A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens
Phase: NA
Conditions: Myopia, Myopic Astigmatism
Sponsor: Staar Surgical Company

TITLE PAGE 
 
 
 
 
A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable 
Collamer® Lens 
 
PROTOCOL 
 
STUDY #CP19-01 
 
SPONSOR: 
STAAR Surgical Company 
1911 Walker Avenue 
Monrovia, California 91016 
Telephone USA: 626-303-7902 
 
 
 
 
This clinical investigation is being conducted in accordance with 21 CFR Parts 50, 54, 56 and 812, EN-ISO 
14155: 2011 Clinical Investigation of Medical Devices for Human Subjects-Good Clinical Practice (with the 
exception of having Investigators sign the study report), 42 USC 282(j), and with the ethical principles laid 
down in the Declaration of Helsinki. 
Revision Chronology:  
Revision  2.0  
- 
2020.01.30 
 
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®, CentraFLOW®, KS-AquaPORT®, and MicroSTAARTM are registered 
trademarks of STAAR Surgical Company. All other brand names/product names are trademarks of 
their respective owners.  

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 3 of 62 
INVESTIGATOR STATEMENT OF APPROVAL 
 
A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable 
Collamer® Lens 
 
PROTOCOL 
 
STUDY #CP19-01 
 
 
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 50, 54, 56 and 812, EN-ISO 14155: 2011 Clinical Investigation of 
Medical Devices for Human Subjects-Good Clinical Practice (with the exception of having 
Investigators sign the study report), 42 USC 282(j), 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 #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 4 of 62 
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 #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 5 of 62 
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 .............................................................................................................. 18 
3.2.3 
Subject Discontinuation ........................................................................................................ 18 
3.2.4 
Lost to Follow-up ................................................................................................................. 18 
3.3  INVESTIGATORS ............................................................................................................................... 18 
3.4  STUDY DURATION ........................................................................................................................... 19 
4.0  STUDY MATERIALS ....................................................................................................................... 19 
4.1  DESCRIPTION OF INVESTIGATIONAL DEVICE .................................................................................... 19 
4.1.1 
Instructions for Use and Administration ............................................................................... 22 
4.1.2 
Storage Requirements ........................................................................................................... 22 
4.2  TREATMENT REPLACEMENT ............................................................................................................ 22 
4.3  OTHER MATERIALS .......................................................................................................................... 22 
4.4  PACKAGING AND LABELING ............................................................................................................ 22 
4.5  ACCOUNTABILITY ............................................................................................................................ 23 
4.6  RISK ASSESSMENT ........................................................................................................................... 23 
5.0  STUDY CONDUCT ........................................................................................................................... 24 
5.1  STUDY VISITS .................................................................................................................................. 24 
5.1.1 
Preoperative Visit – Days -120 to Day -1 ............................................................................. 25 
5.1.2 
Operative Visit – Day 0 ........................................................................................................ 25 
5.1.3 
Postoperative Visits – Day 1 to Day 1170 ............................................................................ 26 
5.1.4 
Unscheduled Visits ............................................................................................................... 26 
5.1.5 
Missed Visits ........................................................................................................................ 26 
5.2  STUDY COMPLETION ........................................................................................................................ 26 
5.2.1 
Early Study Termination ....................................................................................................... 26 
5.2.2 
Post-study Follow-up ............................................................................................................ 26 
5.3  CONCOMITANT MEDICATIONS/THERAPY ......................................................................................... 27 
5.3.1 
Perioperative Medication Regimen ...................................................................................... 27 
5.4  PROTOCOL DEVIATIONS ................................................................................................................... 27 
6.0  ADVERSE EVENT REPORTING ................................................................................................... 27 
6.1  DEFINITIONS .................................................................................................................................... 28 
6.1.1 
Adverse Event....................................................................................................................... 28 
6.1.2 
Adverse Device Effects ........................................................................................................ 30 
6.2  EVALUATION ................................................................................................................................... 31 
6.3  REPORTING ...................................................................................................................................... 32 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 6 of 62 
6.3.1 
On-Site Expedited Reporting ................................................................................................ 32 
6.3.2 
Off-Site SAE Reporting ........................................................................................................ 32 
6.3.3 
Reporting of Complaints for Marketed STAAR Surgical Products ...................................... 32 
6.3.4 
Adverse Events and SAEs at Subject Exit ............................................................................ 33 
7.0  STATISTICAL METHODS ............................................................................................................. 33 
7.1  STUDY ENDPOINT AND PARAMETERS .............................................................................................. 33 
7.1.1 
Primary Endpoints ................................................................................................................ 33 
7.1.2 
Secondary Endpoints ............................................................................................................ 33 
7.1.3 
Additional Study Parameters ................................................................................................ 34 
7.2  SAMPLE SIZE ................................................................................................................................... 34 
7.2.1 
Sample Size Justification for a Bi-exponential Model of Endothelial Cell Loss .................. 35 
7.3  ANALYSIS POPULATIONS ................................................................................................................. 35 
7.4  STATISTICAL ANALYSIS ................................................................................................................... 36 
8.0  DATA QUALITY ASSURANCE ..................................................................................................... 36 
8.1  STUDY MONITORING ....................................................................................................................... 36 
8.2  SOURCE DOCUMENTATION .............................................................................................................. 37 
8.3  CASE REPORT FORMS AND DATA VERIFICATION ............................................................................. 37 
8.4  RECORDING OF DATA AND RETENTION OF DOCUMENTS.................................................................. 38 
8.5  AUDITING PROCEDURES .................................................................................................................. 38 
8.6  INSTITUTIONAL REVIEW BOARD/ETHICS COMMITTEE APPROVAL ................................................... 39 
8.7  PUBLICATION OF RESULTS ............................................................................................................... 39 
APPENDIX A: SCHEDULE OF VISITS AND PARAMETERS .......................................................... 40 
APPENDIX B: INSTRUCTIONS FOR USE ........................................................................................... 41 
APPENDIX C: METHODS OF CLINICAL EVALUATION ................................................................ 52 
9.0  REFERENCES ................................................................................................................................... 61 
 
 
 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 7 of 62 
LIST OF ABBREVIATIONS 
Abbreviation 
/Acronym  Term  
ACD Anterior chamber depth 
AC Anterior Chamber 
ADE Adverse device effect 
AE  Adverse event 
AL Axial length 
ATA Angle to angle 
BSS Balanced salt solution 
CDVA Corrected distance visual acuity 
CECC Corneal endothelial cell count 
CFR Code of Federal Regulations 
CLR Crystalline lens rise 
CRF Case Report Form 
CME Cystoid macular edema 
D Diopters 
CV Coefficient of variation 
DFE Dilated fundus exam 
DIA Device Investigator Agreement 
DOA Delegation of Authority 
ECD Endothelial cell density 
eQMS Electronic Quality Management System 
EVO Visian ICL Brand name for VICMO and VTICMO ICL models. 
EVO+ Visian ICL Brand name for VICM5 and VTICM5 lens models. 
FDA United States Food and Drug Administration 
FTP Foam tip plunger 
GCPs Good Clinical Practices 
% hex Percent hexagonality 
HEMA Hydroxyethyl methacrylate 
HPMC Hydroxypropyl methylcellulose 
ICF Informed Consent Form  
ICH International Conference on Harmonisation 
ICL Implantable Collamer Lens 
IOD Implantation Orientation Diagram 
IOL Intraocular lens 
IOP Intraocular pressure 
IRB Institutional Review Board 
ISO International Organization for Standardization 
LogMAR Logarithm of Minimal Angle of Resolution 
MICL Visian ICL for Myopia  
MRSE Manifest refractive spherical equivalent 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 8 of 62 
Abbreviation 
/Acronym  Term  
NSAID Non-steroidal, anti-inflammatory drug 
OCOS STAAR Visian ICL Online Calculation and Ordering Software 
OCT Optical coherence topography 
PI Principal Investigator/ Peripheral iridotomy 
PMA Premarket Approval Application 
PTP Pigment to pigment 
QOL Quality of life 
QID Four times per day 
RD Retinal detachment 
SAE Serious Adverse Event 
SE Spherical equivalent 
SOP Standard Operating Procedure 
SPE Safety and performance endpoint 
STS Sulcus to sulcus 
SUN Standardization of uveitis nomenclature 
TASS Toxic anterior segment syndrome 
TMICL Visian Toric ICL for Myopia with Astigmatism 
 
