Evaluation of Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System
Phase: NA
Conditions: Cataract, Aphakia
Sponsor: ClarVista Medical

Short Title 
ClarVista CVM-00001 / NCT03681886
Long Title 
EVALUATION OF VISUAL AND REFRACTIVE OUTCOMES OF  
THE CLARVISTA HARMONI™ MODULAR INTRAOCULAR LENS 
SYSTEM 
1 
TITLE PAGE 
Protocol Number: 
ClarVista CVM-00001 
Medical Specialty: 
Surgical 
Project Name /Number: 
NA 
Sponsor Name & Address: 
CLARVISTA MEDICAL, INCORPORATED 
26800 ALISO VIEJO PARKWAY, SUITE 120 
ALISO VIEJO, CA 92656 
PHONE +001 949 916-5412 
FAX +001 949 916-5412 
Test Article(s) / Product(s): 
ClarVista HARMONI® Modular Intraocular Lens 
System 
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CLARVISTA MEDICAL 
Rev.03, 7 January 2016                                                                        Confidential                         Page 1 
of 32 
 
TITLE PAGE 
 
 
 
 
 
 
 
EVALUATION OF VISUAL AND REFRACTIVE OUTCOMES OF  
THE CLARVISTA HARMONI™ MODULAR INTRAOCULAR LENS SYSTEM  
Protocol Number  
 
  
#CVM-00001 REV.03 
Sponsor 
 
 
 
 
CLARVISTA MEDICAL, INCORPORATED  
26800 ALISO VIEJO PARKWAY, SUITE 120 
ALISO VIEJO, CA 92656 
PHONE +001 949 916-5412 
FAX +001 949 916-5412 
Rev.03 
7 January 2016 
This clinical investigation is being conducted in accordance with 21 CFR Parts 11, 50, 54, 56, and 812, ISO 14155 
(2011) Clinical Investigation of Medical Devices for Human Subjects, ISO 11979-7:2014 Ophthalmic implants — 
Intraocular lenses — Part 7: Clinical investigations, ANSI Z80.7-2013 Ophthalmic Optics – Intraocular Lenses, 
ICH GCPs, and applicable local regulations. 
CONFIDENTIAL 
The information in this document is confidential and will not be disclosed to others without written authorization 
from ClarVista Medical, except to the extent necessary to obtain informed consent from persons involved in the 
clinical study or their legal guardians, or for discussions with local regulatory authorities, institutional review boards 
(IRB), Ethics Committees (EC) or persons participating in the conduct of the trial. 
 
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Rev.03, 7 January 2016                                                                        Confidential                         Page 
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PROTOCOL CONTACTS 
Sponsor 
ClarVista Medical 
26800 Aliso Viejo Parkway, Suite 120 
Aliso Viejo, CA 92656 
Ph: +001.949.916.5412 
Fax: +001.949.916.5412 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Rev.03, 7 January 2016                                                                        Confidential                         Page 
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PROTOCOL APPROVAL 
 
Evaluation of Visual and Refractive Outcomes  
of The ClarVista HARMONI™ Modular Intraocular Lens  
 
 
 
 
The following individuals approve Protocol #CVM-00001 Rev.03 dated 7 January 2016. Any 
changes to this version of the protocol must have an amendment or administrative letter. 
 
 
 
 
 
 
 
 
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Rev.03, 7 January 2016                                                                        Confidential                         Page 
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STUDY ACKNOWLEDGEMENT 
 
I understand this protocol contains information that is confidential and proprietary to ClarVista 
Medical (ClarVista). 
I have read this protocol and agree that it contains all the details necessary to conduct the study 
as described. I will follow this protocol in the conduct of the study and will make a reasonable 
effort to complete the study in the time noted. 
I will provide the contents of this protocol to study staff under my direct supervision in order to 
conduct the study. I will discuss this information with the study staff to ensure they are fully 
informed about the study and the test article. I will provide the contents of the protocol to the 
responsible Ethics Committee. These disclosures may be made; providing the contents are not 
used in any other clinical study and they are not disclosed to any other person or entity without 
prior written consent from ClarVista. This condition does not apply to disclosure required by 
government regulations or laws; however, I agree to give prompt notice to ClarVista of any such 
disclosure. 
I understand the study may be terminated or enrollment suspended at any time by ClarVista, with 
or without cause, or by me if it becomes necessary to protect the interests of the study subjects. 
Any additional information added to this protocol is also confidential and proprietary to ClarVista 
and must be treated in the same manner as the contents of this protocol. 
 
___________________________________ 
Printed Name of Principal Investigator 
___________________________________ 
 
_____________________ 
Investigator Signature  
 
 
 
Date 
Protocol # CVM-00001 Rev.03 
Date: 7 January 2016 
 
 
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TABLE OF CONTENTS 
TITLE PAGE .............................................................................................................................................................. 1 
PROTOCOL CONTACTS ............................................................................................................................................. 2 
PROTOCOL APPROVAL ............................................................................................................................................. 3 
STUDY ACKNOWLEDGEMENT .................................................................................................................................. 4 
TABLE OF CONTENTS ............................................................................................................................................... 5 
TABLE OF FIGURES .................................................................................................................................................. 7 
LIST OF ABBREVIATIONS ......................................................................................................................................... 7 
PROTOCOL SYNOPSIS ............................................................................................................................................... 9 
1.0 INTRODUCTION ................................................................................................................................................. 12 
2.0 OBJECTIVE ........................................................................................................................................................ 14 
3.0 STUDY DESIGN .................................................................................................................................................. 14 
3.1 
DESCRIPTION OF THE STUDY .............................................................................................................. 14 
3.2 
STUDY POPULATION ........................................................................................................................ 14 
3.2.1 
Inclusion Criteria .......................................................................................................... 14 
3.2.2 
Exclusion Criteria Prior to Surgery ............................................................................... 15 
3.2.3 
Exclusion Criteria During Surgery ................................................................................ 15 
3.2.4 
Exclusion Criteria –Post-Primary Cataract Extraction (Affecting Eligibility For HMIOL 
Optic Exchange) ........................................................................................................... 16 
3.3 
STUDY VISITS ................................................................................................................................. 16 
3.3.1 
Pre-Operative Visit – Screening/Baseline (Day -90 to Day 0) ...................................... 16 
3.3.2 
Day 0 Visit (Primary Cataract Extraction Surgery) ....................................................... 16 
3.3.3 
Post-Operative Visits (Days 1 – 60) ............................................................................. 16 
3.3.4 
Cohort 2: Optic Exchange Visit .................................................................................... 16 
3.3.5 
Cohort 2: Post-Operative Visits (Days 1 - 30 Post-Optic Exchange Visit) ..................... 17 
3.3.6 
Unscheduled Visits ...................................................................................................... 17 
3.3.7 
Missed Visits ................................................................................................................ 17 
4.0 
STUDY METHODS ..................................................................................................................................... 17 
4.1 
INFORMED CONSENT ....................................................................................................................... 17 
4.2 
ASSIGNMENT OF SUBJECT IDENTIFICATION ........................................................................................... 18 
4.3 
SCREEN FAILURE ............................................................................................................................. 18 
4.4 
SUBJECT COMPLETION ..................................................................................................................... 18 
4.5 
SUBJECT DISCONTINUATION .............................................................................................................. 18 
4.6  
LOST TO FOLLOW-UP ...................................................................................................................... 19 
4.7 
STUDY COMPLETION ....................................................................................................................... 19 
4.7.1 
Early Study Termination .............................................................................................. 19 
4.8  
TRANSPORTATION AND MEAL ALLOWANCE .......................................................................................... 19 
4.9 
CONCOMITANT THERAPIES ............................................................................................................... 20 
4.9.1 
Concomitant Medication ............................................................................................. 20 
4.9.2 
Concomitant Procedures ............................................................................................. 20 
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4.10 
PROTOCOL DEVIATIONS ................................................................................................................... 20 
5.0 
STUDY MATERIALS .................................................................................................................................. 21 
5.1 
DESCRIPTION OF TEST ARTICLE .......................................................................................................... 21 
5.1.1 
Instructions for Use – Study Eye .................................................................................. 21 
5.2 
PACKAGING AND LABELING ............................................................................................................... 21 
5.3 
ACCOUNTABILITY ............................................................................................................................ 22 
5.4  
OTHER MATERIALS ......................................................................................................................... 22 
6.0 
ADVERSE EVENTS .................................................................................................................................... 22 
6.1 
DEFINITIONS .................................................................................................................................. 22 
6.1.1 
Adverse Event (AE) ...................................................................................................... 22 
6.1.2 
Adverse Device Effect (ADE) ........................................................................................ 23 
6.1.3 
Unanticipated Adverse Device Effect (UADE) .............................................................. 24 
6.1.4 
Device Deficiencies (DD) .............................................................................................. 24 
6.2 
AE EVALUATION ............................................................................................................................. 24 
6.2.1 
Evaluation .................................................................................................................... 24 
6.3 
REPORTING ................................................................................................................................... 26 
6.3.1 
On-Site Expedited Reporting ....................................................................................... 26 
6.3.2 
Off-Site SAE Reporting ................................................................................................. 27 
6.3.3 
Reporting of Complaints for Ancillary Marketed Products ......................................... 27 
6.3.4 
Adverse Events and Serious Adverse Events at Subject Exit ....................................... 27 
6.4 
SAFETY MONITORING AND REVIEW .................................................................................................... 27 
7.0  
CLINICAL ENDPOINTS .............................................................................................................................. 27 
7.1 
ENDPOINTS ................................................................................................................................... 27 
8.0 
STATISTICAL METHODS .......................................................................................................................... 28 
8.1 
SAMPLE SIZE CALCULATION .............................................................................................................. 28 
8.2 
ANALYSES POPULATIONS .................................................................................................................. 28 
8.2.1 
Implanted-Eye Population ........................................................................................... 28 
8.2.2 
Per Protocol Population .............................................................................................. 28 
8.3 
STATISTICAL METHODS .................................................................................................................... 28 
8.3.1 
Outcomes .................................................................................................................... 29 
9.0 
DATA MANAGEMENT ............................................................................................................................... 29 
9.1 
DATA QUALITY ASSURANCE .............................................................................................................. 29 
9.1.1 
Data Monitoring .......................................................................................................... 29 
9.2 
RECORD RETENTION ........................................................................................................................ 29 
10.0 
REFERENCES ............................................................................................................................................ 30 
APPENDIX A – TABLE 1: SCHEDULE OF ASSESSMENTS – HMIOL & COHORT 1 ................................................ 31 
APPENDIX A – TABLE 2: SCHEDULE OF ASSESSMENTS – COHORT 2 .................................................................... 31 
APPENDIX B ............................................................................................................................................................ 32 
 
