A Clinical Validation Study to Evaluate the Performance of a Hand-held Device Supported by a Mobile Application Compared With Standard Eye Care Diagnostic Devices in Measuring Refractive Error of the Eye
Phase: NA
Conditions: Refractive Errors, Astigmatism
Sponsor: EyeQue Corp.

Protocol EYEQUE-001 
EyeQue Corporation 
 
 
1. 
TITLE PAGE 
CLINICAL STUDY PROTOCOL 
 
Title:  A clinical validation study to evaluate the performance of a hand-held device supported by 
a mobile application compared with standard eye care diagnostic devices in measuring refractive 
error of the eye 
 
 
Sponsor: 
EyeQue Corporation 
39608 Eureka Drive 
Newark, CA 94560 
Protocol Number:  
EYEQUE-001 
Investigational Device: 
EyeQue VisionCheck  
Investigational Device Exemption: 
Not applicable 
 
Protocol Version: 
 
Version 3.0 (17 June 2019) 
 
Authorized Signatory: 
John Serri 
Chief Technology Officer/Chief 
Operating Officer 
 
Study Contact: 
Paul TanPiengco 
Director of Product Management 
818-564-5414 
 
 
 
Confidentiality Statement 
The confidential information in this document is provided to you as an investigator or consultant 
for review by you, your staff, and the applicable Institutional Review Board.  Your acceptance of 
this document constitutes agreement that you will not disclose the information contained herein 
to others without written authorization from the sponsor. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Protocol EYEQUE-001 
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PROTOCOL APPROVAL - SPONSOR SIGNATORY 
 
Study Title 
A clinical validation study to evaluate the performance of a hand-held 
device supported by a mobile application compared with standard eye 
care diagnostic devices in measuring refractive error of the eye   
Protocol Number 
EYEQUE-001 
Protocol Version 
Version 3.0 
Protocol Date 
17 June 2019 
 
 
Protocol accepted and approved by: 
John Serri 
Chief Technology Officer/Chief Operating Officer 
EyeQue Corporation 
39608 Eureka Drive 
Newark, CA 94560 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature  
 
 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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INVESTIGATOR’S AGREEMENT 
Study Title 
A clinical validation study to evaluate the performance of a hand-held 
device supported by a mobile application compared with standard eye 
care diagnostic devices in measuring refractive error of the eye   
Protocol Number 
EYEQUE-001 
Protocol Version 
Version 3.0 
Protocol Date 
17 June 2019 
 
My signature indicates my commitment to do the following: 
• Conduct the investigation in accordance with the agreement, the investigational plan, 
21 CFR Part 812, and other applicable regulatory requirements, and conditions of 
approval imposed by the reviewing institutional review board/independent ethics 
committee and appropriate regulatory agencies. 
• Supervise all testing of the device involving human subjects. 
• Ensure that the requirements for obtaining informed consent are met. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Investigator 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Investigator 
 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
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PROCEDURES IN CASE OF EMERGENCY 
Emergency contact information is provided below.   
Role in Study 
Name 
Address and Telephone Number 
Sponsor Main Contact 
Paul TanPiengco 
EyeQue Corporation 
39608 Eureka Drive 
Newark, CA 94560 
Cell: 818-564-5414 
Sponsor Secondary Contact 
Noam Sapiens 
EyeQue Corporation 
39608 Eureka Drive 
Newark, CA 94560 
Cell: 408-630-5086 
Medical Monitor 
Jack Modell, MD 
Vice President and Senior 
Medical Officer, or on-call 
medical monitor 
Address as of 08 April 2019: 
Rho, Inc. 
2635 E NC Hwy 54 
Durham, NC  27713 
Phone: 919-595-6461 (Medical 
Monitor Hotline) 
8:00 am - 8:00 pm ET, 
Monday - Friday 
 
Email: 
MedicalMonitorSupport@rhoworld.com, 
with cc to jack_modell@rhoworld.com  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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2. 
SYNOPSIS 
Name of Sponsor/Company:  EyeQue Corporation 
Name of Investigational Device:  EyeQue VisionCheck 
Title of Study:  A clinical validation study to evaluate the performance of a hand-held device 
supported by a mobile application compared with standard eye care diagnostic devices in 
measuring refractive error of the eye 
Study Number:  EYEQUE-001 
Study center(s):  1 
Studied period (years):  
Estimated date first patient enrolled:  Q2 2019 
Estimated date last patient completed:  Q3 2019 
Objectives:  
Primary: 
• The primary objective of this study is to determine whether EyeQue VisionCheck is 
statistically non-inferior to the phoropter as assessed by best corrected visual acuity 
(BCVA) for each eye independently, measured using trial lens frames that correct the 
refractive error measured by each device, for the age stratum 45 through 65 years. 
Secondary: 
The secondary objectives include: 
• Assessing similarity of refraction values (sphere, cylinder, axis) from the EyeQue 
VisionCheck compared with the phoropter through comparative plots and Pearson 
correlations 
• Determining whether EyeQue VisionCheck is statistically non-inferior to the 
autorefractor as assessed by BCVA measured using trial lens frames that correct the 
refractive error measured by each device 
• Assessing similarity of refraction values (sphere, cylinder, axis) from the EyeQue 
VisionCheck compared with the autorefractor through comparative plots and Pearson 
correlations 
• Determining whether EyeQue VisionCheck is statistically non-inferior to the 
phoropter as assessed by BCVA measured using trial lens frames that correct the 
refractive error measured by each device, for the age stratum 30 through 65 years. 
Exploratory: 
• The exploratory objective of this study is to assess subject preference among the 
3 trial lens frames that correct the refractive error measured by the EyeQue 
VisionCheck, phoropter, and autorefractor.  
 
 
 
 
 
 
 
 
 
 
 
 
 
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Safety:   
• To evaluate the safety of EyeQue VisionCheck compared with the phoropter and the 
autorefractor 
Study design:  This is a single-center, open-label, prospective study in healthy volunteers 
desiring refraction for correction of visual acuity to compare the EyeQue VisionCheck with the 
phoropter and autorefractor. 
Approximately 200 subjects will be enrolled in this study to achieve a minimum of 
100 evaluable subjects.  Subjects will be enrolled to obtain a population of approximately 35% in 
the age range of 30 through 44 years and approximately 65% in the age range of 45 through 
65 years.  Subjects will be screened for study participation and, if enrolled, will complete the 
testing procedures at the same visit.  Subjects will not undergo any study-specific screening or 
testing procedures until written informed consent is obtained.  A subject will be enrolled in the 
study after confirming that the subject has met all of the inclusion criteria and none of the 
exclusion criteria. 
 
Screening procedures   
The subject will complete the following assessments and procedures at Screening to confirm 
eligibility:   
• demographics/medical history/concomitant medication review,  
• slit-lamp biomicroscopy,  
• laser retinal scan or fundoscopy,  
• optical coherence tomography (OCT) (retina and anterior chamber), 
• tonometry (non contact), 
• Ishihara color test,  
• cover test,  
• retinoscopy 
• phoropter refraction, and  
• visual acuity with phoropter correction.   
During the OCT and laser retinal scan/fundoscopy, images will be taken of the retina, anterior 
chamber, and fundus.  All eye procedures will be completed without dilation using standard 
procedures.     
Retinoscopy will be used as a basis for further refinement by phoropter refraction.  Refraction 
values (sphere, cylinder, axis) for oculus dexter (OD, right eye) and oculus sinister (OS, left eye) 
will be recorded for each subject using the phoropter.  These values will be used to adjust the 
lenses in the phoropter while the subject is looking through the device at an Early Treatment 
Diabetic Retinopathy Study (ETDRS) eye chart to determine BCVA, as subjects are eligible to 
participate in the study only if their vision (oculus uterque [OU]; both eyes) can be corrected to 
20/20 (logarithm of the minimum angle of resolution [LogMAR] 0.0).     
 
 
 
 
 
 
 
 
 
 
 
 
 
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The Screening procedures will be used to confirm that the subject does not have an exclusionary 
diagnosis (see exclusion criteria below). 
 
Testing procedures   
Once eligibility is confirmed, the subject will be enrolled and proceed with study testing 
procedures.  The refraction values (sphere, cylinder, axis) for each subject (OD and OS) will be 
assessed using 2 additional devices: autorefractor and the EyeQue VisionCheck.  Subjects will be 
assessed with the autorefractor using standard device methodology.  The refraction values 
generated from the EyeQue VisionCheck, the autorefractor and the phoropter (during screening) 
will be used to prepare 3 sets of trial lens frames.  Pupillary distance, measured using the 
autorefractor, will be recorded for all subjects and will be used for preparation of trial lens 
frames.   
All subjects will be trained on how to use the EyeQue VisionCheck device prior to initiating 
testing.  In order to obtain refraction values using the EyeQue VisionCheck, the subject will be 
required to take 1 practice test followed by a minimum of 3 saved tests for each eye using the 
EyeQue VisionCheck device and mobile application (app).  After completion of a set of tests 
(1 test for each eye), the subject may elect to save or discard that set of tests.  They may choose 
to discard for any reason which may include not following instruction, pressing the wrong button 
in error, etc.  Each test consists of the subject looking through the VisionCheck device and using 
the app controls to fully overlap red and green bars at 9 different angles.  After completion of all 
tests (1 practice test and 3 saved tests with each eye), the refraction values will be displayed on 
the mobile app.  These values will be used for preparation of the trial lens frames.  If the EyeQue 
system determines that the overall test results are unreliable, subjects may have to complete 3 
additional tests per eye before the system may be able to provide refraction values.  Subjects will 
not be allowed to complete more than 6 saved tests and 1 practice test with each eye.  If the 
EyeQue system determines that the overall test results are unreliable, no values will be provided. 
  
