled eyes will be 
emmetropia with an acceptable variation of ±0.50 D spherical equivalent (SE), at the 
Investigator’s discretion. 
All EVO ICL lenses will be shipped to the site from STAAR Surgical. Lenses will be 
provided in commercial packaging, as approved by FDA in March 20221 and must be 
stored as specified on the package labeling. 
4.2.1 
Instructions for Use and Administration  
Refer to current approved EVO ICL Directions for Use (DFU) for surgical instructions.2  

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 23 of 45 
 
Study surgeons will use 2% HPMC OVD for EVO ICL surgery as recommended in the 
DFU.2 
The Investigator will be responsible for keeping current and accurate records of all study 
lenses received, dispensed, and returned to the Sponsor. 
 
STUDY CONDUCT 
5.1 
Study Visits  
All Subjects who meet the eligibility criteria will be seen according to the following 
schedule.  
 
Table 3: Study Visit Schedule 
Visit (per eye) 
Time 
Preoperative Visit 
Days - 180 to 0 
Operative Visit 
Day 0 
Postoperative Visit 1 
1 to 6 hours postoperatively  
Postoperative Visit 2 
Day 1 postoperatively  
Postoperative Visit 3 
Day 5 - 9 postoperatively  
Postoperative Visit 4  
Day 10 - 18 postoperatively 
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 will also be provided with a copy of the FDA approved 
Patient Information Booklet (PIB) for the EVO ICL.3 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. 
5.1.1 
Preoperative Visit – Days -180 to Day -1 
Prospective subjects who have provided informed consent will be screened to determine 
eligibility for treatment in the study. All preoperative testing for the study must be 
completed within 180 days prior to the first surgery. Data from routine (non-study 
specific) preoperative ophthalmic assessments for ICL surgery performed prior to the 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 24 of 45 
 
informed consent process may be included. In such cases, the date of the test will be 
documented in the subjects’ source document. 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 180 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 and changes in concomitant medications 
or AEs will be recorded. Subjects who no longer meet eligibility criteria, or if they 
qualify but decide not to participate further in the study, or if they decide not to proceed 
with surgery, will be considered screen failures and exited from the study.  
If the subject is eligible, he/she will be enrolled in the study and undergo surgery in 
accordance with the surgical procedure described in the current DFU for the EVO ICL.2 
If the study lens in not implanted due to a surgical complication, the subject will be 
discontinued from the study. For subjects who qualify to participate bilaterally, fellow 
eye implantation should occur from 1 – 14 days after uneventful surgery in the first eye. 
Any complications, AEs, or associated treatment given will be appropriately documented 
and reported in the CRFs. 
5.1.3 
Postoperative Visits 
Each treated eye will be seen for 4 postoperative visits according to the schedule in 
Appendix A. Postoperative visits for both eyes may be scheduled on the same day only if 
the study visit window for each eye allows. 
 Postoperative Visit 1 – Operative Day (1 – 6 hours after surgery) 
At approximately 1 – 6 hours after surgery, an IOP reading and slit lamp examination in 
the implanted eye(s) will be conducted. Any complications, AEs, or associated treatment 
given will be appropriately documented and reported in the CRFs. 
5.1.4 
Postoperative Visits Day 1 – 18 
An IOP reading will be performed at these visits in addition to other standard 
postoperative assessments as part of the normal postoperative standard of care. Any AEs 
of increased IOP compared to baseline will be documented.  Evaluation of the anterior 
chamber angle is to be performed by gonioscopy or AS-OCT in cases where gonioscopy 
is contraindicated as presented in Appendix B. Associated treatments will be 
appropriately documented and reported in the CRFs. 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 25 of 45 
 