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TABLE OF FIGURES 
FIGURE 1 - COHORT SCHEDULE ..................................................................................................................................... 10 
FIGURE 2 - COHORT DESIGNATION ................................................................................................................................ 14 
FIGURE 3 - THE HARMONI™ MODULAR INTRAOCULAR LENS (HMIOL) SYSTEM .................................................................. 21 
 
LIST OF ABBREVIATIONS 
Abbreviation/Acronym  Term  
AE  Adverse Event 
ACD Anterior Chamber Depth 
ADE  Adverse Device Effect 
AL Axial Length 
ANSI American National Standards Institute 
BCDVA Best-Corrected Distance Visual Acuity 
CFR Code of Federal Regulations 
D Diopter 
DD Device Deficiencies 
DFE Dilated Fundus Examination 
EC Ethics Committee 
CRF Case Report Form 
EPR Error Predicted Refraction  
ETDRS Early Treatment Diabetic Retinopathy Study (Chart) 
EtO Ethylene oxide 
FDA United States Food and Drug Administration 
GCPs Good Clinical Practices 
HIPAA Health Insurance Portability and Accountability Act 
HMIOL HARMONI™ Modular Intraocular Lens System 
IB Investigator Brochure 
ICF Informed Consent Form  
ICH International Conference on Harmonization 
ID Identification 
IDE Investigational Device Exemption 
IOL Intraocular Lens 
IOP Intraocular Pressure 
IRB Institutional Review Board 
ISO International Organization for Standardization 
K Keratometry 
LASIK Laser In-Situ Keratomileusis 
MR Manifest Refraction 
MRSE Manifest Refraction Spherical Equivalent 
MST MicroSurgical Technology 
Nd:YAG Neodymium:Yttrium-aluminum-garnet 
ND Not Done 
OD Right Eye 
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OS Left Eye 
OVD Ophthalmic Viscoelastic Device 
PCO Posterior Capsule Opacification 
PH Pinhole 
PMA Premarket Approval 
PRK Photorefractive Keratectomy 
RRE Residual Refractive Error 
SAE Serious Adverse Event 
SLE Slit Lamp Examination 
SOC Standard of Care 
SPK Superficial Punctate Keratitis 
SSI Secondary Surgical Intervention 
TRRE Target Residual Refractive Error 
UCDVA Uncorrected Distance Visual Acuity 
US United States 
VA Visual Acuity 
NOTE: 
The first occurrence of some abbreviations are not spelled out in the document (e.g. units of measure). 
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                                                                                                      PROTOCOL CVM-00001 REV.03 
 
Rev.03, 7 January 2016                                                                        Confidential                         Page 9 of 32
 
 
PROTOCOL SYNOPSIS 
Protocol Number 
#CVM-00001 Rev.03 
Title 
Evaluation of Visual and Refractive Outcomes of The ClarVista HARMONI™ 
Modular Intraocular Lens System  
Regulatory Status 
CE marked 
Investigational Device 
ClarVista HARMONI™ Modular Intraocular Lens System (HMIOL) 
Objectives 
• To evaluate visual and refractive outcomes of the ClarVista HARMONI™ 
Modular Intraocular Lens System in primary implantation and optic exchange 
procedure 
 
• To evaluate surgeon experience in the use of the ClarVista HARMONI™ 
Modular Intraocular Lens System in primary implantation and optic exchange 
procedure 
Number of Clinical Sites 
and Study Subjects 
Up to 200 subjects will be treated in this study at up to 5 investigational sites. 
Enrollment will be monitored as outlined in Sample Size section and adjusted 
accordingly. 
Study Duration 
All subjects will be followed for at least 1 month. 
Total patient participation duration will be approximately 5 months. 
Total study duration will be approximately 24 months. 
Study Design 
Prospective, non-randomized, multi-center clinical study. 
All subjects will be seen for a Preoperative Visit to capture baseline 
measurements then undergo cataract surgery with the study eye receiving a 
test lens (HMIOL). The investigator will determine if the test lens is to be 
implanted in OD, OS, or OU based on target refraction and the best interests of 
the subject. Subjects will be followed for 1 month after primary implantation. 
The HMIOL design allows easy optic exchange. The Investigator and Subject will 
decide if an optic exchange in the study eye is in the best interests of the 
subject based on refractive outcome and target. Subjects will be followed for 1 
month after an optic exchange procedure. Subjects may be followed up beyond 
1 month as deemed necessary by the surgeon. 
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For purposes of accountability and analysis, there will be the following Cohorts: 
• 
HMIOL Cohort 1 (HMIOL eyes without optic exchange) 
• 
HMIOL Cohort 2 (HMIOL eyes with optic exchange) 
Post-Operative Visits 
HMIOL Cohort 1 (HMIOL subjects not undergoing optic exchange) 
1 Day, 1 Week, 1 Month visits following primary cataract extraction 
 
HMIOL Cohort 2 (HMIOL subjects undergoing optic exchange) 
• 
Optic exchange decision and assignment to Cohort 2 as deemed 
necessary by Investigator and Subject 
• 
1 Day, 1 Week, 1 Month visits following optic exchange 
 
 
FIGURE 1 - COHORT SCHEDULE  
Study Endpoints 
 
 
 
 
 
 
 
 
The surgeon experience with HMIOL for the treatment of aphakia in subjects 
following cataract extraction will be characterized along with the HMIOL optic 
exchange procedure in the subgroup of study subjects with optic exchange. 
Endpoints: 
• 
Uncorrected Distance Visual Acuity (UCDVA) 
• 
Manifest Refraction Spherical Equivalent (MRSE) 
• 
Best Corrected Distance Visual Acuity (BCDVA) 
• 
Surgeon questionnaire 
• 
Secondary Surgical Intervention (SSI) (other than optic exchange) 
• 
Adverse Events (AEs) 
 
Planned Analyses: 
Postoperative data will be summarized in the following visit windows.  
 Cohort 1 
• 
1 Day: 1-2 Days 
• 
1 Week: 7 – 14 Days 
• 
1 Month: 30 – 60 Days 
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Cohort 2 (Available pre-exchange visits, plus post-exchange visits below) 
• 
1 Day: 1-2 Days  
• 
1 Week: 7 – 14 Days  
• 
1 Month: 30 – 60 Days 
 
Descriptive statistics will be used to summarize the data. Continuous variables 
will be summarized by mean, standard deviation, median, minimum, and 
maximum. Categorical variables will be summarized by frequency and 
percentage.  
 