UDVA Uncorrected Distance Visual Acuity 
US United States 
UV Ultraviolet 
VA Visual acuity 
VICM5 Model number for EVO+ Visian ICL for Myopia 
VTICM5 Model number for EVO+ Visian ICL for Myopia with Astigmatism 
VICMO Model number for EVO Visian ICL for Myopia 
VTICMO Model number for EVO Visian ICL for Myopia with Astigmatism 
WTW White to white 
YAG Yttrium Aluminum Garnet 
NOTE: The first occurrence of some abbreviations is not spelled out in the document (e.g., units of 
measure). 
 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 9 of 62 
SYNOPSIS  
STAAR Surgical Company Study #CP19-01 
Revision chronology: 
Rev 2, 2020.01.30 
Title: 
A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® 
Implantable Collamer® Lens  
Type of study:  
Prospective, open-label, multicenter. 
Objective(s): 
The objective of this study is to evaluate the safety, and to collect 
supportive data concerning the effectiveness of the EVO/EVO+ Visian® 
Implantable Collamer® Lens (ICL).   
Study design: 
This study will enroll and implant approximately 333 subjects (up to 333 
primary eyes and up to an additional 333 fellow eyes) at up to 20 clinical 
sites in the US. Potential subjects who meet all eligibility criteria will be 
offered consecutive enrollment in the study and have surgery to implant 
study lenses in either one or both eyes. Postoperatively, subjects will return 
for visits at regularly scheduled intervals through Postoperative Visit 8 
(1050 – 1170 days after surgery; see Appendix A). The analysis of the 
primary endpoints will be conducted after a minimum of 300 primary eyes 
complete Postoperative Visit 5 (Day 147 – 182) to support Supplement 35 
to PMA P030016. 
Inclusion criteria: 
1. 
Subjects 21 through 45 years old at time of surgery. 
2. 
For EVO/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/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). 
 
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. 
For a subject who is expected to have residual postoperative 
cylindrical refractive error of  ≥ 1 D (as determined by STAAR Online 
Calculation and Ordering Software, OCOS), the subject should be 
given the opportunity to experience his/her vision with the anticipated 
correction. 
5. 
Anterior chamber depth (ACD) 3.00 mm or greater, when measured 
from the corneal endothelium to the anterior surface of the crystalline 
lens. 
6. 
Meet minimum endothelial cell density (ECD) requirements for age 
and ACD (refer to the “Minimum ECD for Age and True ACD*” table 
below).  

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 10 of 62 
STAAR Surgical Company Study #CP19-01 
7. 
Correctable Distance Visual Acuity (CDVA) to at least 20/40 in the 
eye(s) to be treated; and absent of ocular pathology (except that 
myopic degeneration is allowed). 
8. 
Difference between cycloplegic refraction spherical equivalent 
(CRSE) and manifest refraction spherical equivalent (MRSE) of  
< 0.75 D. 
9. 
For current contact lens wearers, stable MRSE (within ±0.5 D) on two 
consecutive examination dates with stability of the refraction 
determined by the following criteria: 
 
Discontinuation of contact lens use for at least 2 weeks (rigid 
contact lenses and all toric contact lenses) or 3 days (non-toric 
soft contact lenses) prior to the first refraction; 
 
Two refractions performed at least 7 days apart. 
10. Able and willing to return for scheduled follow-up examinations after 
surgery. 
11. 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. 
Coefficient of variation (CV) of endothelial cell area of > 0.45. 
6. 
Percent hexagonality (% hex) of endothelial cell shape ≤ 45 %. 
7. 
Unstable or worsening nearsightedness. 
8. 
Ocular hypertension or glaucoma. 
9. 
Pseudoexfoliation. 
10. Pigment dispersion. 
11. History or clinical signs of iritis/uveitis. 
12. Insulin-dependent diabetes or diabetic retinopathy.  
13. History of previous ocular surgery. 
14. Cataract of any grade.  
15. 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.  
16. 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.). 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 11 of 62 
STAAR Surgical Company Study #CP19-01 
17. Monocular subjects. 
18. For EVO/EVO+ ICL for myopia: myopia less than -3.00 D 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). 
19. 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. 
20. 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. 
21. 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. 
22. 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 
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 8 
postoperative study visits over the course of approximately 3 years (1050 
– 1170 days) after surgery. 
Investigational device: 
The investigational devices, EVO/EVO+ lenses, 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 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 12 of 62 
STAAR Surgical Company Study #CP19-01 
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: 
VICMO12.1, 
VICMO12.6, 
VICMO13.2, 
VICMO13.7, 
VICM5_12.1, VICM5_12.6, VICM5_13.2, VICM5_13.7 
 
EVO/EVO+ Visian Toric Implantable Collamer Lens for 
Myopia with Astigmatism: 
VTICMO12.1, VTICMO12.6, VTICMO13.2, VTICMO13.7, 
VTICM5_12.1, VTICM5_12.6, VTICM5_13.2, VTICM5_13.7 
All study lenses will be available in -3.00 D to -16.00 D spherical 
equivalent dioptric powers. The EVO/EVO+ Visian Toric ICLs will also 
be available in cylinder dioptric power of 1.00 D to 4.00 D. 
Study endpoints: 
Primary Endpoints 
Primary endpoints will be evaluated in primary eyes only. 
 
Incidence of peripheral iridotomy (PI) required to treat elevated 
intraocular pressure (IOP) caused by mechanical pupillary block 
through Postoperative Visit 5 (Day 147 – 182).  
The prespecified safety and performance endpoint (SPE rate) target for the 
first primary study endpoint is the rate of secondary PI required to treat 
elevated IOP caused by mechanical pupillary block with the approved and 
currently marketed MICL and TMICL devices in the United States, which 
is approximately 0.3%. 
The additional primary endpoints have no prespecified performance 
targets: 
 
Distribution of percent ECD losses and the percent of eyes that have 
ECD <1500 and ECD <1000 through Postoperative Visit 5 (Day 147 
– 182).  
 
Incidence of adverse events (AEs) through Postoperative Visit 5 
(Day 147 – 182). 
Secondary Endpoints 
Secondary endpoints will be evaluated in all eyes (primary and fellow 
eyes) using descriptive statistics with comparisons to PMA data for the 
approved and currently marketed MICL and TMICL devices, where 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 14 of 62 
 