After collection of refraction values from each device (phoropter, autorefractor, and EyeQue 
VisionCheck), the 3 trial lens frames will be prepared and given to the subject in a masked 
fashion.  Best corrected visual acuity will be assessed using the ETDRS eye chart.  For each 
subject, BCVA LogMAR scores will be collected for OD, OS, and OU for each of the 3 trial lens 
frames.  Subjects will also be asked a question regarding overall satisfaction with visual acuity 
using each of the 3 trial lens frames.  Subjects will be monitored for adverse events (AEs) and 
adverse device effects (ADEs) during the study.    
Number of subjects (planned):  Approximately 200 subjects will be enrolled in this study to 
achieve a minimum of 100 evaluable subjects.  An initial cohort of 39 subjects will be excluded 
from the analysis populations due to a software error identified in the EyeQue app that has since 
been corrected; therefore, approximately 160 additional subjects will be enrolled in the study.  
Subjects will be enrolled to obtain a population of approximately 35% in the age range of 30 
through 44 years and approximately 65% in the age range of 45 through 65 years. 
Diagnosis and main criteria for inclusion:  
Inclusion criteria:  
1. Male or Female 
 
 
 
 
 
 
 
 
 
 
 
 
 
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2. Age 30 through 65 years at the time of consent 
3. Binocular vision 
4. Subject desires refraction for correction of visual acuity and vision (OU) can be corrected 
to 20/20 (LogMAR 0.0) 
5. Willing and able to give informed consent and follow all study procedures and 
requirements  
6. Ability to speak and understand the English language 
Exclusion criteria:  
1. Spherical correction > +8 or < -10 
2. Using anticholinergic medications (including first-generation antihistamines) or other 
medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior 
to enrolling in this study 
3. Using an investigational drug or approved therapy for investigational use within the 
greater of 3 days or 5 half-lives prior to enrolling in this study 
4. Has initiated any new medication in the past 2 weeks that, in the best medical judgment 
of the investigator, would impact their participation in the study or ability to use the 
EyeQue VisionCheck device  
5. Eye disease, including but not limited to:  
• Glaucoma (≥ 22 mmHg intraocular pressure)  
• Cataracts (≥ 1+ nuclear sclerotic cataract, ≥ 1+ cortical, posterior subcapsular cataract 
[any grade using the Lens Opacities Classification System III]) 
• Macular degeneration (retinal pigmented epithelium mottling and/or any drusen 
within 500 µm of macula) 
• Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis) 
• Keratoconus  
• Diabetic neuropathy/retinopathy (≥ mild nonproliferative diabetic retinopathy) 
• Cytomegalovirus retinitis 
• Color blindness (any color deficiency) 
• Diabetic macular edema (evidence of fluid) 
• Amblyopia  
• Chronic or acute uveitis (cells and/or flare in anterior chamber) 
• Strabismus (exotropia, esotropia, and hypertropia) 
• Abnormal astigmatism (mild to severe, > 5 diopters) 
• Macular hole 
 
 
 
 
 
 
 
 
 
 
 
 
 
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6. Eye surgery within the last 12 months (including Lasik or lens replacement) 
7. Subject does not have the physical dexterity to properly operate the EyeQue VisionCheck 
device or the EyeQue app on the smartphone in the investigator’s opinion 
Investigational device and mode of administration:  The investigational device is the EyeQue 
VisionCheck, and the intended use is to measure the refractive error of the eye.  This is a 
self-administered, portable, monocular refraction system consisting of 3 main components:  a 
mobile app, a cloud-based processing platform, and the VisionCheck optical device that attaches 
to a compatible smartphone owned/operated by the end user.  The EyeQue app guides the subject 
through interactive measurements with the EyeQue VisionCheck device in order to determine 
refractive error.   
Study duration:  The study duration for each subject will be 1 day.  All study-related 
procedures, including screening, will be completed in 1 visit. 
Reference devices and mode of administration:  The reference devices will be the phoropter 
and autorefractor.  Prior to enrollment of study subjects, both devices will be calibrated 
following standard practice. Standard device methodology for refraction tests will be used to 
obtain refraction values with each device. 
Criteria for evaluation: 
Efficacy: 
Primary Endpoint:   
• Statistical non-inferiority of EyeQue VisionCheck compared with phoropter assessed 
by BCVA (OD, OS, and OU) measured using trial lens frames that correct the 
refractive error measured by each device analyzed with age stratum 45 through 
65 years.   
Secondary Endpoints: 
• Comparison of raw refraction values produced using the EyeQue VisionCheck and 
the phoropter analyzed with age strata 30 through 65 years and 45 through 65 years. 
• Statistical non-inferiority of EyeQue VisionCheck compared with autorefractor 
assessed by BCVA (OD, OS, and OU) measured using trial lens frames that correct 
the refractive error measured by each device analyzed with age strata 30 through 
65 years and 45 through 65 years.   
• Comparison of raw refraction values produced using the EyeQue VisionCheck and 
the autorefractor analyzed with age strata 30 through 65 and 45 through 65 years. 
• Statistical non-inferiority of EyeQue VisionCheck compared with phoropter assessed 
by BCVA (OD, OS, and OU) measured using trial lens frames that correct the 
refractive error measured by each device analyzed with the age stratum 
30 through 65 years. 
Exploratory Endpoint: 
• Subject preference of trial lens frames that correct the refractive error measured by 
 
 
 
 
 
 
 
 
 
 
 
 
 
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each of the 3 devices:  EyeQue VisionCheck, phoropter, and autorefractor. 
Safety: 
If any AEs occur during the study, the safety endpoints will include the frequency and severity of 
AEs, ADEs, and serious adverse events (SAEs). 
Statistics: 
Analysis Populations  
Modified Intent to Treat Population:  All subjects that perform BCVA for trial frames with 
test lenses based on both phoropter and EyeQue VisionCheck. 
Safety Population:  All subjects that meet the screening criteria and are enrolled in the study.   
 
After enrollment in this study was initiated, a software error was identified in the EyeQue app 
used with the EyeQue VisionCheck.  The error was corrected and the algorithm for the EyeQue 
app was updated.  An initial cohort of 39 subjects was enrolled in the study prior to these 
changes being implemented.  Due to these EyeQue app updates, this initial cohort of 39 subjects 
will be excluded from the analysis populations and any safety information for these subjects will 
be listed separately.   
 
Power and Sample Size 
Approximately 200 subjects will be enrolled in this study to achieve a minimum of 
100 evaluable subjects to assess the effectiveness and safety of the EyeQue VisionCheck.  The 
initial cohort included 39 subjects; therefore, approximately 160 additional subjects will be 
enrolled in the study.  Based on prior study data, rejection of non-inferiority bounds of 0.1 
LogMAR (one line) and 0.05 LogMAR (one-half line) would require approximately 10 and 40 
subjects, respectively, with 90% power on the BCVA from the resulting lens from each 
approach.  This assumes the devices are roughly equivalent and the standard deviation (SD) is 
0.077; these data are based on a previous version of the EyeQue VisionCheck device tested 
against an autorefractor.  The proposed sample size has been inflated to allow for the possibility 
that a larger standard deviation will be observed in the current study, as well as to allow for 
comparisons within each stratum.   
When the software error in the EyeQue app was identified, the algorithm for the EyeQue app 
was updated with more stringent parameters which may also impact the number of evaluable 
subjects.  Due to the updates to the parameters, there may be additional subjects for which 
EyeQue VisionCheck refraction values are not produced, leading to an increase in the number of 
subjects that will not be evaluated for the primary endpoint.  Of the approximately 160 additional 
subjects that will be enrolled in the study, it is anticipated that approximately 60 subjects will not 
be evaluable due to failing screening or not having refraction values produced with the EyeQue 
VisionCheck.  Additionally, the larger sample size provides a sufficiently robust database for 
investigations of the secondary outcomes and descriptions of the EyeQue VisionCheck’s 
performance characteristics.  
 
Efficacy Analysis 
Best corrected visual acuity will be assessed independently for each eye and the worse value for 
 
 
 
 
 
 
 
 
 
 
 
 
 
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each test lens set and subject will be selected for the primary analysis.  Each subject’s BCVA 
LogMAR score from the phoropter-based lenses will be subtracted from the BCVA LogMAR 
score from the EyeQue VisionCheck-based lenses.  The mean, SD, and two-sided 95% 
confidence interval (CI) will be reported across all subjects for worst eye, OD, OS, and OU, and 
if the upper bound (one-sided 95% CI) does not include the value 0.1 for the worst eye 
comparison, then non-inferiority will be declared.  This will be repeated using BCVA scores 
from the autorefractor-based lenses and EyeQue VisionCheck-based lenses. 
Raw refraction values for the phoropter and EyeQue VisionCheck will be plotted and Pearson 
correlations calculated.  This will be repeated using autorefractor and EyeQue VisionCheck 
values. 
Subject preference data will be tabulated with counts and percentages of subjects that considered 
the EyeQue VisionCheck trial lenses better as well as the counts and percentages of subjects that 
considered the EyeQue VisionCheck trial lenses better or equal. 
Analyses will be repeated for each age stratum including ages 30 through 65 and ages 
45 through 65. 
 