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, are not Unscheduled 
Visits. In these cases, the visit data will be collected and transcribed to the appropriate 
scheduled visit CRF. 
5.1.6 
Missed Visits  
If a subject misses any scheduled follow-up visit and cannot be seen prior to the start of 
the visit range for the next scheduled follow-up visit, 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. 
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. 
5.2.2 
Post-study Follow-up 
If a subject requires further follow-up of an Adverse Event/Serious Adverse Event (SAE) 
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 following medication regimen will be followed by all sites: 
 topical 4th generation fluoroquinolone four times a day (QID) starting 3 days 
prior to surgery for a total of 10 days, 
 topical non-steroidal anti-inflammatory drugs (NSAIDs) QID, twice a day (BID) 
or once a day (QD) per NSAID labeled dosing instructions for postoperative 
inflammation starting 3 days prior to surgery for a total of 10 days and then 
tapered weekly, 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 26 of 45 
 
 topical steroid QID starting 3 days prior to surgery for a total of 10 days and then 
tapered weekly. 
Note: No prophylactic systemic or topical IOP lowering medications (e.g., 
acetazolamide) will be used.  Ocular hypotensive agents may not be used for prophylaxis 
of increased IOP because doing so will confound the results of the study. 
During the study follow-up period, 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 and “other” non-medication therapy 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 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. 
 
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 serious AEs (both ocular and 
non-ocular) and all interventions to treat these AEs (i.e., concomitant medications, 
release of aqueous from a pre-existing corneal incision or needle paracentesis, etc.) will 
be documented on source documents and reported to the Sponsor/designee in the CRFs. 
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. 
6.1 
Definitions  
6.1.1 
Adverse Event 
An Adverse Event 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, see Section 6.1.2). 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 27 of 45 
 
AEs Associated with IOLs 
Adverse events associated with implantation of all types of Intraocular Lenses (IOLs) 
(i.e., aphakic and phakic), need to be reported as AEs on the AE CRF. These can include, 
but are not limited to the following: 
 Complications during phakic IOL surgery 
 Worsening of a pre-existing ocular condition during the study  
 Chronic Anterior Uveitis: anterior chamber (AC) cells or flare of greater than 
grade 2 (using the Standardization of Uveitis Nomenclature, SUN criteria4) at 
postoperative Visit 3 (Day 5 – 9) or later 
 Clinically significant cystoid macular edema (CME): macular edema diagnosed 
by clinical examination and adjunct testing (e.g., optical coherence topography 
[OCT], fluorescein angiography) resulting in CDVA of 20/40 or worse at Visit 3 
(Day 5-9) or later. 
 Clinically significant corneal edema: corneal swelling (stromal or epithelial) at 
postoperative Visit 3 (Day 5 – 9) or later 
 Endophthalmitis: intraocular inflammation requiring diagnostic vitreous tap and 
intraocular antibiotics, 
 Mechanical pupillary block: shallowing of anterior chamber due to obstruction of 
aqueous humor flow from the posterior to anterior chamber through the pupil by 
the crystalline lens, vitreous face, or implanted device. 
 Rhegmatogenous retinal detachment (RD): partial or complete RD associated 
with retinal tear. 
 Toxic anterior segment syndrome (TASS): acute, non-infectious inflammation of 
the anterior segment that starts within 24 to 48 hours after surgery, usually 
resulting in hypopyon and commonly presenting with corneal edema and 
improving with steroid treatment. 
 All Secondary Surgical Interventions (SSIs) and events that cause these 
interventions should be reported as AEs, regardless of when they occur. 
o For SSIs of secondary IOL intervention* 
- Exchange – investigational device is replaced with the same lens 
model 
- Removal – investigational device is removed and replaced with a non-
investigational lens or no lens is implanted 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 28 of 45 
 