1.0 
INTRODUCTION  
The Visian® ICL for myopia (model MICL) was approved by FDA (PMA P030016) in 2005. The 
Visian® Toric ICL for the correction/reduction of myopia with astigmatism (model TMICL) was 
approved by FDA (PMA Supplement P030016/S001) in 2018.   
These lens models offer an intraocular alternative for the correction of refractive error in those 
who currently utilize spectacle and/or contact lens correction.  Other alternative refractive surgical 
procedures include: excimer laser surgery (including photorefractive keratectomy (PRK), laser 
assisted in situ keratomileusis (LASIK) and small incision lenticular extraction (SMILE)), radial 
keratotomy (RK), automated lamellar keratectomy (ALK), epikeratoplasty, intracorneal implants 
(lenses or rings), anterior chamber and sulcus-placement phakic intraocular lenses (IOLs), or a 
combination of one or more of these procedures. 
In 2011, alternate designs of the current FDA approved lenses were introduced outside of the US; 
the EVO Visian® Implantable Collamer® Lens for myopia (model VICMO), and EVO Visian® 
Toric Implantable Collamer® Lens for myopia with astigmatism (model VTICMO). These devices 
(EVO lenses) are largely the same as the parent devices available in the US (MICL and TMICL), 
with the main difference being the addition of a 0.36 mm central hole in the optic. In 2015, EVO+ 
lenses (models VICM5 and VTICM5 for myopia and myopia with astigmatism, respectively) were 
introduced outside of the US. These models include a slightly larger optic diameter than the EVO 
lens models to offer additional options for patients with larger pupil sizes.    
The addition of the central hole to the EVO/EVO+ lens models facilitates the flow of aqueous 
humor through the lenses, eliminating the need for peripheral iridotomies (PIs) prior to 
implantation. Where these lens models are available, patients require fewer office visits and 
procedures prior to implant surgery, without introducing new adverse events (AEs) or increasing 
the occurrence of known AEs as compared to the parent devices. 
The benefits of the STAAR ICL (all models) have been demonstrated by predictable, stable 
refractive correction1  and a high efficacy index,2 as well as improvements in quality of vision3 and 
quality of life (QOL).4 Long-term studies investigating the safety profile of the STAAR ICL have 
demonstrated low rates of AE.5,6  
2.0 
OBJECTIVE 
The objective of this study is to evaluate the safety, and to collect supportive data concerning 
effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL). 
3.0 
STUDY DESIGN 
3.1 
Description of Study Design  
This study will enroll and implant approximately 333 primary eyes and up to an additional 333 
fellow eyes from subjects who qualify for bilateral implantation, at up to 20 clinical sites in the 
US. Postoperatively, subjects will return for visits at regularly scheduled intervals through 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 15 of 62 
Postoperative Visit 8 (Day 1050 – 1170) as described in Appendix A. The analysis of the primary 
endpoint will be conducted after a minimum of 300 primary eyes complete Postoperative Visit 5 
(Day 147 – 182) to support the Premarket Application (PMA Supplement P0930016/S035) of the 
investigational devices. 
3.2 
Selection of Study Population  
The study population will include approximately 333 primary eyes of up to 333 subjects who meet 
all eligibility criteria.  Potential subjects who meet all eligibility criteria will be offered consecutive 
enrollment in the study.   Enrolled subjects will have surgery to implant study lenses in either one 
or both eyes. For subjects who qualify to participate bilaterally, fellow eye implantation will occur 
between 7 days and 14 days after uneventful surgery in the first eye. If, in an Investigator’s medical 
judgment, second eye surgery should be postponed to a date more than 14 days from primary eye 
implantation due to a safety concern, the Medical Monitor’s approval for second eye surgery will 
be required. 
3.2.1 
Eligibility 
 
Inclusion Criteria  
This study will include subjects or eyes meeting the following criteria: 
1. Subjects 21 through 45 years old at time of surgery. 
2. For EVO/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/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). 
 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. For a subject who is expected to have residual postoperative cylindrical refractive error of   
≥ 1 D (as determined by STAAR Online Calculation and Ordering Software, OCOS), the 
subject should be given the opportunity to experience his/her vision with the anticipated 
correction. 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 16 of 62 
5. Anterior chamber depth (ACD) 3.00 mm or greater, when measured from the corneal 
endothelium to the anterior surface of the crystalline lens. 
6. Meet minimum ECD requirements for age and ACD (refer to the “Minimum ECD for Age and 
True ACD*” table below).  
7. CDVA to at least 20/40 in the eye(s) to be treated; and absent of ocular pathology (except that 
myopic degeneration is allowed). 
8. Difference between cycloplegic refraction spherical equivalent (CRSE) and manifest 
refraction spherical equivalent (MRSE) of < 0.75 D. 
9. For current contact lens wearers, stable MRSE (within ±0.5 D) on two consecutive examination 
dates with stability of the refraction determined by the following criteria: 
 Discontinuation of contact lens use for at least 2 weeks (rigid contact lenses and all toric 
contact lenses) or 3 days (non-toric soft contact lenses) prior to the first refraction; 
 Two refractions performed at least 7 days apart. 
10. Able and willing to return for scheduled follow-up examinations after surgery. 
11. Subjects must be able to read, understand and provide written informed consent on the IRB 
approved ICF and provide authorization as appropriate for local privacy regulations. 
 
Exclusion Criteria 
This study will exclude subjects or eyes meeting the following 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. Coefficient of variation (CV) of endothelial cell area of > 0.45. 
6. Percent hexagonality (% hex) of endothelial cell shape ≤ 45 %. 
7. Unstable or worsening nearsightedness. 
8. Ocular hypertension or glaucoma. 
9. Pseudoexfoliation. 
10. Pigment dispersion. 
11. History or clinical signs of iritis/uveitis. 
12. Insulin-dependent diabetes or diabetic retinopathy.  
13. History of previous ocular surgery. 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 17 of 62 
14. Cataract of any grade. 
15. 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.  
16. 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.). 
17. Monocular subjects. 
18. 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). 
19. 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. 
20. 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. 
21. 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. 
22. 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 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 18 of 62 
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 Postoperative Visit 8 (Day 1050 – 1170) is 
concluded. Subjects who require further follow-up for an AE will be followed according to  
Section 6.0. 
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 EVO/EVO+ study 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 up to 20 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 who are determined by STAAR Surgical to be suitably qualified by 
training and experience to conduct this study in compliance with all applicable Good Clinical 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 19 of 62 
Practices (GCPs) and FDA Federal Regulations. Sub-Investigators will be identified on the 
Device Investigator Agreement (DIA)/DOA (Delegation of Authority Log). 
 
Each clinical site should enroll a minimum of 20 subjects and no one site can have 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 46 
months. Eligible subjects who are enrolled in the study will be seen for 10 scheduled study visits 
(per eye) over the course of approximately 3 years (1050 – 1170 days) after surgery. 
4.0 
STUDY MATERIALS 
4.1 
Description of Investigational Device  
The EVO/EVO+ Visian® Implantable Collamer® Lens for Myopia, and EVO/EVO+ Visian® 
Toric Implantable Collamer® Lens for Myopia with Astigmatism investigational devices 
(EVO/EVO+ lenses), are sterile intraocular implants manufactured from Collamer, a proprietary 
hydroxyethyl methacrylate (HEMA)/porcine- collagen biocompatible polymer material. These 
lenses contain a 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. 
The EVO/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/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/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). 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 20 of 62 
Figure 1: EVO/EVO+ Lens Models for Myopia 
 
 
The EVO/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/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.    
 
Figure 2: EVO/EVO+ Toric Lens Models for Myopia with Astigmatism 
 
 
 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 25 of 62 
 
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 be provided a copy of the IRB approved consent form and a copy of the 
Patient Information Booklet for the appropriate FDA approved parent model. 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 -120 to Day -1 
Prospective subjects who have provided informed consent will be screened to determine eligibility 
for implantation of study lenses in one or both eyes. 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.  Determination of eligibility will include consideration of all inclusion and 
exclusion criteria, including preoperative ECD as measured by the central reading center, 
calculation of the appropriate spherical and cylindrical lens power and size as provided by the 
STAAR OCOS system, and the opportunity for prospective subjects to experience their correction 
in the event that postoperative cylindrical refractive error of ≥ 1 D is predicted.   
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 surgical procedure described in Appendix B. If the study lens is 
not implanted due to a surgical complication, the subject will be discontinued from the study.  
At approximately 1-6 hours after surgery, an intraocular pressure (IOP) reading in the implanted 
eye will be conducted. Any complications, AEs, or associated treatment given will be 
appropriately documented and reported. 
For subjects who qualify to participate bilaterally, fellow eye implantation will occur between 7 
days and 14 days after uneventful surgery in the first eye. If, in an Investigator’s medical judgment, 
second eye surgery should be postponed to a date more than 14 days from primary eye implantation 
due to a safety concern, the Medical Monitor’s approval for second eye surgery will be required.  

