Assessing the Impact of eSight Go At-Home Usage in Individuals With Visual Impairment
Phase: NA
Conditions: Low Vision Aids
Sponsor: Brooks Rehabilitation

Title: Assessing the Impact of eSight Go At-Home Usage in Individuals with Visual Impairment 
Protocol #: 00085670                                                            Date: 04/18/2025 
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TITLE 
Assessing the Impact of eSight Go At-Home Usage in Individuals with 
Visual Impairment 
SHORT TITLE 
eSight 
PROTOCOL NO. 
00085670 
SPONSOR 
Gentex Corporation  
INVESTIGATOR 
Katelyn Jordan 
ADDRESS 
3901 University Blvd. S., Jacksonville, FL 32216 
TELPHONE 
(904) 345-7373   
EMAIL 
katelyn.jordan@Brooksrehab.org 
VERSION 
7.0 
DATE 
04/18/2025 
 
 
 
 
 
 
 

Title: Assessing the Impact of eSight Go At-Home Usage in Individuals with Visual Impairment 
Protocol #: 00085670                                                            Date: 04/18/2025 
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Contents 
Brief Overview ........................................................................................................................................................... 3 
Section 1: Procedures ................................................................................................................................................ 3 
1.1 Screening/Recruitment Procedures ................................................................................................................. 3 
1.1.1 Inclusion/Exclusion Criteria ....................................................................................................................... 3 
1.2 Informed Consent Process ............................................................................................................................... 4 
1.3 Assessments ..................................................................................................................................................... 4 
1.4 Intervention ..................................................................................................................................................... 5 
1.5 Data Analysis .................................................................................................................................................... 5 
Section 2: Risk Information ........................................................................................................................................ 6 
2.1 Risks, Side Effects, and/or Discomforts ........................................................................................................... 6 
2.2 Alternatives to Participation ............................................................................................................................ 6 
2.3 Cost .................................................................................................................................................................. 6 
Section 3: Monitoring/Reporting of AE/SAE .............................................................................................................. 6 
Section 4: Study Oversight ......................................................................................................................................... 7 
Section 5: Data Management .................................................................................................................................... 7 
 
 
 
 
 
 
 
 
 
 
 

Title: Assessing the Impact of eSight Go At-Home Usage in Individuals with Visual Impairment 
Protocol #: 00085670                                                            Date: 04/18/2025 
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Brief Overview 
 
The purpose of the study is to assess the effect of the updated version of Gentex’s device, eSight Go, an 
image-enhancing wearable device to assist those with vision impairment. The study will comprise at least 50 
vision impaired individuals to evaluate the efficacy or improvements in visual, quality of life, and mobility arising 
from the use of eSight Go.  The primary aim of the study is to measure the effect of eSight Go on visual acuity, 
reading performance, and quality of life. The secondary aim is to measure the impact of eSight Go on mobility, 
balance, cybersickness, and user satisfaction. The study assessments will take place at the Brooks Rehabilitation 
Clinical Research Center at 4 time points: 
1) at visit 1 before using the device; 
2) during visit 1, while using the device; 
3) at visit 2, while using the device; and,  
4) during visit 2 without the device. 
Participants will receive a personal eSight device and comprehensive training on its operation at visit 1. 
They will then use the unit in daily living, such as home, work, or school settings, over a period of 4 weeks, and 
then return for visit 2. If prescription lenses are determined to be needed to correct refractive error, visit 1 will 
be divided into 2 visits to allow time for the lenses to be ordered prior to starting the at-home trial period.  
Section 1: Procedures 
1.1 Screening/Recruitment Procedures 
 
Potential participants may be identified by healthcare staff who are part of their normal clinical care or research 
staff. Potential participants may also hear about the study by word of mouth or by their ophthalmologist. 
1.1.1 Inclusion/Exclusion Criteria 
 
Inclusion Criteria 
• 
Aged 18 to 90. 
• 
Best-corrected visual acuity between 20/50 to 20/400 in the better eye. 
• 
Subjects who have been diagnosed with an ocular condition causing visual impairment 
• 
Have a functional binocular field of view of at least 20 degrees. 
• 
Visual status stable for at least six months. 
• 
Demonstrate visual benefit from magnification. 
• 
Agree to wear the eSight Go in a variety of situations in the home and community. 
• 
Score ≥ 20 on the Short Orientation-Memory-Concentration Test of Cognitive Impairment (OMCT). 
• 
Subject must be able to provide an informed consent 
• 
Subject must agree to use eSight Eyewear only under conditions that will not jeopardize the safety of either 
the user or the device. 
 
