A Multicenter Clinical Evaluation of the Clinical Performance of a Phakic Intraocular Lens
Phase: NA
Conditions: Presbyopia
Sponsor: Staar Surgical Company

TITLE PAGE 
 
 
 
 
A Multicenter Clinical Evaluation of the Clinical Performance of a Phakic Intraocular Lens 
 
PROTOCOL 
 
STUDY #CP17-01 
 
SPONSOR: 
STAAR Surgical Company 
1911 Walker Avenue 
Monrovia, California 91016 
Telephone USA: 626-303-7902 
 
 
 
This clinical investigation is being conducted in accordance with EN ISO 14155: 2011 Clinical Investigation 
of Medical Devices for Human Subjects-Good Clinical Practice, ICH GCPs, applicable local regulations, and 
with the ethical principles laid down in the Declaration of Helsinki. 
Revision Chronology:  
Revision 1  
Revision 2 
Revision 3 
Revision 4 
- 
2017.11.09 
2018.01.19 
2018.01.30 
2018.08.14 
 
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 Ethics Committee. 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, KS-AquaPORT, and MICROSTAAR® ™ are registered trademarks of STAAR 
Surgical Company.  

Study #CP17-01 - Protocol 
 
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Page 3 of 53 
 
 
INVESTIGATOR STATEMENT OF APPROVAL 
 
A Multicenter Clinical Evaluation of the Clinical Performance of a Phakic Intraocular Lens 
 
PROTOCOL 
 
STUDY #CP17-01 
 
 
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, EN ISO 14155: 
2011 Clinical Investigation of Medical Devices for Human Subjects-Good Clinical Practice, ICH GCPs, 
applicable local regulations 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 EC and have complied with 
all financial and administrative requirements of the governing body of the clinical institution and the Sponsor. 
I will obtain written informed consent from each study subject prior to performing any study specific 
procedures.  
I understand that my signature on a case report form indicates that the data therein has been reviewed and 
accepted by me. 
I understand that this document and related information is subject to confidentiality terms found in my signed 
Confidentiality or Clinical Services Agreement. I agree to protect the confidentiality of my patients when 
allowing the Sponsor of this clinical investigation, and/or relevant regulatory authorities and ECs, 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 #CP17-01 - Protocol 
 
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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 ............................................................................................................................. 13 
1.1  CLINICAL AND NON-CLINICAL INFORMATION .................................................................................. 14 
1.2  HYPOTHESIS .................................................................................................................................... 14 
2.0  OBJECTIVE ...................................................................................................................................... 14 
3.0  STUDY DESIGN ................................................................................................................................ 14 
3.1  DESCRIPTION OF STUDY DESIGN...................................................................................................... 14 
3.2  SELECTION OF STUDY POPULATION ................................................................................................. 14 
3.2.1 
Eligibility .............................................................................................................................. 14 
3.2.2 
Subject Completion .............................................................................................................. 16 
3.2.3 
Subject Discontinuation ........................................................................................................ 16 
3.2.4 
Lost to Follow-up ................................................................................................................. 16 
3.3  INVESTIGATORS ............................................................................................................................... 16 
3.4  STUDY DURATION ........................................................................................................................... 17 
4.0  STUDY MATERIALS ....................................................................................................................... 17 
4.1  DESCRIPTION OF INVESTIGATIONAL DEVICE .................................................................................... 17 
4.2  INSTRUCTIONS FOR USE AND ADMINISTRATION .............................................................................. 17 
4.2.1 
Surgical Procedure ................................................................................................................ 17 
4.2.2 
Storage Requirements ........................................................................................................... 17 
4.3  TREATMENT REPLACEMENT ............................................................................................................ 17 
4.4  OTHER MATERIALS .......................................................................................................................... 17 
4.5  PACKAGING AND LABELING ............................................................................................................ 17 
4.6  ACCOUNTABILITY ............................................................................................................................ 18 
4.6.1 
Treatment Allocation ............................................................................................................ 18 
4.7  RISK ASSESSMENT ........................................................................................................................... 18 
5.0  STUDY CONDUCT ........................................................................................................................... 18 
5.1  STUDY VISITS .................................................................................................................................. 18 
5.1.1 
Preoperative Visit – Days -90 to Day 0 ................................................................................ 19 
5.1.2 
Operative Visit – Day 0 ........................................................................................................ 19 
5.1.3 
Postoperative Visits – Day 1 to Month 6 .............................................................................. 19 
5.1.4 
Unscheduled Visits ............................................................................................................... 19 
5.1.5 
Missed Visits ........................................................................................................................ 19 
5.2  STUDY COMPLETION ........................................................................................................................ 19 
5.2.1 
Early Study Termination ....................................................................................................... 20 
5.2.2 
Post-study Follow-up ............................................................................................................ 20 
5.3  CONCOMITANT MEDICATIONS/THERAPY ......................................................................................... 20 
5.4  PROTOCOL DEVIATIONS ................................................................................................................... 20 
6.0  ADVERSE EVENT REPORTING ................................................................................................... 20 
6.1  DEFINITIONS .................................................................................................................................... 20 

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6.1.1 
Adverse Event (AE) .............................................................................................................. 20 
6.1.2 
Adverse Device Effect (ADE) .............................................................................................. 21 
6.1.3 
Device Deficiency ................................................................................................................ 21 
6.1.4 
Malfunction .......................................................................................................................... 21 
6.1.5 
Serious Adverse Device Effect (SADE) ............................................................................... 21 
6.1.6 
Serious Adverse Event (SAE) .............................................................................................. 21 
6.1.7 
Unanticipated Serious Adverse Device Effect (USADE) ..................................................... 22 
6.1.8 
Use error ............................................................................................................................... 22 
6.2  EVALUATION ................................................................................................................................... 22 
6.3  REPORTING ...................................................................................................................................... 22 
6.3.1 
On-Site Expedited Reporting ................................................................................................ 22 
6.3.2 
Safety Reporting within the European Economic Area ........................................................ 23 
6.3.3 
Off-Site SAE Reporting ........................................................................................................ 24 
6.3.4 
Reporting of Complaints for STAAR Surgical Products ...................................................... 24 
6.3.5 
Adverse Events and SAEs at Subject Exit ............................................................................ 24 
7.0  STATISTICAL METHODS ............................................................................................................. 25 
7.1  HYPOTHESIS .................................................................................................................................... 25 
7.2  STUDY ENDPOINTS .......................................................................................................................... 25 
7.2.1 
Performance Endpoints ......................................................................................................... 25 
7.2.2 
Safety Endpoint .................................................................................................................... 26 
7.3  SAMPLE SIZE ................................................................................................................................... 26 
7.4  STUDY POPULATIONS ...................................................................................................................... 26 
7.5  STATISTICAL ANALYSIS ................................................................................................................... 26 
8.0  DATA QUALITY ASSURANCE ..................................................................................................... 27 
8.1  STUDY MONITORING ....................................................................................................................... 27 
8.2  SOURCE DOCUMENTATION .............................................................................................................. 27 
8.3  CASE REPORT FORMS AND DATA VERIFICATION ............................................................................. 28 
8.4  RECORDING OF DATA AND RETENTION OF DOCUMENTS.................................................................. 28 
8.5  AUDITING PROCEDURES .................................................................................................................. 28 
8.6  ETHICS COMMITTEE APPROVAL ...................................................................................................... 28 
8.7  PUBLICATION OF RESULTS ............................................................................................................... 29 
 
APPENDICES 
APPENDIX A: 
SCHEDULE OF VISITS AND PARAMETERS .................................................. A-1 
APPENDIX B: 
SURGICAL PROCEDURE ....................................................................................B-1 
APPENDIX C: 
METHODS OF CLINICAL EVALUATION ....................................................... C-1 
APPENDIX D: 
REFERENCES ........................................................................................................ D-1 
 

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LIST OF ABBREVIATIONS 
Abbreviation 
/Acronym  
Term  
ACD Anterior Chamber Depth 
ADE Adverse Device Effect 
AE  Adverse Event 
AL Axial Length 
BCDVA Best Corrected Distance Visual Acuity 
BCNVA Best Corrected Near Visual Acuity 
BfArM Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel 
und Medizinprodukte) 
BSS Balanced Salt Solution 
CE Conformité Européene 
CECC Corneal Endothelial Cell Count 
CIP Clinical Investigation Plan 
CRF Case Report Form 
CRO Contract Research Organization 
CTS Clinical Trial Suite 
D Diopter 
DCIVA Distance Corrected Intermediate Visual Acuity 
DCNVA Distance Corrected Near Visual Acuity 
DOA Delegation of Authority 
EC Ethics Committee 
ECD Endothelial Cell Density 
EDOF Extended Depth of Focus 
eQMS Electronic Quality Management System 
ETDRS Early Treatment Diabetic Retinopathy Study 
EU European Union 
FAS Full Analysis Set 
FMEA Failure Mode Effects Analysis 
FTP Foam Tip Plunger 
GCPs Good Clinical Practices 
HEMA Hydroxyethylmethacrylate 
HOA Higher Order Abberrations 
ID Identification 
ICF Informed Consent Form  
ICH International Conference on Harmonisation/ Implantable Collamer® Lens for 
Hyperopia 
ICL Implantable Collamer® Lens 
ICM Implantable Collamer® Lens for Myopia 
IOL Intraocular Lens 

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Abbreviation 
/Acronym  
Term  
ISO International Organization for Standardization 
LASIK Laser Assisted In Situ Keratomileusis 
MeDRA Medical Dictionary for Regulatory Devices 
MPG Medical Devices Act- Germany 
MPSV German Safety Plan for Medical Devices (Medizinproduktesicherheitsverordnung) 
MRSE Manifest Refractive Spherical Equivalent 
OCT Optical Coherence Tomography 
PI Principal Investigator/ Peripheral iridotomy/iridectomy 
pIOL Phakic Intraocular Lens 
PPS Per Protocol Set 
PT Preferred Term 
SADE Serious Adverse Device Effect 
SAE Serious Adverse Event 
SAP Statistical Analysis Plan 
SD Standard Deviation 
SE Spherical Equivalent 
SES Safety Evaluation Set 
SOC Standard of Care/System Organ Class 
SOP Standard Operating Procedure 
SPK Superficial Punctate Keratitis 
UCDVA Uncorrected Distance Visual Acuity 
UCIVA Uncorrected Intermediate Visual Acuity 
UCNVA Uncorrected Near Visual Acuity 
US United States 
USADE Unanticipated Serious Adverse Device Effect 
UV Ultraviolet 
VA Visual Acuity 
VICH6 STAAR EVO+ Visian™ Implantable Collamer® Lens (VICL) with Aspheric 
(EDOF) Optic for hyperopia 
VICL Visian™ Implantable Collamer®  Lens 
VICM6 STAAR EVO+ Visian™ Implantable Collamer® Lens (VICL) with Aspheric 
(EDOF) Optic for myopia 
NOTE: The first occurrence of some abbreviations is not spelled out in the document (eg, units of 
measure). 
 