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 26 of 62 
5.1.3 
Postoperative Visits – Day 1 to Day 1170 
Each treated eye will be seen for 8 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.  
5.1.4 
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 case report forms (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. 
5.1.5 
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. 
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 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. 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 27 of 62 
5.3 
Concomitant Medications/Therapy  
5.3.1 
Perioperative Medication Regimen 
The following medication regimen will be followed by all sites: 
 topical 4th generation fluoroquinolone QID starting 3 days prior to surgery for a total of 
10 days,  
 topical NSAID QID, BID or 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 
through 28 days after surgery, 
 topical steroid QID starting 3 days prior to surgery for a total of 10 days and then tapered 
weekly through 28 days after surgery.  
Note:  No prophylactic systemic or topical IOP lowering medications (e.g., acetazolamide) will be 
used. 
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 
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 (only eyes implanted with study lenses) and all serious AEs (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 #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 28 of 62 
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). 
In this study, all untoward events (aside from the exceptions noted for the early postoperative 
period in the following sections) that occur during the study need to be reported as AEs. In 
addition, all secondary surgical interventions (SSIs) and events that cause these interventions, and 
all events that have sequelae should be reported as AEs, regardless of when they occur. 
AEs Associated with IOLs 
Complications during phakic IOL surgery must be reported as AEs on the AE CRF. 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. All events that have sequelae should be reported as AEs, 
regardless of when they occur. 
Adverse events associated with implantation of all types of IOLs (i.e., aphakic and phakic), need 
to be reported in this study. These can include, but are not limited to the following: 
 
Chronic Anterior Uveitis: anterior segment inflammation characterized by grade 1+ cell or 
greater that is persistent for > 3 months after surgery, or relapses in < 3 months after 
discontinuation of therapy, or for which the subject is maintained on therapy for > 3 months 
to control inflammation should be reported as an AE. In addition, anterior chamber (AC) 
cells or flare of greater than grade 2 (using the Standardization of Uveitis Nomenclature, 
SUN criteria10) at Visit 2 (Day 5 – 9) or later should be reported as an AE. 
 
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 21 – 35) or later. 
 
Clinically significant corneal edema: corneal swelling (stromal or epithelial) at Visit 2 (Day 5 
– 9) or later should be reported as an AE. 
 
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. 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 29 of 62 
 
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 SSIs and events that cause these interventions should be reported as AEs, regardless of 
when they occur. 
 
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 
- 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 events can 
be considered normal or expected 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 Standardization of Uveitis Nomenclature, SUN criteria)10 
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; increased IOP ≥ 
10 mmHg above baseline to a minimum of 25 mmHg at one week or later should be reported 
as an AE. 
 
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. 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 30 of 62 
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 anterior subcapsular cataracts  
 narrowing of the anterior chamber angle 
 glaucoma 
 corneal endothelial cell loss 
 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 
 
All ocular AEs that fall outside of the above definitions should still be reported as AEs. In 
addition all SSIs and events that cause these interventions, and, all events that have sequelae 
should be reported as AEs, regardless of when they occur. 
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.   

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 31 of 62 
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 
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.) 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 32 of 62 
 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 secondary surgical interventions (removal, replacement or repositioning) involving the 
study lens and events that cause these interventions, 
 loss of CDVA ≥10 letters compared to the baseline (Preop Visit) at Postoperative Visit 5 
(Day 147-182), or later 
 all non-serious AEs determined to be related to the study device (ADEs) 
 all device malfunctions that do not result in one of the above reportable events 
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. 
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 Marketed 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 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 33 of 62 
procedures (SOPs) 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 
Study Endpoint and Parameters 
7.1.1 
Primary Endpoints 
Primary endpoints will be evaluated in primary eyes only. 
 
Incidence of PI required to treat elevated IOP caused by mechanical pupillary block through 
Postoperative Visit 5 (Day 147 – 182).  
The prespecified safety and performance endpoint (SPE rate) for the first primary study endpoint 
is the rate of PI required to treat elevated IOP caused by mechanical pupillary block with the 
approved and currently marketed MICL and TMICL devices, which is approximately 0.3%.  
The additional primary endpoints have no prespecified performance targets: 
• 
Distribution of percent ECD losses and the percent of eyes that have ECD <1500 and 
ECD <1000 through Postoperative Visit 5 (Day 147 – 182).  
• 
Incidence of AEs through Postoperative Visit 5 (Day 147 – 182).  
7.1.2 
Secondary Endpoints 
Secondary endpoints will be evaluated in all eyes (primary and fellow eyes) using descriptive 
statistics with comparisons to PMA data for the approved and currently marketed MICL and 
TMICL devices, where appropriate. The secondary endpoints have no prespecified performance 
targets. 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 34 of 62 
 
Incidence of PI required to treat elevated IOP caused by mechanical pupillary block through 
Postoperative Visit 5 (Day 147 – 182).  
 
Distribution of percent ECD losses and the percent of eyes that have ECD <1500 and ECD 
<1000 through Postoperative Visit 5 (Day 147 – 182).  
 
Incidence of AEs through Postoperative Visit 5 (Day 147 – 182). 
7.1.3 
Additional Study Parameters 
The following will also be assessed in this study: 
• 
MRSE within ± 1.00 D of target at Postoperative Visit 5   
• 
MRSE within ± 0.50 D of target at Postoperative Visit 5  
• 
UDVA of 20/40 or better at Postoperative Visit 5 (for those eyes with CDVA 20/20 or 
better at Preoperative Visit) 
• 
CDVA through Postoperative Visit 8 (Day 1050 – 1170)  
• 
Distribution of percent ECD losses and the percent of eyes that have ECD <1500 and 
ECD <1000 through Postoperative Visit 8  
There are no prespecified performance targets for the additional study parameters. 
7.2 
Sample Size 
Based on complaint data, the event rate for secondary PI required to treat elevated IOP caused by 
mechanical pupillary block for the approved and currently marketed MICL and TMICL devices is 
approximately 0.3%.  Following the recommended analysis in ISO 11979-7:2018, Annex E, for 
cumulative adverse events, the null hypothesis is that the true rate of PI required to treat elevated 
IOP caused by mechanical pupillary block is less than or equal to the SPE rate, and the alternative 
hypothesis is that the true rate of PI required to treat elevated IOP caused by mechanical pupillary 
block is greater than the SPE rate:  
H0 (null hypothesis):    0.3% 
Ha (alternative hypothesis):   > 0.3% 
where 𝜋 is the observed rate of PI required to treat elevated IOP caused by mechanical pupillary 
block. Based on the analysis in ISO 11979-7:2018, Annex E, the maximum number of cases 
allowed before the SPE rate is exceeded for 300 primary eyes of 300 subjects is 3.   
To allow for losses of 10% per year, a total of up to 333 primary eyes of up to 333 subjects will 
be enrolled. 
In addition, in order to detect an AE with a true probability of occurrence among eyes of 1% with 
95% probability, based on the binomial distribution, a sample of at least 300 eyes is required.  

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 35 of 62 
7.2.1 
Sample Size Justification for a Bi-exponential Model of Endothelial Cell Loss 
The fitting of a bi-exponential model involves estimating 4 parameters, named by SAS PROC 
NLIN, a, b, p, and q in the following model: 
 
ECD = p*exp(-a*time) + q*exp(-b*time) 
 
Prior modeling submitted by STAAR from the MICL PAS study11 was based on data from 169 
subjects.  Based on that sample size, the standard errors for the four model parameters are 
provided in the following table: 
                               
Parameter 
Estimate 
Approx Std 
Error 
a 
13.2593 
44.9425 
b 
0.0208 
0.00278 
p 
66.2263 
33.6633 
q 
2591.8 
22.8947 
 
The sample size was then doubled to slightly over 338, which is a number close to the proposed 
sample size in this study, i.e., 300, in order to demonstrate the resulting increased precision. That 
doubling of the sample size yielded a reduction of the standard errors, as would be expected: 
                               
Parameter 
Estimate 
Approx Std 
Error 
a 
13.2593 
31.7562     
b 
0.0208 
0.00197       
p 
66.2263 
23.7864      
q 
2591.8 
16.1773      
 