Aggregate data will be categorized, explored and analyzed in an ad hoc manner 
as deemed necessary or desirable by ClarVista. 
 
 
Main Clinical 
Assessments 
1) UCDVA 
2) Manifest Refraction (MR) 
3) BCDVA 
4) Slit Lamp Exam (SLE) 
5) Intraocular Pressure (IOP) 
6) Dilated fundus exam (DFE) 
7) Surgeon Questionnaire 
Sample Size 
Up to 200 patients eligible for cataract surgery will be enrolled to evaluate the 
visual and refractive outcomes of patients and surgeon experience in the use of 
the HMIOL. This study is not designed to test a hypothesis. 
 
 
 
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1.0 INTRODUCTION 
Cataract surgery is a minimally invasive procedure designed to restore vision with short recovery time.  Advances in 
instrumentation and techniques over the past few decades have facilitated the enhancement in safety1 while allowing 
for reproducible outcomes.  While the serious adverse event rate remains low, selecting the right intraocular lens 
(IOL) implant for spectacle independence remains an on-going challenge.  This is referred to as residual refractive 
error (RRE) and typically involves ~0.6 diopters (D)2 of uncorrected focusing power.  Furthermore, it is reported that 
current biometry measurements for selecting the correct IOL and subsequent surgical methods are associated with: 
1. Up to 16% of patients undergoing additional surgical correction to achieve 20/20 unassisted vision2. 
2. Up to 55% of patients falling outside of their targeted postoperative refraction by at least 0.5D3,4,5. 
3. Between 14 and 24% of surgeries result in greater than 1 D of residual refractive error, when using 
manufacturer suggested constants3.  
Patients are frequently satisfied with the results of their cataract surgery and enjoy relatively quick recovery with 
restoration of vision. However, as expectations have evolved over time, patients are demanding the same degree of 
spectacle independence that other refractive surgeries such as LASIK provide.  Currently available options to help 
achieve spectacle independence when RRE is present include: contact lenses, corneal modification (surgery or other), 
IOL exchange/manipulation, or sulcus placement of a “piggyback” IOL.  These alternatives have significant limitations 
and risks. 
Complications due to contact lenses are rare; however, contact lens intolerance and contact lens-related infections 
could be serious and sight threatening. For some patients, contact lens wear is contraindicated and they must resort 
to the use of spectacles.  Elderly patients in particular have difficulty handling contact lenses.  
If the patient is willing to accept the additional cost and risks of a secondary procedure, the physician has more 
options; however, each of them poses a significant risk to the patient as outlined below.  
Corneal modifications have been performed on tens of millions of people across the world with some form of 
refractive surgery (e.g. LASIK).  For example, in the U.S. (where the most extensive data exists) 11.5M Americans have 
had corneal refractive surgery and over the next two decades many will need cataract surgery.   LASIK increases the 
likelihood for residual refractive error post cataract surgery due to inaccurate IOL power calculations with biometry.  
There is hesitation among many ophthalmologists to repeat LASIK for RRE after cataract surgery because the FDA has 
not specifically evaluated the safety and effectiveness of repeated LASIK in this setting.  All the risks associated with 
the original LASIK procedure apply to retreatment, along with the increased potential for epithelial ingrowth, corneal 
ectasia and less robust nomograms for IOL selection for post cataract patients.   
Furthermore, even for eyes that have not undergone prior corneal refractive surgery, the FDA has not specifically 
evaluated the safety and effectiveness of corneal refractive procedures (e.g., astigmatic keratotomy, LASIK, PRK, etc.) 
to address RRE following lens replacement surgery, so the use of approved lasers for this purpose in the U.S. is 
considered off-label and the risks are not well characterized.  For example, it is unclear how optical aberrations that 
might be present with an IOL in place are increased by aberrations induced by corneal refractive procedures, how 
likely corneal refractive procedures are to induce irregular astigmatism and worsen dry eye that is induced by cataract 
surgery, and whether corneal refractive procedures could create potential complications related to cataract surgery 
wound healing or IOL stability.   
Furthermore, cornea based interventions do not address the root cause of RRE after cataract extraction (imprecise 
IOL power selection) and expose the patient to a new and independent set of possible adverse events.  Thus, it would 
be desirable to be able to correct or modify the optical result without the need to irreversibly and unpredictably alter 
corneal tissue following cataract extraction. 
Sulcus placement of a “piggyback” IOL is a procedure that has not been evaluated for safety and effectiveness by the 
FDA so the use of approved IOLs for this purpose in the U.S. is off-label.  Among the complications reported with this 
procedure are secondary pigment dispersion, iris/pupil irregularities, chronic iritis, hyphema, glaucoma, zonular 
disruption and/or posterior capsular rupture.  Thus, it would be desirable to be able to correct or modify the optical 
result without the need to implant a “piggyback” IOL with its inherent serious risks. 
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IOL Exchange/Manipulation in general, is technically challenging for the surgeon and poses an iatrogenic risk to 
intraocular structures including the lens capsule, iris, and endothelium of the cornea.  Manipulation of the capsular 
bag to remove an IOL is the major risk in this setting and can damage the capsular bag including posterior capsular 
rupture and capsular bag dislocation. The capsular bag cannot be repaired once damaged. This risk increases over 
time as the capsular bag adheres to the IOL and haptics. Even when IOL exchange is not required, manipulation of 
traditional IOL’s to rotate or center the optic introduces the risk of capsular or zonular damage which can cause further 
lens instability and lens malposition.  Thus, it would be desirable to be able to correct RRE without the need to remove 
the entire IOL particularly after capsular contraction or fibrosis. 
The modular IOL concept will serve as a valuable addition to the armamentarium of cataract surgeons. The goal of 
this technology is to improve refractive (spherical and toric) outcomes and avoid the significant risks of secondary 
procedures currently being performed as standard practice to address RRE in an indirect manner. It is anticipated that 
this modular lens will provide clinical utility in two basic areas, the first being the focus of this study. 
1. Post-operative correction of residual spherical refractive error – Based on existing performance of 
conventional cataract surgery, researchers have concluded that refractive outcomes in normal eyes should 
be within 0.5D for 45% and within 1D for 85% of cataract cases5.  This theoretical performance goal still 
falls substantially short of the real-world outcomes seen with corneal refractive surgery and which cataract 
patients and surgeons increasingly demand. As a consequence, secondary procedures to optimize visual 
outcomes following cataract surgery can be as high as 16% in some practices, particularly for premium lens 
patients2.    
Another common approach associated with residual spherical refractive error is referred to as monovision 
(which can be achieved with contact lenses, corneal refractive surgery, or IOL selection), a monofocal IOL 
which targets distance vision is used in the dominant eye and the opposite, the non-dominate eye is 
targeted for near vision.  This approach allows patients to see at both distance and near and is a popular 
choice for patients wishing to achieve spectacle independence. 
While it is commonly used for this purpose, not all patients are able to adapt to monovision.7,8,9,10 They 
may have difficulty with acuity-based tasks and with tasks demanding depth perception.  Monovision 
patients may also experience problems with headaches and troublesome visual symptoms such as glare 
and halos around point sources of light, particularly under low-light conditions.  Typically, within three 
months of the surgery a patient’s acceptance or lack of acceptance of monovision correction will be known. 
At that point, dissatisfied patients are offered glasses to overcome the refractive disparity between eyes. 
Of course, this is contrary to the patient’s desire to be independent of glasses. Furthermore, spectacle 
correction is not ideal due to the significant imbalance between the required lens power for each eye 
creating visual discomfort and intolerance (i.e. asthenopia).  Refractive surgery on the cornea (e.g., LASIK 
or PRK) to reverse the over correction of the non-dominant eye is also an option, but not all monovision 
patients have a suitable cornea (e.g., too thin) and such surgery introduces additional risk. 
Modular IOL technology is intended to directly improve refractive outcomes without the inherent risk of a 
full lens exchange or resorting to the use of a corneal refractive laser.  With the HARMONI™ design the 
spherical optic component is intended to allow exchange for a different power optic or adjusted to align 
with the visual axis without extensive manipulation of the delicate capsular bag, thereby avoiding the 
potential for intraocular (e.g., capsular and endothelial) trauma that is seen with traditional IOL exchanges. 
2. Post-operative correction of displaced or off-axis toric lens – For every 1 degree a toric IOL axis is off from 
the true postoperative axis of astigmatism, there will be a 3.3% loss of toric correction.  Study data 
supporting a recent approval of a toric IOL (P930014/S045) showed that 6.7% of eyes underwent a 
secondary surgical intervention (SSI) in the form of IOL repositioning to resolve RRE.  The HARMONI™ 
modular technology can be used to improve outcomes in patients where the toric lens has been displaced 
to an unintended position during the post-operative period.  The HARMONI™ optic allows for adjustment 
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Postop Visit 
(Post-HMIOL 
Implant) 
Primary HMIOL 
Implant 
Pre-Op Visit 
to align with the astigmatic meridian or visual axis without manipulation of the base component thereby 
avoiding the potential for capsular trauma that is seen when approved toric IOLs are manipulated in the 
post-operative period. 
 