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SYNOPSIS  
STAAR Surgical Company Study #CP17-01 
Revision chronology: 
Rev 01, 2017.11.09 
Rev 02, 2018.01.19 
Rev 03, 2018.01.30 
Rev 04, 2018, 08.14 
Title: 
A Multicenter Clinical Evaluation of the Clinical Performance of a Phakic 
Intraocular Lens 
Type of study:  
Performance 
 
Objective(s): 
The objective of this clinical study is to evaluate the clinical performance 
of the STAAR EVO+ Visian™ Implantable Collamer® Lens (VICL) with 
Aspheric (EDOF) Optic [EDOF ICL] in improving uncorrected near visual 
acuity (UCNVA).  
Study design: 
This prospective, open-labeled, evaluation of clinical performance of the 
CE-Marked EDOF ICL for the improvement of UCNVA will be 
conducted at approximately 6 clinical sites in Europe. Approximately 48 
subjects who meet all eligibility criteria will undergo phakic IOL 
implantation in both eyes.  
Postoperatively, subjects will undergo ophthalmic examination at regular 
intervals per the study visit schedule up to 6 months after surgery.  
Inclusion criteria: 
1. Subjects must be able to read, understand and provide written 
informed consent on the Ethics Committee (EC) approved Informed 
Consent Form (ICF) and provide authorization as appropriate for local 
privacy regulations, 
2. Willing and able to comply with all treatment and follow-up study 
related procedures, 
3. Subjects who require a spherical lens power from -0.50 D to -18.00 D 
must be 40 – 60 years of age at time of surgery,  
4. Subjects who require a spherical lens power from 0.0 D to +3.00 D 
must be 35 – 45 years of age at time of surgery, 
5. Preoperative refraction that can be fully corrected (target emmetropia) 
with available ICL powers, with ≤ 0.75 D preoperative refractive and 
residual cylinder,   
6. Must have less than 0.75 D spherical equivalent (SE) difference 
between cycloplegic and manifest refractions,  
7. Must have a stable correction (± 0.50 D) as determined by manifest 
refractive spherical equivalent (MRSE) from consecutive refractions, 
medical records, or prescription history, 
8. Best Corrected Distance Visual Acuity (BCDVA) 20/20 or better in 
both eyes, 
9. Requires +1.00 D to +2.50 D reading add, 
10. 
 

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STAAR Surgical Company Study #CP17-01 
12. Allergy to anesthetics or other postoperative medications required in 
this study, 
13. Subject who is pregnant, plans to become pregnant, or is lactating 
during the course of the study, or has another condition associated 
with the fluctuation of hormones that could lead to refractive changes, 
14. 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. 
Investigational device: 
The EDOF ICL includes a refractive optic and features a single piece lens 
design with a convex/concave optic zone of 4.9 to 6.1 mm diameter 
(according to model and power) and a 0.36 mm diameter central hole in 
the optic known as the KS-AquaPORT®. The lens is manufactured in five 
overall diameters: 11.6, 12.1, 12.6, 13.2, and 13.7 mm to accommodate 
different eye sizes. The lens is manufactured from Collamer, a proprietary 
polymer made from collagen, hydroxyethylmethacrylate (HEMA) and an 
ultraviolet (UV) absorber. The 10% UV cut-off for the ICL is at 387 nm 
wavelength. The lens is supplied with a delivery system for implantation 
through an incision of 3.5 mm or less. 
Study endpoints: 
Performance Endpoints 
Primary performance endpoint: 
 Achievement of monocular UCNVA of Snellen equivalent 20/40 or 
better at 40 cm at Visit 5 (6 months after implantation) in equal to or 
greater than 75% of implanted eyes (responder rate)  
Secondary performance endpoints include the following: 
 Percentage of implanted eyes achieving monocular UCNVA of 
Snellen equivalent 20/40 or better at 40 cm at Visit 3 and 4 (1 and 3 
months after implantation respectively)  
 Change from baseline in monocular uncorrected intermediate visual 
acuity (UCIVA) at 80 cm at postoperative Visit 3, 4 and 5 
 Change from baseline in monocular UCNVA at 40 cm at 
postoperative Visit 3, 4 and 5 
 Change from baseline in monocular distance corrected intermediate 
visual acuity (DCIVA) at 80 cm at postoperative Visit 3, 4 and 5 
 Change from baseline in monocular distance corrected near visual 
acuity (DCNVA) at 40 cm at postoperative Visit 3, 4 and 5 
 Change from baseline in binocular UCNVA at 40 cm at postoperative 
Visit 3, 4 and 5 
There are no prespecified performance targets for the secondary 
performance endpoints. 
Safety Endpoint 
 
Ocular adverse event (AE) rates assessed in implanted eyes 
There are no prespecified performance targets for the safety endpoint. 
Statistical methods: 
The primary performance endpoint is defined as achievement of 
monocular UCNVA of Snellen equivalent 20/40 or better at 40 cm at 
Visit 5 (6 months after implantation) in equal to or greater than 75% of 
implanted eyes (responder rate). The analysis will be performed on all 

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STAAR Surgical Company Study #CP17-01 
eyes.  
The implant procedure is defined as successful if the responder rate is 
equal to or greater than 75%. The corresponding statistical hypothesis 
is therefore as follows: 
H0 (null hypothesis):  
 
π < 0.75 
Ha (alternative hypothesis):  
π ≥ 0.75 
where π is the true proportion of eyes that achieve the performance 
endpoint at 6 months postoperative (6-month responder rate).  
Fleming’s two-stage design was used to optimize the sample size while 
allowing for early termination due to rejecting the null hypothesis. It is 
expected that 90% of eyes will achieve the performance endpoint and 
the sample size was therefore conservatively determined based on an 
87.5% responder rate.  
In the first stage, 27 patients (54 eyes) will be evaluated. If there are 43 
or less response the trial will be stopped for futility since the likelihood 
of still obtaining a significant result is too low to continue the study 
under ethical considerations. If there are 48 or more responses the trial 
will be stopped and the null hypothesis rejected as enough statistical 
evidence has been accrued to determine that, within the certainty of the 
controlled one-sided type I error probability of 2.5%, the true responder 
rate is not lower than 75%.  
Otherwise, 16 additional patients (32 eyes) will be recruited for a total 
of 43 patients (86 eyes). The null hypothesis will be rejected if 73 or 
more responses are observed among the 86 eyes. This design yields a 
one-sided type I error probability of 2.5% and a power of 80% if the 
true response rate is 87.5%. 
Summaries for continuous variables will include the number of non-
missing observations, mean, standard deviation (SD), median, minimum, 
and maximum. Summaries for discrete variables will include the 
tabulation of frequencies and percentages. 
 

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1.0 
INTRODUCTION  
The STAAR Implantable Collamer® Lens (ICL) first obtained approval in 1997 for the original ICH (for 
hyperopia) and ICM (myopia) lens models. Since the approval of the first ICL, incremental improvements 
and expansion in the technology have been brought to patients globally. The ICL has a substantial history of 
clinical effectiveness while presenting a favorable safety profile with over 700,000 ICLs implanted globally. 
The STAAR EVO+ Visian™ Implantable Collamer® Lens (VICL) with Aspheric (EDOF) Optic (models 
VICH6 and VICM6 [EDOF ICL]) received CE Mark on May 11, 2017.  
The EDOF ICL is indicated for use in phakic eye treatment in adults with an anterior chamber depth (ACD) 
equal to or greater than 3.0 mm, as measured from the corneal endothelium to the anterior lens capsule, and:  
1. 21- 60 years of age for the correction/reduction of myopia in adults ranging from -0.5 D to -20.0 D 
at the spectacle plane. 
Or 
2. 21- 45 years of age for the correction/reduction of hyperopia in adults ranging from +0.5 D to 
+16.0 D at the spectacle plane. 
The EDOF ICL models include a combination of the most advanced elements of the ICL platform, an 
increased diameter of the optic to accommodate larger pupils and the center port (KS-AquaPORT®) allowing 
for implantation without the need of peripheral iridotomies/iridectomies (PIs). These features are combined 
with asphericity, the addition of hyperfocal optics utilizing circularly-symmetric Zernike polynomial 
aberrations (to 8,0). The added aspheric optic is designed to provide extended depth of focus (EDOF).  
The ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the 
anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of 
refractive error in those who currently utilize spectacle and/or contact lenses correction.  Other alternative 
refractive surgical procedures include: excimer laser surgery (including photorefractive keratectomy (PRK) 
and laser assisted in situ keratomileusis (LASIK)), radial keratotomy (RK), automated lamellar keratectomy 
(ALK), epikeratoplasty, intracorneal implants (lenses or rings), anterior chamber and sulcus-placed phakic 
intraocular lenses (pIOLs), refractive lens exchange, and combinations of two or more of these procedures. 
Presbyopia is a condition associated with the expected age-related decline in near-focusing ability that 
becomes manifest at approximately age 45.1,2  Presbyopia affects all people, regardless of their underlying 
refractive error.  Those who are farsighted prior to the onset of presbyopia will likely experience difficulty 
with near vision at a somewhat younger age, while those who are nearsighted may not notice the onset of 
presbyopia until somewhat later.  Regardless, all people will eventually require optical correction in addition 
to any distance correction for near vision tasks such as reading. 
Presbyopia is associated with reduced health-related quality of life,3 and presbyopia corrected with glasses is 
associated with a nominal decrease in quality of life, similar to that of treated systemic hypertension.  
Approximately 10% of presbyopic patients suffer such inconvenience from spectacle correction that they 
would consider surgical intervention.4   
Individuals who have had refractive surgery such as LASIK for correction of their distance vision will still 
experience presbyopia when they reach their mid-forties.  Monovision, the intended correction of one eye for 
near vision and the fellow eye for distance vision, represents a common strategy for addressing presbyopia 
in older patients undergoing LASIK.  Intraocular lens (IOL) implants intended for use at the time of cataract 
surgery have also been used to provide monovision. While monovision correction of presbyopia is related to 
some improvements in health-related quality of life, the quality of life with monovision is still worse than the 
quality of life for younger subjects with emmetropia.1  Specific presbyopia-correcting IOLs have also been 
developed incorporating multifocal and EDOF optical elements intended to provide simultaneous vision at 
near and far distances.5,6  While monovision LASIK, multifocal IOLs and corneal implants have been 
developed to improve near vision, these methods typically result in some expected degradation of distance 
vision and unwanted optical side effects such as halos and glare in order to gain an improvement in 
uncorrected near vision.  

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3. Subjects who require a spherical lens power from -0.50 D to -18.00 D must be 40 – 60 years of age at 
time of surgery,  
4. Subjects who require a spherical lens power from 0.0 D to +3.00 D must be 35 – 45 years of age at 
time of surgery, 
5. Preoperative refraction that can be fully corrected (target emmetropia) with available ICL powers, with 
≤ 0.75 D preoperative refractive and residual cylinder,   
6. Must have less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest 
refractions,  
7. Must have a stable correction (± 0.50 D) as determined by manifest refractive spherical equivalent 
(MRSE) from consecutive refractions, medical records, or prescription history, 
8. Best Corrected Distance Visual Acuity (BCDVA) 20/20 or better in both eyes, 
9. Requires +1.00 D to +2.50 D reading add, 
10. 
 