The doubling of the sample has the effect of reducing the standard error for each parameter by 
about 30%, as would be expected given that the reduction in the standard error is a function of 
the square root of N.  Thus, the planned sample size of 300 in this study will allow more precise 
estimation of the curve than previously presented to the FDA in P030016/S022. Given the 
diminishing return from increasing the sample size further, we believe that 300 eyes will provide 
sufficient accuracy to model endothelial cell loss. 
7.3 
Analysis Populations 
The safety analysis population will include all eyes implanted with an investigational EVO/EVO+ 
lens.  Imputation of missing data will not be performed. 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 36 of 62 
7.4 
Statistical Analysis 
The first primary study endpoint is defined as the incidence of PI required to treat elevated IOP 
caused by mechanical pupillary block through Postoperative Visit 5.  The primary analysis will be 
performed on a minimum of 300 primary eyes that have completed Postoperative Visit 5. Based 
on complaint data, the SPE rate for secondary PI required to treat elevated IOP caused by 
mechanical pupillary block is approximately 0.3% for MICL/TMICL.  Based on the recommended 
analysis in ISO 11979-7:2018, Annex E, the maximum number of cases allowed before the SPE 
rate is exceeded for 300 primary eyes of 300 subjects is 3.   
The other primary endpoints will be studied using the first treated (i.e., primary) eyes. Secondary 
endpoints and additional study parameters will be studied using all (primary and fellow) eyes. Data 
will be summarized with point estimates and exact binomial confidence intervals for binary 
outcomes such as MRSE within 0.50 D and 1.00 D of target and UDVA 20/40 or better. 
Continuous outcomes (e.g., %hex, CV) will be described with summary statistics to include N, 
mean, standard deviation, minimum and maximum, first and third quartiles, and median. 
Distributions, such as CDVA loss, trabecular pigmentation, PAS, AC cells and flare will be 
summarized by number and percentage for each visit.     
ECD loss over the 1050 – 1170 days of follow up will be modeled using a bi-exponential model 
with adjustment for correlation between paired eyes. ECD and change in ECD will be summarized 
at each visit.  The number and percentage of eyes with ECD < 1000 and < 1500 will be summarized 
over time using descriptive statistics. 
 
 
8.0 
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 and Medical 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 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 37 of 62 
 
the conduct of the investigation is in compliance with the currently approved 
protocol/amendment, IRB requirements, 21 CFR Parts 50, 54, 56 and 812, EN-ISO 14155: 
2011 Clinical Investigation of Medical Devices for Human Subjects-Good Clinical Practice 
(with the exception of having Investigators sign the study report), 42 USC 282(j), and with 
the ethical principles laid down in the Declaration of Helsinki 
 
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 automated 
instruments, and subject files. Source data also include information initially recorded in an 
electronic format (e.g., specular microscopy 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 for each eye enrolled 
in the study. 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.  

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 38 of 62 
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/year of birth if also 
required. 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 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 (CV) and medical licenses for the PI and all sub-investigators (if 
applicable) 
 regulatory documents (e.g., financial disclosure and DOA 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 

 
Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 39 of 62 
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/Ethics Committee 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 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 #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 40 of 62 
APPENDIX A: SCHEDULE OF VISITS AND PARAMETERS  
All study tasks should be performed by qualified study site personnel as indicated on the DOA log under the supervision of the PI.  
Table 2: Preoperative, Surgical Assessments, and Postoperative Assessments (for each implanted eye) 
Note: Postoperative visits for both eyes may be scheduled on the same day only if the study visit window for each eye allows. 
PROCEDURE/ ASSESSMENTS 
PreOp& 
Day -120 to Day -1 
Op 
Day 0 
V1 
Day 1 
V2     
 Day 5-9 
V3 
Day 21-35 
V4 Day 
70-98 
V5 Day 
147-182 
V6 Day 
330-420 
V7 Day 
690-810 
V8 Day 
1050-1170 
Demographics/ Medical and Ocular History 
X 
 
 
 
 
 
 
 
 
 
UDVA 
X 
Xa 
 
X 
X 
X 
X 
X 
X 
X 
X 
CDVA 
X 
Xa 
 
 
X 
X 
X 
X 
X 
X 
X 
Manifest Refraction 
X 
Xa 
 
 
X 
X 
X 
X 
X 
X 
X 
Keratometry 
X 
 
 
 
 
 
 
 
 
 
Gonioscopy 
X 
 
 
 
 
 
X 
X 
X 
X 
Slit Lamp Examination 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
Crystalline Lens Status 
X* 
 
 
 
X* 
X* 
X* 
X* 
X* 
X* 
Specular Microscopy (CECC@) 
X 
 
 
 
 
 
X 
X 
X 
X 
@AL, ACD, WTW, pupil size, corneal 
topography 
X 
 
 
 
 
 
 
 
 
 
IOP 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Dilated Fundus Exam 
X 
 
 
 
X 
 
 
X 
X 
X 
Cycloplegic Refraction 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Lens Vault$ (via OCT) 
 
 
 
 
X 
X 
X 
X 
X 
X 
ConMeds/AEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
aContact lens wearers only-see Appendix B of study protocol. 
&Subject must provide informed consent to participate in study prior to undergoing any study specific procedures  
* Assign LOCS III grade (see Appendix C). If lens opacity observed, obtain photograph at this visit and each subsequent visit 
@CECC: corneal endothelial cell count; AL: axial length; WTW: white to white 
  
$distance between the posterior surface of the phakic IOL and the anterior surface of the natural crystalline lens 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 41 of 62 
APPENDIX B: INSTRUCTIONS FOR USE   
 
STAAR Surgical EVO/EVO+ Visian® Implantable Collamer® Lens for Myopia, 
and EVO/EVO+ Visian® Toric Implantable Collamer® Lens for Myopia with 
Astigmatism Investigational Devices (EVO/EVO+ lenses)  
 
Study CP19-01: INSTRUCTIONS FOR USE 
Manufacturer: 
STAAR Surgical Company 
1911 Walker Avenue 
Monrovia, CA 91016 
USA 
Tel: (800)352-7842 
Fax: (800) 952-4923 
 
CAUTION – Investigational Device. Limited by Federal (or United States) law to 
investigational use  
 
INDICATIONS 
The EVO/EVO+ ICL for myopia is indicated for use in patients 21-45 years of age: 
1. for the correction of myopia ranging from -3.0 D to ≤ -15.0 D spherical equivalent 
(SE) in the spectacle plane, with less than or equal to 2.5 D of astigmatism (in the 
spectacle plane); 
2. for the reduction of myopia ranging from greater than -15.0 D to -20.0 D SE (in the 
spectacle plane), with less than or equal to 2.5 D of astigmatism (in 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 ICL is intended for placement in the posterior chamber (ciliary sulcus) of the 
phakic eye. 
The ICL functions as a refractive element to optically reduce moderate to high myopia. 
 
The EVO/EVO+ Toric ICL for myopia with astigmatism 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. 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 42 of 62 
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 Toric ICL is intended for placement in the posterior chamber (ciliary sulcus) 
of the phakic eye. 
The Toric ICL functions as a refractive element to optically reduce moderate to high 
myopia with astigmatism. 
 