- Reposition – existing IOL is surgically moved to another location or 
rotated 
*Exchanges, removals, and repositions should be further sub-
categorized by the problem that caused the need for the intervention 
(e.g., pupil ovalization, subject-reported undesirable optical 
phenomena, damaged IOL, malpositioned IOL, lens optic abnormality, 
iris pigment epithelial loss, endothelial cell loss, incorrect IOL power, 
chronic anterior uveitis, cataract, etc.). 
Experience with intraocular surgery and the implantation of IOLs has shown that some 
AEs can be considered normal or expected events after these procedures. Early, low 
grade anterior chamber cell/flare, corneal edema, and increase in IOP can often be 
considered normal or expected after phakic IOL surgery. They do not need to be reported 
as AEs if they occur prior to 1 week postoperatively AND if they meet the following 
criteria:  
 AC cells or flare of grade 2 (using the SUN criteria3) or less that require no 
change in standard postoperative medication regimen; if persisting to 1 week or 
more these should be reported as an AE.  
 Corneal edema of ≤ grade 2 that does not reduce CDVA to 20/40 or worse and 
does not require any change in standard postoperative medication regimen; if 
corneal edema persists to 1 week or more it should be reported as an AE.  
 Increased IOP that is <10 mmHg above baseline or is <25 mmHg and requires no 
change in standard postoperative medication regimen or any other special 
treatment. Any increased IOP ≥ 10 mmHg above baseline to a minimum of 25 
mmHg or any increase in IOP that is treated in any way, should be reported as an 
AE regardless of whether it is observed before or after 1 week postoperatively. 
 Loss of CDVA ≥10 letters up to 1 week postoperatively; loss of CDVA ≥10 
letters at any time point > 1 week postoperatively should be reported as an AE. 
All other untoward events that occur during the study, and all events that have sequelae 
should be reported as AEs, regardless of when they occur. 
AEs Associated with the ICL Platform 
Ocular AEs associated with the ICL platform will be reported in this study. These can 
include, but are not limited to the following: 
 anterior subcapsular opacities or clinically significant cataracts, 
 narrowing of the anterior chamber angle, 
 increased IOP, 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 29 of 45 
 
 pupillary block, 
 glaucoma, 
 lens malposition, 
 corneal endothelial cell loss (which may result in corneal edema), 
 loss of CDVA, 
 increase in refractive astigmatism, 
 pigment dispersion, 
 iris transillumination defects. 
In addition, ocular AEs associated with the ICL platform may require a secondary 
surgery in the implanted eye(s). The following surgeries have been associated with the 
ICL platform:  
 secondary IOL intervention (see above*) 
 vitreous aspiration  
 iridotomy/iridectomy for pupillary block  
 wound leak repair  
 retinal detachment repair  
 corneal transplantation 
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. 
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. 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 30 of 45 
 
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 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 
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 
 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 31 of 45 
 
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 
All AEs, regardless of severity (Mild, Moderate or Severe) or causality (Not Related, 
Related, Unknown), will be reported to FDA.   
 
6.3 
Reporting 
All untoward events (aside from the exceptions noted for the early postoperative period 
in Section 6.1.1) that occur during the study need to be reported as AEs.  
All interventions used to treat AEs (i.e., concomitant medications, aqueous release from a 
pre-existing corneal incision or needle paracentesis to treat increased IOP) will be 
recorded in the subject’s source document and applicable CRFs. 
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 
In addition, the following events are to be reported to the Sponsor as SAEs in this study:  
 
endophthalmitis 
 
pupillary block 
 
retinal detachment 
 
stromal thinning/corneal melting 
 
≥2 lines CDVA loss not secondary to any underlying condition 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 32 of 45 
 
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. 
Note: All device-related ADEs (SAEs or AEs related to the EVO ICL) must also be 
reported by the clinical site to STAAR Complaint Handling department according 
to STAAR Standard Operating Procedures (SOPs) for Complaint Handling. 
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 reconsenting of patients if the SAE provides new information regarding risk to 
the study subject.  
6.3.3 
Reporting of Complaints for Ancillary Marketed STAAR Surgical Products 
All information collected on a CRF could potentially be identified as a product 
complaint, as defined in Sections 6.1.2 and 6.3.1. 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. 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 33 of 45 
 
 
STATISTICAL METHODS 
Analysis of the superiority of the proportion of primary eyes that have IOP ≥ 30 mmHg 
and IOP ≥ 40 mmHg at 1 – 6 hours postoperatively compared with the outcomes of Study 
CP19-01, i.e., 15.3% (50/327) primary eyes with IOP ≥ 30 mmHg, and 7.0% (23/327) 
primary eyes with IOP ≥ 40 mmHg (Table 3, below). Analysis of fellow eye rates will be 
used to support the findings of the two primary eye analyses. 
Any deviations from the analysis plan will be documented in the final report. 
Table 3: Maximum IOP Among Incidences of Elevated IOP with Onset at 
Postoperative Visit 0 (Safety Population) 
Adverse Event - Elevated IOP 
Primary Eyes 
(N=327) 
All Treated Eyes 
(N=629) 
Number of elevated IOP events (n) 
67 
125 
 