11. ACD  2.8 mm as measured from the corneal endothelium to the anterior lens capsule for subjects who 
require a spherical lens power from -0.50 D to -18.00 D,  
12. ACD  3.0 mm as measured from the corneal endothelium to the anterior lens capsule for subjects who 
require a spherical lens power from 0.0 D to +3.00 D, 
13. Anterior chamber angle  Grade III,  
14. Phakic in both eyes, 
15. Current contact lens wearers need to demonstrate a stable refraction,  
(± 0.5 D), expressed as MRSE, on two consecutive examination dates with refractive stability 
determined by the following criteria: 
 
contact lenses were not worn for at least 2 weeks (rigid and toric contact lenses) or 3 days (soft 
contact lenses) prior to the first refraction, 
 
two refractions were performed at least 7 days apart. 
 
Exclusion Criteria 
This study will include subjects who do not meet the following criteria: 
1. Participation in a clinical trial within 30 days prior to entry into this study and/or during the period of 
study participation, 
2. Previous intraocular or corneal surgery in either eye, including refractive surgery (e.g., LASIK), 
3. Progressive sight threatening disease or other previous or current ocular conditions, other than myopia, 
that may predispose for future complication (e.g., diabetic retinopathy, pseudoexfoliation, retinal 
detachment, ocular hypertension or glaucoma, clinically significant corneal disease (Fuchs, 
keratoconus, herpes simplex or zoster keratitis), retinal vascular disease, cataract, etc.) in either eye, 
4. Low/abnormal corneal endothelial cell density (ECD) according to recommendations in ISO-11979-10 
(Tab. A.1), 
5. 
 
6. Amblyopia, 
7. Presence of active or history of chronic inflammation in either eye (e.g., scleritis, uveitis, etc.), 
8. Clinically significant irregular astigmatism in either eye, as determined by the Investigator, 
9. Serious (i.e., life threatening), acute, chronic or systemic, non-ophthalmic disease or illness that would 
increase the operative risk, confound the outcome(s) of the study or which may preclude study 
completion (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, 
uncontrolled diabetes, insulin dependent diabetes, etc.), 
10. Use of topical steroids at time of implantation, 
11. Systemic or topical medication, other than prescribed study medications (e.g., systemic corticosteroids, 
anti-metabolites) that may confound the outcome or increase the risk to the subject, 
12. Allergy to anesthetics or other postoperative medications required in this study, 

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13. Subject who is pregnant, plans to become pregnant, or is lactating during the course of the study, or 
has another condition associated with the fluctuation of hormones that could lead to refractive changes, 
14. 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. 
3.2.2 
Subject Completion 
The subject has completed the entire study when the study lenses have been implanted bilaterally and the 
Sponsor receives completed CRF documentation for all visits. Subjects who require further follow-up for an 
adverse event (AE) will be followed according to Section 6.3.5. 
A Study Exit CRF for each eye must be completed for all subjects who complete the study.  
3.2.3 
Subject Discontinuation 
A subject may be discontinued (at the discretion of the Investigator, the Sponsor and/or the EC) 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 
 
explant of the study lens(es)  
 
If the study lens is explanted, a minimum of one post-explant visit should be completed to record safety 
measures for the subject (e.g., BCDVA, cataract/lens evaluation, endothelial cell count, etc.). 
Prior to discontinuing a subject, every effort should be made to contact the subject, schedule a final study 
visit, and obtain as much follow-up data as possible.  
Adverse events will be followed as described in Section 6.3.5. Subject withdrawals will be documented 
clearly on the source document and applicable CRF. 
Only subjects who do not receive successful bilateral implantation MAY be replaced. Subjects who are 
discontinued from the study following treatment will not be replaced. 
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 postoperative Visit 5, as defined by the visit window and cannot be contacted, 
will be considered lost to follow-up. All follow-up attempts will be documented in the subject’s source 
documentation, and the applicable CRFs will be completed. 
3.3 
Investigators 
 
The study will be conducted at approximately 6 clinical site(s) located in Europe (Spain, Belgium and 
Germany).  
 
The study will be conducted by Investigators who have completed the STAAR Surgical EVO Visian 
ICL Physician Certification Program and are determined by STAAR Surgical to be suitably qualified by 
training and experience to conduct this study in compliance with all applicable GCPs and local 
regulations. Sub-Investigators will be identified on the Device Investigator Agreement (DIA)/ 
Delegation of Authority Log (DOA). 
 
Each Investigator will enroll approximately 10 subjects (20 eyes). In the event that selected sites do not 
meet full enrollment, the Sponsor may decide to increase enrollment as needed at other currently active 
sites and additional site(s) may be added to satisfy the enrollment requirements of the study.  

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3.4 
Study Duration  
The duration of the study, including the time to recruit all subjects, will be approximately 18 months. Eligible 
subjects who are enrolled in the study will be seen for 7 scheduled study visits (per eye) over the course of 
approximately 6-9 months. 
4.0 
STUDY MATERIALS 
4.1 
Description of Investigational Device  
The EVO+ Visian ICL with Aspheric (EDOF) Optic includes a refractive optic and features a single piece 
lens design with a convex/concave optic zone of 4.9 to 6.1 mm diameter (according to model and power) and 
a 0.36 mm diameter central hole in the optic known as the KS-AquaPORT®. The lens is manufactured in 
five overall diameters: 11.6, 12.1, 12.6, 13.2, and 13.7 mm to accommodate different eye sizes. The lens is 
manufactured from Collamer, a proprietary polymer made from collagen, hydroxyethylmethacrylate 
(HEMA) and an ultraviolet (UV) absorber. The 10% UV cut-off for the ICL is at 387 nm wavelength. The 
lens is supplied with a delivery system for implantation through an incision of 3.5 mm or less. STAAR will 
provide the following materials:  
 
EVO+ Visian ICL with Aspheric (EDOF) Optic  
 
Supplemental lens  for each eye 
 
MICROSTAAR injector MSI-PF or MSI-TF reusable injector with SFC-45, single use cartridge and 
foam tip plunger (FTP) 
The study lenses will be packaged and labeled in a manner consistent with the study design and applicable 
regulations.  
4.2 
Instructions for Use and Administration  
4.2.1 
Surgical Procedure 
Surgery to implant the EDOF ICL will be performed in accordance with instructions provided in  
Appendix B.  
4.2.2 
Storage Requirements 
The study lenses are to be stored at room/ambient temperature. The storage location at the clinical site must 
have limited access, available to study site personnel only.   
4.3 
Treatment Replacement 
A supplemental lens will be provided for each eye. Study lens accountability should be maintained as 
described in Section 4.6.  
4.4 
Other Materials  
STAAR will provide the following ancillary materials for use during the study: 
 
M&S Clinical Trial Suite Vision Tester 
 
iTrace Aberrometer 
4.5 
Packaging and Labeling  
The Study Lenses will be packaged and labeled in a manner consistent with the study design and applicable 
regulations. In addition to the standard labelling of the product, a study-specific label will be attached to the 
outer packaging and will contain information as required by EN ISO 14155 and local labelling requirements 
together with caution statement that it is for clinical trial use only. 

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4.6 
Accountability 
The Investigator will be responsible for keeping current and accurate records of all study lenses received, 
dispensed, and returned to the Sponsor. The study lenses must be stored under the appropriate conditions in 
a secure, limited access area and are to be implanted only in subjects enrolled in the study, in accordance 
with the conditions specified in this protocol.  
Accountability records will include: 
 
Serial number of each study lens 
 
Date received by site 
 
Names of site personnel who receive, use and dispense the study lens 
 
Date of dispensation/use 
 
Subject treated with each study lens 
 
Date of return to Sponsor and reason (e.g., damaged, defective, back-up not used), if applicable 
At time points throughout the study and/or upon completion of the study, the Sponsor/Sponsor's 
representative will review and verify the Investigator's accountability records. Following verification, and as 
directed by the Sponsor, all unused or explanted study lenses must be returned to the Sponsor, as directed.  
4.6.1 
Treatment Allocation 
All patients at study sites who provide informed consent to participate and meet all eligibility criteria will be 
offered the opportunity to enroll in this study in a consecutive manner. Upon enrollment, subjects will be 
assigned the next available Subject ID number.  
4.7 
Risk Assessment  
The EVO+ EDOF ICL has been assessed for risk control measures per established risk analysis and FMEA 
reports. The use of CE-Marked model in the context of this clinical study requires the residual risk to be 
balanced against the anticipated benefit of the procedure. The risk level has been determined to be in the 
lowest category, deeming the risk to be acceptable, and it is believed that the benefits outweigh any of the 
identified or associated residual risks with this clinical evaluation.  
If new information regarding new risks to patients is made available during the course of the study, the EC 
and applicable regulatory agencies will be notified, the informed consent will be updated and the Investigator 
will be required to provide new information to patients and have them sign the revised ICF. 
5.0 
STUDY CONDUCT 
5.1 
Study Visits  
All Subjects who meet the eligibility criteria will be seen according to the following schedule.  
Preoperative Visit 
Days -90 to 0 
Operative Visit 
Day 0 
Postoperative Visit 1 
Day 1 (1 day) 
Postoperative Visit 2 
 
Week 1 (5 – 9 days) 
Postoperative Visit 3 
 
Month 1 (3 – 5 weeks) 
Postoperative Visit 4 
 
Month 3 (10 – 14 weeks) 
Postoperative Visit 5 
 
Month 6 (21 – 26 weeks) 
 

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Refer to Appendix A for a schedule of visits and parameters and Appendix C for methods of clinical 
evaluation.  
Following identification of a potential subject, the Investigator (or designee) will explain the purpose of the 
study, procedures, risks/benefits, and subject responsibilities to the potential subject. The subject’s 
willingness and ability to meet the follow-up requirements of the study will be determined. If the subject 
chooses to participate in the investigation, written informed consent will be obtained. The subject and the 
person obtaining written consent, will sign and date the EC-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 -90 to Day 0 
Prospective subjects who have provided informed consent will be screened to determine eligibility for 
treatment in the study. Demographic information, relevant ocular medical history, and current ocular 
medication use will be collected. The preoperative clinical evaluation will consist of a complete ophthalmic 
examination conducted no more than 90 days prior to surgery.  
Refer to Appendix A: Schedule of Visits and Parameters for assessments to be performed. 
5.1.2 
Operative Visit – Day 0 
Subjects will be reassessed to confirm eligibility. In addition, any changes in concomitant medications or 
AEs will be recorded. If the subject no longer meets eligibility criteria, he/she will be considered a screen 
failure. If the subject is eligible, he/she will be enrolled in the study and undergo surgery according to the 
surgical procedure described in Appendix C. 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(s) will 
be conducted. Any complications, AEs, or associated treatment given will be appropriately documented and 
reported. 
5.1.3 
Postoperative Visits – Day 1 to Month 6 
Each treated subject will be seen for 5 postoperative visits according to the schedule in Appendix A.  
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 CRFs, as 
appropriate. Visits intended to fulfill scheduled visit requirements that fall outside the designated scheduled 
visit range, are not Unscheduled Visits. In these cases, the visit data will be collected and transcribed to the 
appropriate scheduled visit CRF. 
If a subject is seen for multiple visits during a given visit timeframe, the data from the visit that is intended 
to meet the protocol requirements for the scheduled visit should be captured on the visit CRF. Where such a 
determination cannot be made, the first visit within the scheduled visit interval will be used for completion 
of the protocol required scheduled visit CRF. Data from any additional visits within a scheduled visit interval 
will be captured on an Unscheduled Visit CRF. 
5.1.5 
Missed Visits  
If a subject misses any scheduled follow-up visit and cannot be seen prior to the start of the visit range for 
the next scheduled follow-up visit, the visit will be documented as missed in the source documents and CRFs.  
5.2 
Study Completion  
STAAR Surgical will notify the Investigator when to contact the EC to inform them that the study is 
complete. 