CONTRAINDICATIONS AND EXCLUSION CRITERIA 
 Younger than 21 or older than 45 years of age. 
 With true ACD < 3.00 mm*. 
 Anterior chamber angle less than Grade III as determined by gonioscopic examination. 
 Do not meet the minimum ECD as defined in the “Minimum ECD for Age and True 
ACD*” table below. 
 Unstable or worsening nearsightedness. 
 Coefficient of variation of endothelial cell area of > 0.45. 
 Percent hexagonality of endothelial cell shape ≤ 45 %. 
 Difference between cycloplegic refraction spherical equivalent (CRSE) and manifest 
refraction spherical equivalent (MRSE) of > 0.75 D. 
 Ocular hypertension or glaucoma. 
 Pseudoexfoliation. 
 Pigment dispersion. 
 History or clinical signs of iritis/uveitis. 
 Insulin-dependent diabetes or diabetic retinopathy.  
 History of previous ocular surgery. 
 Cataract of any grade. 
 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.  
 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 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 43 of 62 
preclude study completion (e.g., immunocompromised, connective tissue disease, 
clinically significant atopic disease, uncontrolled diabetes, etc.). 
 Monocular subjects. 
 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). 
 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 spectacle 
plane) less than 1.00 D and greater than 4.00 D. 
 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. 
 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. 
 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 from the anterior corneal surface, the thickness of the cornea 
must be subtracted to get the true ACD. 
WARNINGS 
 Some subjects in the STAAR ICL for Myopia Clinical Study demonstrated 
endothelial cell loss >30% (range, 30.9% to 42.6%) at 5-7 years postoperatively. The 
longer-term effects (beyond 5 – 7 years) on the corneal endothelium have not been 
established.  Subjects should be advised about the potential risk of corneal edema, 
possibly requiring corneal transplantation.  ECD should be monitored periodically as 
long as the ICL remains implanted in the eye(s). 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 44 of 62 
 Secondary to implantation of the ICL, subjects may have increased risk of 
development of cataract, including visually significant cataract that continues to 
increase with each year. Implanted eyes should be monitored for cataract periodically 
as part of normal standard of care for ICL subjects. The long-term risk of visually 
significant cataract and related secondary surgery may be higher in older subjects and 
those with higher myopia. The long-term rate (beyond 5-7 years) of cataract 
formation secondary to implantation, removal and/or replacement of the ICL is 
unknown.  
 Implantation of the ICL is associated with an elevated risk of early postoperative 
increase in intraocular pressure (IOP; usually associated with pupillary block) that 
requires secondary surgical intervention. The long-term risks of glaucoma, peripheral 
anterior synechiae and pigment dispersion are not well established. 
 Do not attempt to resterilize or repackage the ICL. 
 Do not autoclave the ICL. Do not expose to temperature greater than 40°C. Do not 
freeze. If temperature requirements are not met, return the ICL to STAAR Surgical as 
instructed by the study monitor. 
 The iridocorneal angle distance may decrease after implantation of the ICL. 
Iridocorneal angle should be assessed 1 week after implantation and monitored if the 
angle is extremely narrow. 
 A subject with mesopic pupil size that is greater than the optic diameter of the ICL 
may experience symptoms of glare and/or halos. Subjects should be advised about 
this potential risk prior to ICL implantation. 
 Complete removal of viscoelastic from the eye after completion of the surgical 
procedure is essential. STAAR Surgical will provide a low molecular weight 2% 
hydroxypropyl methylcellulose (HPMC) ophthalmic viscosurgical device (OVD) for 
use in the study.  
NOTE:  The primary OVD used with the MICL/TMICL during the FDA clinical trials 
was a low molecular weight 2% HPMC preparation. Short chain sodium hyaluronate 
acids (viscoelastics) are not to be used in the study due to increased risk of cataract 
formation related to trapped viscoelastic. 
PRECAUTIONS 
Prior to surgery, the Investigator must provide prospective subjects with a copy of the study 
informed consent form and patient information booklet for the predicate product approved 
in the US and inform subjects of the possible benefits and complications associated with 
the use of this device. 
 Subjects with higher degrees of myopia or myopic astigmatism may experience lower 
efficacy and higher rates of adverse events (AEs) and complications. 
 Inadequate flushing of the viscoelastic from the eye may lead to IOP spikes. IOP will 
be checked at 1-6 hours after surgery at the Op Visit and at the 1 day postoperative 
visit. 
 The effectiveness of ultraviolet (UV) absorbing intraocular lenses (IOLs) in reducing 
the incidence of retinal disorders has not been established. 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 45 of 62 
 The relationship between the ICL and retinal detachment is undetermined. 
ADVERSE EVENTS 
All ocular AEs (only eyes implanted with study lenses) and all serious AEs (both ocular 
and non-ocular) will be reported in this study. The collection of AEs begins at the time the 
subject completes the informed consent process to participate in the study. 
Adverse events that have been associated with the ICL platform 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. 
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:  
 surgery to exchange, remove 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 
events 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 Standardization of Uveitis Nomenclature, SUN 
criteria10) 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; 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 46 of 62 
increased IOP ≥ 10 mmHg above baseline to a minimum of 25 mmHg at one week or 
later should be reported as an AE. 
 
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. 
 
All ocular AEs that fall outside of the above definitions should still be reported as AEs.  
 
SURGICAL INFORMATION 
Implantation of the study lenses should only be attempted by a surgeon who has completed 
the STAAR Surgical Visian ICL Physician Certification Program. Only subjects who have 
provided written informed consent and meet all eligibility criteria listed in the study 
protocol can receive investigational lenses in Study CP19-01.   
Calculation of Lens Power and Size 
The lens power and size calculation for all eyes to receive EVO/EVO+ lenses will be 
performed by the surgeon using the STAAR Visian ICL Online Calculation and Ordering 
Software (www.ocos.STAAR.com). 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. Investigators must use the lens diameter recommended by OCOS. 
In the case of an EVO/EVO+ Toric ICL, OCOS will provide the surgeon a cylinder power 
and a range of spherical powers along with their expected postoperative values (i.e., 
residual sphere, cylinder, axis and spherical equivalent). An Implantation Orientation 
Diagram (IOD) will be generated for each study lens identifying the amount and direction 
of rotation required of the lens after insertion in the eye to provide optimal alignment.  
 
IMPORTANT 
Preoperative YAG iridotomies are NOT to be performed with the lenses to be 
implanted in this study. 
 
Perioperative Medications 
The following medication regimen will be followed by all sites: 
 Topical 4th generation fluoroquinolone QID starting 3 days prior to surgery for a 
total of 10 days.  
 Topical NSAID QID, BID or 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 through 28 days after surgery. 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 47 of 62 
 Topical steroid QID starting 3 days prior to surgery for a total of 10 days and then 
tapered weekly through 28 days after surgery.  
Note:  No prophylactic systemic or topical IOP lowering medications (e.g., acetazolamide) 
will be used. 
Preoperative Procedures 
 The subject will be prepared for surgery according to the surgeon’s standard of care for 
STAAR Visian MICL/TMICL surgery.  
 Examine the package for correct lens model, dioptric and cylinder power and overall 
diameter.  
 EVO/EVO+ Toric ICLs Only: As part of the implantation procedure, the lens may 
need to be rotated up to 22.5 degrees clockwise or counterclockwise from the 0°-180° 
meridian in order to align the lens axis at the preoperative plus cylinder axis. The 
surgeon should mark the horizontal axis (0°-180°) of the eye at the slit lamp prior to 
surgery. These horizontal axis marks will be used as reference points to mark the 
desired orientation of the lens under the operating microscope, using a suitable 
corneal axis marking device. For example, if the preoperative plus cylinder axis is at 
136° and the lens selected has the cylinder axis at 115°, the lens will need to be 
rotated 21° counterclockwise from the temporal meridian in eye. In this case the 
desired axis marked on the cornea would be 21°counterclockwise from the 0°-180° 
meridian.    The online ordering software for the toric ICL is designed to generate an 
IOD to guide the surgeon in determining the amount and direction of rotation for the 
specific lens selected.  See example below: 
 
 
Intraoperative Procedures 
Preparation of the lenses for use  
Perform the following steps in a sterile field. 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 48 of 62 
 
Inspect the lens vial. Ensure that it is not damaged or opened. Do not use if the vial is 
opened or damaged. 
 
Peel the Tyvek lid stock from the tray, then transfer the vial into the operating field. 
 
While keeping the vial in a vertical position, remove the aluminum seal and remove 
the cap. 
 
Carefully remove the lens from the vial. Handle the lens by the haptic portion. Do not 
grasp the optic with forceps as this could potentially lead to damage to the smooth 
anterior and posterior optical surfaces. 
 
Examine the lens carefully under the microscope for damage or particulate matter. 
 
