eQUEST -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY A Multi-center, Prospective Cohort Study to Assess the Impact of eSight Eyewear on Functional Vision Improvement and Quality of Life in a Low Vision Population
Phase: NA
Conditions: Vision, Low
Sponsor: eSight Corporation

eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY1 
A multi-center, prospective cohort study to assess the impact of eSight Eyewear 
on functional vision improvement and quality of life in a low vision population 
 
Sponsored By: 
eSight Corporation 
 
156 Front Street West, Suite 601, Toronto ON M5J 2L6, Canada 
Principal Investigators: Scott Gartner, OD, Lighthouse Palm Beach  
 
Miami, FL 
 
Judith Goldstein, OD, Johns Hopkins University Wilmer Eye Institute 
 
Baltimore, MD 
 
Kanishka Jayasundera, MD, University of Michigan Kellogg Eye Center 
 
Ann Arbor, MI 
 
Samuel Markowitz, MD, University of Toronto, Toronto Western Hospital 
 
Toronto, ON 
 
Michael Tolentino, MD, The Center for Retina and Macular Disease 
 
Lakeland, FL 
 
Walter Wittich, Ph.D, Université de Montréal Clinique Universitaire de la Vision 
 
Montreal, QC 
Co-Investigators: 
Gislin Dagnelie, PhD, Johns Hopkins University School of Medicine 
 
Baltimore, MD  
 
Byron Lam, MD, Bascom-Palmer Eye Institute 
 
Miami, FL 
 
Sonya Braudway, OD 
 
The Center for Retina and Macular Disease 
 
Robert Devenyi, MD 
 
University of Toronto, Toronto Western Hospital 
 
Ashley Howson, OTR 
 
University of Michigan Kellogg Eye Center 
 
Flavio Rezende, MD 
 
Université de Montréal 
Study Management: 
eSight Corp 
 
Protocol: 
Rob Hilkes, eSight Corp. 
 
Revision 1.4, January 21, 2016 
                                                
1 Entered at CIRBI and www.clinicaltrials.gov as Protocol 00014027 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 2 
Signature of Principal Investigators 
 _____________________________________________  
 _________________________  
 
Gislin Dagnlie, PhD 
Date 
 _____________________________________________  
 _________________________  
 
Judith Goldstein, OD 
Date 
 _____________________________________________  
 _________________________  
 
Scott Gartner, OD 
Date 
 _____________________________________________  
 _________________________  
 
Kanishka Jayasundera, MD 
Date 
 _____________________________________________  
 _________________________  
 
Samuel Markowitz, MD 
Date 
 _____________________________________________  
 _________________________  
 
Michael Tolentino, MD 
Date 
 _____________________________________________  
 _________________________  
 
Walter Wittich, Ph.D 
Date 
 
Signature of Study Sponsor 
 _____________________________________________  
 _________________________  
 
Brian Mech, President and CEO, eSight Corporation 
Date 
 
 
 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 3 
Table of Contents 
Abbreviations & Definitions ........................................................................................................... 5 
1. 
Background ............................................................................................................................ 8 
1.1. 
Prior Research ................................................................................................................. 9 
2. 
Study Objectives .................................................................................................................. 11 
3. 
Study Sample ....................................................................................................................... 11 
3.1. 
Sample Size ................................................................................................................... 11 
3.2. 
Inclusion Criteria ............................................................................................................ 12 
3.3. 
Exclusion Criteria ........................................................................................................... 13 
4. 
Study Design ........................................................................................................................ 14 
4.1. 
Schedule of Events ........................................................................................................ 15 
STEP 1: Pre-Screen, Subject Profile, and Informed Consent .............................................. 15 
STEP 2: Pre-Study LV Inventory Assessment & VA LV VFQ-48 ......................................... 16 
STEP 3: Clinic Visit – LV Assessment & eSight Demonstration .......................................... 16 
STEP 4: Clinic Visit – Fitting & Baseline Testing with eSight Eyewear ................................ 20 
STEP 5: Take-Home Trial, Month One ................................................................................ 21 
STEP 6: Subject Visit – Midterm Assessment ..................................................................... 22 
STEP 7: Take-Home Trial, Months Two & Three ................................................................. 22 
STEP 8: Telephone Survey .................................................................................................. 22 
SETP 9: Final Assessment .................................................................................................. 23 
5. 
Withdrawal from the Study ................................................................................................... 24 
6. 
eSight Support for Clinical Sites ........................................................................................... 24 
7. 
Adverse Events .................................................................................................................... 24 
8. 
Stopping Criteria ................................................................................................................... 26 
9. 
Study Materials ..................................................................................................................... 26 
10. 
Analysis .............................................................................................................................. 27 
11. 
Ethical and Regulatory Requirements ................................................................................ 28 
11.1. 
Institutional Review ...................................................................................................... 28 
11.2. 
Informed Consent ........................................................................................................ 29 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 4 
12. 
General Information ............................................................................................................ 29 
12.1. 
Study Record Retention ............................................................................................... 29 
12.2. 
Protocol Changes ........................................................................................................ 29 
12.3. 
Deviations From Protocol ............................................................................................ 29 
12.4. 
Team Member Expertise ............................................................................................. 29 
12.5. 
Record of Revisions to this Document ......................................................................... 31 
13. 
References ......................................................................................................................... 31 
 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 5 
Abbreviations & Definitions 
Through this document, the following acronyms and terms are used.  Terms, when capitalized, 
carry the specific meanings described below. 
ADL: 
Activities of Daily Living 
AE: 
An Adverse Event is defined as any untoward medical occurrence, 
including deterioration of a pre-existing medical condition in a patient or 
clinical 
investigation 
subject 
administered 
a 
pharmaceutical 
product/device and which does not necessarily have a causal 
relationship with this treatment. 
AT: 
Assistive Technology. 
BCVA: 
Best Corrected Visual Acuity 
CRF: 
Case Report Form 
CCTV: 
Closed-circuit television, which uses a video camera to project a 
magnified image onto a TV screen. For people with low vision, it can help 
with reading, viewing photos and other such tasks 
CTA: 
Clinical Trial Agreement.  Legally binding document between the 
Sponsor and the Institution and the Investigator defining roles, 
responsibilities, payment, consideration, intellectual property ownership, 
liability, publication rights, etc. 
DEVICE: 
eSight Eyewear.  A wearable, video based low vision AT device. 
eSKILLS PROFICIENCY PROGRAM:  The eSkills program is a structured training program for 
eSight Eyewear users.  It includes various tasks the improve the user’s 
effectiveness with the device.  Normally, eSkills is administered by eSight 
staff by telephone.  For the eQUEST study, eSkills will be administered 
by Site staff. 
ETDRS: 
Early Treatment Diabetic Retinopathy Study – the worldwide standard for 
visual acuity testing. 
EYECARE PHYSICIAN: 
Optometrist or Ophthalmologist at the Study Site. 
EXAMINER: 
Any staff at the test site who, under the supervision and oversight of the 
INVESTIGATOR, will administer portions of the protocol and record 
results in the CRF. 
INSTITUTION: 
The Low Vision Clinic, Hospital or other location where Eyecare 
Physicians and low vision rehabilitation specialists are equipped to 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 6 
conduct this study.  The Institution shall have a CTA in place with the 
Study Sponsor.  
INVESTIGATOR: 
The eyecare physician responsible for oversight of Study activities at the 
Institution. 
LV: 
Low vision 
MLVAI: 
Melbourne Low-Vision ADL Index Test 
MN Read Eye Charts: A continuous text chart designed for normal and low vision at the 
Minnesota (MN) Laboratory for Low Vision Research 
PD: 
Pupil Distance.  For the purposes of this study, PD means independent 
left and right pupil distances from nasal center.  PD does not mean the 
distance between the two pupils. 
QOL: 
Quality of Life 
RESEARCH ASSISTANT: Site associate deemed qualified, and authorized by the Site PI, to 
carry out portions of the protocol and complete related sections of the 
CRF.  Often the Research Assistant will be the same Site staff person as 
the Site Administrator. 
SAE: 
A Serious Adverse Event is defined as any untoward medical occurrence 
that: 
• Results in death, 
• Is life-threatening, 
• Requires 
inpatient 
hospitalization 
or 
prolongation 
of 
existing 
hospitalization (visit to emergency department without admission to 
the hospital is not considered hospitalization), 
• Results in persistent or significant disability/incapacity or 
• Is a congenital anomaly/birth defect. 
SITE ADMINISTRATOR: 
Often the Site Administrator will be the same Site staff person as the 
Research Assistant. 
SPONSOR: 
eSight Corp. 
STUDY: 
The research protocol as defined herein. 
SUBJECT ID: 
A unique number used to identify a Study Subejct.  This facilitates the 
provision of study data if necessary amongst different Study Sites, and 
between the Study Site and the Sponsor, without disclosing breaching 
the confidentially of the Subject. 
STUDY MANAGER: 
Person appointed by eSight to oversee the overall management of the 
Study, manage data integrity, and the overall Study schedule. 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 7 
STUDY SITE: 
Also, “Site”. There are six Study Sites in the eQUEST Study.  These are 
the locations at which the research is being conducted.  In all cases, 
Study Sites have achieved ethics approval to conduct the Study, and 
informed consent from the Study Subject.   
SUBJECT: 
An individual enlisted as a participant in the eQUEST Study. 
THIRD PARTY SURVERYOR:  A HIPAA-trained independent third party, trained to administer 
the VA LV VFQ-48 and eSight-8 Questionnaires by telephone. 
VA LV VFQ-48: 
Visual function questionnaire designed to measure the difficulty a person 
has performing daily activities 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 8 
1. Background 
eSight Corp., Toronto, Canada (Sponsor), has developed a wearable, electronic low vision aid, 
“eSight Eyewear” (Device).  eSight Eyewear deploys ophthalmic grade video camera and 
display components, and real-time video modification algorithms to significantly improve the 
functional visual performance of people with non-correctable, inoperable low vision caused by 
eye diseases such as but not limited to: 
• 
Macular Degeneration 
• 
Diabetic Retinopathy 
• 
Stargardt’s Disease 
 
