Low Vision AidseSightNCT07149259
Assessing the Impact of eSight Go At-Home Usage in Individuals With Visual Impairment
A study testing At Home Use in people with Low Vision Aids, run by Brooks Rehabilitation at 1 site in United States.
Trial summary
This research aims to test the updated version of Gentex's device, eSight Go, an image enhancing wearable device to assist those with vision impairments limiting activities of daily living. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Low Vision Aids
- What is being tested?
- At Home Use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Participant must not be currently undergoing any medical or surgical procedures resulting in unstable vision.
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brooks Rehabilitation
Jacksonville, Florida, 32216
Hannah Grimes, 904-528-3159, hannah.grimes@brooksrehab.org
Katelyn Jordan
About this study
This research aims to test the updated version of Gentex's device, eSight Go, an image enhancing wearable device to assist those with vision impairments limiting activities of daily living.
Read the detailed description
Subjects will receive introductory training on the controls of the study device at the initial study visit and regular follow-up phone calls once per week from a member of the research staff (e.g., an occupational therapist, or low vision therapist) who is familiar with the study device, to assist with possible troubleshooting as well as device use strategies. You will take the study device home for four weeks to use at school, work, and various daily activities.
- Conditions
- Low Vision Aids
- Being tested
- At Home Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At Home UseDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| At Home Device Utilization | Experimental | eSight Go device will be utilized at home for a total of 4 weeks in environments the participant feels comfortable using it (e.g. home, work, stores). Receives: Device: At Home Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Acuity
Early Treatment Diabetic Retinopathy Study Chart (ETDRS) assessing visual acuity. A lower logMAR value indicates an improved score.
Measured: Pre-intervention and post-intervention at 4 weeks
Change in Reading Performance
Minnesota Low Vision Reading Test assessing reading performance. A lower logMAR value indicates an improved score.
Measured: Pre-intervention and post-intervention at 4 weeks
Secondary outcomes (1)
Change in Mobility
Dynamic Gait Index (DGI) assessing the ability of the participant to maintain walking balance. 8 items are scored on a scale of 0 to 4, where 0=severe impairment, 1=moderate impairment, 2=mild impairment, and 3=normal. An increase in score reflects an improvement in mobility.
Measured: Pre-intervention and post-intervention at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start18 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Vision AidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooks Rehabilitation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katelyn Jordan, Brooks Rehabilitation
- Investigators
- Katelyn Jordan, OD, Principal investigator, Brooks Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149259
- Sponsor's protocol ID
- PRO00085670
- Acronym
- eSight
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of eSight Go At-Home Usage in Individuals With Visual Impairment
- ClinicalTrials.gov ID
- NCT07149259
- Acronym / sponsor ID
- eSight / PRO00085670
- Conditions
- Low Vision Aids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brooks RehabilitationUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research aims to test the updated version of Gentex's device, eSight Go, an image enhancing wearable device to assist those with vision impairments limiting activities of daily living.
Detailed description
Subjects will receive introductory training on the controls of the study device at the initial study visit and regular follow-up phone calls once per week from a member of the research staff (e.g., an occupational therapist, or low vision therapist) who is familiar with the study device, to assist with possible troubleshooting as well as device use strategies. You will take the study device home for four weeks to use at school, work, and various daily activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| At Home Device Utilization | Experimental | Device: At Home UseeSight Go device will be utilized at home for a total of 4 weeks in environments the participant feels comfortable using it (e.g. home, work, stores). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- Participant must not be currently undergoing any medical or surgical procedures resulting in unstable vision.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| At Home UseParticipants 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. | Device | At Home Device Utilization |
Primary outcome
Change in Visual Acuity
Time frame: Pre-intervention and post-intervention at 4 weeks
Early Treatment Diabetic Retinopathy Study Chart (ETDRS) assessing visual acuity. A lower logMAR value indicates an improved score.
Change in Reading Performance
Time frame: Pre-intervention and post-intervention at 4 weeks
Minnesota Low Vision Reading Test assessing reading performance. A lower logMAR value indicates an improved score.
1 secondary outcome
Change in Mobility
Time frame: Pre-intervention and post-intervention at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katelyn Jordan, OD principal investigator
Brooks Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing At Home Use in people with Low Vision Aids, run by Brooks Rehabilitation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taisiya Matev (904-345-8973, Taisiya.Matev@brooksrehab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Acuity (time frame: Pre-intervention and post-intervention at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.