Safety Analyses 
Adverse events, ADEs, and SAEs will be reported with counts and percentages.  Adverse events 
that can be associated with a particular device will be reported separately from those without 
clear attribution.  A subject experiencing more than 1 instance of an event will be counted only 
once for that event.  Analyses will be repeated for each age stratum including ages 30 through 65 
and ages 45 through 65.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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3. 
TABLE OF CONTENTS AND LIST OF TABLES 
TABLE OF CONTENTS 
1. 
TITLE PAGE ................................................................................................................1 
PROTOCOL APPROVAL - SPONSOR SIGNATORY .................................................................2 
INVESTIGATOR’S AGREEMENT ...............................................................................................3 
PROCEDURES IN CASE OF EMERGENCY ...............................................................................4 
2. 
SYNOPSIS ...................................................................................................................5 
3. 
TABLE OF CONTENTS AND LIST OF TABLES ..................................................12 
4. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS.............................15 
5. 
INTRODUCTION ......................................................................................................16 
6. 
STUDY OBJECTIVES ..............................................................................................17 
6.1. 
Primary Objective .......................................................................................................17 
6.2. 
Secondary Objectives .................................................................................................17 
6.3. 
Exploratory Objectives ...............................................................................................17 
6.4. 
Safety Objective ..........................................................................................................17 
7. 
INVESTIGATIONAL PLAN .....................................................................................18 
7.1. 
Overall Study Design ..................................................................................................18 
7.2. 
Number of Subjects ....................................................................................................19 
7.3. 
Study Endpoints ..........................................................................................................20 
7.3.1. 
Efficacy Endpoints ......................................................................................................20 
7.3.2. 
Safety Endpoints .........................................................................................................20 
7.4. 
Rationale for Study Design and Control Group .........................................................20 
8. 
SELECTION AND WITHDRAWAL OF SUBJECTS ..............................................22 
8.1. 
Subject Inclusion Criteria ...........................................................................................22 
8.2. 
Subject Exclusion Criteria ..........................................................................................22 
8.3. 
Subject Withdrawal Criteria .......................................................................................23 
8.4. 
Study Termination ......................................................................................................23 
9. 
TEST ARTICLE .........................................................................................................24 
9.1. 
Description ..................................................................................................................24 
9.2. 
Packaging, Labeling, and Dispensing .........................................................................24 
9.3. 
Storage and Accountability .........................................................................................24 
 
 
 
 
 
 
 
 
 
 
 
 
 
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9.4. 
Device Risk Analysis and Risk Assessment ...............................................................24 
10. 
TREATMENT OF SUBJECTS ..................................................................................26 
10.1. 
Concomitant Medications ...........................................................................................26 
10.1.1. 
Prohibited Concomitant Medications .........................................................................26 
10.1.2. 
Permitted Concomitant Medications ..........................................................................26 
10.2. 
Treatment Compliance ................................................................................................26 
10.3. 
Randomization and Masking ......................................................................................26 
10.4. 
Randomization ............................................................................................................26 
10.5. 
Masking ......................................................................................................................26 
11. 
STUDY SCHEDULE AND PROCEDURES ............................................................28 
11.1. 
Study Schedule ...........................................................................................................28 
11.2. 
Study Visits .................................................................................................................28 
11.2.1. 
Visit 1..........................................................................................................................28 
11.2.1.1. 
Screening Procedures ..................................................................................................28 
11.2.1.2. 
Testing procedures ......................................................................................................28 
11.2.1.3. 
Early Termination .......................................................................................................29 
12. 
STUDY ASSESSMENTS ..........................................................................................30 
12.1. 
Efficacy Assessments .................................................................................................30 
12.1.1. 
Best Corrected Visual Acuity .....................................................................................30 
12.1.2. 
Refraction Values .......................................................................................................30 
12.1.3. 
Subject Preference ......................................................................................................30 
12.2. 
Safety Assessments .....................................................................................................30 
12.2.1. 
Adverse Events ...........................................................................................................30 
12.2.2. 
Demographics and Medical History ...........................................................................30 
12.2.3. 
Concomitant Medications/Therapies ..........................................................................30 
12.3. 
Adverse Events ...........................................................................................................31 
12.3.1. 
Adverse Events, Adverse Device Effects, and Serious Adverse Events ....................31 
12.3.1.1. 
Definitions of Terms ...................................................................................................31 
12.4. 
Severity of Adverse Events ........................................................................................32 
12.5. 
Relationship to Test Article ........................................................................................32 
12.6. 
Recording Adverse Events .........................................................................................33 
12.7. 
Reporting SAEs and Unanticipated Adverse Device Effects .....................................33 
 
 
 
 
 
 
 
 
 
 
 
 
 
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12.8. 
Reporting SAEs and Unanticipated Adverse Device Effects to Health 
Authorities ..................................................................................................................33 
12.9. 
Medical Emergency ....................................................................................................34 
13. 
STATISTICS ..............................................................................................................35 
13.1. 
Power and Sample Size Determination ......................................................................35 
13.2. 
Analysis Populations ..................................................................................................35 
13.3. 
Efficacy Analyses .......................................................................................................35 
13.4. 
Safety Analyses ..........................................................................................................36 
13.4.1. 
Adverse Events ...........................................................................................................36 
14. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS.........................................37 
14.1. 
Study Monitoring ........................................................................................................37 
14.2. 
Audits and Inspections ................................................................................................37 
14.3. 
Institutional Review Board/Independent Ethics Committee ......................................37 
15. 
QUALITY CONTROL AND QUALITY ASSURANCE .........................................39 
16. 
ETHICS ......................................................................................................................40 
16.1. 
Ethics Review .............................................................................................................40 
16.2. 
Ethical Conduct of the Study ......................................................................................40 
16.3. 
Written Informed Consent ..........................................................................................40 
16.4. 
Authorization to Disclose Protected Health Information ...........................................40 
17. 
DATA HANDLING AND RECORDKEEPING .......................................................42 
17.1. 
Electronic Case Report Forms/Source Data Handling ...............................................42 
17.2. 
Inspection of Records .................................................................................................42 
17.3. 
Retention of Records ..................................................................................................42 
18. 
PUBLICATION POLICY ..........................................................................................43 
19. 
LIST OF REFERENCES ............................................................................................44 
20. 
APPENDICES ............................................................................................................45 
APPENDIX 1.  SCHEDULE OF ASSESSMENTS ...................................................................45 
 
LIST OF TABLES 
Table 1: 
Attribution of adverse events ......................................................................................32 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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4. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
Abbreviation 
Explanation 
AE 
adverse event 
ADE 
adverse device effect 
app 
application 
BCVA 
best corrected visual acuity 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
eCRF 
electronic case report form 
EDC 
electronic data capture 
ETDRS 
Early Treatment Diabetic Retinopathy Study 
EyeQue 
EyeQue Corporation 
GCP 
Good Clinical Practice 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
IEC 
independent ethics committee 
IRB 
institutional review board 
LogMAR 
logarithm of the minimum angle of resolution 
OD 
oculus dexter (right eye) 
OS 
oculus sinister (left eye) 
OU 
oculus uterque (both eyes) 
PHI 
protected health information 
SAE 
serious adverse event 
UADE 
unanticipated adverse device effect 
US 
United States 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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5. 
INTRODUCTION 
Uncorrected refractive errors account for more than 40% of the major causes for visual 
impairment globally (Pascolini D, 2010; World Health Organization, Blindness and vision 
impairment fact sheet).  The most common types of refractive errors include myopia, hyperopia, 
presbyopia, and astigmatism.  When an individual has an uncorrected refractive error, symptoms 
may include blurred vision, double vision, haziness, squinting, headaches, and eye strain.  
Refractive error correction is accomplished through the use of eye glasses, contacts, or refractive 
surgery.  Traditionally, refraction measurements are conducted by an eye care professional 
during a comprehensive eye exam using diagnostic devices such as a phoropter or autorefractor.  
However, not all of the population has access to optometrists/ophthalmologists and these 
diagnostic devices or can afford these exams.  Additionally, for some instances it may be more 
convenient to be able to obtain refraction values outside of the clinic.   
The EyeQue Corporation (EyeQue) is developing an inexpensive, portable, self-administered 
device to measure refraction values that can be used outside of the clinic.  The EyeQue 
VisionCheck device is a monocular refraction system consisting of 3 components:  a mobile 
application (app), a cloud-based processing platform, and the VisionCheck optical device that 
attaches to a compatible smartphone owned/operated by the end user.  The EyeQue app guides 
the subject through interactive measurements with the EyeQue VisionCheck device in order to 
determine refractive error.   
This is a single center, clinical evaluation study to evaluate the performance of the EyeQue 
VisionCheck device compared with standard eye care diagnostic devices of phoropter and 
autorefractor in measuring refractive error of the eye.  The intent of this study is to determine 
whether EyeQue VisionCheck is statistically non-inferior to the phoropter and autorefractor in 
correcting visual refractive errors.  The best corrected visual acuity (BCVA) using trial lens 
frames prepared using refraction values from each of the 3 devices, raw refraction values from 
each device, and subject satisfaction with the 3 different trial lens frames will be assessed during 
the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
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6. 
STUDY OBJECTIVES  
6.1. 
Primary Objective 
The primary objective of this study is to determine whether EyeQue VisionCheck is statistically 
non-inferior to the phoropter as assessed by BCVA for each eye independently measured using 
trial lens frames that correct the refractive error measured by each device, for the age stratum 
45 through 65 years.   
6.2. 
Secondary Objectives 
The secondary objectives include: 
• Assessing similarity of refraction values (sphere, cylinder, axis) from the EyeQue 
VisionCheck compared with the phoropter through comparative plots and Pearson 
correlations 
• Determining whether EyeQue VisionCheck is statistically non-inferior to the 
autorefractor as assessed by BCVA measured using trial lens frames that correct the 
refractive error measured by each device 
• Assessing similarity of refraction values (sphere, cylinder, axis) from the EyeQue 
VisionCheck compared with the autorefractor through comparative plots and Pearson 
correlations 
• Determining whether EyeQue VisionCheck is statistically non-inferior to the 
phoropter as assessed by BCVA measured using trial lens frames that correct the 
refractive error measured by each device, for the age stratum 30 through 65 years.  
6.3. 
Exploratory Objectives 
The exploratory objective of this study is to assess subject preference among the 3 trial lens 
frames that correct the refractive error measured by the EyeQue VisionCheck, phoropter, and 
autorefractor. 
6.4. 
Safety Objective 
The safety objective of this study is to evaluate the safety of EyeQue VisionCheck compared 
with the phoropter and the autorefractor. 
 