Over 100 million people in the developed world have low vision, defined by the World Health 
Organization as best corrected visual acuity in the better eye of 20:60 or worse2.  Other factors 
can also contribute to low vision such as diminished field of view or impaired occipital/cognitive 
image processing. 
In most cases of low vision, individuals will retain sufficient residual visual function that, with the 
help of Assistive Technology (AT) devices they can still perform various life tasks or Activities of 
Daily Living (ADLs).    The eSight device can help people perform various ADLs such as: 
• 
Reading  
• 
Interacting with others 
• 
Viewing a computer screen  
• 
Orientation and Mobility 
• 
Watching television  
• 
Distance Viewing 
 
The mechanism of eSight Eyewear is to stimulate vestigial retinal function through existing 
retinal photoreceptors (rods and cones), thereby enabling more effective neurological 
(cortical/occipital) visual processing, helping the brain to extract more usable information from a 
visual scene.  We do not believe eSight Eyewear affects disease progression, nor does it 
interact with the body’s metabolism or physiology in any way other than through the stimulus 
described above.  eSight Eyewear is a Class-I medical device.  The mechanism of 
                                                
2 “The Global Economic Cost of Visual Impairment”, AMD Alliance International, April 2010 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 10 
(LVES), developed by researchers at John Hopkins University3.  The LVES device was the 
subject of various studies and notably, was evaluated extensively by the U.S. Department of 
Veterans Affairs as an aid suitable for visually impaired veterans.4 
More recently, the “Joint Optical Reflective Display (Jordy) system was developed by Enhanced 
Vision Systems, Huntington CA, in collaboration with scientists from the National Aeronautics 
and Space Administration.  The Jordy enjoyed margin commercial success, but has been 
discontinued5. 
The use of head worn video as opposed to optical magnification does present exciting 
possibilities for the partially sighted.  Various researchers have sought to understand how video 
enhancements such as contrast, edge enhancement, overlays, and various other techniques not 
possible through simple optical magnification or filtering, can be used to enhance functional 
vision6, 7, 8, 9. 
There have been other attempts at head-borne video devices for low vision.  Historically, all 
have suffered from the same drawbacks, largely due to technological implementation at that 
time.  These units were large and cumbersome, with limited field of view, poor camera 
performance, and unacceptable latency10.  eSight Eyewear, by far the most commercially 
successful such device to date, overcomes these historical shortcomings through leading edge 
technology choices and various proprietary design elements. 
                                                
