Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
National Eye Institute (NEI) · NCT04289571
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 5–120 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 1
- Target enrollment
- 165
- US sites recruiting
- 1
- Study start
- July 25, 2023
- Record last updated
- August 10, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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....
Being studied: VR Mobility Tool
Conditions: Cone-Rod Degeneration; Rod-Cone Degeneration
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
- INCLUSION CRITERIA:
To be eligible, the following inclusion criteria must be met.
- For the NEI site: Participant must be five years of age or older.
- For the USyd site: Participant must be thirteen (13) years of age or older.
- Participant (or legal guardian) must understand and be willing to sign the protocol s informed consent document.
- Participant must be able to cooperate with the testing required for this study.
- Participant must be able to read and speak English.
a. If participant is a minor, their parent or legal guardian must be able to read and speak English.
- For healthy volunteers only:
- Participant must not have retinal disease in either eye.
EXCLUSION CRITERIA
A participant is not eligible if any of the following exclusion criteria are present.
- Participant is in another investigational study and actively receiving study therapy.
- Participant is unable to comply with study procedures.
STUDY EYE ELIGIBILITY CRITERIA
The participant must have at least one eye meeting all inclusion criteria.
STUDY EYE INCLUSION CRITERIA
- Healthy Volunteers Only
a. Study eye must have visual acuity of 20/20 or better, with or without correction (e.g., glasses or contact lens).
- Participants with Retinal Disease Only
- Study eye must have retinal disease, defined as retinal dysfunction and/or degeneration as previously established by standard clinical methods including perimetry, ERG and imaging.
Recruiting US locations
National Institutes of Health Clinical Center
Bethesda, MD 20892
Site contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · 800-411-1222 · prpl@cc.nih.gov
Study contacts (from the official record)
- Daniel W Claus, R.N. · (301) 451-1621 · daniel.claus@nih.gov
- Brett G Jeffrey, Ph.D. · (301) 402-2391 · jeffreybg@mail.nih.gov
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