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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), EC, and Local Health 
Authority, as applicable. STAAR Surgical will instruct the Investigators to stop dispensing study 
materials/treatment, to assure appropriate follow-up for all enrolled subjects and arrange for study closeout 
at each site as appropriate. 
5.2.2 
Post-study Follow-up 
If a subject requires further follow-up of a serious adverse event (SAE) upon discontinuation or completion 
of the study, the Investigator should schedule post-study follow-up visits, as necessary. Refer to Section 6.3.5 
for follow-up of SAEs following study exit. 
5.3 
Concomitant Medications/Therapy  
The Investigator may use any medical treatment that is judged appropriate and beneficial to the subject. All 
medications that are considered necessary for the subject’s welfare may be used at the Investigator’s 
discretion. Documentation of all medications used for ocular indications by the subject during this study will 
be recorded in the subject’s source document and applicable CRFs. 
5.4 
Protocol Deviations 
The date of and reason for deviations will be documented in all cases. Significant or major protocol deviations 
impacting the safety of the subject or the integrity of the study must be reported by the Investigator to the EC 
immediately. Reporting of all other protocol deviations must adhere to the requirements of the governing EC.  
Protocol assessments will continue until the end of the study, unless the protocol deviations put the subject 
at risk or the subject’s condition requires that he/she be discontinued from the study. 
6.0 
ADVERSE EVENT REPORTING 
Throughout the course of this study, all efforts will be made to remain alert to possible AEs. If an AE occurs, 
the first concern will be the safety of the subject, and appropriate medical intervention will be made. All 
ocular AEs and all SAEs (both ocular and non-ocular) will be reported by the Investigator in this study. Non-
serious non-ocular AEs will not be documented in the eCRF. The collection of AEs begins at the time the 
subject completes the informed consent process to participate in the study.  
All device-related AEs and SAEs reported in this study will be reviewed by the responsible Medical Monitor 
and forwarded to STAAR Complaint Handling department. In addition, all other events that meet the 
definition of a product complaint (i.e., device deficiency) will be evaluated and investigated in accordance 
with STAAR’s complaint handling procedures.  
Refer to Section 6.3.1 for instructions on events that require expedited reporting to the Sponsor. 
6.1 
Definitions  
6.1.1 
Adverse Event (AE) 
According to EN ISO 14155,8 an Adverse Event is any untoward medical occurrence, unintended disease or 
injury, or untoward clinical sign (including abnormal laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device.  
NOTE 1: This definition includes events related to the investigational device or the comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or persons, this definition is restricted to events related to investigational medical devices. 
Complications during phakic IOL surgery of the study eye must be reported as AEs in the corresponding 
eCRF section. 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.  

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Experience with intraocular surgery and the implantation of phakic IOLs has shown that some findings can 
be considered normal or expected events after these procedures. These findings may be considered normal 
or expected events after phakic IOL surgery, and need only be reported as AEs if the following criteria are 
met or exceeded: 
 
iritis/cells/flare if present at postoperative Visit 3 or later 
 
corneal edema if present at postoperative Visit 3 or later  
 
moderate or severe subjective visual disturbance (e.g., glare/halos) if present at postoperative Visit 4 or 
later (i.e., halo and glare in the early postoperative period is not reportable as an AE) 
 
elevated IOP if measuring ≥ 30 mmHg or ≥ 10 mmHg above baseline  
 
postoperative ocular event(s) if requiring a change in the standard postoperative medication regimen 
 
inadequate or excessive vault if ICL exchange is necessary to prevent permanent impairment, i.e., is 
sight threatening (if the lens is still performing as intended, variations in vault are not reportable as an 
AE) 
 
paracentesis to relieve elevated IOP if performed >1 week after implantation (paracentesis ≤ 1 week 
postoperative is not reportable as an AE) 
6.1.2 
Adverse Device Effect (ADE) 
According to EN ISO 141558 an Adverse Device Effect is an AE related to the use of an investigational 
medical device.  
NOTE 1: This definition includes AEs resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device.  
6.1.3 
Device Deficiency 
According to EN ISO 141558, a Device Deficiency is any inadequacy of the medical device with respect to 
its identity, quality, durability, reliability, safety or performance.  
NOTE: Device deficiencies include malfunctions, use errors and inadequate labeling. 
6.1.4 
 Malfunction 
According to EN ISO 141558, 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 or 
Clinical Investigation Plan (CIP). 
6.1.5 
Serious Adverse Device Effect (SADE) 
According to EN ISO 141558, a Serious Adverse Device Effect is any ADE that has resulted in any of the 
consequences characteristic of an SAE. 
6.1.6 
Serious Adverse Event (SAE) 
According to EN ISO 141558, a Serious Adverse Event is any AE that 
a) led to death, 
b) led to serious deterioration in the health of the subject, that either resulted in 
1) a life-threatening illness or injury, or, 
2) a permanent impairment of a body structure or body function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or permanent 

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impairment to a bod structure or body function, 
c) led to foetal distress, foetal death or a congenital abnormality or birth defect. 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, without 
serious deterioration in health, is not considered an SAE. 
6.1.7 
Unanticipated Serious Adverse Device Effect (USADE) 
According to EN ISO 141558, an Unanticipated Serious Adverse Device Effect is any Serious Adverse 
Device Effect (SADE) which by its nature, incidence, severity or outcome has not been identified in the 
current version of the risk analysis report. 
6.1.8 
Use error 
According to EN ISO 141558, Use Error is any act or omission of an act that results in a different medical 
device response than intended by the manufacturer or expected by the user. 
NOTE 1: User error includes slips, lapses, and mistakes. 
NOTE 2: An unexpected physiological response of the subject does not in itself constitute a use error.   
6.2 
Evaluation 
Adverse events experienced in this study may be associated with the study device (i.e., ADE) or the study 
procedures described in this protocol.  
When evaluating AEs, the Investigator must determine if the event is serious, according to the definitions in 
6.1.6, and assess the severity of symptoms and evaluate the relationship of the event to the study device and 
study protocol, using the following guidelines: 
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: AEs which are clearly and incontrovertibly due to causes other than the study device or 
study protocol (e.g., concomitant disease, etc.) 
 
Related: AEs which are felt with a reasonable degree of certainty to be related to the study device or 
study protocol 
 
Unknown: AEs for which a connection with the study device or study protocol cannot be ruled-out with 
certainty, or not enough information is available to assess the relationship 
6.3 
Reporting 
6.3.1 
On-Site Expedited Reporting 
The Investigator is obligated to report the following to the Sponsor within 24 hours of becoming aware of 
the event to ensure the safety of all participants in the study and to meet regulatory reporting requirements: 
 
all SAEs, regardless of relationship to study device or study protocol 
 
all non-serious AEs determined to be related to the study device (ADE) 

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Condition for reporting to BfArM 
Country of 
occurence 
Timeline for 
reporting to 
BfArM 
Report type, form 
A causal relationship between the 
SAE and the investigational medical 
device, a comparator device, 
diagnostic or therapeutic procedures 
performed as part of the clinical trial 
or other conditions of the trial 
conduct cannot be excluded 
Germany 
Immediately 
Single report, SAE report 
form 
All other countries 
where the clinical 
trial is performed 
Immediately 
Summary table, SAE report 
table 
 
All SAEs shall be 
documented using the 
same Excel file, in a 
cumulative manner, 
using the same Excel 
sheet 
A causal relationship between the 
SAE and the investigational medical 
device, a comparator device, 
diagnostic or therapeutic procedures 
performed as part of the clinical trial 
or other conditions of the trial 
conduct can be excluded 
All 
Quarterly 
Summary table, SAE report 
table 
 
All SAEs 
All 
Quarterly 
SAE summary 
evaluation 
Regardless of the criteria mentioned in the table, the Sponsor must report all SAEs occurring in Germany to 
the competent authorities of other contractual states of the Agreement on the European Economic Area 
immediately if the clinical trial is also being performed in those countries. 
6.3.3 
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 EC per their established reporting procedures. The EC may require a 
revision to the ICF and reconsenting of patients if the SAE provides new information regarding risk to the 
study subject.  
6.3.4 
Reporting of Complaints for STAAR Surgical Products 
Refer to Section 6.1.1 and 6.3.1 for instruction on reporting of product complaints that meet the definition of 
AEs/SAEs and ADEs that occur during the study.  
All information collected on a CRF could potentially be identified as a product complaint, as defined in 
Section 6.1.3. The Sponsor has identified what information collected under this study could potentially be 
identified as a complaint. 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. 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. 
6.3.5 
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 

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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 
This section describes the statistical analyses intended at the time of investigation planning. Further details 
on the statistical and analytical aspects will be presented in the Statistical Analysis Plan (SAP). 
Any deviations from planned analyses, the reasons for such deviations, and all alternative or additional 
statistical analyses that may be performed before database close will be described in amendments to the 
clinical protocol or the SAP. All deviations and/or alterations will be summarized in the clinical study report. 
Continuous variables (values and changes from baseline) will be summarized by N, mean, SD, median, 
minimum, and maximum. For qualitative variables, absolute and percent frequencies (N, %) and, if 
applicable, shift tables will be displayed. Confidence limits will be given where appropriate. 
7.1 
Hypothesis 
The implant procedure is defined as successful if the responder rate is equal to or greater than 75%. The 
corresponding statistical hypothesis is therefore as follows: 
H0 (null hypothesis):  
 