3 Massof, Rickman, “Obstacles encountered in the development of the low vision enhancement system”, Optometry and Viision 
Science. 1992 Jan;69(1):32-41 
4 Ballinger, Lalle, Maino, Stelmack, Tallman, Wacker, “Veterans Affairs Multicenter Low Vision Enhancement System (LVES) study: 
clinical results. Report 1: effects of manual-focus LVES on visual acuity and contrast sensitivity”.  Optometry. 2000 Dec;71(12):764-
74. 
5 Chang, “Sleek New Devices Help Low-Vision Patients See “, NY Times, April 2004 
6 Peli et al., “Applications of Augmented Vision Head-Mounted Systems in Vision Rehabilitation”,  Journal of the Society for 
Information Displays. 2007 Dec; 15(12): 1037–1045. 
7 Arici, Dikbas, Altunbasak, “A Histogram Modification Framework and Its Application for Image Contrast Enhancement”.  IEEE 
Transactions on Image Processing, Vol. 18, No. 9, 2009. 
8 Peli, “Augmented Vision for Central Scotoma and Peripheral Field Loss”, 1999 
9 Moshtael, Aslam, Underwood, Dhillon, “High Tech Aids Low Vision: A Review of Image Processing for the Visually Impaired”, 
Translational Vision Science and Technology. 2015 Aug; 4(4): 6. 
10 Culham, Chabra, Ruben, “Clinical performance of electronic, head-mounted, low-vision devices”, Ophthalmic and Physiological 
Optics. 2004 Jul;24(4):281-90. 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 12 
About ⅓ to ½ of subjects who fall into the acuity and visual field inclusion criterion described in 
Section 3.2 below, demonstrate acute objective improvement and an immediate aptitude with 
the device.  Therefore, we anticipate a total of 150-200 to be enrolled in screening arm of the 
study, from which 60 will be selected to participate in the extended arm, a three month take-
home trial of the device.  We expect attrition to be low due to the rigorous screening process for 
participation.13 
In addition to a clinician’s unit, which incorporates trial lens frames and other unique features for 
fitting and demonstration, each Site will receive devices for Subjects as they are required.  The 
Site and eSight can, at any time, agree to deploy additional devices to accelerate the collection 
of data. 
3.2. Inclusion Criteria 
1. Male or female subjects between the ages of 13-75.  The goal for the extended arm is 
that  50% of subjects will be 65 years of age or younger, and 50% will be older than 6514.  
2. Subject must have distance BCVA measured with ETDRS of between 20:60 and 20:400 
in the better eye. 
3. Subjects have been diagnosed with a condition that presents as one or all of the 
following: Central scotomata, geographic atrophy, or scattered scotomata.  These are 
typically symptoms attributed to conditions such as:  Diabetic Retinopathy, Stargardt’s 
Disease, Age Related Macular Degeneration, Leber’s Disease, Retinopathy of 
Prematurity, Cone Rod Dystrophy, or Ocular Albinism 15. 
4. Subject must have an estimated functional field of view of at least 20 degrees (bilateral or 
monocular).16.  
5. If the subject is employed, they must be prepared to use eSight Eyewear in their 
workplace environment, have informed their employer of their involvement in the study, 
and received permission from their employer to bring eSight Eyewear into the workplace. 
If the subject is self-employed, they must be prepared to use eSight Eyewear in their 
                                                
13 “Sample size estimation and power analysis for clinical research studies”, Suresh & Chandrashekara, J Hum Reprod Sci. 2012 
Jan-Apr; 5(1): 7–13.  “G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences”, 
Erdfelder, Faul, & Buchner, Behav Res Methods. 2007 May;39(2):175-91. 
14 The intention of this stratification of the cohort is to understand age effects related to the eSight Eyewear device.  This stratification 
does not impact the statistical analysis in Section 3.1 
15 These have been demonstrated by current eSight users to be conditions for which eSight Eyewear can provide significant benefit.  
For other conditions, especially those which present as peripheral degeneration encroaching inwardly ultimately towards the central 
vision, eSight Eyewear’s effectiveness has not yet been convincingly demonstrated (e.g.: early stage Retinitis Pigmentosa, early 
stage Glaucoma). 
16 Acuity and field criteria, while firm requirements here, are inflection points in the real world population.  Evidence indicates that 
eSight users outside of the 20/60 – 20/400 BCVA and 20° field can still have success with the eSight device, but results are less 
consistent. 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 13 
workplace environment.  Similarly if the subject is a student, they must be prepared to 
use eSight Eyewear in their educational environment.   
6. Subject must be, in the opinion of the examiner, highly motivated, alert, articulate, 
mentally competent and able to understand and comply with the requirements of the 
study (defined herein). 
7. Subject must provide informed consent.  Subjects under the age of majority must have a 
legal guardian present during the informed consent process, who must sign the Informed 
Consent form on their behalf. 
8. Subject must agree to use eSight Eyewear only under conditions that will not jeopardize 
the safety of either the user or the device. 
3.3. Exclusion Criteria 
1. Subject must not be currently undergoing any medical or surgical procedures resulting in 
unstable vision. 
2. Subjects for whom their vision, for whatever reason, can be considered unstable. 
3. Subjects who have undergone cataract, refractive, or other surgical procedures related to 
vision in the six month period prior to the study. 
4. Subjects who have undergone any eyesight-related injections (e.g. anti-VEGF) in the six 
month period prior to the study. 
5. Subjects unable or unwilling to adhere to the examination schedules as they are 
described in the study protocol.  This may also include Subjects already enrolled who, for 
whatever reason become unable or unwilling to continue the study.  This may also 
include subjects for whom the travel time to/from the study site is unacceptable. 
6. Subjects who self report a history of alcoholism or use of illegal drugs, Subjects who 
exhibit clinical evidence of depression, poor motivation, emotional or intellectual 
problems, who are deemed unsuitable psychologically or physiologically for study 
participation by the investigator. 
7. Subjects who may have a conflict of interest with eSight Corp, which could reasonably 
influence their participation in the study. 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 15 
Note that the Case Report Form (CRF) that will be used for the eQUEST Study will be Microsoft 
Excel spreadsheet with appropriate constraints (restricted cells, validated data entry, drop down 
choices, help text, etc.).  Each site will be provided with a tablet computer with the CRF pre-
installed.  This will help to ensure data completeness and integrity.  Each section of the CRF will 
identify the level of staff (eSight or Study Site) that is required to conduct that portion of the 
protocol.  Information provided to the Study sponsor will be de-identified. 
The components of the study are described in greater detail in Section 4.1 below: 
4.1. Schedule of Events 
This section indicates data that will be collected for each subject.  Subjects will be screened for 
enrollment prior to their initial visit.  At the initial visit, subjects will provide informed consent and 
the investigator will obtain medical and ophthalmic history information as described in the CRF, 
and conduct a complete low vision assessment. 
At various points through the protocol, decision points are identified as red boxes below. 
STEP 1: Pre-Screen, Subject Profile, and Informed Consent 
The Eyecare Physician at the Study Site will select potential candidates from the Site’s regular 
flow of patients.  In some cases, eSight may direct interested persons to the Site, who have 
contacted eSight directly. 
 