 
 
The HARMONI™ IOL is a CE marked medical device and complies with all the Health Essentials and Safety requirements 
from all directives that apply to this product.  
2.0 OBJECTIVE  
The primary objective of this study is to evaluate visual and refractive outcomes with the use of the HARMONI™ 
Modular Intraocular Lens (HMIOL) System implantation, assembly, and optic exchange in subjects undergoing cataract 
surgery.  
 
 
3.0 STUDY DESIGN 
3.1 
DESCRIPTION OF THE STUDY 
This is a prospective, non-randomized, multi-center study. The site will have Institutional Review Board (IRB) or Ethics 
Committee (EC) review and approval prior to recruiting potential subjects. Up to 200 eligible subjects with cataracts 
will undergo cataract extraction in each eye during participation. 
Subjects with satisfactory outcomes, or those opting not to pursue an optic exchange, will be entered into Cohort 1.  
Subjects who opt for an HMIOL optic exchange in their primary eye will be entered into Cohort 2. 
 
                                                                                                                                                           
                                                                
 
FIGURE 2 - COHORT DESIGNATION 
All subjects enrolled in this study will be evaluated for at least 1 month following either primary cataract extraction or 
optic exchange, whichever is later (see Appendix A – Schedule of Assessments). 
3.2 
STUDY POPULATION 
After completing the informed consent process, subjects will be screened for participation in the study.  
3.2.1 INCLUSION CRITERIA 
Cohort 2 
(Optic Exchange Attempted) 
Cohort 1 
(No Optic Exchange) 
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1. Must be able to understand and provide informed consent themselves or through a representative with a 
witness present on the IRB or EC approved Informed Consent Form (ICF) 
2. Must be willing and able to return for scheduled treatment and follow-up examinations for at least month 
study duration  
3. Must be at least 22 years of age or older at the time of consent 
4. Planned removal of cataracts (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification 
cataract extraction 
5. Dilated pupil size ≥ 6 mm in primary study eye 
3.2.2 EXCLUSION CRITERIA PRIOR TO SURGERY 
1. Participation in any other drug or device clinical trial within 30 days prior to enrolling in this study and/or 
during study participation 
2. History of any ocular conditions which could affect the stability of the IOL (e.g. pseudoexfoliation, zonular 
dialysis, evident zonular weakness or dehiscence, etc.) in either eye 
3. Traumatic or congenital cataract 
4. Any anterior segment pathology that may increase the risk of operative complications such as chronic iritis, 
uveitis, aniridia, corneal opacity, etc 
5. Pregnancy or planned pregnancy during the study period. 
6. Subject who, in the clinical judgment of the investigator, is not suitable for participation in the study for 
another clinical reason, as documented by the investigator 
7. Taking systemic medications that, in the opinion of the investigator, may confound the outcome or increase 
the risk to the subject (e.g. Tamsulosin Hydrochloride – Flomax) or other medications including 
anticholinergics, alpha adrenergic blocking agents with similar side effects (e.g. small pupil/floppy iris 
syndrome) 
3.2.3 EXCLUSION CRITERIA DURING SURGERY 
1. Vitreous loss prior to use of the investigational device 
2. Positive posterior pressure preventing safe implantation of the lens system 
3. Anterior chamber hyphema preventing visualization of implantation 
4. Any zonular or capsular rupture or capsular bag instability 
5. Intraoperative miosis preventing visualization of fixation features 
6. Need for concomitant procedures (e.g. glaucoma surgery, LRI, RK, LASIK, etc.) 
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7. Subject who, in the clinical judgment of the investigator, is not suitable for participation in the study for 
another clinical reason, as documented by the investigator 
3.2.4 EXCLUSION CRITERIA –POST-PRIMARY CATARACT EXTRACTION (AFFECTING ELIGIBILITY FOR HMIOL OPTIC 
EXCHANGE) 
1. Any clinical finding or intraocular complication during primary cataract extraction that (in the judgment of the 
Investigator) is likely to increase complications with optic exchange procedure or present undue risk to the 
subject (e.g. unexplained endothelial cell loss, post-primary cataract extraction macular edema, persistent 
ocular inflammation, etc.) 
2. Presence of YAG Capsulotomy in the primary (HMIOL) eye 
3.3 
STUDY VISITS 
The timing and frequency of each assessment to be performed at each visit, will be carried out according to “Appendix 
A – Schedule of Assessments.”   
3.3.1 PRE-OPERATIVE VISIT – SCREENING/BASELINE (DAY -90 TO DAY 0) 
After providing informed consent (see Section 4.1), prospective subjects will be screened to determine 
whether they meet enrollment criteria. Demographic information, relevant ocular history, and current ocular 
medication use will be collected. If all criteria are met, the subject will be considered enrolled, IOL calculation 
completed to determine appropriate HMIOL power, and the subject scheduled for surgery. 
3.3.2 DAY 0 VISIT (PRIMARY CATARACT EXTRACTION SURGERY)  
Prepare the subject for surgery in the study eye and review inclusion/exclusion criteria to ensure subject still 
qualifies to participate.  
The principal investigator will perform the cataract surgery and implant the Harmoni Modular IOL. 
Once the subject is confirmed stable post-surgery, provide standard post-operative instructions and 
discharge.  
Record any AEs, adverse device effects (ADEs), unexpected adverse device effects (UADEs), or device 
deficiencies (DD) (see Sections 6.1.1, 6.1.2, 6.1.3, or 6.1.4 respectively) observed pre-, intra-, or post-
operatively. 
In the event the subject is not implanted with an HMIOL device due to an intra-operative complication, the 
subject will be discontinued (see Section 4.5). 
3.3.3 POST-OPERATIVE VISITS (DAYS 1 – 60) 
All subjects implanted with a study lens will be seen for 1 Day, 1 Week, and 1 Month assessments as outlined 
in Appendix A. 
3.3.4 COHORT 2: OPTIC EXCHANGE VISIT  
The Investigator will carry out the optic power determination, surgical procedure, and HMIOL optic exchange. 
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Once the subject is confirmed stable post-surgery, provide standard post-operative instructions and 
discharge.  
Following successful completion of HMIOL optic exchange, the subject is entered into Cohort 2. Record any 
AEs, ADEs, UADEs, or DDs (see Sections 6.1.1, 6.1.2, 6.1.3, or 6.1.4 respectively) observed pre-, intra-, or post-
operatively. 
3.3.5 COHORT 2: POST-OPERATIVE VISITS (DAYS 1 - 30 POST-OPTIC EXCHANGE VISIT) 
All subjects in Cohort 2 will be seen for 1 Day, 1 Week, 1 Month (post-optic exchange) assessments. (see 
Appendix A – Table 3). 
NOTE: All concomitant medication, AE, ADE, UADE, DD, and SAE collection must be continued throughout the 
course of the study. 
3.3.6 UNSCHEDULED VISITS  
If at any time during the study, outside of the above scheduled visits, the subject requests or the Investigator 
determines the subject should be assessed, an unscheduled visit may occur. Adverse events and concomitant 
medications will be recorded and assessments deemed necessary by the Investigator should be performed on either 
or both eyes. NOTE: Only data relevant to the primary study eye (if applicable) will be captured on the Unscheduled 
Visit CRFs.  
If a subject is seen for multiple visits during a given visit window, the data from a visit that is intended to meet the 
protocol requirements for the scheduled visit should be captured in the visit CRF. Where such a determination cannot 
be made, the first visit within the scheduled visit window will be used for completion of the protocol required visit. If 
assessments are missing from that visit, however captured at subsequent visits within window, those assessments 
can be collected as part of the protocol visit. In such a circumstance, the visit date will remain consistent with the first 
visit established within the visit window, per the scenario above. Any additional and applicable data captured and 
associated with the Study Eye will be captured as an Unscheduled Visit. 
3.3.7 MISSED VISITS 
If a subject misses any scheduled visit and cannot be seen prior to the start of the next visit window, the visit 
will be considered “missed.” 
4.0 STUDY METHODS 
Prior to recruitment of any subjects into the study, review and written approval of the protocol and informed consent 
must be obtained from the Institutional Review Board (IRB) or Ethics Committee (EC) by each participating clinical site.   
4.1 
INFORMED CONSENT 
Informed consent must be obtained and documented in writing prior to the initiation of any study procedures. The 
