RECRUITING

Assessing the Impact of eSight Go At-Home Usage in Individuals With Visual Impairment

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Assessing the Impact of eSight Go At-Home Usage in Individuals With Visual Impairment

Quick Facts

Study Start:2025-06-18

Study Completion:2026-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07149259

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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)

Inclusion Criteria

Exclusion 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.

* 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)

Contacts and Locations

Study Contact

Hannah Grimes

CONTACT

904-597-3478

hannah.grimes@brooksrehab.org

Principal Investigator

Katelyn Jordan, D.O.

PRINCIPAL_INVESTIGATOR

Brooks Rehabilitation

Study Locations (Sites)

Brooks Rehabilitation

Jacksonville, Florida, 32216

United States

Collaborators and Investigators

Sponsor: Brooks Rehabilitation

Katelyn Jordan, D.O., PRINCIPAL_INVESTIGATOR, Brooks Rehabilitation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-18

Study Completion Date2026-06-01

Study Record Updates

Study Start Date2025-06-18

Study Completion Date2026-06-01

Terms related to this study

Additional Relevant MeSH Terms

Low Vision Aids