Using eSight Go at home to help adults with visual impairment perform daily activities
Assessing the Impact of eSight Go At-Home Usage in Individuals With Visual Impairment
This project will test whether the eSight Go wearable helps adults with low vision perform everyday tasks when used at home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Brooks Rehabilitation Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT07149259 on ClinicalTrials.gov |
What this trial studies
Participants receive hands-on training with the eSight Go device at an initial visit and then take the device home for four weeks to use during school, work, and daily activities. Research staff (for example an occupational or low-vision therapist) will provide weekly phone follow-up for troubleshooting and device-use strategies. The study enrolls adults with stable visual impairment who demonstrate benefit from magnification and have sufficient cognitive function and visual field to use the device. Outcomes focus on real-world device use and practical functional benefit over the four-week home period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–90 with best-corrected visual acuity between 20/50 and 20/400 in the better eye, a stable visual status for at least six months, a functional binocular field of at least 20 degrees, and demonstrated benefit from magnification who can consent and use the device safely.
Not a fit: People with unstable vision, recent vision-related surgery, insufficient visual field, significant cognitive impairment, or who do not benefit from magnification are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, eSight Go could help people with low vision perform daily tasks more independently by enhancing visual input with a wearable device.
How similar studies have performed: Wearable electronic low-vision devices have been explored previously and have reported promising functional benefits in smaller trials and pilot studies, though results vary by device and population.
Eligibility criteria
Show full 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.
* 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)
Where this trial is running
Jacksonville, Florida
- Brooks Rehabilitation — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Katelyn Jordan, D.O. — Brooks Rehabilitation
- Study coordinator: Hannah Grimes
- Email: hannah.grimes@brooksrehab.org
- Phone: 904-597-3478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.