Steps 1.01 through 1.03 may be administered by a Research Assistant or a similarly suitable 
staff person at the clinic (e.g.: CLVT, OT, etc.). 
Step 1.01 
Subject ID:  When a potential Study Subject has been identified, the Site 
Administrator will assign a unique subject identification number from the site-specific list of 
numbers provided by eSight. 
Step 1.02 
Demographic Data:  The Site Administrator will contact prospective study 
participants and obtain demographic data. 
Step 1.03 
Inclusion/Exclusion, and Informed Consent:  The Site Administrator will work 
through the inclusion/exclusion criteria to verify the subject is qualified for the study, and then 
work with the subject through the informed consent process, obtaining their written approval to 
proceed.  An IRB approved informed consent form will be used. 
The site administrator will then provide to the Third Party Surveyor, contact information for the 
study subject in order to proceed with Step 2 below.  The Third Party Surveyor will complete 
Step 2 and send that information back to the Site Manager for inclusion in the Subject’s CRF. 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 16 
STEP 2: Pre-Study LV Inventory Assessment & VA LV VFQ-48 
Steps 2.01 through 2.03 will be administered by telephone using a Third Party Surveyor17.  
Step 2.01 
AT Inventory:  The Third Party Surveyor will conduct a telephone interview with 
each subject.  The purpose of this phone interview is to inventory the subject’s current assistive 
devices and usage habits.  This background information will be used by the study examiner to 
determine which visual aids will be used during benchmarking activities. 
Step 2.02 
Baseline VA LV VFQ-48 Questionnaire:  Third Party Surveyor will work with the 
subject to complete the VA LV VFQ-4818 questionnaire. 
Step 2.03 
Baseline eSight-8 Questionnaire:  Third Party Surveyor will work with the 
subject to complete seven QoL type questions which will provide predictive insights regarding 
their affinity with the eSight device. 
Step 2.04 
Advancement Decision:  Based on the Subject’s responses to 2.02 and 2.03 
above the Eyecare Physician will determine whether or not the Subject ought to proceed through 
the Protocol.   
Note:  While not an explicit inclusion criterion, there are seven questions on the VA LV VFQ-48 
items identified in red (2, 3, 5, 12, 14, 19, 45) for which the eSight Eyewear device has been 
shown to be particularly effective.  If a subject scores four or more of these items as “moderately 
difficult” or “extremely difficult”, they will be considered a strong candidate. 
STEP 3: Clinic Visit – LV Assessment & eSight Demonstration 
Subjects will also be asked to complete a series of supervised activities to establish a baseline 
of their visual function and functional visual performance without eSight Eyewear19. 
Duration: 2-3 hours. 
Steps 3.01 through 3.04 may be administered by a Research Assistant or a similarly suitable 
staff person at the clinic (e.g.: CLVT, OT, etc.). 
Step 3.01 
Low Vision Rehabilitation Goals:  The CRF form identifies five ADLs, prioritized 
by the subject, which they wish do (or do better).  It also asks how satisfied they are currently 
with their ability to perform this task, and how important this task is to their day-to-day quality of 
life.  The purpose of this step is provide the subject with specific goals that they can work to 
achieve (or improve) using eSight Eyewear over the course of the study. 
                                                
17 In the case of Johns Hopkins University Wilmer Eye Institute, research assistants from the institute will conduct Step 2.  These 
research assistants will be dis-assoicated from the PI and other researchers who have face-to-face interaction with the subject. 
18 Using the VA LV VFQ-48 and LV VFQ-20 in Low Vision Rehabilitation, Stelmack, Massof, Optom Vis Sci. 2007 Aug;84(8):705-9. 
19 Because we intend to deploy standardized ADL measures, it may be possible to compare our findings directly to some other 
interventions (e.g.: Haymes, Johnston, & Heyes, 2001). 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 17 
Note: If, in the estimation of the researcher, the Subject identifies goals which are too abstract 
(e.g. “I want to do more”, “I want to be happier”), or not suitable uses for eSight Eyewear (e.g. “I 
want to swim”, “I want to drive”, “I want to go downhill skiing”), they will be encouraged to 
elaborate or identify a different goal that can be considered applicable to the Study/Device. 
Step 3.02 
Cognitive Assessment:  To determine the cognitive capability of the subject to 
continue with the remainder of the study protocol, an assessment using the Montreal Cognitive 
Assessment – BLIND (MoCA)20 test will be conducted.  Psychometric properties of the MoCA in 
its full version include a test-retest correlation of r = .92, while internal consistency was 
evaluated with a Cronbach’s alpha of .83.21 
While the cognitive suitability of the Subject for the test protocol is ultimately the decision of the 
researcher, a MoCA score of less than 20 indicates that careful consideration is necessary22.  If 
the researcher determines that the subject is cognitively unsuited for the study, the remaining 
steps below are unnecessary (skip to 3.10). 
Step 3.03 
36-item short-form health survey (RAND SF-36)23:  The SF-36 is a brief 
questionnaire that provides a validated indication of the subject’s broad general health.  It was 
chosen in part because of its excellent psychometric properties, which include a minimum of .70 
for reliability statistics.  Content, concurrent, construct, criterion, and predictive validity have 
been shown to be satisfactory (Ware & Gandek, 1998) 24 
 
 
Steps 3.05 through 3.11 are administered by the Eyecare Physician or suitably trained and 
supervised clinical staff.  These tests benchmark the subject’s visual performance with their 
habitual low vision aids where possible25.  As a minimum for these tests, the subject should wear 
their corrective lenses (distance or reading) as applicable.  NOTE: if the lens prescription as 
                                                
20 “Sensitivity and Specificity of the Montreal Cognitive Assessment Modified for Individuals Who Are Visually Impaired”, Wittich, 
Phillips, Nasreddine, Chertkow, JVIB 06/2010; 104(6):360-368.  See also: http://www.mocatest.org. 
21 Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, et al. The Montreal Cognitive Assessment, MoCA: 
a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695‑9.] 
22 The MoCA scoring tool does not provide regarding pass/fail criterion.  Ultimately, a subject’s performance in the test is meant to 
provide clues to the researcher about cognitive deficiencies.  
23 Ware, Sherbourne.  “The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection”.  Med Care. 
1992 Jun;30(6):473-83. 
24 Ware JE, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J 
Clin Epidemiol. nov 1998;51(11):903‑12. 
25 References: The forms provided with this study are a subset of LV rehabilitation practice guidelines from the following sources: 
a) 
Ontario Practice Template - Low Vision Assessment. 
b) 
New 
York 
Lighthouse 
for 
the 
Blind 
LV 
Intake 
Exam 
(Dr. 
Bruce 
Rosenthal) 
http://www.lighthouse.org/for-
professionals/practice-management/structured-low-vision-exam. 
c) 
VisionionAware: http://www.visionaware.org/info/your-eye-condition/eye-health/low-vision/low-vision-examination/1235 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 18 
determined in step 1.04 is substantially different from the subject’s habitual glasses, this portion 
of the protocol may be conducted with a trial lens frame. 
Step 3.04 
Medical and Ophthalmic History:  The clinician and/or site administrator will 
record the following information on the CRF: 
• 
OD and OS disease type(s), and approximate number of years, if possible.26 
• 
Free-form field: other eye-health related history (e.g.: laser photocoagulation, Lucentis, 
etc.), considered by the examiner to be relevant. 
• 
subject’s verbal description of visual scotoma if present 
Step 3.05 
Refractive Prescription:  The clinician will perform a refraction to determine the 
prescription lenses required by the subject for best distance and near vision.  Note:  No prism 
element may be included in the refraction prescription. 
Step 3.06 
Acuity Test:  Choose ONE OF ETDRS or Snellen 
ETDRS27:  Using the subject’s habitual corrective lenses (if applicable).  For each eye 
independently, and then binocularly, determine the ETDRS acuity. 
• 
Determine the last row where the subject can correctly identify all 5 letters on that row. 
• 
Determine the log score for that row (these scores are shown in the margin of the 
ETDRS test, e.g. the 20/25 line has a log score of 0.1) 
• 
subtract 0.02 log units for every letter that is correctly identified beyond the last row 
where all of the letters are correctly identified. 
For example: if the subject reads all of the letters correctly on the 20/32 row and then 3 
letters correctly on the 20/25 row, the Log Score would be calculated as follows: 
 