subject (or the subject's legally authorized representative) must be allowed sufficient time to thoroughly read (or have 
explained), the informed consent form. The Investigator or his/her designee should answer any questions that the 
subject/representative might have. If the subject agrees to participate in the study, (i.e. provides informed consent) 
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the subject/representative must sign two copies of the informed consent form. The witness and the Investigator must 
also sign both copies of the informed consent form. One copy of the informed consent form should be given to the 
subject/representative. If applicable, it will be provided in a certified translation of the local language. As part of the 
consenting process, the subjects will be informed of their right to treatment for any injuries related to the study. Any 
and all such treatment if necessary, will be paid for by the Sponsor to the extent it is not covered by a subject’s 
healthcare coverage (subject to local ethics committee approval). Completion of the consenting process as well as the 
date of the subject’s signature on the informed consent form should be noted in the subject’s medical chart.   
Subjects who complete the informed consent process will be screened for eligibility. Screened subjects will be 
recorded on site-specific screening logs and once they are determined as being eligible, they will be enrolled into the 
study and an HMIOL order placed with the Sponsor if necessary.  
Subjects scheduled for an optic exchange will complete an addition IRB / EC approved informed consent process for 
this procedure. 
4.2 
ASSIGNMENT OF SUBJECT IDENTIFICATION 
A unique and sequential subject identification number (ID) will be assigned at screening and never duplicated for 
another subject. This ID will be used on all study-related documents. To maintain confidentiality, the subject’s name 
will not be recorded on any study document other than the informed consent form. 
4.3 
SCREEN FAILURE 
A record of screen failures and the reasons for the screen failures will be recorded in the subject source documents 
and captured in the CRF for summary. 
4.4 
SUBJECT COMPLETION 
The subject has completed the entire study when the HMIOL has been implanted and / or the Optic Exchange 
completed and the Sponsor receives completed electronic Case Report Form (CRF) documentation for all visits and a 
Study Exit CRF. Subjects who require further follow-up for an AE will be followed according to Section 6.3.4. 
A Study Exit CRF must be completed for all subjects who complete the clinical investigation. 
4.5 
SUBJECT DISCONTINUATION 
A subject MUST be discontinued prior to the final study visit for any of the following reasons: 
• 
Death  
• 
Subject is enrolled and scheduled for surgery but is not implanted with an HMIOL at Day 0 (Operative Visit – 
Primary Cataract Extraction) 
• 
Surgical complication(s) unrelated to the investigational device preventing the implantation of the HMIOL (i.e. 
capsulorhexis tear, zonular rupture, evident zonular weakness or dehiscence, posterior capsular rupture, vitreous 
loss, posterior capsular plaque, significant detached Descemet’s membrane, significant anterior chamber 
bleeding, iris incarceration or damage, corneal endothelial touch, unsuccessful/incomplete phacoemulsification, 
haptic and/or optic damage/haptic amputation) 
• 
Explantation of the HMIOL System 
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If the study lens is explanted, one postoperative visit should be completed to record best-corrected distance visual 
acuity (BCDVA) before the subject is discontinued. The sponsor will provide a commercially available IOL to replace 
the explanted study lens. 
Subjects who withdraw from the study will be asked to complete procedures outlined in the 1 Month Visit (if 
withdrawn prior to that visit). Subjects who are terminated due to an AE will be followed, if possible, at least until 
resolution or stabilization of the AE. Subject withdrawals will be documented clearly on the source document and 
applicable CRF. 
Prior to discontinuing a subject, every effort should be made to contact the subject, schedule a final study visit, and 
obtain as much follow-up data as possible. Adverse events will be followed as described in Section 6.3.4. Discontinued 
subjects should be followed outside of the study protocol according to the Investigator’s normal postoperative 
standard of care.  
A Study Exit CRF must be completed for all subjects who discontinue from the clinical investigation. 
4.6  
LOST TO FOLLOW-UP 
Subjects who miss at least two consecutive visits, as defined by the visit windows and cannot be contacted, may be 
considered lost to follow-up. All follow-up attempts will be documented and kept with the subject’s source 
documentation, and the applicable CRFs will be completed. 
Subjects that voluntarily withdraw consent after implantation with the HMIOL will be considered Lost to Follow-Up. 
4.7 
STUDY COMPLETION 
ClarVista will notify the Investigators when to contact the IRB / EC to announce study completion at the site.  
4.7.1 EARLY STUDY TERMINATION 
ClarVista has the right to terminate this study at any time. Reasons for terminating the study may include, but 
are not limited to, the following: 
• 
The incidence or severity of adverse events in this or any ongoing studies involving the same technology 
(if applicable), indicates a potential health hazard to subjects 
• 
Subject enrollment is unsatisfactory 
• 
Data recording is inaccurate or incomplete. 
In the event of premature study termination, appropriate notification will be given to the Investigators, IRB / 
ECs, and regulatory bodies as applicable. In addition, ClarVista (or designee) will instruct all Investigators to 
discontinue dispensing study materials or treatments, will ensure all subjects complete appropriate follow-
up, and will arrange study closeout visits at each site as appropriate. 
4.8  
TRANSPORTATION AND MEAL ALLOWANCE 
Subjects will receive monetary allowance to cover transportation and meal expenses as specified in the ICF. 
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4.9 
CONCOMITANT THERAPIES  
4.9.1 CONCOMITANT MEDICATION 
Concomitant medications are any prescription drugs used by a subject until conclusion of study participation. 
Any medication the Investigator deems in the best interest of the subject, is acceptable to prescribe or 
administer. However, any and all ophthalmic medications are to be recorded in both the Concomitant 
Medication source document and CRF as well as the reason for use (indication). An AE is to be reported and/or 
recorded as appropriate (see Section 6.0). 
4.9.2 CONCOMITANT PROCEDURES 
A concomitant procedure is any invasive or non-invasive ocular or peri-ocular procedure that takes place 
during study participation and will be captured in both the Concomitant Procedure Source Document and 
CRF. The following are examples of two such procedures: 
• 
Fellow Eye cataract extraction and IOL implantation, which will be listed as “Phaco with PCIOL.”  
• 
Neodymium: Yttrium-aluminum-garnet (Nd:YAG) procedure to treat Posterior Capsule Opacification 
(PCO), if necessary. This will be listed as “Nd:YAG Capsulotomy.” 
Note: Any Nd:YAG capsulotomy procedures prior to exit will be performed only in response to spontaneous 
subject complaints (i.e. not solicited by study personnel) of reduced Visual Acuity (VA) or glare that affects 
functional vision, which is associated with PCO or striae, and captured on the eCRF in SLE findings. 
An AE is to be reported and/or recorded as appropriate (see Section 6.0). Any procedure reported in the 
Concomitant Procedure eCRF must have a corresponding Indication listed in either the Ocular History or AE 
CRF (Only exception: PCO – See Section 6.1 for further details). 
4.10 PROTOCOL DEVIATIONS 
All protocol deviations, the date of deviation, and reason will be documented in the Source Document and eCRF. All 
deviations will be categorized as either major or minor in the following manner: 
Major:   
• 
Deviations impacting subject safety    
• 
Deviations impacting subject rights 
• 
Deviations impacting data integrity 
Minor:  
• 
All other deviations (e.g. out of window visits, missed data point, etc.)  
All major deviations must be reported by the Investigator to the Sponsor and IRB/EC immediately. Subject assessments 
will continue per protocol for the duration of planned participation unless the deviations put the subject at risk or the 
subject’s condition requires that he/she be discontinued from the study. 
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5.0 STUDY MATERIALS 
5.1 
DESCRIPTION OF TEST ARTICLE 
The HARMONI™ Modular Intraocular Lens (HMIOL) System is an investigational device designed to allow safe 
exchange or adjustment of an IOL optic after implantation. 
 