 
 
 
 
 
 
 
 
 
 
 
 
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7. 
INVESTIGATIONAL PLAN 
7.1. 
Overall Study Design 
This is a single-center, open-label, prospective study in healthy volunteers desiring refraction for 
correction of visual acuity to compare the EyeQue VisionCheck with the phoropter and 
autorefractor.  Prior to enrollment of study subjects, both the phoropter and autorefractor devices 
will be calibrated following standard practice. 
Approximately 200 subjects will be enrolled in this study to achieve a minimum of 
100 evaluable subjects.  The initial cohort included 39 subjects; therefore, approximately 
160 additional subjects will be enrolled in the study.  Subjects will be enrolled to obtain a 
population of approximately 35% in the age range of 30 through 44 years and approximately 
65% in the age range of 45 through 65 years.  Subjects will be screened for study participation 
and, if enrolled, will complete the testing procedures at the same visit.  Subjects will not undergo 
any study-specific screening or testing procedures until written informed consent is obtained.  A 
subject will be enrolled in the study after confirming that the subject has met all of the inclusion 
criteria and none of the exclusion criteria. 
Screening procedures   
The subject will complete the following assessments and procedures at Screening to confirm 
eligibility:   
• demographics/medical history/concomitant medication review,  
• slit-lamp biomicroscopy,  
• laser retinal scan or fundoscopy,  
• optical coherence tomography (OCT) (retina and anterior chamber), 
• tonometry (non contact), 
• Ishihara color test,  
• cover test,  
• retinoscopy, 
• phoropter refraction, and  
• visual acuity with phoropter correction.   
During the OCT and laser retinal scan/fundoscopy, images will be taken of the retina, anterior 
chamber, and fundus.  All eye procedures will be completed without dilation using standard 
procedures.     
Retinoscopy will be used as a basis for further refinement by phoropter refraction.  Refraction 
values (sphere, cylinder, axis) for oculus dexter (OD, right eye) and oculus sinister (OS, left eye) 
will be recorded for each subject using the phoropter.  These values will be used to adjust the 
lenses in the phoropter while the subject is looking through the device at an Early Treatment 
Diabetic Retinopathy Study (ETDRS) eye chart to determine BCVA, as subjects are eligible to 
 
 
 
 
 
 
 
 
 
 
 
 
 
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participate in the study only if their vision (oculus uterque [OU]; both eyes) can be corrected to 
20/20 (logarithm of the minimum angle of resolution [LogMAR] 0.0).     
The Screening procedures will be used to confirm that the subject does not have an exclusionary 
diagnosis. 
Testing procedures   
Once eligibility is confirmed, the subject will be enrolled and proceed with study testing 
procedures.  The refraction values (sphere, cylinder, axis) for each subject (OD and OS) will be 
assessed using 2 additional devices: autorefractor and the EyeQue VisionCheck.  Subjects will be 
assessed with the autorefractor using standard device methodology.  The refraction values 
generated from the EyeQue VisionCheck, the autorefractor, and the phoropter (during screening) 
will be used to prepare 3 sets of trial lens frames.  Pupillary distance, measured using the 
autorefractor, will be recorded for all subjects and will be used for preparation of trial lens 
frames.     
All subjects will be trained on how to use the EyeQue VisionCheck device prior to initiating 
testing.  In order to obtain refraction values using the EyeQue VisionCheck, the subject will be 
required to take 1 practice test followed by a minimum of 3 saved tests for each eye using the 
EyeQue VisionCheck device and mobile app.  After completion of a set of tests (1 test for each 
eye), the subject may elect to save or discard that set of tests.  They may choose to discard for 
any reason which may include not following instruction, pressing the wrong button in error, etc.  
Each test consists of the subject looking through the EyeQue VisionCheck device and using the 
app controls to fully overlap red and green bars at 9 different angles.  After completion of all 
tests (1 practice test and 3 saved tests with each eye), the refraction values will be displayed on 
the mobile app.  These values will be used for preparation of the trial lens frames.  If the EyeQue 
system determines that the overall test results are unreliable, subjects may have to complete 3 
additional tests per eye before the system may be able to provide refraction values.  Subjects will 
not be allowed to complete more than 6 saved tests and 1 practice with each eye.  The system 
evaluates the statistical spread of the test results taken by the subject.  If the spread is too large, 
the results are considered to be unreliable and values will not be provided.  Such spread can be 
due to testing error, improper instruction, etc. 
After collection of refraction values from each device (phoropter, autorefractor, and EyeQue 
VisionCheck), the 3 trial lens frames will be prepared and given to the subject in a masked 
fashion.  Best corrected visual acuity will be assessed using the ETDRS eye chart.  For each 
subject, BCVA LogMAR scores will be collected for OD, OS, and OU) for each of the 3 trial 
lens frames.  Subjects will also be asked a question regarding overall satisfaction with visual 
acuity using each of the 3 trial lens frames.  Subjects will be monitored for adverse events (AEs) 
and adverse device effects (ADEs) during the study.    
Appendix 1 presents the schedule of assessments for the study.  Section 11 details the study 
evaluations for screening and testing at the 1 study visit.   
7.2. 
Number of Subjects 
Approximately 200 subjects will be enrolled in this study to achieve a minimum of 
100 evaluable subjects.  The initial cohort included 39 subjects; therefore, approximately 
 
 
 
 
 
 
 
 
 
 
 
 
 
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160 additional subjects will be enrolled in the study.  Subjects will be enrolled to obtain a 
population of approximately 35% in the age range of 30 through 44 years and approximately 
65% in the age range of 45 through 65 years. 
7.3. 
Study Endpoints 
7.3.1. 
Efficacy Endpoints 
Primary Endpoint:   
• Statistical non-inferiority of EyeQue VisionCheck compared with phoropter assessed 
by BCVA (OD, OS, and OU) measured using trial lens frames that correct the 
refractive error measured by each device analyzed with age stratum 45 through 
65 years. 
Secondary Endpoints: 
• Comparison of raw refraction values produced using the EyeQue VisionCheck and 
the phoropter analyzed with age strata 30 through 65 years and 45 through 65 years. 
• Statistical non-inferiority of EyeQue VisionCheck compared with autorefractor 
assessed by BCVA (OD, OS, and OU) measured using trial lens frames that correct 
the refractive error measured by each device, analyzed with age strata 30 through 
65 years and 45 through 65 years.   
• Comparison of raw refraction values produced using the EyeQue VisionCheck and 
the autorefractor analyzed with age strata 30 through 65 and 45 through 65 years. 
• Statistical non-inferiority of EyeQue VisionCheck compared with phoropter assessed 
by BCVA (OD, OS, and OU) measured using trial lens frames that correct the 
refractive error measured by each device analyzed with the age 
stratum 30 through 65 years.   
Exploratory Endpoint: 
• Subject preference of trial lens frames that correct the refractive error measured by 
each of the 3 devices:  EyeQue VisionCheck, phoropter, and autorefractor 
7.3.2. 
Safety Endpoints 
If any adverse events occur during the study, the safety endpoints will include the frequency and 
severity of AEs, ADEs, and serious adverse events (SAEs). 
7.4. 
Rationale for Study Design and Control Group 
A clinical study based on statistical non-inferiority is the most appropriate means to assess the 
effectiveness and performance of the EyeQue VisionCheck device relative to the comparator 
devices, the phoropter and autorefractor, that are standard eye care diagnostic devices used to 
obtain refraction values.   
Masking of the subjects and assessors to the refraction values used to prepare the 3 trial lens 
frames is appropriate to control and minimize bias in the assessment of BCVA as these LogMAR 
 
 
 
 
 
 
 
 
 
 
 
 
 
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scores will be used for determination of statistical non-inferiority.  A statistical non-inferiority 
margin of 0.1 LogMAR has been chosen because the one-line ETDRS difference is an 
acceptable boundary for corrected visual acuity, with larger differences likely to be unacceptable 
to patients and smaller differences difficult to reliably detect and/or reproduce.   
Based on the intended use for obtaining refraction values, a one-day evaluation is appropriate 
because standard-of-care eye exams in which refraction values are obtained are typically 
repeated on a periodic basis, such as yearly, and it is not anticipated that refraction values would 
change over a short duration where additional repeated measurements would be necessary for 
this study.  Visual acuity may fluctuate often; however, there is no appreciable change over a 
period of a several months.   
The design allows for enrollment of subjects 30 to 65 years because subjects younger than 
30 years of age are more likely to have visual accommodation that would add complexity to this 
comparative study.  Younger subjects may be assessed in a separate clinical study.   
 