ETDRS Acuity Log Score = 20/32 Row = 0.20, plus 3 letters on 20/25 row 
 
 = 0.20 – (3 × 0.02) 
 
 = 0.14 
Snellen: 
Using the Subject’s habitual corrective lenses (if applicable).  For each eye 
independently, and then binocularly, determine the Snellen acuity28. 
 
Step 3.07 
Mars Contrast Sensitivity Test:  Test Contrast Sensitivity using the Mars chart.  
Mars test score sheet to be provided 29. 
                                                
26 On the CRF this will be a date range, because subjects will not recall with accuracy.  E.g.:  <6mos, 6-12mos, 1-2yrs, 2-5yrs, 5-
10yrs, >10yrs. 
27 https://www.good-lite.com/Details.cfm?ProdID=639 
28 In some cases (e.g. dense scotoma) the test Subject may have difficulty reading ALL 5 letters on any line of the ETDRS chart, 
which limits the precise ETDRS scoring algorithm above. Adding Snellen allows greater flexibility in participant inclusion and data 
analysis. 
29 © 2003-2004 The Mars Perceptrix Corporation.  https://www.good-lite.com/Details.cfm?ProdID=549&category=26&Secondary=71 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 19 
Step 3.08 
eSight Demonstration:  eSight Eyewear will be demonstrated using a clinician’s 
version of the device30.  The subject will be provided basic instruction on its use (zoom in/out, 
contrast adjust). The researcher will observe the Subject’s performance in tests of, acuity 
(ETDRS) contrast performance, facial recognition, and reading (MNRead).  These above tests 
are observational only, and are not recorded to provide a baseline performance measure with 
the eSight Device. 
 
Step 3.09 
Advancement Decision: At this point in the protocol the Subject and the Eyecare 
Physician will come to an agreement about whether to continue with the extended portion of the 
protocol evaluating eSight Eyewear.  The decision will be based on a minimum 4-line ETDRS 
improvement using the device, the subject’s performance of the various tasks above, their 
impressions of the eSight Eyewear demonstration, and the continued compliance with 
inclusion/exclusion criteria as defined in Sections 3.2 and 3.3 respectively.  There is a subjective 
and personal aspect to this decision, not unlike a patient’s decision about whether or not to 
purchase the device.  
Should the subject and/or the examiner decide not to proceed with the remainder of the study, 
this should be noted on the CRF, along with their reason for withdrawal. 
 
Step 3.10 
Microperimter Test (without eSight):  This test is optional.  Bilateral. The intent 
is to understand how field performance correlates with efficacy results.  Because this diagnostic 
test requires a significant time commitment, the subject will be asked for consent, as indicated 
on the CRF.  Ideal candidates for this test are <60 years old, with a central scotoma in both 
eyes.  A 10-2 pattern is preferred.  Indicate on the Case Report Form which test was conducted. 
 
Steps 3.11 through 3.13 may be administered by a Research Assistant, or a similarly suitable 
staff person at the clinic (e.g.: CLVT, OT, etc.). 
Step 3.11 
Minnesota Low Vision Reading Test (MN READ):  Under normal “office” lighting 
conditions, using the hand held MNREAD charts, record the subject’s score.  Score sheets to be 
provided31.  This test will be conducted without eSight Eyewear, using the Subject’s habitual 
spectacle correction if applicable. 
Step 3.12 
Cohn-Kanade Facial Recognition Test:  The subject will complete a task of 
recognizing the sex and facial expressions on a randomized selection of faces from the 
University of Pittsburgh Cohn-Kanade Facial Images Database.  These will be displayed on a 
                                                
30 The clinician’s version of eSight Eyewear is more adjustable (e.g. trial lenses, pupil distance, etc.), but compromises on weight, 
comfort and aesthetics.  Subjects who receive eSight Eyewear for the trial will be provided a consumer version of the product,  
appropriately sized, incorporating their prescription lenses and correct pupil spacing. 
31 Scoresheets will follow Lighthouse Low Vision Products format. 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 21 
Steps 4.01 through 4.04 are administered by the eyecare physician (Optometrist or 
Ophthalmologist), or suitably trained and supervised clinical staff.  eSight staff will be in 
attendance throughout this visit to provide guidance and support. 
Step 4.01a 
Fitting subject’s eSight Eyewear:  The subject’s personalized eSight Eyewear 
will have their ophthalmic lens prescription incorporated into the prescription frames, and the left 
and right PD set internally.  The device will be properly fitted to the subject by adjusting the nose 
bridge, forehead strap, and headband. 
Step 4.01b 
Training on eSight Eyewear Controls:  The subject will receive complete 
training on the features and controls of eSight Eyewear.  This will include a demonstration of 
1. Using the HDMI input for computer use and television viewing, including using the motion 
sensors in the device to control panning across the scene. 
2. Using the various binary colour modes to improve reading capability. 
3. Various other features such as saving images, etc. 
 
