Using eSight Go at home to help adults with visual impairment perform daily activities

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Brooks Rehabilitation
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Katelyn Jordan, OD — Brooks Rehabilitation
• Study coordinator: Taisiya Matev
• Email: Taisiya.Matev@brooksrehab.org
• Phone: 904-345-8973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.