 
 
Maximum IOP (mmHg) 
n (%) 
n (%) 
< 30 
17 (5.2) 
40 (6.4) 
≥ 30 
50 (15.3) 
85 (13.5) 
≥ 40 
23 (7.0) 
38 (6.0) 
≥ 50 
13 (4.0) 
24 (3.8) 
≥ 60 
6 (1.8) 
11 (1.7) 
≥ 70 
0 (0.0) 
1 (0.2) 
Source: Table 13, EVO/EVO+ DFU2 
Percentage calculated as (n/N)*100. 
 
7.1 
Hypothesis 
The observed rates of increased IOP seen in the absence of planned training in primary 
eyes in PMA Study CP19-01 were 15.3% (50/327) for IOP ≥ 30 mmHg and 7.0% 
(23/327) for IOP ≥ 40 mmHg. Based on Study CP19-01 data from investigators who 
followed the instructions in the proposed EVO Physician Certification Program regarding 
removal of OVD (Table 6), it is assumed that the proportion of primary eyes that will 
reach or exceed an IOP of 30 mmHg is 6% and the proportion of primary eyes that will 
reach or exceed an IOP of 40 mmHg is 1%. 
 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 34 of 45 
 
Table 4:  Incidence of elevated IOP in primary eyes for investigators who followed 
proposed EVO Physician Certification Program instructions for removal of OVD.5 
Site # 
 
Reported 
Irrigation 
Volume  
Primary Eyes 
with elevated 
IOP in specified 
range (n) 
Primary 
Eyes 
implanted  
All Eyes with 
elevated IOP in 
specified range 
(n) 
All 
Implanted 
Eyes 
 
cc 
>/= 30 
>/= 40 
N 
>/= 30 
>/= 40 
N 
 09 
10-20 cc 
5 
0 
39 
9 
0 
74 
 13 
20-30 cc 
3 
0 
19 
7 
0 
37 
07 
10-20 cc 
1 
0 
10 
1 
0 
20 
02 
> 30 cc 
1 
0 
11 
2 
0 
20 
10 
10-20 cc 
0 
0 
29 
0 
0 
36 
11 
20-30 cc 
1 
0 
76 
1 
0 
148 
04 
> 30 cc 
0 
0 
12 
0 
0 
22 
06 
10-20 cc 
0 
0 
8 
0 
0 
12 
03 
10-20 cc 
4 
0 
31 
11 
0 
60 
05 
20-30 cc 
0 
0 
5 
0 
0 
9 
 
 
 
 
 
 
 
 
 
Total 
15 
0 
240 
31 
0 
438 
 
 
 
 
 
Proportion, 
n/N 
 
6.25% 
0.00% 
 
7.08% 
0.00% 
 
 
7.2 
Study Endpoints and Statistical Analysis 
Primary endpoints of this study are: 
 the proportion of primary eyes that have IOP ≥ 30 mmHg at 1 – 6 hours 
postoperatively 
 the proportion of primary eyes that have IOP ≥ 40 mmHg at 1 – 6 hours 
postoperatively 
Secondary endpoints of this study are: 
 the proportion of fellow eyes that have IOP ≥ 30 mmHg at 1 – 6 hours 
postoperatively 
 the proportion of fellow eyes that have IOP ≥ 40 mmHg at 1 – 6 hours 
postoperatively 
The following other endpoints of this study will be analyzed for the entire postoperative 
follow-up period (including the 1 – 6 hr postop Visit through Visit 4, postop Day 10 – 
18): 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 35 of 45 
 
 Rates of increased IOP in primary and all (primary + fellow) eyes attributed to 
retained OVD 
 Rates of increased IOP in primary and all eyes attributed to other causes (e.g., 
pupillary block, steroid response, etc.)  
 Rates of all categories of AEs (in primary and in all eyes)  
 