Tests 4.02 through 4.07 below are repeats of previous tests, but using eSight Eyewear. 
Step 4.02 
Acuity Test – with eSight Eyewear (ETDRS or Snellen) 
Step 4.03 
Mars Contrast Sensitivity Test – with eSight Eyewear 
Step 4.04 
n/a 
 
Steps 4.05 through 4.08 may be administered by a Research Assistant or a similarly suitable 
staff person at the clinic (e.g.: CLVT, OT, etc.). 
Step 4.05 
Minnesota Low Vision Reading Test (MN READ) – with eSight Eyewear 
Step 4.06 
Cohn-Kanade Facial Recognition Test – with eSight Eyewear 
Step 4.07 
Melbourne Low-Vision ADL Index Test (MLVAI) – with eSight Eyewear 
Step 4.08 
Introduction to eSkills Program36:  The subject will be introduced to eSight’s 
“eSkills Program”.  This is a program which guides the individual through various activities, 
helping them to understand how to use the eSight controls to optimize their functional visual 
performance for various activities.  While in clinic, Site staff will guide the Subject through 
session one of the eSkills program. 
STEP 5: Take-Home Trial, Month One 
The subject will now take the eSight Eyewear with them for a period of about four weeks, during 
which they will be encouraged to use eSight Eyewear for as many of their ADLs as possible.  
                                                
36 “eSkills Proficiency Program”, Oct 30, 2014. 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 22 
The subject will be trained that there are certain ADLs that are not permitted, such as driving or 
operating any sort of dangerous machinery (e.g.: power tools), and walking or performing other 
mobility tasks while using the device in “immersive” mode.  Other ADLs will be prescribed, using 
eSight to purchase a coffee, using eSight to attend an event where distance viewing is required 
(e.g. church, theatre, wedding, conference, classroom, etc.), watching television, using a 
computer, social event, etc. 
Site staff will contact the subject by telephone in accordance with the “eSkills Proficiency 
Program” as follows: 
- 
Day 9: verify Session One steps are satisfactory, confirm commitment to proceed with 
session Two steps.  This interaction can occur within a window of ±2 days of Step 4. 
- 
Day 16: Verify Session Two steps are satisfactory, confirm commitment to proceed with 
Session Three steps.  This interaction can occur within a window of ±2 days of Step 4. 
- 
Day 23:  Verify Session Three steps are satisfactory, confirm commitment to proceed 
with Session Four steps, and confirm one-month check in appointment.  This interaction 
can occur within a window of ±2 days of Step 4. 
STEP 6: Subject Visit – Midterm Assessment 
Step 6 must occur within  26-34 days of Step 4. 
Step 6.01 
The purpose of this visit is to assess the subject’s progress with the eSight device, 
and provide additional guidance and training as required.  Part of this visit will be to assess the 
Subject’s self reported progress with the goals identified in Step 3.01 above, and to work with 
the Subject to improve their achievement of these goals through further device training.  If 
necessary, the researcher may contact eSight to learn goal-specific ways that eSight Eyewear 
can be used.  This visit may be conducted in-clinic. 
Step 6.02 
Also in this visit, the Subject will complete Session Four, the final part of the 
eSkills program. 
STEP 7: Take-Home Trial, Months Two & Three 
The subject will again take the eSight Eyewear home with them, this time for a period of two 
more months. 
STEP 8: Telephone Survey 
Within 86-94 days of Step 4 (total of three months), subjects will be contacted by the Third Party 
Surveyor to revisit the VFQ-48, and RAND SF-36 questionnaires37. 
                                                
37 In the case of Johns Hopkins University Wilmer Eye Institute, research assistants from the institute will conduct Step 2.  These 
research assistants will be dis-assoicated from the PI and other researchers who have face-to-face interaction with the subject. 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 23 
Step 8.01 
Final VA LV VFQ-48 Questionnaire 
Step 8.02 
Final eSight-8 Questionnaire 
SETP 9: Final Assessment 
Within 86-94 days of Step 4, subjects will be required to come to the clinic for a two hour 
assessment.  Subjects will again repeat various supervised tasks and a VA LV VFQ-48 
questionnaire to assess improvements in their functional visual performance compared to 
baseline. 
Duration 2-3 hours 
Step 9.01 through 9.03 may be administered by a Research Assistant or a similarly suitable staff 
person at the clinic (e.g.: CLVT, OT, etc.). 
Step 9.01 
Re-Assessment of Goals Established in Step 3.01:  The Research Assistant or 
Site Administrator will reassess the Subject’s satisfaction with their performance of the personal 
goals as reported in Step 3.01. 
Step 9.02 
Re-administration of RAND SF-36 Questionnaire 
Tests 9.03 through 9.09 below are repeats of previous tests, intended to assess changes in 
visual function and functional visual performance over time using eSight Eyewear. 
Steps 9.03 through 9.05 are administered by the eyecare physician (Optometrist or 
Ophthalmologist), or suitably trained and supervised clinical staff. 
 
Step 9.03 
Acuity Test – with and without eSight Eyewear (ETDRS or Snellen) 
Step 9.04 
Mars Contrast Sensitivity Test – with eSight Eyewear 
Step 9.05 
n/a 
 
Steps 9.06 through 9.09 may be administered by a Research Assistant or a similarly suitable 
staff person at the clinic (e.g.: CLVT, OT, etc.). 
Step 9.06 
Minnesota Low Vision Reading Test (MN READ) – with eSight Eyewear 
Step 9.07 
Cohn-Kanade Facial Recognition Test – with eSight Eyewear 
Step 9.08 
Melbourne Low-Vision ADL Index Test (MLVAI) 
Step 9.09 
Final comments, opportunity for freeform feedback, relinquishment of the 
device. 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 24 
5. Withdrawal from the Study 
A subject may withdraw or be removed from the study at any time without prejudice for any of 
the following reasons: 
• 
The subject wishes to withdraw 
• 
Occurrence of any serious or adverse device-related effect that is considered by the 
investigator to represent an unacceptable risk to the subject’s physical or mental well-being. 
• 
Occurrence of any physical or mental illness that affects the subject’s further participation. 
• 
The subject fails to comply with the requirements of the study. 
Time permitting, subjects that withdraw from the study will be replaced by other candidates.  
Every effort will be made to have withdrawn subjects complete the follow-up procedures (Part 4). 
6. eSight Support for Clinical Sites 
At each site, before the Study commences, eSight staff will visit the Study location to provide 
one full day of training with the eSight Eyewear device.  This will include the following: 
• 
Training on device demonstration and fitting (trial lenses, adjustment of forehead strap and 
headband, P.D. adjustment, etc.). 
• 
Explanation of device controls (zoom, video modes, OS/OD displays on/off, saving images. 
• 
Training on various ADLs (bioptic and immersive activities). 
• 
Using direct video feed for television and computer use. 
• 
Facial Recognition test training. 
• 
Training on the eSkills program. 
• 
Training on study management, data collection, and CRF administration. 
In addition, eSight will visit site locations for clinical visit number two, during which fitting and 
training of the subject is provided.  To control costs, sites will attempt to consolidate multiple 
subjects in a single day for this step in the process.  This means that each study site will have 
two or three visits by eSight staff over the course of the study, assuming 8-12 subjects per study 
site. 
7. Adverse Events 
An adverse event (AE) is defined as any untoward medical occurrence, including deterioration of 
a pre-existing medical condition in a patient or clinical investigation subject which may or may 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 25 
not have a causal relationship with the investigational product (i.e. eSight Eyewear). An AE can 
therefore be any unfavourable and unintended sign, symptom, or disease temporally associated 
with the use of an investigational product, whether or not considered related to the 
investigational product. 
The Principal Investigator/Sub-Investigator will assess the relationship of all adverse reactions to 
the investigational product, using the following scale: 
 