 
 
 
 
  
FIGURE 3 - THE HARMONI™ MODULAR INTRAOCULAR LENS (HMIOL) SYSTEM 
The HMIOL includes a base component (A) and an optic component (B) that are delivered and assembled (C) in the eye.             
 
 All components are sterilized using ethylene oxide (EtO) and has a 
shelf life 1 year from the date of sterilization.  
Test article: 
• 
HARMONI™ Modular Intraocular Lens System Base Component 
• 
HARMONI™ Modular Intraocular Lens System Optic Component  
5.1.1 INSTRUCTIONS FOR USE – STUDY EYE 
Refer to the Surgical Guide for all use and administration details. 
5.2 
PACKAGING AND LABELING 
All packaging and labeling will be consistent with the current study design. The labeling will include at a minimum, the 
following: 
• 
Sponsor name and address 
• 
 “For Single Use Only” statement (or equivalent symbol) 
• 
Sterility symbol 
• 
Storage temperature range requirements or equivalent  
• 
Expiration date 
• 
Power designation 
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• 
Unique serial number 
• 
Model number 
5.3 
ACCOUNTABILITY 
The Investigator is responsible for keeping accurate accountability records of the number of study lenses received, 
dispensed, and returned to Sponsor. The study lenses must be stored under the appropriate conditions in a secure 
area and are to be implanted only in subjects enrolled in the study, in accordance with the conditions specified in this 
protocol.  
All accountability records will include the following: 
• 
Model and serial numbers 
• 
Receipt date 
• 
Quantities received 
• 
Initials (attributability) of site personnel who received, dispensed, or returned study lenses 
• 
Date of use 
• 
Subject treated with the study lens (by Subject ID and Initials only) 
• 
Date returned to Sponsor 
• 
Defective or damaged study devices  
Periodically throughout the study and/or upon completion, the Sponsor (or designee) will review and verify the 
Investigator’s accountability records. Following verification, and as directed by the Sponsor, all unused and explanted 
products must be returned to the Sponsor.  
Note: In addition, any study lenses or components deemed defective, damaged, malfunctioning, or explanted must be 
retained by the site and returned to the Sponsor for evaluation. Under no circumstances are any components to be 
discarded or otherwise disposed of. If there is any question as to the applicability of this directive, consult the Protocol 
Contacts page of this protocol and discuss the situation with a Sponsor representative.  
5.4  
OTHER MATERIALS 
Additional materials can be provided to sites for the duration of the study on an as-needed basis and may include: 
• 
Medicel injectors  
• 
IOL micro-incision cutter and forceps 
6.0 ADVERSE EVENTS 
Safety assessments include ocular adverse events, all serious adverse events, and adverse device events. The reporting 
time period is from the time of consent through the last study visit (1 Month Visit post-primary cataract extraction for 
Cohort 1 and post-optic exchange for Cohort 2).  
6.1 
DEFINITIONS  
6.1.1 ADVERSE EVENT (AE) 
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An AE is any untoward ocular event in a subject that does not necessarily have a causal relationship to the 
study device or protocol. AEs include Adverse Device Effects (ADEs). Conditions or diseases that are chronic 
but stable should not be recorded on AE pages of the CRF.  Similarly, changes in a chronic condition of disease 
that are consistent with natural disease progression are NOT adverse events and also should not be recorded 
on the AE pages of the CRF.   
Refer to Section 6.3.1 for instructions regarding events that require expedited reporting to the Sponsor and 
IRB/EC. 
Experience with cataract surgery and the implantation of IOLs has shown that some conditions can be 
considered normal or expected events following these procedures. The following may be considered normal 
or expected events after cataract surgery and only need to be reported as AEs as specified here: 
• 
Iritis (cell / flare) – if treated 
• 
Persistent Corneal Stroma Edema (if present at 1 Month) 
• 
Increased IOP only if medical/surgical intervention is required (i.e. medication, paracentesis manipulation) 
• 
VA decrease of 10 or more letters (2 lines) from any previous visit not secondary to any underlying 
condition 
• 
Any expected post-operative ocular event requiring a change in standard postoperative medication 
regimen 
Note: PCO is not to be reported as an AE, as per ISO 11979-7:2014. 
Particular attention should be paid to ensure timely and accurate reporting of any of the following cataract 
surgery related events: 
• 
Endophthalmitis 
• 
Capsular injury 
• 
Vitreous loss 
• 
Macular edema 
• 
Retinal detachment 
• 
Lens dislocation 
• 
Moderate to severe corneal edema 
• 
Pupillary block / angle closure 
• 
Hypopyon or hyphema 
6.1.2 ADVERSE DEVICE EFFECT (ADE) 
An ADE is any untoward or unintended effect, event, or response surrounding and with a causal relationship 
with the use of a medical device. This definition may include any event resulting from insufficiencies or 
inadequacies in the instructions for use or the deployment of the device or other device malfunctions. This 
definition includes any event that is a result of a user error and any event that affects a user of the device (i.e. 
caregiver, bystander, etc). 
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6.1.3 UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) 
A UADE is any ADE, which is unanticipated and poses a risk to health or safety, or any life-threatening problem 
or death caused by or associated with a device, if that effect, problem, or death was not previously identified 
in nature, severity or degree of incidence (see Investigator Brochure [IB]). UADEs also include any 
unanticipated sight-threatening events and any other unanticipated serious problem associated with a device 
that relates to the rights, safety, or welfare of subjects.  
6.1.4 DEVICE DEFICIENCIES (DD) 
A Device Deficiency (DD) is a failure of the device to meet its performance specifications or expectations, or otherwise 
not perform as intended. This can include either a malfunction or damage to the device or any part thereof, regardless 
of the source of malfunction or damage, including user error, and regardless of the presence of injury (or lack thereof) 
to subject, user, or bystander.  
6.2 
AE EVALUATION  
AEs experienced in this study may be associated with the study device (i.e. ADE) or the study protocol as demonstrated 
in the following non-exhaustive list of examples: 
Study Device (ADE) 
• 
IOL dislocation 
• 
Explant due to haptic break/damage 
• 
Explant due to base and/or optic damage 
Study Protocol 
• 
Allergic reaction to dilating drops 
• 
Lens remnants following surgery 
• 
Capsular tear during surgery to implant study device 
6.2.1 EVALUATION 
All AEs will be evaluated for and by the following criteria: 
• 
Classification (SAE, AE, ADE or combination) 
• 
Diagnosis (or description if ADE) 
• 
Severity 
• 
Relationship (Causality) to study protocol or device 
• 
Outcome 
• 
Treatment or action taken 
 