π < 0.75 
Ha (alternative hypothesis):  
π ≥ 0.75 
where π is the true proportion of eyes that achieve the performance endpoint (i.e. UCNVA of Snellen 
equivalent 20/40 or better at 40 cm) at 6 months after implantation (6-month responder rate). 
7.2 
Study Endpoints 
7.2.1 
Performance Endpoints 
The primary performance endpoint is defined as achievement of monocular UCNVA of Snellen equivalent 
20/40 or better at 40 cm at Visit 5 (6 months after implantation) in equal to or greater than 75% of implanted 
eyes (responder rate). 
Fleming’s two-stage design was used, which enables early termination of the study at an interim analysis for 
futility or performance. Here, an interim analysis will be performed with the results obtained from 27 subjects 
(54 eyes). If there are 43 or less responses, the trial will be stopped for futility since the likelihood of still 
obtaining a significant result is too low to continue the study under ethical considerations. If there are 48 or 
more responses observed at the interim analysis, the trial will be stopped and the null hypothesis rejected as 
enough statistical evidence has been accrued to determine that, within the certainty of the controlled one-
sided type I error probability of 2.5%, the true responder rate is greater or equal to 75%.  
Otherwise, 16 additional patients (32 eyes) will be recruited for a total of 43 patients (86 eyes). The null 
hypothesis will be rejected if 73 or more responses are observed among the 86 eyes. This design yields a one-
sided type I error probability of 2.5% and a power of 80% if the true response rate is 87.5%. 
Secondary performance endpoints include the following: 
 Percentage of implanted eyes achieving monocular UCNVA of Snellen equivalent 20/40 or better at 40 
cm at Visit 3 and 4 (1 and 3 months after implantation respectively)  
 Change from baseline in monocular uncorrected intermediate visual acuity (UCIVA) at 80 cm at 
postoperative Visit 3, 4 and 5 
 Change from baseline in monocular UCNVA at 40 cm at postoperative Visit 3, 4 and 5 
 Change from baseline in monocular distance corrected intermediate visual acuity (DCIVA) at 80 cm at 
postoperative Visit 3, 4 and 5 
 Change from baseline in monocular distance corrected near visual acuity (DCNVA) at 40 cm at 
postoperative Visit 3, 4 and 5 
 Change from baseline in binocular UCNVA at 40 cm at postoperative Visit 3, 4 and 5 
 

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There are no prespecified performance targets for secondary performance endpoints. 95% confidence limits 
will be calculated for all secondary performance endpoints. 
7.2.2 
Safety Endpoint 
Ocular AE rates will be assessed for all implanted eyes. There are no prespecified performance targets for 
the safety endpoint. 
7.3 
Sample Size 
Fleming’s two-stage design was used to optimize the sample size while allowing for early termination of the 
trial for futility or performance. It is expected that 90% of eyes will achieve the performance endpoint and 
the sample size was therefore conservatively determined based on an 87.5% responder rate. 
Based on Fleming’s two-stage design, 27 subjects (54 eyes) will be enrolled prior to the interim analysis. In 
case the study is not terminated due to futility or reaching the performance endpoint, an additional 16 subjects 
(32 eyes) will be enrolled for a total of 43 patients (86 eyes). To allow for 10% attrition over 6 months, a 
total of 48 subjects (96 eyes) will be enrolled for assessment of the primary and secondary performance 
endpoints and the primary safety endpoint in case the study is not terminated after the first stage. 
This design yields a one-sided type I error probability of 2.5% and a power of 80% if the true response rate 
is 87.5%. 
7.4 
Study Populations 
Subjects aged 35-60 that meet the eligibility criteria will be included in the study. No subgroup analysis is 
planned and subjects will not be stratified into different groups. Furthermore, there are no control groups as 
the achievement of a VA threshold is assessed for each eye and further analysis aims at assessing the 
improvement of VA from baseline to follow-up visit for each eye 
7.5 
Statistical Analysis 
Primary analysis: 
The analysis of the primary performance endpoint is based on Fleming’s two-stage design. Threshold 
responder rates and observed responder rates will be compared to determine if the study is discontinued for 
futility or achievement of the performance endpoint. The performance endpoint is met and the null hypothesis 
will be rejected at least 48 responses were observed among the 54 eyes at the interim analysis or 73 responses 
of 86 eyes at the study end. Conversely, the study will be terminated prematurely for futility if 43 or less 
responses were observed among the 54 eyes at the interim analysis or the alternative hypothesis will be 
rejected if less than 73 responses were observed at the study end. This analysis yields a power of 80% and a 
one-sided type I error probability of 2.5% for the targeted sample size. 
Secondary analysis: 
The analysis of secondary performance endpoints will include summary statistics for continuous variables: 
Number of non-missing values, mean, SD, median, minimum, maximum and 95% exact binomial confidence 
limits. 
Safety analysis: 
All AEs will be coded according to the Medical Dictionary for Regulatory Devices (MedDRA) version in 
effect at the time the database is closed. Incidences will be calculated for ocular and serious ocular and non-
ocular AEs on the system organ class (SOC) level and on the preferred term (PT) level by intensity and by 
relationship to the study lens. Listings and, if applicable, tables displaying incidences of ocular AEs leading 
to discontinuation, serious AEs, and deaths will be provided. 
Exploratory analysis: 
All additional variables will be summarized by summary statistics for continuous variables (including 
number of non-missing values, mean, SD, median, minimum, maximum) and frequency (N, %) for discrete 
variables. 

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Analysis sets: 
The analyses of the primary and secondary performance endpoints will be based on the Full Analysis Set 
(FAS) and Per Protocol Set (PPS). Safety analyses will be based on the Safety Evaluation Set (SES) and 
FAS. Further analyses will be based on the FAS and PPS. 
Safety Evaluation Set: 
The SES contains the data of each eye implanted with the study lens. 
Full Analysis Set:  
The FAS contains the data of each eye in the SES for which data has been collected for the primary 
performance endpoint. 
Per Protocol Set:  
The PPS contains data of each eye in the FAS without major protocol deviations. Protocol deviations are 
further classified in the SAP.  
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 Standard Operating Procedures (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 
 
the conduct of the investigation is in compliance with the currently approved protocol/amendment, 
ICH GCPs and EN ISO 141558 (2011) Clinical Investigation of Medical Devices for Human Subjects, 
EC requirements, and applicable local regulations 
 
the integrity of the data, including adequate study documentation 
 
the facilities remain acceptable 
 
the Investigator and site personnel remain qualified and able to conduct the study 
 
test article accountability 
During the course of the study, if the Sponsor determines that an Investigator is non-compliant with the study 
plan and/or applicable regulatory requirements, the Sponsor will take action to secure compliance. In 
addition, the Sponsor may terminate the Investigator’s participation in the study if appropriate, or if the 
Investigator remains non-compliant despite the Sponsor’s actions.  
8.2 
Source Documentation 
All medical information obtained at each study visit must be recorded in the subject’s record (source 
documentation) in real time as it is collected. Source documentation consists of original subject documents, 
as well as data and records with information relevant to the subject and his/her participation in the study.  
Examples of acceptable source documents include: hospital records, clinical and office charts, notes, or 
memoranda. The signed ICF, evaluation checklists, recorded data from automated instruments, and subject 
files. Source data also include information initially recorded in an electronic format (e.g., iTrace images, 
etc.). 
Source documentation worksheets will be provided by the Sponsor to record pertinent information which are 
not part of the standard of care treatment for the particular study population to ensure that all critical study 
data are captured.  The completed worksheets should then be incorporated into the subject’s medical chart.    

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8.3 
Case Report Forms and Data Verification 
Subject data required by this protocol are to be recorded per standard of care at each clinical site and 
transcribed onto electronic CRFs. The Investigator and his/her study site personnel will be responsible for 
completing the CRFs. The Investigator is required to verify that all of the requested information is accurately 
recorded on the CRFs. All information requested on the CRFs needs to be supplied, including subject 
identification, date(s), assessment values, etc., and any omission or discrepancy will require explanation. All 
information on CRFs must be traceable to source documents if not otherwise specified in the Monitoring 
Plan for the study.  
A STAAR Surgical designee will be responsible for reviewing and verifying the data recorded on the CRFs, 
utilizing the original source documentation and issuing queries as necessary for clarifications or 
discrepancies. The Investigator and study site personnel will be responsible for answering all queries. The 
CRFs will be submitted to STAAR Surgical via an electronic data capture system for quality assurance review 
and statistical analysis.  
A copy of the CRFs will be retained by the Investigator at the conclusion of the study, who must ensure that 
it is stored in a secure place. 
8.4 
Recording of Data and Retention of Documents 
Subject data recorded on CRFs during the study will be documented in a coded fashion. The subject will only 
be identified by the subject number, and by their initials/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 according to the applicable local regulatory requirements 
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 the Principal Investigator  
 
EC approved blank as well as copies of all signed subject ICFs 
 
all EC approvals, correspondence and reports (e.g., SAE reports, protocol deviations, and safety 
updates) 
 
curriculum vitae and medical licenses for the PI and all sub-investigators (if applicable) 
 
regulatory documents (e.g., financial disclosure and 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 EC). The Investigator will 
provide notice of such transfer in writing to STAAR Surgical. 
8.5 
Auditing Procedures 
Audits of clinical research activities in accordance with the Sponsor’s internal SOPs to evaluate compliance 
with the principles of GCP may take place. A regulatory authority may also wish to conduct an inspection 
(during the study or after its completion). If an inspection is requested by a regulatory authority and/or EC, 
the Investigator must inform the Sponsor immediately that this request has been made. 
8.6 
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 EC, or if not using their 
institution's EC, approved by the reviewing central EC prior to entering any subjects in the study. 
Documentation of EC approval of the study protocol and informed consent must be provided to the Sponsor 

Study #CP17-01 - Protocol 
 
Rev 4, 2018.08.14 
 
Page 29 of 53 
prior to initiation of the study and maintained during the course of the study. In addition, the Investigator 
must ensure that the reviewing EC has provided approval for any protocol amendments prior to 
implementation. If the amendment necessitates a revision to the ICF, the Investigator should ensure the 
revised form is also submitted to and approved by the Sponsor and the EC prior to reconsenting 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 #CP17-01 - Protocol 
Rev 4, 2018.08.14 
 
Page A-1  
APPENDIX A: 
SCHEDULE OF VISITS AND PARAMETERS  
All study tasks should be performed by qualified study site personnel as indicated on the delegation of authority log under the supervision of the Principal Investigator.  
Shown below are all assessments to be done at the Preoperative, Operative, and each Postoperative Visit for the first surgical eye. A “B” in an assessment block indicates that the 
assessment is done for both the study eye alone and binocularly as well. All testing for the fellow eye is found in Table 2. 
Table A1: First Surgical Eye Schedule 
 
PROCEDURE/ASSESSMENTS 
PreopVisit 
Day -90 to 
Day 01 
Operative 
Visit 
Day 0 
Postop 
Visit 1 
Day 1 
Postop  
Visit 2 
Day 5 - 9 
Postop 
Visit 3 
Week 3 – 5 
Postop 
Visit 4 
Week 10 – 14 
Postop 
Visit 5 
Week 21 – 26 
Informed Consent 
X 
 
 
 
 
 
 
Demographics/Medical and Ocular History 
X 
 
 
 
 
 
 
Eligibility Criteria 
X 
X 
 
 
 
 
 
Eye Dominance  
X 
 
 
 
 
 
 
Pupil Diameter (photopic) 
X 
 
 
 
 
 
 
UCDVA (uncorrected distance visual acuity) 
X, B 
 
X 
X 
X 
X 
X 
UCIVA 
X, B 
 
 
X 
X 
X 
X 
UCNVA  
X, B 
 
 
X 
X 
X 
X 
BCDVA 
X, B 
 
 
 
X 
X 
X 
DCIVA 
X, B 
 
 
 
X 
X 
X 
DCNVA 
X, B 
 
 
 
X 
X 
X 
BCNVA 
X, B 
 
 
 
X 
X 
X 
Manifest Refraction 
X 
 
 
 
X 
X 
X 
Photopic & Mesopic Contrast Sensitivity (with and 
without glare) 
X, B 
 
 
 
 
X 
X 
Defocus Curves 
X, B 
 
 
 
 
X 
X 
Keratometry 
X 
 
 
 
 
 
X 
Specular Microscopy (corneal endothelial cell count-
CECC) 
X 
 
 
 
 
 
X 
Axial Length (AL)/ACD/Corneal Thickness (CT)  
X 
 
 
 
 
 
 
Slit Lamp Examination 
X 
 
X 
X 
X 
X 
X 
1 If surgery for either eye is delayed past 90 days, testing must be repeated. 
 