Probable 
A clinical event, including laboratory test abnormality, with a 
reasonable time sequence to device usage, unlikely to be attributed 
to concurrent disease or other drugs or chemicals, and which 
follows a clinically reasonable response on withdrawal. 
Possible 
A clinical event, including laboratory test abnormality, with a 
reasonable time sequence to device usage, but which could also be 
explained by concurrent disease or other drugs or chemicals. 
Information on device withdrawal may be lacking or unclear. 
Unlikely 
A clinical event, including laboratory test abnormality, with a 
temporal relationship to device usage which makes a causal 
relationship improbable, and which other drugs, chemicals or 
underlying disease provide plausible explanation. 
Unrelated 
This category is applicable to Aes which are judged to be clearly 
and 
incontrovertibly 
due 
to 
extraneous 
causes 
(diseases, 
environment, etc.) and do not meet the criteria for device 
relationship listed for the above mentioned conditions. 
 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 26 
The incidence, severity and duration of all adverse events will be recorded according to the 
following scale: 
 
Mild 
Adverse event resulting in discomfort, but not sufficient to cause 
interference in normal daily activities. 
Moderate 
Adverse event resulting in discomfort that is sufficient to cause 
interference in daily activities.  
Severe 
Adverse event resulting in discomfort causing an inability to carry 
out normal daily activities.  
 
All severe Aes, whether or not the event is deemed device-related, will be reported to the 
Sponsor by telephone within twenty-four hours of being aware of a severe AE, followed by a 
written report within five business days. 
Practically speaking, the risk of adverse events with eSight Eyewear is extremely low.  The most 
significant risk is injury resulting from disorientation or poor psycho-spatial hand-eye 
performance related to using the device to perform any task where injury may be possible.  
Some examples include: Falling or tripping while wearing the eSight device in an immersive 
mode while walking; risk of burns while cooking or drinking hot beverages; participating in 
specifically prohibited activities such as riding a bicycle or driving. 
8. Stopping Criteria 
Should any AE necessitate that a specific Subject must terminate their participation in the Study, 
the Site Administrator will, within their best judgement, inform his/her counterparts at the other 
Study Sites so that they are prepared for similar circumstances at their respective Study Sites. 
9. Study Materials 
If the study site does not already own any of the materials below, they will be provided by eSight 
at the beginning of the study: 
• 
Case Report Form (CRF):  This form is used to record and track the subject’s progress 
through the course of the study.  For each unique CRF, Subject identifying information 
appears on the first page of the form only.  Subsequent pages show only a unique 
identification number provided by the Study Sponsor.  CRFs returned to eSight for 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 27 
analysis will be “de-identified”, referenced by this identification number only.  The first 
page will be removed. 
• 
ETDRS Acuity Chart 
• 
Mars Contrast Chart 
• 
MN READ Test Charts 
• 
Clinical Unit:  This unit is identical to the subject’s configured unit except that it 
incorporates provision for trial lenses so that it may be used on multiple subjects. 
• 
eSight Facial Recognition Test:  Materials required to conduct this test and record 
results38. 
• 
MLVAI Materials 
• 
Subject’s Unit:  If the subject is deemed a suitable candidate for an extended evaluation 
period, they will receive a unit with the user interface customized for them, along with 
their prescription lenses incorporated, if applicable. 
• 
Materials for In-Clinic ADL Testing:  Telephone book, kitchen ingredients, etc. 
10. Analysis 
Some of the data gathered through the course of this study is subjective, and will be used by 
eSight to prioritize ongoing improvements to the device. 
The minimum objective data that will be reported is acuity, contrast, reading speed, without 
eSight Eyewear at the beginning of the trial, and with eSight Eyewear at its conclusion. 
Further objective data is the comparison between the initial VFQ, and RAND SF-36 scores, and 
the change, if any, in score at the conclusion of the study. 
Data analysis will be conducted using IBM SPSS Statistics version 22.  The data will be pooled 
from all testing sites by the Study Manager.  Before merging of the data, any systematic 
differences among testing sites will be assessed.  Should such differences exist, they will be 
considered in subsequent analyses.   
Repeated measures Analysis of Variance (ANOVA) and t-tests will be used to compare the 
effect of the eSight devices on all dependent variables that adhere to the assumptions of 
parametric data analysis (continuous variables, normal distribution etc.).  Categorical variables 
or those who do not adhere to parametric assumptions will be compared using repeated-
measures non-parametric techniques (e.g. Friedman Test).  Qualitative data will be analyzed 
using qualitative description (Sandelowski, 2000). 
                                                
38 Requires 22” monitor with HDMI input.  To be provided by eSight in the event that the study location does not have one available. 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 28 
The eSight device contains an electronic logging capability, wherein daily on-time hours, and 
user commands (e.g.: zoom in/out, focus distance, increase/decrease contrast, etc.) are saved 
to an SD card.  No images or video or other information that may personally identify the subject 
is recorded.  These electronic logs may be used to validate user reported usage data39. 
Methodological Limitations: Given the multi-site nature of the study, it is possible that inter-site 
differences may occur, based on recruitment possibilities or slight differences in procedural or 
testing administration differences.  The research teams will closely work together with eSight 
during the preparation phase, in order to minimize such differences.  In addition, before data are 
pooled across sites, statistical comparison will be conducted in order to detection and possibly 
compensate statistically for such site differences. 
As for the limited follow-up time of 3 months, the current study may be limited in its ability to 
show long-term benefits (or device abandonment).  However, follow-up and continuation 
possibilities are currently being discussed, in order to eventually examine the long-term 
variables involved in the eSight device use. 
 
11. Ethical and Regulatory Requirements 
The following must be observed to comply with Health Canada and U.S. Food and Drug 
Administration regulations for conduct and monitoring of clinical investigations.  These 
requirements also represent sound research practices. 
11.1. Institutional Review 
The Institutional Review Board (IRB) must review this Protocol, the Informed Consent Form, and 
the Case Report Form in accordance with Health Canada and U.S. Food and Drug 
Administration regulations. 
A status report must be submitted to the IRB upon conclusion of the study.  The lead 
investigator must maintain an accurate and complete record of all reports and documents 
submitted to and received from the IRB. 
Each subject withdrawal from the study is to be reported to the IRB in writing within three (3) 
days.  
                                                
