Assessing the Impact of eSight Go At-Home Usage in Individuals With Visual Impairment
ConditionLow Vision Aids
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorBrooks Rehabilitation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
At Home Use
DeviceParticipants 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: At Home Device UtilizationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Visual Acuity
Early Treatment Diabetic Retinopathy Study Chart (ETDRS) assessing visual acuity. A lower logMAR value indicates an improved score.
Time frame
Pre-intervention and post-intervention at 4 weeks2
Change in Reading Performance
Minnesota Low Vision Reading Test assessing reading performance. A lower logMAR value indicates an improved score.
Time frame
Pre-intervention and post-intervention at 4 weeksSecondary 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.
Time frame
Pre-intervention and post-intervention at 4 weeksSponsors and contacts
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Source ClinicalTrials.gov