 
 
 
 
 
 
 
 
 
 
 
 
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8. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
8.1. 
Subject Inclusion Criteria 
Subjects must meet all of the following inclusion criteria to be enrolled in the clinical study: 
1. Male or female 
2. Age 30 through 65 years at time of consent 
3. Binocular vision 
4. Subject desires refraction for correction of visual acuity and vision (OU) can be corrected 
to 20/20 (LogMAR 0.0) 
5. Willing and able to give informed consent and follow all study procedures and 
requirements  
6. Ability to speak and understand the English language 
8.2. 
Subject Exclusion Criteria 
The presence of any of the following exclusion criteria excludes a subject from study enrollment: 
1. Spherical correction > +8 or < -10 
2. Using anticholinergic medications (including first-generation antihistamines) or other 
medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior 
to enrolling in this study 
3. Using an investigational drug or approved therapy for investigational use within the 
greater of 3 days or 5 half-lives prior to enrolling in this study 
4. Has initiated any new medication in the past 2 weeks that, in the best medical judgment 
of the investigator, would impact their participation in the study or ability to use the 
EyeQue VisionCheck device  
5. Eye disease, including but not limited to:  
• Glaucoma (≥ 22 mmHg intraocular pressure)  
• Cataracts (≥ 1+ nuclear sclerotic cataract, ≥ 1+ cortical, posterior subcapsular cataract 
[any grade using the Lens Opacities Classification System III]) 
• Macular degeneration (retinal pigmented epithelium mottling and/or any drusen 
within 500 µm of macula) 
• Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis) 
• Keratoconus  
• Diabetic neuropathy/retinopathy (≥ mild nonproliferative diabetic retinopathy) 
• Cytomegalovirus retinitis 
• Color blindness (any color deficiency) 
 
 
 
 
 
 
 
 
 
 
 
 
 
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• Diabetic macular edema (evidence of fluid) 
• Amblyopia 
• Chronic or acute uveitis (cells and/or flare in anterior chamber) 
• Strabismus (exotropia, esotropia, and hypertropia) 
• Abnormal astigmatism (mild to severe, > 5 diopters) 
• Macular hole 
6. Eye surgery within the last 12 months (including Lasik or lens replacement) 
7. Subject does not have the physical dexterity to properly operate the EyeQue VisionCheck 
device or the EyeQue app on the smartphone in the investigator’s opinion 
8.3. 
Subject Withdrawal Criteria 
Subjects may be withdrawn from treatment or assessment for the occurrence of an adverse effect 
or any other conditions that may create a safety risk.  Subjects may also be withdrawn at the 
discretion of the investigator.   
Subjects can withdraw consent at any time for any reason without effect on subsequent care.  
Any enrolled subjects desiring to discontinue prior to study completion should be encouraged to 
discuss his or her reasons and concerns with the investigator.  A subject who discontinues during 
the study visit prior to completion of all study procedures may be replaced.  
8.4. 
Study Termination 
If the study is suspended or prematurely terminated, the appropriate institutional review board 
(IRB)/independent ethics committee (IEC) and regulatory authority(ies) will be promptly 
informed of the termination/suspension and will be provided the reason(s) for the 
termination/suspension.  All obligations and responsibilities of the sponsor and the investigator 
under the United States (US) Code of Federal Regulations (CFR) will remain in force if the study 
is terminated prematurely. 
This study may be discontinued at any time if, in the opinion of the investigator, in consultation 
with the medical monitor and EyeQue, continuation of the study represents a significant medical 
risk to participating subjects.  All unanticipated ADEs, will be examined to determine whether 
the ADE presents an unreasonable risk to subjects.  If deemed an unreasonable risk, the study 
will be terminated or suspended. 
 
 
 
 
 
 
 
 
 
 
 
 
 
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9. 
TEST ARTICLE 
9.1. 
Description 
The investigational device is the EyeQue VisionCheck, and the intended use is to measure the 
refractive error of the eye.  The EyeQue VisionCheck is a self-administered, portable, monocular 
refraction system consisting of 3 main components:  a mobile app, a cloud-based processing 
platform, and the VisionCheck optical device that attaches to a compatible smartphone 
owned/operated by the end user.  The EyeQue app guides the subject through interactive 
measurements with the EyeQue VisionCheck device in order to determine refractive error.  The 
device and mobile app operate on the inverse Shack-Hartmann principle described in patent US 
8783871 B2, “Near Eye Tool for Refraction Assessment” (Pamplona V, US Patent, 2014). 
The EyeQue VisionCheck device is manufactured for EyeQue Corporation.   
9.2. 
Packaging, Labeling, and Dispensing 
All material containers will be appropriately labeled with the study number and product 
identification as applicable, as well as any other information as required by applicable 
regulations.   
The compatible smartphones and access to the app will be provided to the sites to be used with 
the EyeQue VisionCheck.   
9.3. 
Storage and Accountability 
All test articles will be stored in a secure location at the investigational site.   
A log of all test articles received and used during the study will be maintained by the study site.  
All test articles will be accounted for at the termination of the study and a written explanation 
provided for any discrepancies.  The EyeQue VisionCheck devices and smartphones will be 
returned to EyeQue.  Shipping and handling of all test articles will conform to regulations for 
investigational devices.     
9.4. 
Device Risk Analysis and Risk Assessment 
The device risk analysis and risk assessment were conducted in compliance with 21 CFR 820.  
Based on this assessment, the EyeQue VisionCheck is non-invasive and considered a low-risk 
device that requires periorbital surface contact.  Even if the EyeQue VisionCheck is misused, the 
likelihood it will cause harm is low.  The comparators in this study, phoropter and autorefractor, 
are used as part of standard eye exams.  Most of the anticipated adverse effects are generally well 
tolerated and would be expected to occur infrequently.  The risk and impact of these adverse 
effects is low. 
Based on the design and the intended use of the EyeQue VisionCheck, and given the low risk of 
potential adverse effects, this is considered a nonsignificant risk medical device study that is 
subject to abbreviated investigational device exemption (IDE) regulations, and exempt from the 
requirement to submit an IDE application. 
 
 
 
 
 
 
 
 
 
 
 
 
 
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The following adverse effects may potentially occur with the use of the EyeQue VisionCheck 
device itself, the comparators, or the procedure used for the device: 
• Transient blurred vision 
• Transient dizziness 
• Headache 
• Transient eye irritation  
• Superficial eye or periorbital infection 
The following approaches have been used to minimize risk in this investigation:    
• Subjects will be screened before receiving treatment to ensure they meet the 
protocol-defined inclusion and exclusion criteria.  The inclusion and exclusion 
criteria have been developed to ensure appropriate subjects are included in the studied 
population and subjects with confounding conditions or conditions that could put 
them at risk are excluded from participation. 
• The test articles (investigational and comparator devices) are intended for measuring 
refraction values and/or accessing BCVA.  To minimize risk during the evaluations, 
the site staff will be trained on all devices and subjects will be instructed how to use 
each device.  The phoropter and autorefractor are both operated by the site staff.  The 
EyeQue VisionCheck device will be operated by the subject and subjects will be 
trained in advance of completing testing with the device.  The mobile app provides 
detailed instructions on how to operate the EyeQue VisionCheck device.  Detailed 
instructions for the site staff to provide to subjects about the EyeQue VisionCheck are 
provided in the study operations manual. 
• To minimize the risk of eye irritation or infection, the devices will be sanitized 
between users. 
• Adverse device effects will be monitored throughout the study by site staff.   
If an adverse event occurs, site staff will follow medical procedures appropriate to the type of 
event.  
 
 
 
 
 
 
 
 
 
 
 
 
 
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10. 
TREATMENT OF SUBJECTS 
10.1. 
Concomitant Medications 
Any treatment including all prescription drugs, herbal products, vitamins, minerals, and 
over-the-counter medications or therapies administered from the time of consent through the end 
of study participation is considered a concomitant medication.  Concomitant medication use will 
be recorded in the subject source documentation and may include the medication name, dose, 
frequency, route of administration, and the dates of administration. 
10.1.1. 
Prohibited Concomitant Medications 
The following concomitant medications and therapies are prohibited for the duration of the study 
and cannot be used within the greater of 3 days or 5 half-lives prior to enrolling in this study, 
unless otherwise specified: 
• Anticholinergic medications (including first-generation antihistamines) 
• Medications known to affect visual acuity 
• Investigational drugs or approved therapies for investigational use 
10.1.2. 
Permitted Concomitant Medications 
Other than the prohibited medications and therapies listed in Section 10.1.1, treatment with 
concomitant medications and therapies is permitted during the study.  Concomitant medication 
deemed necessary for the welfare of the subject during the study may be given at the discretion 
of the investigator.   
10.2. 
Treatment Compliance 
The investigational device will be used on site with the assistance of a study staff member during 
the study visit and thus is an observed compliance.  The number and percentage of subjects not 
completing assessments on each device will be reported. 
10.3. 
Randomization and Masking 
10.4. 
Randomization 
Not applicable to this clinical study.   
10.5. 
Masking 
This is an open-label study and the site and subjects will not be masked to the assessment device.  
Three sets of trial lens frames will be prepared using the refraction values from the 3 devices, 
including the EyeQue VisionCheck, phoropter, and autorefractor.  During the study, the subjects 
and site personnel performing the BCVA assessments will be masked to the refraction values 
that are used to prepare each of the trial lens frames.  Masking regarding the trial lens frames will 
 
 
 
 
 
 
 
 
 
 
 
 
 
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be maintained throughout the study by use of separate site personnel to prepare the frames and 
perform the BCVA assessment.   
If the site personnel performing the BCVA assessments or a subject is unmasked, the subject 
must be discontinued from the study.  Additionally, the sponsor and or designee must be notified. 
 