The following will also be assessed in this study through postoperative Visit 4 using 
descriptive statistics: 
 Device deficiencies, 
 Distribution of lens vault measured by OCT, 
 Slit lamp findings and distributions of gradings (e.g., anterior chamber cell 
and flare) 
 Notable ophthalmoscopy findings; 
 UDVA and CDVA  
 Instances of loss of ≥10 letters of CDVA from baseline, along with analyses 
of the causes. 
Statistical Analysis 
Summaries for continuous variables will include the number of non-missing values, 
mean, standard deviation, median, minimum, and maximum. Summaries for discrete 
variables will include the tabulation of frequencies and percentages.  Analyses of 
increases in IOP attributed to other causes will include distribution of maximum IOP 
measured and summaries of causes and treatments used.  A presentation of all 
relevant clinical observations and symptoms, severity, diagnoses, treatments, 
duration, resolution, and sequelae will be provided for all significant AEs. In addition, 
classification of whether each event was a “serious adverse event” or “device or 
procedure-related” will be provided. Rates and descriptions of all device deficiencies 
and SAEs observed during the course of the study will be provided. 
7.3 
Sample Size  
For a single sample exact binomial test with a two-tailed alpha of 0.05 to demonstrate 
that a hypothesized rate of 6% is significantly lower than 15.3% for IOP spikes ≥ 30 
mmHg with 98% power, a sample of 181 eyes would be required. Demonstrating that the 
rate of IOP spikes ≥ 40 mmHg is significantly lower, given a hypothesized rate of 1% vs 
the Study CP19-01 rate of 7%, a sample size of 181 primary eyes of 181 subjects will 
achieve 96% power. Power to achieve both endpoints can be conservatively estimated by 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 36 of 45 
 
the product of the two powers, .98 times .96, or 94%. Analysis of fellow eye rates will 
also be conducted, and results will be used to support the findings of the two primary eye 
analyses. We assume no more than 10% loss to follow up in this 2-week study, so plan to 
enroll a minimum of 200 subjects (i.e., 200 primary eyes and 200 fellow eyes). 
 
DATA QUALITY ASSURANCE  
8.1 
Study Monitoring 
STAAR Surgical (or its representatives/agents/designees) must be allowed to visit all 
study site locations to assess the data, quality, and study integrity in a manner consistent 
with applicable health authority regulations and internal SOPs.  
Prior to the start of the study, member(s) of STAAR Clinical Affairs Department (or 
designees) will review the protocol, CRF, regulatory obligations, and other material or 
equipment relevant to the conduct of the study with the Investigator/Sub-Investigator and 
relevant site personnel.  
Monitoring visits and telephone consultations will occur as necessary during the course 
of the investigation to verify the following: 
 
the rights and well-being of subjects are protected 
 
the conduct of the investigation is in compliance with the currently approved 
protocol/amendment, 21 CFR Parts 11, 50, 54, 56, 803, 814.82(a)(2), 820; 42 USC 
282(j), FDA GCPs, IRB requirements, and applicable local regulations 
 
the integrity of the data, including adequate study documentation 
 
the facilities remain acceptable 
 
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 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 37 of 45 
 
automated instruments, and subject files. Source data also include information initially 
recorded in an electronic format (e.g., OCT images, 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/designee 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. Confidentiality of subject records must be maintained to ensure adherence to 
applicable local privacy regulations. 
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 

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 38 of 45 
 
 all IRB approvals, correspondence and reports (e.g., SAE reports, protocol 
deviations, and safety updates) 
 curriculum vitae (CV) 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 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 has 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 reconsenting study subjects.  

Study #CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 39 of 45 
 
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 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. 
 
 
REFERENCES 
 
1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030016S03
5 
2. Directions for Use, EVO Visian® ICL (Implantable Collamer® Lens). 
https://edfu.staar.com/edfu/ 
3. Patient Information Booklet, EVO Visian® ICL (Implantable Collamer® Lens). 
https://us.discovericl.com/safety-information 
4. Jabs DA, Nussenblatt RB, Rosenbaum JT. Standardization of uveitis nomenclature 
for reporting clinical data. Results of the First International Workshop. Am J 
Ophthalmol. 2005 Sep;140(3):509-16. 
5. P030016_S035 Interactive Review 2-16-2022 Quest response, Attachment K -
STAAR Surgical P030016 PAS#2 Protocol Synopsis 2-17-2022. 
6. Isotani H, Fukumoto Y, Kitaoka H, et al. Oval pupil in patients with diabetes 
mellitus: examination by measurement of the dark-adapted pupillary area and 
pupillary light reflex. Diabetes Res Clin Pract. 1995; 29:43-48. 
 