Exclusion Criteria 
• 
Participant must not be currently undergoing any medical or surgical procedures resulting in unstable vision. 

Title: Assessing the Impact of eSight Go At-Home Usage in Individuals with Visual Impairment 
Protocol #: 00085670                                                            Date: 04/18/2025 
4 
 
• 
Participants who have undergone cataract, refractive, or other surgical procedures related to vision in the 
six-month period prior to study enrollment. 
• 
Severe (>20/400) visual impairment in the better seeing eye.  
• 
Cognitive limitations (< 20 on OMCT). 
• 
Participants who have undergone any vision-related injections (e.g. anti-VEGF) in the two-month period 
prior to the study because of active bleeding in the retina. Ongoing anti-VEGF treatments are permitted if 
the participant is in a "Treat and Extend" or pro re nata ("PRN") disease management, and macula is dry. 
• 
Participants are unable or unwilling to adhere to the examination schedules as they are described in the 
study protocol. This may also include participants already enrolled, who for whatever reason, have become 
unable or unwilling to continue the study. This may also include participants for whom the travel time 
to/from the study site is unacceptable. 
• 
Participants who self-report a history of alcoholism, drug abuse, or psychosis. 
• 
Participants who exhibit clinical evidence of depression, poor motivation, emotional or intellectual 
problems, or any other conditions which would likely limit validity of consent or appropriate responses to 
participate in the study or who are deemed unsuitable psychologically or physiologically for study 
participation by the investigator. 
• 
Participants who may have a conflict of interest with eSight Corp, which could reasonably influence their 
participation in the study. 
• 
Refractive error outside the range correctable by lens inserts in the device (> +/-8.00 D sph or -4.00 cyl) 
 
 
1.2 Informed Consent Process 
Informed consent will be obtained by approved study staff in a quiet area to allow for answering all questions. 
• 
Participants must be able to provide consent 
o Must give accurate yes/no responses 
• 
This study does not allow consent to be provided by a legally authorized representative (LAR) 
 
1.3 Assessments 
Participants will complete assessments four times, twice at visit 1 and twice at visit 2, except for the OMCT and 
the refraction which will only be performed once at visit 1.  
Study Timeline 
5/2025 
5/2025-4/2026 
5/2026-7/2026 
Open 
enrollment 
Visit 1 
4 Weeks At Home 
Usage 
Visit 2 
Complete Analysis, 
Study Close Out 
 
 
 
 

Title: Assessing the Impact of eSight Go At-Home Usage in Individuals with Visual Impairment 
Protocol #: 00085670                                                            Date: 04/18/2025 
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Assessments will include the following procedures: 
Primary Aim Assessments (Visual) 
• 
Early Treatment Diabetic Retinopathy Study Chart (ETDRS) 
• 
MNREAD 
• 
MARS Test 
• 
NEI VFQ-25 
• 
Reading Behavior Inventory 
• 
Refraction Test 
Secondary Aim Assessments (Mobility & Cognitive) 
• 
Dynamic Gait Index 
• 
Timed Up and Go 
• 
Spaciotemporal Gait Kinematics 
• 
OMCT 
• 
PROMIS Short Form v2.0 - Cognitive Function 8a 
Questionnaires 
• 
Demographic information 
• 
Ophthalmic History 
• 
36-Item Short Form Health Survey 
• 
Cybersickness in Virtual Reality 
• 
Device Usage Willingness and Participation 
• 
Activities Balance Confidence Scale 
 
1.4 Intervention 
Participants will take the device home for 4 weeks to use in daily living, such as the home and community 
settings. There will be regular follow-up phone calls once per week from a member of the research team (e.g., 
an occupational therapist, or low vision therapist) who is familiar with the device to assist with possible 
troubleshooting as well as device use strategies. The follow up calls will also collect information about device 
use time and activities.  The device will be returned at visit 2. 
 
 
1.5 Data Analysis 
Data will be captured during all assessments. Data will be compared against normative values, when available 
and change scores from pre- to post-testing will be calculated for absolute differences. Continuous data will be 
compared pre- to post-testing using independent samples t-tests. Ordinal data, including all questionnaires, will 
be evaluated using a Mann-Whitney U test.   
 