 
 
 
 
 
 
 
 
 
 
 
 
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11. 
STUDY SCHEDULE AND PROCEDURES 
11.1. 
Study Schedule 
The study schedule can be found in Appendix 1.  Detailed information on study assessments is 
provided in Section 12.  
11.2. 
Study Visits 
11.2.1. 
Visit 1 
All study-related procedures, including screening, will be completed in 1 visit.   
11.2.1.1. Screening Procedures 
The subject will complete the following assessments and procedures at Screening:   
• Informed consent 
• Demographics/medical history/concomitant medication review 
• Slit-lamp biomicroscopy  
• Laser retinal scan or fundoscopy; images will be taken during this procedure 
• Optical coherence tomography; images will be taken during this procedure 
• Tonometry (non contact) 
• Ishihara color test 
• Cover test  
• Retinoscopy; results will be used as a basis for further refinement by phoropter 
refraction 
• Refraction values (sphere, cylinder, axis) for OD and OS using the phoropter 
• Best corrected visual acuity (LogMAR scores for OD, OS, and OU) assessed using 
the phoropter refraction values and ETDRS eye chart; subjects are eligible to 
participate in the study only if their vision can be corrected to 20/20 (LogMAR 0.0)   
All eye procedures will be completed without dilation using standard procedures.  
11.2.1.2. Testing procedures   
Once eligibility is confirmed, the subject will be enrolled and proceed with study testing 
procedures.  
The following testing procedures and assessments will be completed: 
• Refraction values (sphere, cylinder, axis) for OD and OS using the autorefractor 
• Measurement of pupillary distance using the autorefractor; pupillary distance will be 
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• Refraction values (sphere, cylinder, axis) for OD and OS using the EyeQue 
VisionCheck; all subjects will be trained on how to use the EyeQue VisionCheck 
device prior to initiating testing 
In order to obtain refraction values using the EyeQue VisionCheck, the subject will be required 
to take 1 practice test followed by a minimum of 3 saved tests for each eye using the EyeQue 
VisionCheck device and mobile app. After completion of a set of tests (1 test for each eye), the 
subject may elect to save or discard that set of tests.  They may choose to discard for any reason 
which may include not following instruction, pressing the wrong button in error, etc.  Each test 
consists of the subject looking through the VisionCheck device and using the app controls to 
fully overlap red and green bars at 9 different angles.  After completion of all tests (1 practice 
test and 3 saved tests with each eye), the refraction values will be displayed on the mobile app.  
If the EyeQue system determines that the overall test results are unreliable, subjects may have to 
complete 3 additional tests per eye before the system may be able to provide refraction values.  
Subjects will not be allowed to complete more than 6 saved tests and 1 practice test with each 
eye.  If the EyeQue system determines that the overall test results are unreliable, no values will 
be provided. 
• Best corrected visual acuity (LogMAR scores for OD, OS, and OU) assessed using 
the ETDRS eyechart and trial lens frames produced from: 
− Phoropter refraction values 
− Autorefractor refraction values 
− EyeQue VisionCheck refraction values 
*Subject and assessor will be masked to the refraction values used to produce the 
trial lens frames 
• Subject preference regarding each of the trial lens frames  
• Adverse event recording 
11.2.1.3. Early Termination 
Unless otherwise indicated, subjects will be discontinued from the study if any of the following 
events occur: 
• The subject wants to withdraw from the study.  
• The subject is non-compliant with the study protocol 
• The subject has no refraction values produced with the EyeQue VisionCheck device 
• At the investigator’s discretion, continued testing is medically contraindicated. 
The reason(s) for premature discontinuation from the study will be recorded.   
 
 
 
 
 
 
 
 
 
 
 
 
 
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12. 
STUDY ASSESSMENTS 
12.1. 
Efficacy Assessments 
Results from all efficacy assessments will be recorded on the appropriate eCRF pages.   
12.1.1. 
Best Corrected Visual Acuity 
Best corrected visual acuity will be measured using trial lens frames prepared based on the 
refractive error measured by each device including the EyeQue VisionCheck, phoropter, and 
autorefractor.  Best corrected visual acuity will be assessed using the ETDRS eye chart.  For 
each subject, BCVA logMAR scores will be collected for OD, OS, and OU for each of the 3 trial 
lens frames.   
12.1.2. 
Refraction Values 
Refraction values (sphere, cylinder, axis) for OD and OS will be recorded for each subject using 
the EyeQue VisionCheck, phoropter, and autorefractor.  The refraction values will be used to 
prepare 3 sets of trial lens frames.    
12.1.3. 
Subject Preference 
Subjects will be asked which of the 3 trial lens frames affords them the best overall visual acuity.  
Subjects will be asked to order the trial lens frames by which frame(s) provides the best vision.  
A tie is permitted when a subject feels 2 or more frames afford indistinguishable differences in 
visual acuity.   
12.2. 
Safety Assessments 
All subjects who enter the study will be assessed for safety.  Safety will be monitored by 
observation of and direct inquiry regarding AEs during the study visit. 
12.2.1. 
Adverse Events 
All AEs, ADEs, and SAEs will be collected from the start of informed consent through the end 
of the study visit.  Details regarding AE definitions, collection, recording, and reporting are 
found in Section 12.3. 
12.2.2. 
Demographics and Medical History 
Demographic information relating to the subject’s sex, age, race, ethnicity, and medical history 
will be collected during the Screening procedures and recorded on the appropriate eCRF page. 
12.2.3. 
Concomitant Medications/Therapies 
All concomitant medications/therapies will be recorded in the subject source documentation.  
The prohibited and/or allowed concomitant medications/therapies for the study are discussed in 
Section 10.1. 
 
 
 
 
 
 
 
 
 
 
 
 
 
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12.3. 
Adverse Events 
12.3.1. 
Adverse Events, Adverse Device Effects, and Serious Adverse Events 
Adverse events will be recorded throughout the study and will be coded using the Medical 
Dictionary for Regulatory Activities (MedDRA).  
The investigator is responsible for the detection and documentation of AEs and ADEs.  For all 
AEs/ADEs, the investigator must pursue and obtain information adequate to determine the 
outcome of the AE and to assess whether the AE meets the criteria for classification as an SAE 
requiring immediate notification to the sponsor or its designated representative. 
12.3.1.1. Definitions of Terms 
12.3.1.1.1. Adverse Events  
Any undesirable clinical occurrences observed in subjects during an investigational clinical 
study.  In addition to novel events, an AE may be an exacerbation of a pre-existing medical 
condition that was present before the subject was assigned to a treatment group.   
12.3.1.1.2. Serious Adverse Event  
Adverse events considered serious are those that result in one or more of the following  
• Death 
• Immediately life-threatening  
NOTE:  The term “life-threatening” refers to an event in which the subject was at 
immediate risk of death at the time of the event.  It does not refer to an event that 
hypothetically might have caused death if it were more severe.  
• Result in hospitalization or prolongation of an existing hospitalization 
• Persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions. 
• Results in a congenital anomaly/birth defect 
• Important medical events that are not fatal, life-threatening, or require hospitalization 
may be considered serious when, based upon appropriate medical judgment, they may 
jeopardize the subject and may require medical intervention to prevent one of the 
outcomes listed in this definition.  
Non-serious adverse events are all other adverse events not deemed serious. 
12.3.1.1.3. Adverse Device Effect 
An adverse device effect is an AE that is suspected to be related to the device.  Adverse device 
effects can be either anticipated, which means that they have been previously identified in this 
protocol or the investigator’s brochure, or unanticipated.  
 