6.2.1.1  
CLASSIFICATION 
When evaluating AEs, the Investigator must determine if the event is serious using the following guidelines: 
A Serious Adverse Event (SAE) is any AE (ocular or non-ocular) that: 
• 
results in death 
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• 
results in serious injury, defined as: 
♦ life-threatening  
♦ permanent impairment of a body function (e.g. blindness) or structure  
♦ necessitates medical or surgical intervention to prevent permanent impairment of a body function or 
permanent damage to a body structure, or 
♦ results in a potentially sight-threatening condition 
• 
is a malfunction that might cause or contribute to a serious injury or death if it were to recur 
• 
requires in-patient hospitalization or prolongation of existing hospitalization*, or 
• 
leads to fetal distress, fetal health, a congenital abnormality, or birth defect  
* Hospitalization is a criterion for assessment of seriousness. Hospitalization in the absence of a medical AE is 
not in itself an AE. For example, the following reports of hospitalization without a medical AE should not be 
considered either serious or an AE:  
• 
admission for treatment of a pre-existing condition not associated with the development of a new AE or 
with worsening of the pre-existing condition (e.g. for work-up of persistent pretreatment lab abnormality)  
• 
social admission (e.g. subject has no place to sleep)  
• 
administrative admission (e.g. for yearly physical exam)  
• 
optional admission not associated with a worsening of a pre-existing condition (e.g. elective cosmetic 
surgery or elective surgery for pre-existing repair of the Achilles tendon [which had not worsened while 
on study]) 
• 
hospitalization for admission without a medical AE 
NOTE: For the purposes of this protocol, any UADE will be considered an SAE.  
6.2.1.2  
DIAGNOSIS OR DESCRIPTION 
In all instances, it is preferable to report all AEs and SAEs by diagnosis rather than a sign or symptom if possible. 
This may necessitate the revision of a previously reported AE or SAE as more information is obtained.  
6.2.1.3  
SEVERITY 
When evaluating AEs, the Investigator must determine the severity of symptoms using the following 
guidelines: 
• 
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 
6.2.1.4  
RELATIONSHIP (CAUSALITY) TO STUDY DEVICE OR STUDY PROTOCOL  
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When evaluating AEs, the Investigator must evaluate the relationship of the event to the study device and 
study protocol, using the following guidelines: 
• 
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: Adverse events for which a connection with the study device or study protocol cannot be ruled-
out with certainty, or not enough information is available to assess the relationship 
6.2.1.5  
OUTCOME 
The clinical outcome of an AE will be categorized as follows: 
• 
Resolved without sequellae 
• 
Resolved with sequellae (specify) 
• 
Ongoing (i.e. continuing at time of study discontinuation) 
• 
Death 
6.2.1.6  
TREATMENT OR ACTION TAKEN 
Treatment or Action Taken will be categorized as follows: 
• 
None 
• 
Medical Intervention (specify on Concomitant Medication Source and CRF) 
• 
Surgical Intervention (specify on Concomitant Procedure Source and CRF) 
• 
Other (specify) 
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 AEs determined to be related to the study device (ADEs or UADEs)  
• 
All HMIOL explants (consult Medical Monitor listed on Protocol Contacts page prior to explant, if possible) 
• 
All Device Deficiencies (DD)  
Refer to the Protocol Contacts page for appropriate Sponsor contact to report the above events. 
NOTE: Any explanted HMIOL devices, exchanged HMIOL optics, or any components of the HMIOL System 
presenting a deficiency or malfunction are to be retained by the site until collected by the Sponsor. Under 
no circumstances are they to be destroyed or otherwise discarded. 
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When reporting these events to the Sponsor, the site should forward any supporting documents along with 
the appropriate reporting form and complete the corresponding CRF, if applicable. Sites must also report 
applicable events to the reviewing IRB/EC per its established reporting procedures. 
6.3.2 OFF-SITE SAE REPORTING 
As a multicenter clinical trial, the Investigators may receive “off-site” reports (e.g. an 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. These should be reported to the reviewing IRB per their 
established reporting procedures. 
6.3.3 REPORTING OF COMPLAINTS FOR ANCILLARY MARKETED PRODUCTS 
Any complaints, malfunctions or similar events related to ancillary marketed products used in this study 
should be reported by the Investigators in accordance with the reference information provided on the 
associated commercial packaging.  
6.3.4 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS AT SUBJECT EXIT 
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 study exit visit or upon discontinuation from the study will be followed 
per the Investigator’s standard of care. Documentation in the CRF of this follow-up is not required although 
subject care should continue as appropriate.  
6.4 
SAFETY MONITORING AND REVIEW 
All reported AEs will be reviewed on a weekly basis and assessed for trending and causality to study device or 
procedure. ADEs, UADEs, DDs, and SAEs will be reviewed upon receipt of expedited reporting (Section 6.3.1). Any 
unexpected trends or events will necessitate careful review and assessment of any change in the risks associated with 
participation or study continuation.  
If an event occurs affecting a subject’s risk of participation, Off-Site Reporting (Section 6.3.2) will be utilized to update 
sites and the IRB(s) / EC(s). If the safety profile of the event provides for the continuation of the study, Informed 
Consent Forms will be revised as necessary to ensure subjects’ consent to continue participation given the known 
revised risks. 
As outlined in Section 4.7.1, the Sponsor reserves the right to discontinue enrollment at any time. 
7.0  CLINICAL ENDPOINTS 
7.1 
ENDPOINTS 
Safety will be evaluated by assessing the following: 
HMIOL Cohort 1 
• 
UCDVA by study visit 
• 
MR by study visit 
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• 
BCDVA by study visit 
• 
Surgeon questionnaire 
• 
AE incidence rate 
• 
Device deficiencies 
• 
SSI (planned Optic Exchanged procedures excluded) 
HMIOL Cohort 2 
• 
UCDVA by study visit 
• 
MR by study visit 
• 
BCDVA by study visit 
• 
Surgeon questionnaire 
• 
AE incidence rate 
• 
Device deficiencies 
• 
SSI (planned Optic Exchanged procedures excluded) 
8.0 STATISTICAL METHODS 
This is a study to evaluate visual and refractive outcomes of patients with HMIOL during primary cataract surgery and 
subjects with HMIOL optic exchange.  In general, the analyses will be provided based on available data.  The mean, 
standard deviation, minimum, and maximum will be prepared for the continuous clinical parameters, and counts and 
percentages will be presented for the categorical outcomes.  
8.1 
SAMPLE SIZE CALCULATION 
This study is not designed to power a hypothesis. 
8.2 
ANALYSES POPULATIONS 
Subjects that are screened but disqualified based on the preoperative and intra-operative eligibility criteria 
will be excluded from the analyses.  However, their reasons for the screen failure will be summarized.  The 
analyses populations defined below are defined for the study lens.   
8.2.1 IMPLANTED-EYE POPULATION 
The Implanted-Eye Population consists of eyes with successful HMIOL implantations during surgeries.   
8.2.2 PER PROTOCOL POPULATION 
The Per Protocol (PP) Population contains eyes with successful HMIOL implantations during surgeries and do 
not have major protocol deviation (such as improperly enrolled in the study or lens power calculation errors) 
and will be considered the primary population for effectiveness outcomes.   
The protocol deviations will be determined reviewed by ClarVista clinical personnel prior to analysis. 
8.3 
STATISTICAL METHODS 
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The data analyses will be based on the analysis populations described above.  No imputation for missing data 
will be performed.  The statistical summaries will be prepared for HMIOL Cohort 1, HMIOL Cohort 2.  
8.3.1 OUTCOMES 
Each endpoint will be analyzed based on the Implanted-eye Population and PP Population.   
9.0 DATA MANAGEMENT 
9.1 
DATA QUALITY ASSURANCE 
All requested information must be entered on the CRF and confirmable through source documentation. If an item is 
not available or not applicable, this fact should be clearly indicated. 
Data will be entered into a computer database developed specifically for this trial. During the course of the trial, data 
queries will be generated for data points that are potentially erroneous and require appropriate clarification or 
correction. 
9.1.1 DATA MONITORING 
Periodic monitoring (either remote and/or on-site) will take place to ensure data integrity. Study monitoring 
involves the following elements: 
ClarVista personnel, or designee, may meet with investigators prior to the initiation of the study in order to 
review the adequacy of the subject population, facilities, and equipment with respect to the needs of the 
study, and to familiarize the investigator and support staff with the study protocol. 
ClarVista personnel, or designee, may meet with the investigators at the time enrollment is initiated in order 
to ensure that subjects are being properly selected, that the methods described in the study protocol are 
thoroughly understood by the investigator, and that study data are being correctly recorded. 
ClarVista personnel, or designee, may visit the clinical site at any time during the course of the study to review 
and/or collect completed case report forms. Additionally, telephone consultation will occur as necessary 
during the course of the study to ensure the proper progress and documentation of the study findings. 
The study data will be carefully protected, and masking utilized to the extent possible, in order to prevent 
bias.  
9.2 
RECORD RETENTION 
The investigator shall maintain all subject records for whichever of the following periods is shorter: 
• 
A period of two years after the date on which FDA approves the marketing of the device  
• 
A period of five years after the date on which the results of the study are submitted to the FDA in support of 
the marketing of the device  
The Investigator / Site must contact ClarVista as provided in the Protocol Contacts page prior to discarding or 
disposing of any study related supplies or documents. The Sponsor retains the right to have all study documents 
shipped (at Sponsor’s expense) for archival purposes, as an alternative to disposal. 
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10.0 REFERENCES 
1. Joshua D. Stein, MD. Serious adverse events after cataract surgery. Current Opinions in Ophthalmology 23 2012 
May: 219-225. 
2. Sverker Norrby, PhD. Sources of error in intraocular lens power calculation. Journal of Cataract and Refractive 
Surgery 34 2008 Mar: 368-376 
3. Retzlaff JA, Sanders DR, Kraff MC. Development of the SRK/T intraocular lens implant power calculation formula. 
J Cataract Refrat Surg 1990 May: 16; 333-340 
4. Lim LH, Lee SY, Ang CL. Factors affecting the predictability of SRK II I patients with normal axial length 
undergoing phacoemulsification surgery. Singapore Med J 2009; 50 (2) 120-125 
5. Gale RP, Saldana M, Johnston RL et al. Benchmark standards for refractive outcomes after NHS cataract surgery. 
Eye 23, no. 1 2009 Jan: 149-152. 
6. Aristiodemou P, Cartwright NE, Sparrow JM, Johnston RL. Intraocular lens formula constant optimization and 
partial coherence interferometry biometry: refractive outcomes in 8108 eyes after cataract surgery. J Cataract 
Refract Surg 2011; 37:50 – 62. 
7. Evans, BJW. Monovision: a review. Ophthal. Physiol. Opt. 2007; 27: 417-439 
8. Erickson, D.B. & Erickson, P. Psychological factors and gender differences in the acceptance of 
monovision. Perceptual and Motor Skills, 2000; 91:1113-1119. 
9. Back AP, Holden BA, Hine NA. Correction of presbyopia with contact lenses: comparative success rates with 
three systems. Optometry & Visual Science. 1989 Aug; 66(8): 528-25  
10. Du Toit R, Ferreira, JT, Nel ZJ. Visual and Nonvisual Variables Implicated in Monovision Wear. Optometry & 
Visual Science. 1998; 75 (2): 119-125 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
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APPENDIX A – TABLE 1: SCHEDULE OF ASSESSMENTS – HMIOL & COHORT 1 
Table 1 
Cohort 1 
 