39 The use of electronic logging has been added to the Johns Hopkins University Wilmer Eye Institute ICF.  Because no PHI is being 
collected, other IRBs have not required that this information be added. 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 29 
11.2. Informed Consent 
The informed consent document used for the study must have been approved by the IRB for 
each site involved in the study.  The Principal Investigator or one of his/her associates must 
explain verbally and in writing the nature of the study and the actions of the device in a manner 
such that all subjects are aware of the potential benefits and risks.  After subjects have been 
informed that participation is voluntary and that they may withdraw from the study at any time, 
without prejudice, they must sign the approved consent form in the presence of a witness.  The 
subject must be provided with a signed copy of the ICF. 
12. General Information 
12.1. Study Record Retention 
All records of device disposition, CRFs, test results, signed consent forms, IRB correspondence 
and documentation, and other documents pertaining to the study shall be retained by the 
investigator for a minimum of five years after the experiment ends. 
12.2. Protocol Changes 
Changes in the protocol may be made only by written amendment agreed upon by the Sponsor 
and the Investigator.  The Institutional Review Board must be advised and the amendments 
attached to the protocol.  The amendment must be approved by the IRB prior to instituting the 
change. 
12.3. Deviations From Protocol 
If a deviation is deemed necessary for an individual subject, it must be recorded.  The decision 
and the reason for any deviation must be documented in writing. 
12.4. Team Member Expertise 
Gislin Dagnelie, PhD,  is an Associate Professor of Ophthalmology in the Johns Hopkins 
University School of Medicine and the associate director of the Lions Vision Research and 
Rehabilitation Center, a division of the Wilmer Eye Institute. His work over the last 20 years has 
been supported by grants from the National Institutes of Health, National Science Foundation, 
Foundation Fighting Blindness, and several companies developing ophthalmic devices and 
visual prosthetics.  

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 30 
Scott Gartner, O.D., has been practicing low vision rehabilitation for over thirty years, and has 
had clinical directorship at various renowned low vision rehabilitation institutions including the 
Bascom Palmer Eye Institute, and the Miami Lighthouse for the Blind.  Dr. Gartner has held 
professorships at New England College of Optometry, Pennsylvania College of Optometry, 
Southern CA College of Optometry, and University of Miami, and has been involved in 
numerous device and treatment clinical trials. 
Judith Goldstein, OD, is  low vision optometrist and researcher. She is an assistant professor 
of ophthalmology and rehabilitative medicine at the Wilmer Eye Institute and chief of the Low 
Vision and Vision Rehabilitation Service. She directs clinical and teaching activities, provides low 
vision rehabilitative care to patients and participates in clinical research. 
Kanishka Jayasundera, MD, is an Assistant Professor, Ophthalmology and Visual Sciences, a  
Fellow of the American College of Surgeons, Fellow of the Royal College of Surgeons of 
Canada, and Fellow of the Royal Australia and New Zealand College of Ophthalmologists.  His 
expertise includes diseases of the retina and vitreous including retinal detachment, diabetic 
retinopathy, retinal vascular diseases, macular diseases, age-related macular degeneration, 
surgical management of complex retinal detachments, anti-angiogenic therapy and 
photodynamic therapy.  Dr. Jayasundera’s areas of research focus include genotype-phenotype 
correlations of inherited retinal diseases, predictors of disease progression, and outcome 
measures for therapeutic clinical trials. 
Samuel Markowitz, MD, is an ophthalmologist who specializes in low vision and is one of 
Canada’s most renowned specialists in low-vision rehabilitation.  He is Director, Low Vision 
Rehabilitation, Department of Ophthalmology and Vision Sciences, University of Toronto, the 
Toronto Western Hospital, and the University Health Network, and a world renowned leader in 
the field of low vision research.  Dr. Markowitz has presented his work at numerous professional 
meetings and in many peer reviewed scientific papers nationally and internationally. In 2006 he 
was awarded the Distinguished Service Award from the Low Vision Rehabilitation Section of the 
American Optometric Association.  Also in 2006 he was awarded the Secretariat Award from the 
American Academy of Ophthalmology for service and leadership in development of scientific 
and continuous education programs in Low Vision Rehabilitation. 
Michael Tolentino, MD, is a retinal surgeon, specializing in macular disease.  He is currently 
the director and founder of the clinical research program at the Center for Retina and Macular 
Disease. The center is now one of the largest retinal clinical trial centers in the world with over 
100 retinal clinical trials in the last 7 years.  Dr. Tolentino helped develop several treatments for 
wet macular degeneration and diabetic retinopathy, including Avastin, Lucentis, Macugen and 
Verteporfin. He has more than 80 peer reviewed publications and 5 issued patents. 
Walter Wittich, Ph.D, is an Assistant Professor at the School of Optometry at the University of 
Montreal, in Montreal, Quebec, who currently holds a Junior Career Award from the Fonds de 
recherche du Québec – Santé (chercheur boursier junior 1), with specific focus on the 
rehabilitation of older adults with combined vision and hearing loss. He is a resident researcher 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 31 
at both the MAB-Mackay Rehabilitation Centre and the Institut Nazareth et Louis-Braille. Coming 
from a background in age-related vision loss, he now conducts research in dual sensory 
impairment and acquired deaf-blindness.  His research domains include basic sensory science, 
as well as medical, psychosocial, and rehabilitation approaches to sensory loss.  He is a Fellow 
of the American Academy of Optometry and is Quebec’s first Certified Low Vision Therapist.  
12.5. Record of Revisions to this Document 
 
Revision 
Description of Change 
v1.0 
Initial Release: November 9, 2015 
V1.1 
November 10, 2015  
Minor edit to flowchart – removed reference to “Geriatric Depression Scale” 
V1.2 
December 14, 2015 
Added footnote to Step #2 and Step #8, indicating that JHU will use in-house 
research assistants to conduct telephone interviews. 
Added in section 10, “Analysis”, that electronic logging of non patient-identifiable 
information will be conducted. 
V1.3 
January 20, 2015 
Removed all Humphreys 10-2 and eSight 10-2 requirements from the protocol. 
Added an optional baseline C24-2 Microperimeter test at Step 3. 
V1.4 
January 21, 2015 
Changed Microperimeter description to be more generic.  C24-2 is no longer 
prescribed, and 10-2 test is preferred.  Researcher will indicate which specific 
microperimeter test was conducted. 
 
13. References 
Erdfelder, E., Faul, F., & Buchner, A. (1996). GPOWER: A general power analysis program. 
Behavior Research Methods, Instruments & Computers, 28, 1–11. 
Haymes, S. a, Johnston, a W., & Heyes, a D. (2001). The development of the Melbourne low-
vision ADL index: a measure of vision disability. Investigative Ophthalmology & Visual Science, 
42(6), 1215–25.   (LINK) 
Sandelowski, M. (2000). Whatever happened to qualitative description? Res Nurs Health, 23(4), 
334–340. 

 eQUEST  -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY 
 
January 21, 2016, (v1.4) 
 
Page 32 
Wittich, W., Phillips, N., Nasreddine, Z. S., & Chertkow, H. (2010). Sensitivity and Specificity of 
the Montreal Cognitive Assessment Modified for Individuals Who Are Visually Impaired. Journal 
of Visual Impairment & Blindness, 104(6), 360–368.  (LINK)