Study #CP17-01 - Protocol 
Rev 4, 2018.08.14 
 
Page A-2  
 
PROCEDURE/ASSESSMENTS 
PreopVisit 
Day -90 to 
Day 01 
Operative 
Visit 
Day 0 
Postop 
Visit 1 
Day 1 
Postop  
Visit 2 
Day 5 - 9 
Postop 
Visit 3 
Week 3 – 5 
Postop 
Visit 4 
Week 10 – 14 
Postop 
Visit 5 
Week 21 – 26 
IOP 2 
X 
X 
X 
X 
X 
X 
X 
Anterior Chamber Angle 3 
X 
 
 
 
 
 
X 
Cycloplegic Refraction 
X 
 
 
 
 
 
 
Wavefront Aberrometry 4 
X 
 
 
X 
X 
X 
X 
Dilated Fundus Examination 
X 
 
 
 
 
 
X 
Surgery 
 
X 
 
 
 
 
 
Lens Vault 5 
 
 
X 
X 
X 
X 
X 
Subjective Questionnaires 
X 
 
 
 
 
 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
AEs 6 
X 
X 
X 
X 
X 
X 
X 
2  IOP measurements will be conducted using surgeon’s standard of care. On surgery day, IOP will be measured approximately 1-6 hours postoperatively. 
3 Measured using Investigator’s standard of care. 
4 Using iTrace aberrometer. 
5 Distance between posterior ICL and anterior natural lens, measured by OCT and documented in µm. 
6 The period of collection of ocular AEs (and any SAEs) starts from signing the informed consent through study exit. 
 
 
NOTE: all footnotes also apply to second eye (Table 2)

Study #CP17-01 - Protocol 
Rev 4, 2018.08.14 
 
Page A-1  
Table 2 includes all assessments to be performed for the second surgical eye at each study visit. A “B” in an assessment block indicates that the assessment is done for both the 
study eye alone and binocularly as well. 
Table A2: Second Surgical Eye Schedule 
 
PROCEDURE/ASSESSMENTS 
PreopVisit 
Day -90 to 
Day 01 
Operative 
Visit 
Day 0 
Postop 
Visit 1 
Day 1 
Postop Visit 2 
Day 5 - 9 
Postop 
Visit 3 
Week 3 – 5 
Postop 
Visit 4 
Week 10 – 14 
Postop 
Visit 5 
Week 21 – 26 
Eligibility Criteria 
X 
X 
 
 
 
 
 
UCDVA 
X 
 
X 
X, B 
X, B 
X, B 
X, B 
UCIVA 
X 
 
 
X, B 
X, B 
X, B 
X, B 
UCNVA  
X 
 
 
X, B 
X, B 
X, B 
X, B 
BCDVA 
X 
 
 
 
X, B 
X, B 
X, B 
DCIVA 
X 
 
 
 
X, B 
X, B 
X, B 
DCNVA 
X 
 
 
 
X, B 
X, B 
X, B 
BCNVA 
X 
 
 
 
X, B 
X, B 
X, B 
Manifest Refraction 
X 
 
 
 
X 
X 
X 
Photopic & Mesopic Contrast Sensitivity (with and 
without glare) 
X 
 
 
 
 
X 
X, B 
Defocus Curves 
X 
 
 
 
 
X 
X, B 
Keratometry 
X 
 
 
 
 
 
X 
Specular Microscopy  
X 
 
 
 
 
 
X 
AL/ACD/Corneal Thickness (CT) 
X 
 
 
 
 
 
 
Slit Lamp Examination 
X 
 
X 
X 
X 
X 
X 
IOP 2 
X 
X 
X 
X 
X 
X 
X 
Anterior Chamber Angle 3  
X 
 
 
 
 
 
X 
Cycloplegic Refraction 
X 
 
 
 
 
 
 
Wavefront Aberrometry4 
X 
 
 
X 
X 
X 
X 
Dilated Fundus Examination 
X 
 
 
 
 
 
X 
Surgery 
 
X 
 
 
 
 
 
Lens Vault 5 
 
 
X 
X 
X 
X 
X 
Subjective Questionnaires 
X 
 
 
 
 
 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
AEs6 
X 
X 
X 
X 
X 
X 
X 
 

Study #CP17-01 - Protocol 
Rev 4, 2018.08.14 
 
Page B-1 
APPENDIX B: 
SURGICAL PROCEDURE  
 
Calculation of Lens Power and Size 
The lens power and size calculation will be performed by the surgeon using the STAAR EVO Visian ICL 
Calculation Software.  Alternatively, the power and size of the lens may be determined utilizing the surgeon’s 
standard of care method. 
Postoperative target will be emmetropia with an acceptable variation of ±0.50 D spherical equivalent (SE), 
at the Investigator’s discretion. 
1. Determine the lens power  
2. Determine the expected postoperative target refraction (SE) 
 
Pre-Surgical Preparation 
1. Prepare the subject for surgery utilizing standard of care techniques. 
2. Check the label of the lens package for correct lens model, dioptric power and overall diameter. 
3. Inspect the package carefully to ensure it is not damaged and sterility seal intact. 
 
Surgical Technique/Directions for Use 
1. Open the package and verify the correct lens model, dioptric power and overall diameter.  
2. Inspect the lens vial to ensure it is not damaged. Verify that the level of the liquid fills at least 2/3 of 
the vial. The thermoform tray and vial should be opened in a sterile field.  
3. While keeping the vial in a vertical position, remove the aluminum seal and remove the cap. 
4. Carefully remove the lens from the vial. 
5. 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. 
6. The lens should be carefully examined under the microscope for damage or particulate matter prior to 
implantation. 
7. The lens should not be exposed to any solutions other than the normally used intraocular irrigating 
solutions (e.g., BSS, viscoelastic, etc.) 
8. Do NOT let the lens dry after removal from the glass vial. It is recommended that the ICL be held in 
sterile BSS solution prior to implantation. 
9. The ICL should be handled carefully. No attempt should be made to reshape or cut any portion of the 
lens. Do not apply undue pressure to the ICL optical portion with a sharp object since this could 
perforate the optic. 
10. The recommended incision size is 3.5 mm or less. 
11. Low molecular weight (2% hydroxypropyl methylcellulose) viscoelastic should be used during loading 
of the injector system, as well as in the anterior chamber to protect the structures of the eye during the 
procedure. 
12. Utilize only the MICROSTAAR injector MSI-PF or MSI-TF reusable injector with SFC-45 single-use 
cartridge and FTP provided to insert the lens in the folded state. 
13. The lens should be injected within 1-2 minutes after loading. 
14. Never touch the center of the optic with instruments once the lens is placed inside the eye. Inadvertent 
pressure through the optic could potentially damage the central crystalline lens resulting in lens 
opacity. 

Study #CP17-01 - Protocol 
Rev 4, 2018.08.14 
 
Page B-2 
15. The intended location of the lens is behind the iris within the posterior chamber and in front of the 
anterior capsule of the crystalline lens. 
16. Complete irrigation and aspiration of the viscoelastic from the eye after completion of the surgical 
procedure is essential. Inadequate flushing of the viscoelastic from the eye may lead to IOP spikes. 
Viscoelastic products that may be difficult to aspirate should not be used. 
17. Double check lens alignment after viscoelastic removal to ensure accurate placement. 
 
Postoperative Care 
For all subjects enrolled in this study, an IOP check will be performed at approximately 1 - 6 hours 
postoperatively. An IOP ≥ 30 mmHg or ≥10 mmHg from preoperative shall be treated using the Investigator’s 
standard method for controlling acute increase in IOP and recorded as an AE.   
 
Prophylactic Medication Regimen 
All subjects are to use a consistent regimen of preoperative and postoperative prophylactic topical therapy, 
per the Investigator’s standard of care. In addition, the participating Investigators will use their standard 
preoperative/ intraoperative/ postoperative surgical suite regimen (including anesthesia) for ICL implantation 
for all subjects enrolled in this clinical study. 
 

Study #CP17-01 - Protocol 
Rev 4, 2018.08.14 
 
Page C-1 
APPENDIX C: 
METHODS OF CLINICAL EVALUATION  
 
Any changes to the procedures described in this appendix will be provided under separate cover. 
It is recommended that preoperative and postoperative testing be completed in the same examination room 
by the same examiner. This will help to eliminate variability in testing equipment, methodology and 
environment.  
Specific Equipment for Study Assessments 
The following equipment will be used for the specified assessments in this study. Unless specified otherwise, 
all other assessments will be conducted using the Investigator’s standard of care methods for ICL surgery.  
▪ 
M&S Clinical Trial Suite (CTS)*– Visual Acuities, Contrast Sensitivity, Defocus Curves  
▪ 
iTrace Aberrometer* – Aberrometry   
*This equipment will be provided by the Sponsor for clinical site use during the study. Manufacturer 
representatives will install the systems, conduct training of the site personnel and ensure calibration and 
maintenance during the course of the study.  
 
Testing Methodologies 
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. Refraction should be performed at an optical 
distance of at least 6 meters. If the subject has a current pair of glasses for distance vision, they can be 
measured with a lensometer and these measurements used as the beginning approximate refraction. If the 
subject does not have glasses for distance vision, retinoscopy should be performed by an examiner proficient 
in this procedure. 
AUTOREFRACTION ALONE IS NOT ALLOWED AT ANY POINT IN THIS STUDY. RESULTS MUST 
BE REFINED USING SUBJECTIVE TECHNIQUES. 
The manifest refraction (adjusted for optical infinity as necessary) will be carried out using a standard “push 
plus” procedure, in 0.25 D increments and utilizing Jackson Cross-cylinder to assess toricity. The end result 
of the refraction must ensure the manifest refraction outcome reflects the very minimum “minus” power 
required to read the smallest line possible. If adding -0.25 does not result in an additional letter read, it must 
not be added. Further, if adding +0.25 does not result in a loss of letters read, it must be added.  
IMPORTANT:   If VA testing is to be evaluated at a 4 meter test distance, +0.25 DS must be added to 
the manifest refraction determined above and this MUST then be transferred to a 
trial frame for VA testing. 
 