Do not allow the ICL to dry after removal from the glass vial. It is recommended that 
the ICL be held in sterile BSS solution prior to implantation. It should not be exposed 
to any solutions other than the normally used intraocular irrigating solutions (e.g., 
isotonic saline, BSS, viscoelastic, etc.) 
Delivery System 
The lenses will be delivered using the provided MICROSTAAR® Injectors, Model MSI-
TF (twist) or MSI-PF (push) with SFC-45 or SFC-45 FP Cartridge. Lenses will be loaded 
and delivered according to the surgeon’s standard of care for STAAR Visian 
MICL/TMICL surgery.  
CAUTION 
The ICL should be injected within 1-2 minutes after loading. Viscoelastic materials tend 
to lose their lubricity if exposed to air too long. 
Viscoelastic Usage 
STAAR Surgical will provide 2% HPMC OVD for use in this study. Complete removal of 
OVD from the eye after completion of the surgical procedure is essential.  
Do not use short chain OVDs due to increased risk of cataract formation related to 
trapped viscoelastic. 
Surgical Procedures 
1) Loading the cartridge 
a. Insert the foam-tipped plunger and holder into the injector, base first. 
b. The vertical tab of the holder is not intended to be snap locked into the 
notch of the injector. 
c. Keeping the plunger and holder in place, advance the injector cap until the 
ball end of the plunger interlocks with the injector. 
d. A click can be felt and heard when the plunger is properly secured. 
e. Retract the plunger fully.  The foam-tipped plunger will remain locked in 
place. 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 49 of 62 
f. Remove the holder by sliding it back out of the front of the injector.  
g. Place the assembled foam-tipped plunger and injector into BSS, making 
sure that the tip of the injector and foam-tipped plunger are completely 
submerged.   
h. Hydrate the foam tip plunger.  Ensure adequate hydration of the foam tip 
plunger.  If not properly hydrated, the foam tip plunger becomes 
dehydrated and compressed.  In this case, the lens may become trapped 
between the cartridge and the foam. 
i. Remove the cartridge from the package.  
j. Add BSS to the cartridge. 
k. Add low molecular weight 2% HPMC viscoelastic after BSS. 
l. Grasp the lens haptic with forceps and place in cartridge loading area.  Do 
not touch the optic of the lens. 
m. Tuck one long edge and then the other long edge of the lens under the 
rails, ensuring proper orientation of the lens in the cartridge.  
n. Close the jaws of the loading forceps and insert them into the barrel, from 
the front of the cartridge. 
o. Advance the forceps through the cartridge until the jaws are about to 
contact the leading edge of the lens. 
p. Open the jaws of the forceps and grasp the footplate of the lens so that the 
positioning mark is aligned with the jaws.  
q. Slowly pull the lens into the barrel while moving the cartridge in the 
opposite direction. 
r. Continue this process until the leading edge of the lens is adjacent to the 
end of the cartridge. 
s. Release the lens from the forceps.  
t. Insert the cartridge into the injector and lock into place. 
u. Observe the lens for proper orientation in the cartridge.  
v. The lens should be injected within 1 to 2 minutes after loading. 
2) Marking the axis (toric lens only) 
a. Using the horizontal axis marks placed preoperatively, mark the desired 
orientation of the lens under the operating microscope, using a suitable 
corneal axis marking device. 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 50 of 62 
3) Constructing the incisions 
a. Construct one or two paracentesis incisions, 60 – 120 degrees away from 
the intended location of the temporal clear corneal main incision.  
b. Inject 2% HPMC viscoelastic into the anterior chamber; do not overfill. 
c. Construct a temporal clear corneal incision of approximately 3.5 mm or 
less in width, parallel to the iris plane, with a tunnel length of 
approximately 1.5 to 1.75 mm. 
4) Inserting the lens 
a. Place the tip of the cartridge just inside the clear corneal incision. 
b. Inject slowly until the “leading right” orientation marking is visible. 
c. Continue to inject slowly, maintaining the proper orientation of the lens by 
rotating the cartridge as necessary, until the lens is released from the 
cartridge. 
d. Withdraw the cartridge from the incision. 
5) Positioning the lens 
a. Inject additional viscoelastic, if needed, anterior to the lens. 
b. Use a manipulator to sequentially position the footplates posterior to the 
iris.  
c. Avoid crossing the manipulator over the central optical zone of the lens. 
d. For a toric lens, orient the lens in the position described on the IOD using 
the manipulator to rotate the lens by the edge, haptic body or footplates.   
6) Removing the viscoelastic 
a. Thoroughly remove all viscoelastic by irrigating with BSS through a 
cannula or using bimanual irrigation and aspiration. Note that inadequate 
flushing of the viscoelastic from the eye may lead to elevated 
postoperative IOP.  
b. Do not irrigate or aspirate directly through the central port of the lens.    
c. Use slight incisional pressure while irrigating to allow egress of 
viscoelastic. 
7) Constricting the pupil 
a. Ensure that all footplates are posterior to the iris by direct inspection. 
b. Ensure that lens axis alignment is at the intended position. 
c. Instill a miotic agent to constrict the pupil. 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 51 of 62 
8) Sealing the incisions 
a. Ensure that the clear corneal incisions and the paracentesis are watertight. 
Postoperative Procedures 
 An IOP check will be conducted at approximately 1-6 hours after surgery, prior to 
release of subject.  
 Perioperative concomitant medication regimen to be followed is described in the 
section “Perioperative Medications”. 
 Ensure all concomitant medications are documented on the subject case report form.  
 
 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 52 of 62 
 
APPENDIX C: METHODS OF CLINICAL EVALUATION  
Any changes to the procedures described in this appendix will be provided under separate 
cover. 
1. 
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. If the subject is a contact lens wearer, they should be advised 
to arrive for preoperative testing wearing their spectacles. If the subject is a contact lens 
wearer, they will need to discontinue contact lens use for at least 2 weeks (rigid contact 
lenses and all toric contact lenses) or 3 days (non-toric soft contact lenses) prior to the first 
refraction. 
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 D does not result in an additional letter read, it must not be 
added. Further, if adding +0.25 D does not result in a loss of letters read, it must be added.  
The manifest subjective refraction result, adjusted for optical infinity, MUST be transferred 
to the trial frame for CDVA testing. The power of the lens used for the distance adjustment 
is subtracted from the sphere power before recording the refraction. For example, for 
testing at 4 meters, the power of the lens used for the distance adjustment is +0.25 D.  The 
manifest refraction spherical power is +0.25 D less than the total sphere power measured 
at 4 meters.   Both the adjusted and unadjusted manifest refractions should be recorded, if 
applicable.    
2. 
Visual Acuity Testing 
a) 
Equipment 
Corrected (CDVA) and uncorrected visual acuity (UDVA) 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 (i.e., a projected or digital ETDRS 
chart may be placed at a distance other than 4 meters to accommodate the size of the 
examination room; however, the size of the optotype should be calibrated accordingly). 
UDVA should be performed using a trial lens with power of +1.00 D/(distance of chart in 
meters) to place the chart at optical infinity.  CDVA (corrected distance visual acuity) 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 53 of 62 
should be performed using a trial lens power reflecting the corresponding CDVA 
refraction.   
The charts are designed according to the following principles described by Bailey and 
Lovie12 and the National Academy of Science-National Research Council (NAS-NRC) 
Committee on Vision 198013:  1) letters of equal legibility; 2) combine the letters so that 
each line is of approximately equal difficulty as described by Ferris et al14; 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 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.14  
b) 
Testing Methods 
In order to provide standardized and well-controlled assessment of VA, all VA 
assessments for a subject should be performed consistently (e.g., the same lighting 
conditions, viewing distance, etc.) at each visit. 
During acuity testing, vision testers should: 
 
observe subjects carefully for squinting (or head turning, etc.) and frequently remind 
patients not to squint or turn their heads, 
 
inform subjects 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 (without 
squinting or head turning, etc.).   
 
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.   

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 54 of 62 
c) 
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.  
d) 
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 4 meters, they 
will be asked to count fingers at 0.5 meters (1 foot and 7 ⅝ inches).  If fingers cannot be 
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 meters (13 feet and 1.5 inches, or 157.5 
inches) or an equivalent optotype-adjusted distance from cornea to chart surface.  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.  
3. 
Keratometry/Corneal Topography 
Keratometry/Corneal topography measurements will be collected using the Investigator’s 
standard of care method for ICL surgery. The site is to ensure a consistent and healthy tear 
film is present on the corneal surface for these measurements. It is permissible to add a 
drop of artificial tears to the subject’s eye if necessary, allowing them to blink several times 
to evenly distribute the drop, in order to obtain the highest quality and reproducible 
measurement possible. 
4. 
Gonioscopy 
Gonioscopy will be used to assess the anterior chamber angle, pigmentation in the posterior 
trabecular meshwork and peripheral anterior synechiae (PAS). 
a) 
Anterior Chamber Angle 
Gonioscopic examination of the anterior chamber angle will be utilized to determine the 
grade of the angle.   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. 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 55 of 62 
The scale is: 
0  
Closed 
I  
10 – 15° 
II  
15 – 25° 
III  
25 – 35° 
IV  
> 40° 
b) 
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.  
c) 
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). 
   
