Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
Part of paid clinical trials in Bethesda, Maryland.
- Sponsor
- National Eye Institute (NEI)
- Study ID
- NCT04289571
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Cone-Rod Degeneration
- Rod-Cone Degeneration
Eligibility Criteria
- Sex
- ALL
- Age
- 5 Years - 120 Years
- Healthy Volunteers
- Accepted
Interventions
- VR Mobility Tool — DIAGNOSTIC_TESTParticipant wears VR goggles and interacts with a visual avatar via a control unit to navigate four courses. Derived parameters automatically recorded by the VR system include number and type of collisions, walking speed, task time, and distance walked.
Study Details
Background: The retina is a thin layer of tissue at the back of the eye. Retinal disease usually reduces a person s mobility because it affects how he or she moves through familiar and unfamiliar environments. Researchers want to see if a virtual reality (VR) tool can provide an easier and more accurate way to assess mobility. Objective: To learn if researchers can track changes in mobility in people with retinal disease using a new VR tool. Eligibility: People aged 5 and older with retinal disease that affects their vision, and healthy volunteers. Design: Participants will have 2-3 clinic visits. Participants will wear goggles or sit in front of a screen while sitting. Using a game controller, they will navigate through 4 obstacle courses presented in VR. Participants will have a medical history exam. They will answer questions about their family history. They will fill out questionnaires about the vision and mobility issues they have in their daily lives. Participants will have a complete eye exam. They will read letters from a chart. Their eye pressure will be measured. Their pupils may be dilated with eye drops. Pictures of their eye will be taken. Lights will be shined in their eyes. Participants will take a visual field test. For this, they will look into a dome and press a button when they see a light. Participants will have an electroretinogram. For this, they will sit in the dark with their eyes patched. Then their eyes will be numbed with eye drops and they will wear contact lenses while watching flashing lights. Participants will have optical coherence tomography. This is a noninvasive procedure. It produces cross-sectional pictures of the retina....
Key Dates
- Start date
- Jul 25, 2023
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2030
- Completion
- Dec 31, 2030
Study Design
- Enrollment
- 165 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: ParticipantsParticipants with retinal disease, healthy volunteers
Primary Outcome Measure
The primary outcome is to determine whether parameters from a recently developed VR mobility tool can serve as biomarkers of functional vision in participants with retinal disease [ Time Frame: Three months ]
Central Contacts
- Daniel W Claus, R.N.(301) 451-1621
- Brett G Jeffrey, Ph.D.(301) 402-2391
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 |