Visual Acuities 
All Distance, Intermediate and Near Vision testing will be conducted using the M&S Technologies CTS 
system per manufacturer’s instructions. ETDRS distance vision will be measured at 4.0 m, near vision at 40 
cm, and intermediate vision at 80 cm. 
Defocus Curves 
Defocus testing will be conducted on the M&S CTS system per manufacturer’s instructions, using a manifest 
refraction adjusted for a 4 M test distance (+0.25 DS). The adjusted manifest refraction will be used to 
designate the zero baseline. A defocus of +2.00 D spherical correction from the adjusted manifest refraction 
will be set and the logMAR acuity will be recorded. Positive spherical power will be decreased in 0.50 D 
increments, except in the region from +0.50 D through Plano, which should be done in 0.25 D steps. LogMAR 
acuity will be recorded at each change in correction until only the adjusted manifest refraction remains. 

Study #CP17-01 - Protocol 
Rev 4, 2018.08.14 
 
Page C-2 
Then a defocus of -3.00 D spherical correction from the BCDVA (manifest refraction) will be set; the 
logMAR acuity at this refraction will be recorded. Negative spherical power will be decreased in 0.50 D 
increments, except in the region from -0.50 D through Plano, which should be done in 0.25 D steps. LogMAR 
acuity will be recorded at each change in correction until only the adjusted manifest refraction remains. 
Ocular Dominance 
Ocular dominance will be determined using the Investigator’s standard of care.  
 
Pupil Diameter 
The pupil diameter will be captured under photopic conditions (approximately 85 cd/m²) using a pupilometer.  
Contrast Sensitivity 
Contrast sensitivity will be evaluated with M&S CTS linear sine grating test at a distance of 2.5 meters under 
best-corrected conditions. Testing will be conducted at spatial frequencies of 1.5, 3, 6, 12, and 18 cpd in 
photopic and mesopic conditions and with and without glare. 
Keratometry 
The keratometry 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. 
Specular Microscopy 
Preoperative and postoperative ECD and coefficient of variation (CV) of the endothelial cell area will be 
measured using a specular microscope in accordance with the manufacturer’s instructions for use. The site 
will retain documentation of the manufacturer and model used in the site Study Binder. 
According to EN ISO 11979-109 subjects enrolled in Study CP17-01 must have the minimum endothelial 
cell density for their age at time of enrollment in accordance with the below table.  
 
Table C1: Recommended Minimum EDC- EN ISO 11979-109  
 
 
Axial Length (AL) and Corneal Thickness (CT) 
AL and CT measurements will be performed using Investigator’s standard method for ICL surgery and 
documented in the CRF in XX.XX mm and XXX µm, respectively. 

Study #CP17-01 - Protocol 
Rev 4, 2018.08.14 
 
Page C-3 
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. 
Slit Lamp Examination 
This examination will be performed using a slit lamp biomicroscope. It is recommended to use a slit beam  
1 mm wide by 1 mm high. The following information will be captured for this study: 
External and Cornea 
Lids 
Normal/Abnormal 
Conjunctiva 
Normal/Abnormal 
Cornea 
Superficial 
Punctate 
Keratitis (SPK) 
 
0 - None 
1 - Mild 
2 - Moderate 
3 - Severe 
4 - Very Severe 
Corneal Wound 
Edema 
 
0 - None 
1 - Mild 
2 - Moderate 
3 - Severe 
Corneal Edema 
 
0 - No evidence of corneal swelling with normal transparency  
1 - Mild corneal swelling 
2 - Moderate corneal swelling 
3 - Severe and definite widespread cloudiness or haziness giving dull ground glass 
appearance to cornea, or numerous coalescent bullae 
Anterior Chamber 
For the cell and flare evaluation, use a slit lamp beam 0.3 mm wide and 1 mm high. 
Cells 
0 - No cells seen 
1 - Mild 1-5 cells seen 
2 - Moderate 6-15 cells seen 
3 - Severe 16-30 cells seen 
4 - Very severe >30 cells seen 
Flare 
0 - No Tyndall effect 
1 - Mild Tyndall effect barely discernible 
2 - Moderate Tyndall beam in anterior chamber is moderately intense 
3 - Severe Tyndall beam in anterior chamber is severely intense 
4 - Very severe Tyndall beam. The aqueous has a white and milky appearance 
Iris/Pupil 
Normal/Abnormal 
 
Intraocular Pressure (IOP) 

Study #CP17-01 - Protocol 
Rev 4, 2018.08.14 
 
Page C-4 
IOP measurements will be obtained using Investigator’s standard of care for ICL surgery. On surgery day, 
IOP will be measured approximately 1-6 hours postoperatively. .  
Aberrometry (iTrace)  
Wavefront aberrometry will be measured using the iTrace (Tracey Technologies, Houston, TX) in accordance 
with the manufacturer’s instructions for use for the study. 
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. 
Lens Vault 
The distance between the posterior surface of the phakic IOL and the anterior surface of the natural crystalline 
lens, measured using OCT and documented in µm. 
 

Study #CP17-01 - Protocol 
Rev 4, 2018.08.14 
 
Page C-5 
Subjective Questionnaires 
NATIONAL EYE INSTITUTE 
42-ITEM REFRACTIVE ERROR QUALITY OF LIFE INSTRUMENT 
 
Date of Completion:  
 
 
  
1. If you had perfect vision without glasses, contact lenses, or any other type of vision correction, how 
different would your life be? 
 
(Mark an X in the one box that best describes your answer.) 
No difference  ....................................................................................1 
 
Small difference for the better  ..........................................................2 
 
Large difference for the better  ..........................................................3 
I have this already  ............................................................................4 
 
The following questions are about the effect of your vision on your activities. 
When you answer the questions, think about the vision correction you normally use for each activity, 
including glasses, contact lenses, a magnifier, or nothing at all. 
 
2. How much difficulty do you have doing work or hobbies that require you to see well up close, such as 
cooking, fixing things around the house, sewing, using hand tools, or working with a computer?   
      
    (Mark One) 
No difficulty at all .............................................................................  1 
A little difficulty ................................................................................  2 
Moderate difficulty ............................................................................  3 
A lot of difficulty ...............................................................................  4 
Never try to do these activities because of vision .............................  5 
Never do these activities for other reasons ........................................  6 
 
3. How much difficulty do you have seeing because of changes in the clarity of your vision over the course 
of the day? 
 
(Mark One) 
Don’t have changes in the clarity of my vision .................................  1 
No difficulty at all .............................................................................  2 
A little difficulty ................................................................................  3 
Moderate difficulty ............................................................................  4 
A lot of difficulty ...............................................................................  5 
 
 

Study #CP17-01 - Protocol 
Rev 4, 2018.08.14 
 
Page C-6 
 
4. How much difficulty do you have judging distances, like walking downstairs or parking a car?  
 
(Mark One) 
No difficulty at all .............................................................................  1 
A little difficulty ................................................................................  2 
Moderate difficulty ............................................................................  3 
A lot of difficulty ...............................................................................  4 
 
5. How much difficulty do you have seeing things off to the side, like cars coming out of driveways or side 
streets or people coming out of doorways?   
 
(Mark One) 
No difficulty at all .............................................................................  1 
A little difficulty ................................................................................  2 
Moderate difficulty ............................................................................  3 
A lot of difficulty ...............................................................................  4 
 
6. How much difficulty do you have getting used to the dark when you move from a lighted area into a 
dark place, like walking into a dark movie theater?   
 
(Mark One) 
No difficulty at all .............................................................................  1 
A little difficulty ................................................................................  2 
Moderate difficulty ............................................................................  3 
A lot of difficulty ...............................................................................  4 
 
7. How much difficulty do you have reading ordinary print in newspapers?    
 
(Mark One) 
No difficulty at all .............................................................................  1 
A little difficulty ................................................................................  2 
Moderate difficulty ............................................................................  3 
A lot of difficulty ...............................................................................  4 
Never try to do this because of vision ...............................................  5 
 
8. How much difficulty do you have reading the small print in a telephone book, on a medicine bottle, or 
on legal forms?   
 
(Mark One) 
No difficulty at all .............................................................................  1 
A little difficulty ................................................................................  2 
Moderate difficulty ............................................................................  3 
A lot of difficulty ...............................................................................  4 
Never try to do this because of vision ...............................................  5 

Study #CP17-01 - Protocol 
Rev 4, 2018.08.14 
 
Page C-7 
 
 
9. How much difficulty do you have driving at night?   
 
(Mark One) 
No difficulty at all .............................................................................  1 
A little difficulty ................................................................................  2 
Moderate difficulty ............................................................................  3 
A lot of difficulty ...............................................................................  4 
Never drive at night because of vision ..............................................  5 
Never do this for other reasons ..........................................................  6 
 
10. How much difficulty do you have driving in difficult conditions, such as in bad weather, during rush 
hour, on the freeway, or in city traffic? 
 
(Mark One) 
No difficulty at all .............................................................................  1 
A little difficulty ................................................................................  2 
Moderate difficulty ............................................................................  3 
A lot of difficulty ...............................................................................  4 
Never drive in these conditions because of vision.............................  5 
Never do this for other reasons ..........................................................  6 
 
11. Because of your eyesight, how much difficulty do you have with your daily activities?   
 
(Mark One) 
No difficulty at all .............................................................................  1 
A little difficulty ................................................................................  2 
Moderate difficulty ............................................................................  3 
A lot of difficulty ...............................................................................  4 
 
12. Because of your eyesight, how much difficulty do you have taking part in active sports or other outdoor 
activities that you enjoy (like hiking, swimming, aerobics, team sports, or jogging)? 
 
(Mark One) 
No difficulty at all .............................................................................  1 
A little difficulty ................................................................................  2 
Moderate difficulty ............................................................................  3 
A lot of difficulty ...............................................................................  4 
Never try to do these activities because of vision .............................  5 
Never do these activities for other reasons ........................................  6 
 
 
 

Study #CP17-01 - Protocol 
Rev 4, 2018.08.14 
 
Page C-8 
 
QUESTIONS ABOUT YOUR VISION 
 
13. Do you need to wear glasses or bi-focal lenses or use a magnifier when you are reading something brief, 
like directions, a menu, or a recipe? 
 
(Mark One) 
Yes, all of the time ............................................................................  1 
Yes, some of the time ........................................................................  2 
No ......................................................................................................  3 
 
14. Do you need to wear glasses or bi-focal lenses or use a magnifier when you are reading something long, 
like a book, a magazine article, or the newspaper? 
 
(Mark One) 
Yes, all of the time ............................................................................  1 
Yes, some of the time ........................................................................  2 
No ......................................................................................................  3 
 
15. When driving at night, do you need to wear glasses or contacts? 
 
(Mark One) 
Yes, all of the time ............................................................................  1 
Yes, some of the time ........................................................................  2 
No ......................................................................................................  3 
Don’t drive at night because of vision ...............................................  4 
Don’t drive at night for other reasons ................................................  5 
 
16.  At dusk, when it is just starting to get dark, do you need to wear glasses or contacts for driving? 
 
(Mark One) 
Yes, all of the time ............................................................................  1 
Yes, some of the time ........................................................................  2 
No ......................................................................................................  3 
Don’t drive at dusk because of vision ...............................................  4 
Don’t drive at dusk for other reasons ................................................  5 
 
 
 

Study #CP17-01 - Protocol 
Rev 4, 2018.08.14 
 
Page C-9 
 
When you answer these questions, think about the vision correction you normally use, including 
glasses, contact lenses, a magnifier or nothing at all. 
 