 

Study CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 40 of 45 
 
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 A1: Schedule of Visits and Parameters 
PROCEDURE/ASSESSMENTS 
 
Preop1 
Day -180 to -1 
Op 
Day 0 
V1 
1-6 hrs. 
postop 
V2 
Day 1 
V3 
Day 5 - 9 
V4 
Day 10 - 18 
Informed Consent/HIPAA Authorization 
X 
 
 
 
 
 
Demographics/ Ocular Hx  
X 
 
 
 
 
 
Eligibility 
X 
X 
 
 
 
 
Surgical Procedure 
 
X 
 
 
 
 
Pupil Diameter 
X 
 
 
 
 
 
UDVA 
X 
 
 
X 
X 
X 
CDVA 
X 
 
 
 
X 
X 
Manifest Refraction 
X 
 
 
 
X 
X 
Keratometry 
X 
 
 
 
 
 
Gonioscopy2 
X 
 
 
 
 
X 
Specular Microscopy (corneal endothelial cell count-CECC) 
X 
 
 
 
 
 
Biometry3  
X 
 
 
 
 
 
Slit Lamp Exam 
X 
 
X 
X 
X 
X 
IOP2, 4 
X 
 
X 
X 
X 
X 
Cycloplegic refraction 
X 
 
 
 
 
 
Lens Vault (via OCT) 
 
 
X 
X 
X 
X 
Dilated Fundus Exam 
X 
 
 
 
 
 
5Adverse Events 
X 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 

Study CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 41 of 45 
 
PROCEDURE/ASSESSMENTS 
 
Preop1 
Day -180 to -1 
Op 
Day 0 
V1 
1-6 hrs. 
postop 
V2 
Day 1 
V3 
Day 5 - 9 
V4 
Day 10 - 18 
Exit Subject 
 
 
 
 
 
X 
1 Subjects must provide informed consent to participate in the study prior to undergoing any study specific procedures 
2 Gonioscopy will also be performed when an AE of increased IOP occurs. If gonioscopy is contraindicated, the reason will be documented and 
AS-OCT will be performed. Refer to Appendix B.  
3Includes: axial length (AL), corneal thickness (CT), pupil size, anterior chamber depth (ACD), white-to-white (WTW) distance 
4Goldmann applanation tonometry will be used at all study visits. Refer to Appendix B for instructions if Goldmann applanation is 
contraindicated at 1 – 6 hr or 1 day postop assessment.  
5AEs will be collected from the time the subject signs the ICF to study exit. 
NOTE: If an oval or irregularly shaped pupil (dyscoria) is observed at any postoperative visit, photographs should be taken at that visit and each 
subsequent visit to determine if the ovalization is progressive. Refer to Appendix B. 
 

Study CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 42 of 45 
 
APPENDIX B: 
METHODS OF CLINICAL EVALUATION  
Any changes to the procedures described in this appendix will be provided under separate 
cover. 
The methods described in this section are to be used for the applicable assessments. All 
other assessments for this study will be conducted using the Investigator’s standard of 
care methods for ICL surgery. 
 