 
 
 
 
 
 
 
 
 
 
 
 
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12.3.1.1.4. Unanticipated Adverse Device Effect 
An unanticipated ADE (UADE) is any serious adverse effect on health or safety, 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 in the application; 
or any other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects.  
12.4. 
Severity of Adverse Events 
The study site will grade the clinical severity of AEs experienced by study participants as either: 
• Mild:  Causes no limitation of usual activities  
• Moderate:  Causes some limitation of usual activities  
• Severe:  Prevents or severely limits usual activities 
It is important to distinguish between serious and severe AEs.  Severity is a measure of intensity 
whereas seriousness is defined by the regulatory criteria in Section 12.3.1.1.2. 
12.5. 
Relationship to Test Article 
An investigator’s causality assessment is the determination of whether there exists a reasonable 
possibility that the investigational device caused or contributed to an AE and must be provided 
for all AEs (serious and non-serious).  
The sponsor’s determination of attribution will be used for reporting to the appropriate health 
authorities.  The relation of an AE to study participation will be determined using the descriptors 
and definitions provided in Table 1. 
Table 1: 
Attribution of adverse events 
Not Related 
The AE is clearly/most probably caused by other etiologies such as participant’s 
underlying condition, therapeutic intervention or concomitant therapy, or the 
delay between administration and the onset of the AE is incompatible with a 
causal relation, or the AE started before administration (screening phase).  
Therefore, there is not a reasonable possibility that the AE was caused by the 
investigational device. 
Related 
There is a reasonable possibility that the AE was caused by the investigational 
device.  The expression “reasonable possibility” is meant to convey in general 
that there are facts (evidence) or arguments to suggest a causal relationship.   
The investigator should decide whether, in his or her medical judgment, there is a reasonable 
possibility that the event may have been caused by the investigational device.  Any AE that is 
suspected to be related to the EyeQue VisionCheck, phoropter, or the autorefractor will be 
classified as an ADE.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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12.6. 
Recording Adverse Events 
All AEs, regardless of relatedness to the use of the test article, are to be recorded on the 
appropriate AE page (either serious or non-serious) in the eCRF throughout the study.  All 
adverse effects during the study will be documented in the subject's medical record.  This 
information will then be transcribed on the AE page of the eCRF by designated study personnel.  
Required information includes a description of the event, date of onset, date of resolution, the 
action taken to manage the AE, the subsequent outcome, and severity. 
Adverse events resulting from concurrent illnesses, reactions to concurrent medications, or 
progression of disease states must also be reported. 
All AEs/ADEs must be followed to adequate resolution or stabilization.  If the AE/ADE has not 
resolved or stabilized by the time the subject completes the single study visit, the investigator 
will follow the status of the subject's AE/ADE for at least 7 days beyond the subject's final study 
visit, unless directed otherwise by the sponsor. 
12.7. 
Reporting SAEs and Unanticipated Adverse Device Effects 
For reporting of SAEs and UADEs, the following process ensures compliance with 21 CFR 812 
and International Conference on Harmonisation (ICH) guidelines.  Investigators and other study 
center staff must inform Rho Product Safety representatives of any SAE/UADE that occurs 
(whether or not attributable to the study drug) in the study within 24 hours of when he or she 
becomes aware of the SAE/UADE.  It is the investigator’s responsibility to ensure that 
SAE/UADE reporting procedures are followed appropriately.  In addition, the investigator must 
ensure that these events are entered on the SAE/UADE eCRF via Rave electronic data capture 
(EDC) or via paper form, if Rave EDC is unavailable.  The form will be entered into EDC or 
faxed to the Rho Product Safety personnel within 24 hours.  The following variables will be 
recorded for each AE:  verbatim/AE description, time and date for AE start and stop, maximum 
intensity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, 
and the outcome. 
Medical Monitor and Emergency Contact Information: 
Rho, Inc. Medical Monitor 
Email:  MedicalMonitorSupport@rhoworld.com  
Serious Adverse Event Reporting Contact Information: 
Rho, Inc. Safety Group Email:  rho_productsafety@rhoworld.com  
Serious Adverse Event Help Line:  1-888-746-7231 
Serious Adverse Event Fax Line:  1-888-746-3293 
The investigator is responsible for informing the IRB of SAEs and UADEs as per local 
requirements, as well as according to applicable regulations.   
12.8. 
Reporting SAEs and Unanticipated Adverse Device Effects to Health 
Authorities  
The sponsor will forward all reportable SAEs/UADEs to the appropriate regulatory authorities 
and participating investigators according to 21 CFR 812 and any other applicable regulations. 
 
 
 
 
 
 
 
 
 
 
 
 
 
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12.9. 
Medical Emergency 
In a medical emergency requiring immediate attention, study center staff will apply appropriate 
medical intervention, according to standards of care.  
An investigator shall notify the Medical Monitor and the reviewing IRB of any deviation from 
the investigational plan to protect the life or physical well-being of a subject in an emergency.  
Such notice shall be given as soon as possible, but in no event later than 1 business day after the 
emergency occurred.  Except in such an emergency, prior approval by the sponsor is required for 
changes in or deviations from a plan.  All deviations must be documented. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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13. 
STATISTICS 
13.1. 
Power and Sample Size Determination 
Approximately 200 subjects will be enrolled in this study to achieve a minimum of 
100 evaluable subjects to assess the effectiveness and safety of the EyeQue VisionCheck.  The 
initial cohort included 39 subjects; therefore, approximately 160 additional subjects will be 
enrolled in the study.  Based on prior study data, rejection of non-inferiority bounds of 0.1 
LogMAR (one line) and 0.05 LogMAR (one-half line) would require approximately 10 and 40 
subjects, respectively, with 90% power on the BCVA from the resulting lens from each 
approach.  This assumes the devices are roughly equivalent and the standard deviation (SD) is 
0.077; these data are based on a previous version of the EyeQue VisionCheck device tested 
against an autorefractor.  The proposed sample size has been inflated to allow for the possibility 
that a larger standard deviation will be observed in the current study, as well as to allow for 
comparisons within each stratum.  A software error in the EyeQue app was identified and the 
algorithm for the EyeQue app was updated with more stringent parameters which may also 
impact the number of evaluable subjects.  Due to the updates to the parameters, there may be 
additional subjects for which EyeQue VisionCheck refraction values are not produced, leading to 
an increase in the number of subjects that will not be evaluated for the primary endpoint.  Of the 
approximately 160 additional subjects that will be enrolled in the study, it is anticipated that 
approximately 60 subjects will not be evaluable due to failing screening or not having refraction 
values produced with the EyeQue VisionCheck.  Additionally, the larger sample size provides a 
sufficiently robust database for investigations of the secondary outcomes and descriptions of the 
EyeQue VisionCheck’s performance characteristics. 
13.2. 
Analysis Populations 
Two analysis populations are defined for this study.  
Modified Intent to Treat Population:  All subjects that perform BCVA for trial frames with 
test lenses based on both phoropter and EyeQue VisionCheck. 
Safety Population:  All subjects that meet the screening criteria and are enrolled in the study.   
 
After enrollment in this study was initiated, a software error was identified in the EyeQue app 
used with the EyeQue VisionCheck.  The software error was corrected and the algorithm for the 
EyeQue app was updated.  An initial cohort of 39 subjects was enrolled in the study prior to 
these changes being implemented.  Due to these EyeQue app updates, this initial cohort of 
39 subjects will be excluded from the analysis populations and any safety information for these 
subjects will be listed separately.   
 
13.3. 
Efficacy Analyses 
Best corrected visual acuity will be assessed independently for each eye and the worse value for 
each test lens set and subject will be selected for the primary analysis.  Each subject’s BCVA 
LogMAR score from the phoropter-based lenses will be subtracted from the BCVA LogMAR 
 
 
 
 
 
 
 
 
 
 
 
 
 
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score from the EyeQue VisionCheck-based lenses.  The mean, SD, and two-sided 95% 
confidence interval (CI) will be reported across all subjects for worst eye, OD, OS, and OU, and 
if the upper bound (one sided 95% CI) does not include the value 0.1 for the worst eye 
comparison, then non-inferiority will be declared.  This will be repeated using BCVA scores 
from the autorefractor-based lenses and EyeQue VisionCheck-based lenses. 
Raw refraction values for the phoropter and VisionCheck will be plotted and Pearson 
correlations calculated.  This will be repeated using autorefractor and EyeQue VisionCheck 
values. 
Subject preference data will be tabulated with counts and percentages of subjects that considered 
the EyeQue VisionCheck trial lenses better as well as the counts and percentages of subjects that 
considered the EyeQue VisionCheck trial lenses better or equal. 
Analyses will be repeated for each age stratum including ages 30 through 65 and ages 
45 through 65. 
13.4. 
Safety Analyses 
13.4.1. 
Adverse Events 
Adverse events, ADEs, UADEs, and SAEs will be reported with counts and percentages.  
Adverse events that can be associated with a particular device will be reported separately from 
those without clear attribution.  Adverse events will be coded using MedDRA terminology.  A 
subject experiencing more than 1 instance of an event will be counted only once for that event.  
Analyses will be repeated for each age stratum including ages 30 through 65 and ages 45 through 
65.  Unanticipated ADEs will be flagged in the by-subject listings of all AEs.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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14. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
The investigator/institution shall provide direct access to source data/documents for study-related 
monitoring, audits, IRB review, and regulatory inspection.  
14.1. 
Study Monitoring 
According to ICH Good Clinical Practice (GCP) guidelines, the sponsor of the study is 
responsible for ensuring the proper conduct of the study with regard to protocol adherence and 
validity of data recorded on the eCRFs.  The sponsor or its designee is responsible for assigning 
the study monitor(s) to this study.  
The investigator shall permit the study monitor to review study data as frequently as deemed 
necessary to ensure that data are being recorded in an adequate manner and that protocol 
adherence is satisfactory. 
The investigator shall access medical records for the study monitor so that entries in the eCRFs 
may be verified.  The investigator, as part of his/her responsibilities, is expected to cooperate 
with the sponsor or designee in ensuring that the study adheres to GCP requirements. 
The investigator may not recruit subjects into the study until such time that a site visit has been 
made by an EyeQue or designee monitor to conduct a detailed review of the protocol and eCRF 
and study instructions. 
14.2. 
Audits and Inspections 
Authorized representatives of EyeQue, a regulatory authority, an IRB or an IEC may visit the 
site to perform audits or inspections, including source data verification.  The purpose of an 
EyeQue audit or inspection is to systematically and independently examine all study-related 
activities and documents to determine whether these activities were conducted, and data were 
recorded, analyzed, and accurately reported according to the protocol, ICH GCP guidelines, and 
any applicable regulatory requirements.  The investigator should contact EyeQue immediately if 
contacted by a regulatory agency about an inspection. 
14.3. 
Institutional Review Board/Independent Ethics Committee 
Prior to the start of the study, the investigator is responsible for ensuring that the protocol and 
informed consent form (ICF) have been reviewed and approved by a relevant IRB/IEC.  The 
IRB/IEC shall be appropriately constituted and perform its functions in accordance with FDA, 
ICH GCP, and local requirements as applicable.  
The IRB shall approve all protocol amendments (except for logistical or administrative changes), 
written ICFs and documents updates, subject recruitment procedures (e.g. advertisements), 
written information to be provided to the subjects, available safety information, information 
about payment and compensation available to subjects, the investigator’s curriculum vitae and/or 
other evidence of qualifications and any other documents requested by the IRB and regulatory 
authority (competent authority) as applicable.   
 