5. 
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 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 56 of 62 
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 
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 
 
6. 
Crystalline Lens Status 
The crystalline lens will be evaluated utilizing the LOCS III grading system15. If a lens 
opacity is observed, a photograph will be taken when the lens opacity is first observed and 
at each subsequent visit to document any progression of the opacity. 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 57 of 62 
7. 
Biometry 
a) 
Axial Length (AL), Corneal Thickness (CT) and Pupil Size 
AL, pupil size and CT measurements will be performed using partial coherence laser 
interferometry and documented in the CRF in XX.XX mm, X.X mm and XXX µm, 
respectively. 
b) 
Anterior Chamber Depth (ACD) 
Preoperative ACD, defined as the distance from the apex of the posterior corneal surface 
to the apex of the anterior crystalline lens surface, will be measured using Investigator’s 
standard method for ICL surgery and documented in X.XX mm. Note: 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. 
c) 
White-to-White (WTW) 
Preoperative WTW (white to white) as defined as horizontal distance from limbus to 
limbus, will be measured using the Investigator’s standard method for ICL surgery and 
documented in XX.XX mm. 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
   
8. 
IOP 
Goldmann applanation tonometry will be used except for Operative Visit day where a non-
contact method may be used. On surgery day, IOP will be measured approximately 1-6 
hours postoperatively. 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 58 of 62 
9. 
Cycloplegic Refraction 
Topical medication will be applied to dilate the pupil and paralyze the ciliary muscle for 
measurement of the cycloplegic refraction. 
10. 
Dilated Fundus Examination (DFE) 
A DFE will be performed according to Investigator’s standard of care for ICL surgery. The 
retina will be examined for presence or absence of posterior segment pathology or ocular 
infection. The examiner will classify the fundus as “normal” or “abnormal.” Any abnormal 
findings will be either documented in ocular history at time of enrollment or documented 
and graded as an AE as appropriate. 
11. 
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. 
12. 
Assessment of Pupil Ovalization 
If an oval or irregularly shaped pupil (dyscoria) is observed at any postoperative visit, 
photographs16 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 
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.  
13. 
Specular Microscopy  
Specular microscopy images will be captured using the Konan CellChek® [CECC] non-
contact specular microscopy device1 and submitted to an independent central reading 
center for analysis. Up to 333 subjects (333 primary eyes and up to 333 fellow eyes) will 
have eyes imaged for analysis.  
In order to satisfy study eligibility requirements, each prospective eye must meet the 
following preoperative criteria: 
 Minimum ECD requirements for age and true ACD identified in the table below 
 CV ≤ 0.45 
 Hex > 45% 
                                                 
 
1 Konan CellCheck® SL and XL models are completely interchangeable 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 59 of 62 
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 
 
Site Training 
Prior to enrollment start, the reading center will establish an SOP for the study and conduct 
pre-study training and certification of site personnel delegated to capture images for the 
study. The reading center will provide image examples that represent the quality required 
for the clinical study.  
Instructions to the sites will include the following: 
 select cell areas to count with fewest distortions- no shadow, blur or wash out 
 the quality of cells selected is critical; be aware of cells with polymegathism and 
pleomorphism post contact lens wear 
 all images obtained in the study will be required to be clear with cells plainly 
visible and without an extreme amount of guttata  
 three images will be obtained at a central corneal location for each eye 
 the same trained imaging technician(s) should be used for all study subjects at 
each site 
Microscopes at each site will be calibrated before study to ensure the same calibration 
throughout the study. Site readers will capture and submit sample images prior to start of 
enrollment as part of the certification process. 
Grading of Images 
Grading will be performed using the center dot method (manual process of identifying 
each endothelial cell in the image). In brief, the grader will identify a region in the image 
where cells are grouped together and will use the mouse or other input device to mark the 
center of each cell, until all the cells or a minimum of 100 cells in the region can be 
identified. Cell counting software will calculate the following parameters:  
 endothelial cell density (ECD) 
 coefficient of variation (CV) 
 hexagonality (Hex) 
 number of cells counted (n, maximum, minimum) 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 60 of 62 
 average cell size  
In addition, the grader will document the Confidence Score (CS) of the image as defined:  
 CS1, at least 100 contiguous cells identified  
 CS2, 25-99 contiguous cells identified (due to image quality or pathology) 
 CS3, image ungradable (< 25 contiguous cells identified)  
The reading center will report ECD, CV, % Hex, number of cells counted (n, max, min), 
average cell size, and mean of the cell counts across the 3 images to STAAR no later than 
90 days of date specular microscopy is performed.  The Sponsor will be notified if a reading 
indicates a cell density loss of 20% or more from the preoperative value or the ECD falls 
below 1500 cells/mm2.  
The Sponsor will notify the Investigator if a cell density loss of 20% or more from the 
preoperative value has occurred or the ECD falls below 1500 cells/mm2. The Investigator 
will recall the subject to retest to confirm the cell loss.  If confirmed, specular microscopy 
will be performed on eyes of concern every 4 to 6 months to evaluate the cell density 
stability. If there appears to be an accelerated annual cell loss rate above 1%/year, then the 
Investigator, in consultation with the Medical Monitor, will consider if implant removal 
may be warranted. 
 
 
 
 
 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 61 of 62 
9.0 
REFERENCES 
1 Sanders DR, Doney K, Poco M; ICL in Treatment of Myopia Study Group.  United 
States Food and Drug Administration clinical trial of the Implantable Collamer Lens 
(ICL) for moderate to high myopia: three-year follow-up. Ophthalmology. 2004 
Sep;111(9):1683-92. 
2 Lisa C, Alfonso JF, Alfonso-Bartolozzi B, Fernández-Vega L, Pérez-Vives C, Montés-
Micó R.   Collagen copolymer posterior chamber phakic intraocular lens supported by 
the ciliary sulcus to treat myopia: one-year follow-up. J Cataract Refract Surg. 2015 
Jan;41(1):98-104. 
3 Sanders DR, Vukich JA. Comparison of Implantable Contact Lens and laser assisted in 
situ keratomileusis for moderate to high myopia. Cornea 2003;22:324–31. 
4 Ieong A, Hau SC, Rubin GS, Allan BD. Quality of life in high myopia before and after 
implantable Collamer lens implantation. Ophthalmology. 2010 Dec;117(12):2295-300. 
5 Packer M. Meta-analysis and review: effectiveness, safety, and central port design of 
the intraocular Collamer lens. Clin Ophthalmol. 2016 Jun 9;10:1059-77. 
6 Packer M. The Implantable Collamer Lens with a central port: review of the literature. 
Clin Ophthalmol. 2018 Dec 12:2427-2436. 
7 STAAR Report Number: TR11-001 Assessment of the Possible Occlusion of a Central 
360µm Hole in STAAR Visian ICL Models VICMO and VTICMO. 
8 STAAR Report Number: TR10-010 Calculation of the Optical Effects of a Central 360 
µm Hole in the ICL Lenses. 
9 Shimizu K, Kamiya K, Igarashi A, Kobashi H. Long-Term Comparison of Posterior 
Chamber Phakic Intraocular Lens With and Without a Central Hole (Hole ICL and 
Conventional ICL) Implantation for Moderate to High Myopia and Myopic 
Astigmatism: Consort-Compliant Article. Medicine (Baltimore). 2016 
Apr;95(14):e3270. 
10 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. 
11 STAAR Surgical MICL 60 month Follow-up of PMA P030016 Subject Cohort. 
12 Bailey IL, Lovie JE.  New design principles for visual acuity letter charts. Am J Optom 
Physiol Opt. 1976 Nov; 53(11):740-5. 
13 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. 
14 Ferris FL, Kassoff A, Bresnick GH, et al: New visual acuity charts for clinical 
research. Am J Ophthalmol 1982; 94:91-96. 
15 Chylack LT, Wolfe JK, Singer DM, et al. The Lens Opacities Classification System III. 
Arch Ophthalmol. 1993;111(6):831–836. 
 

Study #CP19-01 - Protocol 
Rev 2, 2020.01.30 
 
Page 62 of 62 
 
 
16 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.