1. 
Gonioscopy 
Gonioscopy will be used to assess the anterior chamber angle, pigmentation in the posterior 
trabecular meshwork and peripheral anterior synechiae. Gonioscopy will be performed at 
the Preoperative Visit and the Day 10 – 18 postoperative visit. Gonioscopy will also be 
performed when an AE of increased IOP occurs, unless contraindicated by the condition 
of the eye.  If gonioscopy is not performed, the reason that gonioscopy is contraindicated 
will be recorded and the angle will be assessed by AS-OCT.   
If AS-OCT is performed, the images obtained should provide a clear view of the anterior 
chamber angle.  Copies of images should be preserved with the subject’s source documents. 
a) 
Anterior Chamber Angle 
Gonioscopic examination of the anterior chamber angle will be utilized to determine the 
grade of the angle. If gonioscopy is not performed, the reason that gonioscopy is 
contraindicated will be recorded and the angle will be assessed by AS-OCT.  The Shaffer 
system will be used for angle grading. The subject must have a Shaffer grade ≥ III in all 
four quadrants of an eye to be implanted. 
The scale is: 
0  
Closed 
I  
10 – 15° 
II  
15 – 25° 
III  
25 – 35° 
IV  
> 40° 
a) 
Pigmentation of the Trabecular Meshwork 
Pigmentation will be graded on a 0 to 4 scale noting the amount of pigmentation in the 
posterior trabecular meshwork.  
If a transillumination iris defect is identified at the Preoperative Visit, a photograph should 
be taken, and then at each subsequent visit, a photograph should be taken and compared 
with the preoperative photograph via a standardized photographic method.  

Study CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 43 of 45 
 
b) 
Peripheral Anterior Synechiae (PAS) 
PAS is defined as abnormal adhesions of the iris to the angle that are at least half a clock 
hour in width and present to the level of the anterior trabecular meshwork or higher. 
It is important to distinguish PAS from iris processes (the uveal meshwork), which are 
open and lacy and follow the normal curve of the angle. The angle structures are visible in 
the open spaces between the processes. Synechiae are more solid or sheetlike. They are 
composed of iris stroma and obliterate the angle recess. 
If present, PAS will be graded as number of clock hours (0.5 to 12.0 in 0.5 steps). 
   
2. 
Slit Lamp Examination 
This examination will be performed using a slit lamp biomicroscope. It is recommended to 
use a slit beam 1.0 mm wide by 1.0 mm high. The following information will be captured 
for this study: 
a) 
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 
 

Study CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 44 of 45 
 
b) 
Anterior Chamber 
Anterior chamber cells and flare will be graded using the Standardization of 
Uveitis Nomenclature (SUN) grading schemes.  
For the cell and flare evaluation, use a slit lamp beam 1.0 mm wide and 1.0 mm 
high. 
AC Cells 
AC Flare 
Grade  Cells in field  
Grade  Description 
0 
0.5+ 
1+ 
2+ 
3+ 
4+ 
<1 
1-5 
6-15 
16-25 
26-50 
> 50 
0 
1+ 
2+ 
3+ 
4+ 
None 
Faint 
Moderate (iris and lens details clear 
Marked (iris and lens details hazy) 
Intense (fibrin or plastic aqueous) 
Iris/Pupil 
Normal/Abnormal 
Crystalline Lens Status Clear/Abnormal 
 
3. 
IOP 
Goldmann applanation tonometry will be used to measure IOP at all postoperative 
timepoints.* On surgery day, IOP will be measured approximately 1-6 hours 
postoperatively.  
* If the Investigator determines Goldmann tonometry is contraindicated at the 1 – 6 hour 
or 1 day postoperative IOP assessment, the reason and an alternative method must be 
specified in the CRF. 
4. 
Lens Vault 
The distance between the posterior surface of the phakic IOL and the anterior surface of 
the natural crystalline lens will be measured using OCT and documented in µm. 
5. 
Assessment of Pupil Ovalization 
If an oval or irregularly shaped pupil (dyscoria) is observed at any postoperative visit, 
photographs6 should be taken at that visit and each subsequent visit to determine if the 
ovalization is progressive. The photographs may be taken with any camera, including but 
not limited to slit-lamp cameras, topographers, and Scheimpflug devices, but the eye 
images must be captured under photopic conditions (>200 foot-candles or 2153 lux) so the 

Study CP22-01 – EVO PAS 
 
Rev 2, 25Apr2023 
                
                           Page 45 of 45 
 
pupil is maximally constricted. The pupil constriction provides the setting for pupil 
ovalization. The major and minor diameters of the pupil, which may not be orthogonal, are 
measured on the photograph. For the measurement, the diameters must pass through the 
center of the least squares, best-fit ellipse or centroid of the pupil perimeter. The ratio of 
the major to minor diameter will be calculated and reported.