 
 
 
 
 
 
 
 
 
 
 
 
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When required, the IRB and regulatory authority must be notified of completion or termination 
of this study, and sent a copy of the study synopsis in accordance with necessary timelines. 
 
 
 
 
 
 
 
 
 
 
 
 
 
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15. 
QUALITY CONTROL AND QUALITY ASSURANCE 
The sponsor will implement and maintain quality control procedures to ensure that this study is 
conducted and data are generated, documented, and reported in compliance with the protocol, 
and applicable regulatory requirements. 
The sponsor or designee will routinely conduct monitoring and/or auditing visits to the study site 
to verify the adherence to the study protocol, the protection of the rights and well-being of the 
subjects; and the accuracy and completeness of reported study data recorded on the source 
documentation.  A suitable qualified representative will monitor the clinical investigation as 
follows: 
• Conduct pre-study evaluation visits to verify site qualifications. 
• Conduct site initiation visit after IRB/IEC approval and at or before first subject visit. 
• Conduct periodic monitoring visits. 
• Compare eCRFs to source documents for accuracy, completeness, legibility, and 
logic. 
• Review investigator's files for accuracy, currency, and completeness. 
• Conduct ongoing review of site for continued ability to conduct the study. 
• Ensure that informed consents are obtained. 
• Ensure that IRB/IEC review is current. 
• Ensure protocol compliance and document any deviations or violations. 
• Assure untoward effects are reported. 
• Conduct closeout visit after all subject visits are complete and data in eCRFs are 
confirmed. 
• Follow-up with all ongoing issues, as necessary. 
• Prepare reports of visits. 
 
 
 
 
 
 
 
 
 
 
 
 
 
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16. 
ETHICS 
16.1. 
Ethics Review 
The protocol and supporting documents for this study will be reviewed and approved by an 
appropriately constituted IRB/IEC prior to study initiation.  The investigator will not start this 
study before providing EyeQue with evidence of IRB approval.   
The investigator will promptly report to the IRB all changes in the research activity and all 
unanticipated problems involving risks to subjects.  The investigator will not make any changes 
in the research without IRB approval, except where necessary to eliminate apparent immediate 
hazards to the subjects. 
The investigator is responsible for informing the IRB of any amendment to the protocol in 
accordance with local requirements.  In addition, the IRB or IEC must approve all advertising 
used to recruit patients for the study.  The protocol must be re-approved by the IRB or IEC upon 
receipt of amendments and annually, as local regulations require. 
A progress report will be submitted by the investigator to the IRB or IEC at intervals specified 
by the IRB/IEC, but not less than annually.  A copy of this progress report will be sent to 
EyeQue.  After completion of the study, the investigator will submit a final report to the 
IRB/IEC. 
16.2. 
Ethical Conduct of the Study 
The study will be conducted in accordance with GCP as contained in the US CFR governing the 
protection of human subjects (Title 21, Part 50). 
EyeQue is responsible for the ongoing safety evaluation of the product and will expedite the 
notification of all participating investigators and regulatory authorities of findings that are 
reportable, or could alter the IRB/IEC approval to continue the study. 
16.3. 
Written Informed Consent 
The investigator will ensure that written informed consent is obtained from each participant in 
accordance with applicable regulations. 
Subjects will be interviewed at the initial screening visit by qualified staff at the site and will be 
provided with a full description of the nature and purpose of the study.  The subject will be given 
adequate time to consider the risks and benefits associated with participation in the study.  Each 
subject will provide written informed consent prior to participating in any study procedures.  The 
original signed consent forms will be retained on file at the clinical site and a copy will be given 
to the subject.  Case histories (subject charts) will also document that informed consent was 
obtained prior to the subject's participation in the study. 
16.4. 
Authorization to Disclose Protected Health Information 
If required under Health Insurance Portability and Accountability Act regulations, or other 
applicable regulations subjects will be informed of the following information: 
 
 
 
 
 
 
 
 
 
 
 
 
 
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• the sponsor of the study; 
• any contractors that may be involved in the study; 
• the purpose of the protected health information (PHI) being collected; 
• the possibility that the PHI may be re-disclosed; 
• the duration of the authorization; 
• the subject's rights to revoke the authorization; and, 
• the right of the subject to refuse signature and limit access to PHI during the conduct 
of the study (US 21 CFR Title 45, Parts 160 and 164). 
Authorization to disclose PHI must be obtained before the subject enters the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
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17. 
DATA HANDLING AND RECORDKEEPING 
17.1. 
Electronic Case Report Forms/Source Data Handling 
The investigator shall be provided with standardized eCRFs and shall ensure that all data from 
subject visits are promptly entered into the eCRFs in accordance with the specific instructions 
given.  The investigator must sign each eCRF to verify the integrity of the data recorded. 
The investigator must maintain all source documents. 
17.2. 
Inspection of Records 
The investigator agrees that EyeQue or its designated agents, the IRB/IEC, and the FDA (or 
other governmental regulatory entity) will have reasonable access to study source documentation 
for audit and review both during and after completion of the study.  These monitoring visits 
provide EyeQue with the opportunity to evaluate the progress of the study; to verify the accuracy 
and completeness of eCRFs; to assure that all protocol requirements, applicable regulations, and 
investigator's obligations are being fulfilled; and to resolve any inconsistencies in the study 
records.  All participating subjects will be required to signify their approval to permit inspection 
of their medical records by representatives of EyeQue, the IRB/IEC, and regulatory agencies, as 
needed. 
17.3. 
Retention of Records 
The investigator shall maintain adequate records for the study including copies of eCRFs for 
individual subjects, medical records, consent forms, test article disposition records, safety 
reports, information regarding participants who discontinued, and other pertinent data.  The 
investigator shall maintain these records for a period of at least 2 years after the last approval of a 
marketing application and until there are no pending or contemplated marketing applications, or 
at least 2 years have elapsed since the formal discontinuation of clinical development of the test 
article.  These records should be retained for a longer period if required by the applicable 
regulatory requirements or by an agreement with the sponsor.  The sponsor will inform the 
investigator/institution as to when these records no longer need to be retained. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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18. 
PUBLICATION POLICY 
This research may be submitted for publication.  Details of any publication and disclosure terms 
are addressed in a separate agreement with investigators. 
 
 
 
 
 
 
 
 
 
 
 
 
 
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19. 
LIST OF REFERENCES 
Pascolini D, Mariotti SP. Global estimates of visual impairment: 2010.  Br J Opthalmol. 2012 
May; 96(5): 614-8.   
Pamplona V., Menezes de Oliveira Neto M., Mohan A., Raskar R. U.S. Patent No. 
US8783871 B2. 2014.  
World Health Organization (WHO). Blindness and vision impairment fact sheet. 
11 October 2018. Online. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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20. 
APPENDICES 
APPENDIX 1.  
SCHEDULE OF ASSESSMENTS 
 
Assessment 
Visit 1 (Screening 
and Testing) 
Screening 
 
Informed consent 
X 
Demographics/medical history/concomitant medication review 
X 
Slit-lamp biomicroscopy 
X 
Laser retinal scan or fundoscopy 1 
X 
Optical coherence tomography1 
X 
Non-contact tonometry  
X 
Ishihara color test 
X 
Cover test  
X 
Retinoscopy2 
X 
Refraction values using the phoropter 
X 
BCVA3 assessed using the phoropter and eye chart 
X 
Testing 
Refraction values using the autorefractor 
X 
Measurement of pupillary distance 
X 
Refraction values using the EyeQue VisionCheck4 
X 
BCVA3 using trial frames5 produced from: 
• 
phoropter refraction values  
• 
autorefractor refraction values 
• 
EyeQue VisionCheck refraction values 
X 
Subject preference regarding each of the trial lens frames  
X 
 
Adverse event recording 
X 
BCVA = best corrected visual acuity; ETDRS = Early Treatment Diabetic Retinopathy Study; OD = oculus dexter, 
right eye; OS = oculus sinister, left eye; OU = oculus uterque, both eyes  
Note:  All eye procedures will be completed without dilating the eye. 
1 Images will be taken during this procedure.  
2 Results will be used as a basis for further refinement by phoropter refraction. 
3 Best corrected visual acuity will be measured using the ETDRS eye chart; values will be recorded for OD, OS, and 
OU. 
4 All subjects will be trained on how to use the EyeQue VisionCheck device prior to initiating testing. 
5 Trial frames prepared from refraction values from each of the 3 devices will be provided to the subjects in a 
masked fashion and BCVA for each trial lens frames will be measured.   
 
 
 
 
 
 
 
 
 
 
 
 
 
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