  
Pre-Op Visit 
Op Visit 1 
Form 1  
Form 2  
Form 3  
Optic Exchange 
Window 
(Day 1 - 30) 
Procedure/Assessments 
Day -90  
to -0 
Day 0 
1 Day Visit 
(Day 1-2) 
1 Wk Visit (Day 
7-14) 
1 Mo Visit (Day 
30 - 60) 
Informed Consent 
X 
 
 
X 
 
  
Demographics 
X 
  
  
  
  
  
Med/Ophthalmic History 
X 
X 
 
 
 
  
Eligibility 
X 
X 
  
  
  
  
UCDVA 
  
 
X 
X 
X 
  
Manifest Refraction 
X 
 
 
X 
X 
  
BCDVA  
X 
 
 
X 
X 
  
Keratometry 
X 
 
 
 
X 
 
IOL Power Calculation  
X 
  
  
  
  
  
Slit Lamp Examination  
X 
 
X 
X 
X 
  
IOP 
X 
  
X 
X 
X 
  
Pupil Size 
X 
  
  
  
  
  
Dilated Fundus Exam  
X 
 
 
 
X 
  
Primary Surgery (HMIOL) 
 
X 
 
 
 
  
Surgeon Questionnaire 
 
X 
 
 
 
 
Optic Exchange  
(see Table 2) 
  
  
  
  
  
  
APPENDIX A – TABLE 2: SCHEDULE OF ASSESSMENTS – COHORT 2 
Table 2 
Cohort 2 - Optic Exchange Complete 
  
Op-Visit 2 
Form 1.1  
Form 2.1  
Form 3.1  
Procedure/Assessments 
Optic 
Exchange Visit 
( 
+1-301 Days) 
OE 1 Day  
Visit 
(Day 1-2) 
OE 1 Wk  
Visit  
(Day 7-14) 
OE 1 Mo  
Visit  
(Day 30-60) 
Eligibility 
X 
 
 
 
UCDVA 
  
X 
X 
X 
IOL Power Calculation 
X 
 
 
 
Keratometry 
 
 
 
X 
Manifest Refraction 
  
  
X 
X 
BCDVA  
  
 
X 
X 
Slit Lamp Examination  
  
X 
X 
X 
IOP 
  
X 
X 
X 
Dilated Fundus Exam  
  
  
  
X  
Optic Exchange Procedure 
X 
  
  
  
Surgeon Questionnaire 
X 
 
 
 
 
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APPENDIX B 
Surgeon Questionnaire 
Primary Implantation 
1. How would you rate the surgical difficulty of the base implantation? 
a. 
Easier than a traditional single piece IOL 
b. Slightly easier than a traditional single piece IOL 
c. 
The same as a traditional single piece IOL 
d. Slightly more difficult than a traditional single piece IOL 
e. More difficult than a traditional single piece IOL 
2. How would you rate the surgical difficulty of the optic implantation and assembly? 
a. 
Very easy 
b. Easy 
c. 
Neutral 
d. Difficult  
e. Very difficult 
 
Optic exchange 
1. How would you rate the surgical difficulty of the optic disassembly? 
a. 
Very easy 
b. Easy 
c. 
Neutral 
d. Difficult  
e. Very difficult 
2. How would you rate the surgical difficulty of the optic explantation? 
a. 
Very easy 
b. Easy 
c. 
Neutral 
d. Difficult  
e. Very difficult 
3. How would you rate the surgical difficulty of the optic implantation and assembly? 
a. 
Very easy 
b. Easy 
c. 
Neutral 
d. Difficult 
e. Very difficult 
 
 
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