17. How often when you are around bright lights at night do you see starbursts or halos that bother you or 
make it difficult to see? 
 
(Mark One) 
All of the time ...................................................................................  1 
Most of the time ................................................................................  2 
Some of the time ...............................................................................  3 
A little of the time .............................................................................  4 
None of the time ................................................................................  5 
 
18. How often do you experience pain or discomfort in and around your eyes (for example, burning, itching, 
or aching)? 
 
(Mark One) 
All of the time ...................................................................................  1 
Most of the time ................................................................................  2 
Some of the time ...............................................................................  3 
A little of the time .............................................................................  4 
None of the time ................................................................................  5 
 
19. How much does dryness in your eyes bother you? 
 
(Mark One) 
Don’t have dryness ............................................................................  1 
Not at all ............................................................................................  2 
Very little ..........................................................................................  3 
Moderately ........................................................................................  4 
Quite a bit ..........................................................................................  5 
A lot ...................................................................................................  6 
 
20. How often are you bothered by changes in the clarity of your vision over the course of the day? 
 
(Mark One) 
Never .................................................................................................  1 
Rarely ................................................................................................  2 
Occasionally ......................................................................................  3 
Sometimes .........................................................................................  4 
All of the time ...................................................................................  5 
 
 

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21. How often do you worry about your eyesight or vision? 
 
(Mark One) 
Never .................................................................................................  1 
Rarely ................................................................................................  2 
Occasionally ......................................................................................  3 
Sometimes .........................................................................................  4 
All of the time ...................................................................................  5 
 
22. How often do you notice or think about your eyesight or vision? 
 
(Mark One) 
Never .................................................................................................  1 
Rarely ................................................................................................  2 
Occasionally ......................................................................................  3 
Sometimes .........................................................................................  4 
All of the time ...................................................................................  5 
 
 
YOUR VISION CORRECTION 
 
When you answer these questions, think about the vision correction that you normally use, including 
glasses, contact lenses, a magnifier, surgery, or nothing at all. 
 
23. At this time, how clear is your vision using the correction you normally use, including glasses, contact 
lenses, a magnifier, surgery, or nothing at all? 
 
(Mark One) 
Perfectly clear ....................................................................................  1 
Pretty clear ........................................................................................  2 
Somewhat clear .................................................................................  3 
Not clear at all ...................................................................................  4 
 
24. How much pain or discomfort do you have in and around your eyes (for example, burning, itching, or 
aching)? 
 
(Mark One) 
None ..................................................................................................  1 
Mild ...................................................................................................  2 
Moderate ...........................................................................................  3 
Severe ................................................................................................  4 
Very severe ........................................................................................  5 
 

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25. How often do you have headaches that you think are related to your vision or vision correction? 
 
(Mark One) 
Never .................................................................................................  1 
Rarely ................................................................................................  2 
Occasionally ......................................................................................  3 
Sometimes .........................................................................................  4 
All of the time ...................................................................................  5 
 
26. How satisfied are you with the glasses, contact lenses, magnifier, or other type of correction (including 
surgery) you have? 
 
(Mark One) 
Completely satisfied ..........................................................................  1 
Very satisfied.....................................................................................  2 
Somewhat satisfied ............................................................................  3 
Somewhat dissatisfied .......................................................................  4 
Very dissatisfied ................................................................................  5 
Completely dissatisfied .....................................................................  6 
 
27. In terms of your appearance, how satisfied are you with the glasses, contact lenses, magnifier, or other 
type of correction (including surgery) you have? 
 
(Mark One) 
Completely satisfied ..........................................................................  1 
Very satisfied.....................................................................................  2 
Somewhat satisfied ............................................................................  3 
Somewhat dissatisfied .......................................................................  4 
Very dissatisfied ................................................................................  5 
Completely dissatisfied .....................................................................  6 
 
28. If you had perfect vision without glasses, contacts, or any other type of vision correction, how much do 
you think your life would change? 
 
(Mark One) 
No change ..........................................................................................  1 
Small change for the better ................................................................  2 
Large change for the better ................................................................  3 
I have this already .............................................................................  4 
 
 

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29. In terms of your appearance, is the type of vision correction you have now the best you have ever had? 
 
(Mark One) 
Yes ....................................................................................................  1 
No ......................................................................................................  2 
 
30. In terms of your appearance, is there a type of vision correction that is better than what you have now? 
 
(Mark One) 
Yes ....................................................................................................  1 
No ......................................................................................................  2 
 
31. How often did you use a type of correction or treatment that was uncomfortable in the last 4 weeks 
because it made you look better? 
 
(Mark One) 
All of the time ...................................................................................  1 
Most of the time ................................................................................  2 
Some of the time ...............................................................................  3 
A little of the time .............................................................................  4 
None of the time ................................................................................  5 
 
32. How often did you use a type of correction that did not correct your vision as well as another correction 
would have in the last 4 weeks because it made you look better? 
 
(Mark One) 
All of the time ...................................................................................  1 
Most of the time ................................................................................  2 
Some of the time ...............................................................................  3 
A little of the time .............................................................................  4 
None of the time ................................................................................  5 
 
33. Because of your vision, do you take part less than you would like in active sports or other outdoor 
activities (like hiking, swimming, aerobics, team sports, or jogging)? 
 
(Mark One) 
Yes ....................................................................................................  1 
No ......................................................................................................  2 
 
 

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34. Are there any recreational or sports activities that you don’t do because of your eyesight or the type of 
vision correction you have? 
 
(Mark One) 
Yes, many ..........................................................................................  1 
Yes, a few ..........................................................................................  2 
No ......................................................................................................  3 
 
35. Are there daily activities that you would like to do, but don’t do because of your vision or the type of 
vision correction you have? 
 
(Mark One) 
Yes, many ..........................................................................................  1 
Yes, a few ..........................................................................................  2 
No  .....................................................................................................  3 
 
Have you experienced any of the following problems in the last 4 weeks?  If yes, how bothersome has 
it been?  Please respond for problems in either or both eyes. 
 
 
 
 
Mark One 
If yes, how bothersome 
has it been? 
(Mark One) 
 
 
36. 
 
 
Tearing? 
 
a. 
Yes .....................  1 
No  ...................... 2 
b. 
Very ...................   1 
Somewhat ..........   2 
A little ................   3 
Not at all ............   4 
 
 
37. 
 
 
Distorted vision? 
 
a. 
Yes .....................   1 
No ......................   2 
b. 
Very ...................   1 
Somewhat ..........   2 
A little ................   3 
Not at all ............   4 
 
 
38. 
 
 
Glare? 
 
a. 
Yes .....................   1 
No ......................   2 
b. 
Very ...................   1 
Somewhat ..........   2 
A little ................   3 
Not at all ............   4 
 
 

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Have you experienced any of the following problems in the last 4 weeks?  If yes, how bothersome has 
it been?  Please respond for problems in either or both eyes. 
 
 
 
 
 
 
 
Mark One 
If yes, how bothersome 
has it been? 
(Mark One) 
 
 
39. 
 
 
Blurry vision with 
your eyesight or the 
type of vision 
correction you use? 
a. 
Yes .....................   1 
No ......................   2 
b. 
Very ...................   1 
Somewhat ..........   2 
A little ................   3 
Not at all ............   4 
 
 
40. 
 
 
Trouble seeing? 
a. 
Yes .....................   1 
No ......................   2 
b. 
Very ...................   1 
Somewhat ..........   2 
A little ................   3 
Not at all ............   4 
 
 
41. 
 
 
Itching in or around 
your eyes? 
a. 
Yes .....................   1 
No ......................   2 
b. 
Very ...................   1 
Somewhat ..........   2 
A little ................   3 
Not at all ............   4 
 
Have you experienced any of the following problems in the last 4 weeks?  If yes, how bothersome has 
it been?  Please respond for problems in either or both eyes. 
 
 
 
 
Mark One 
If yes, how bothersome 
has it been? 
(Mark One) 
 
 
42. 
 
 
Soreness or tiredness 
in your eyes? 
a. 
Yes .....................   1 
No ......................   2 
b. 
Very ...................   1 
Somewhat ..........   2 
A little ................   3 
Not at all ............   4 
 
 
 

St u d y # C P 1 7- 0 1 - Pr ot oc ol 
Re v 4, 2 0 1 8. 0 8. 1 4  
  
Pa ge C- 1 8 
 
O ver all S atisf acti o n 
 
O ver t he l ast m o nt h, h o w s atisfie d were y o u  wit h y o ur visi o n ?  
 
 
 
 
 
 
( M ar k O ne) 
C o m pletel y satisfie d  … … ….. … … … … … … … … … … … … … … … … … …  1  
 
Ver y satisfie d . … … … ….. … … … … … … … … … … … … … … … … … … …..   2  
 
S o me w hat satisfie d  … … … … … … … … … … … … … … … … … … … … … …  3  
 
S o me w hat dissatisfie d  … … … … … … … ….. … … … … … … … … … … … ….  4  
 
Ver y dissatisfie d  … … … … … … … … … … … …. … … … … … … … … … … … 5  
 
C o m pletel y dissatisfie d  … … … … … … … … … … … … … … … … … … … ….. 6  
 

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APPENDIX D: 
REFERENCES  
1 Frick KD, Joy SM, Wilson DA, Naidoo KS, Holden BA. The Global Burden of Potential Productivity Loss 
from Uncorrected Presbyopia. Ophthalmology 2015 122: 1706-1710. 
 
2 Packer M, Chu YR, Waltz KL, Donnenfeld ED, Wallace RB 3rd, Featherstone K, Smith P, Bentow SS, 
Tarantino N.  Evaluation of the aspheric Tecnis multifocal intraocular lens: one-year results from the first 
cohort of the food and drug administration clinical trial. Am J Ophthalmol. 2010 Apr;149(4):577-584.e1. 
 
3 McDonnell PJ, Lee P, Spritzer K, Lindblad AS, Hays RD. Associations of presbyopia with vision-targeted 
health-related quality of life. Arch Ophthalmol. 2003 Nov;121(11):1577-81. 
 
4 Luo BP, Brown GC, Luo SC, Brown MM. The quality of life associated with presbyopia. 
Am J Ophthalmol. 2008 Apr;145(4):618-622.  
 
5 Cochener B; Concerto Study Group.  Clinical outcomes of a new extended range of vision intraocular lens: 
International Multicenter Concerto Study.  J Cataract Refract Surg. 2016 Sep;42(9):1268-1275. 
 
6 Durrie DS. The effect of different monovision contact lens powers on the visual function of emmetropic 
presbyopic patients (an American Ophthalmological Society thesis).  Trans Am Ophthalmol Soc. 
2006;104:366-401. 
 
 
 
8 EN ISO Standard 14155 Clinical Investigation of Medical Devices for Human Subjects- Good Clinical 
Practice. 
 
9 EN ISO Standard 11979-10 Opthalmic Implants – Intraocular lenses – Part 10: Phakic Intraocular Lenses.