Title: Assessing the Impact of eSight Go At-Home Usage in Individuals with Visual Impairment 
Protocol #: 00085670                                                            Date: 04/18/2025 
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Section 2: Risk Information 
2.1 Risks, Side Effects, and/or Discomforts 
There are minimal risks to participating in this study. There is a minimal risk of visual or physical discomfort 
during the vision tests (though these tests are similar to standard vision testing). Participants might become 
uncomfortable or dizzy while using the device. We will do everything we can to ensure comfort, and the tests 
will be stopped if there is discomfort.  
 
There is also the possibility of loss of confidentiality. All information will be stored within HIPAA compliant 
computers that are protected and deemed safe for university/hospital researcher data storage. We will not be 
sharing your data for anything other than reviewing the results for this study. We will also remove any 
identifying information from your information used for analysis of the computer program.  
 
There is a mild risk of falls during any balance, gait, or mobility assessments. There will be a licensed PT 
supervising all mobility tasks and will assist to prevent a fall. If necessary, there is an overhead, body-weight 
support device that may be utilized for additional protection. 
 
While we believe the risk of injury during this study is minimal, please be advised that Brooks Rehabilitation will 
manage the participant’s care consistent with the management of all treatment-related adverse events. The 
participant’s insurance will be responsible for any medical cost including deductibles, co-insurance, or co-
payments. Any injury requiring medical care will be reported to the Institutional Review Board providing 
oversight of this study. 
 
2.2 Alternatives to Participation 
This study is for research purposes only. The alternative is to not participate in this study. By choosing not to 
participate, your care will not be altered in any way. 
2.3 Cost 
There is no monetary compensation for participation in this study. We will provide a travel reimbursement for 
enrolled participants of $25 per visit, up to $50 per participant. This will be paid to the participant in the form of 
a Visa gift card. 
Section 3: Monitoring/Reporting of AE/SAE 
Records of participation in this study will be held confidential except when sharing the information is required 
by law or as described in this informed consent. The Investigator, the sponsor or persons working on behalf of 
the sponsor, and under certain circumstances, the United States Food and Drug Administration (FDA) and the 
Institutional Review Board (IRB) will be able to inspect and copy confidential study-related records. This means 
that absolute confidentiality cannot be guaranteed. If the results of this study are published or presented at 
meetings, they will be de-identified. 
 

Title: Assessing the Impact of eSight Go At-Home Usage in Individuals with Visual Impairment 
Protocol #: 00085670                                                            Date: 04/18/2025 
7 
 
Participant vitals and visual and physical comfort will be monitored by study staff throughout the assessments. 
Participants will self-report any visual or physical discomfort during the weekly check ins with a study team 
member. Any abnormal or adverse responses to utilizing the device will be reported to the study physician who 
will provide medical recommendations for proceeding or terminating use of the device. Repeated and 
unresolved abnormal responses will result in withdrawal from the study under the advisement of the study 
physician. All adverse events will be tracked and reported to the IRB, primary investigator, and study physician. 
 
Section 4: Study Oversight 
Dr. Katelyn Jordan, who has been practicing for 12 years and participating in research for 10 years, will serve as 
the principal investigator and maintain administrative oversight of this study, ensuring compliance with this 
protocol, related policies and procedures of Brooks Rehabilitation, and relevant rules and regulations. 
Collection, recording, and reporting of data will be accurate and will ensure the privacy, health and welfare of 
participants. All study documents and procedures will be made available for monitoring, auditing, IRB review 
and regulatory inspection as required by the IRB and/or by law. The study will be discontinued if the principal 
investigator, the Brooks Center for Low Vision, or the IRB determines necessary. The principal investigator will 
promptly inform the IRB and provide the reason(s) for the termination or suspension of the study. 
Circumstances that may warrant termination include, but are not limited to: 
• 
Determination of unexpected, significant or unacceptable risks to participants. 
• 
Insufficient adherence to protocol requirements. 
• 
Data that are not sufficiently complete and/or evaluable. 
• 
Determination of futility. 
 
The principal investigator may terminate a participants’ participation in the study if: 
• 
Any situation occurs such that continued participation in the study would not be in the best interest of 
the participant. 
Section 5: Data Management 
Data will be collected and stored on a HIPAA-compliant, encrypted, password-protected server at Brooks 
Rehabilitation that is only accessible to Brooks Rehabilitation Clinical Research Center or Brooks Center for Low 
vision authorized personnel. Paper copies will be kept in a locked storage cabinet within the Brooks 
Rehabilitation Clinical Research Center.