NCT04289571

Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease

Recruiting now Phase 1 Last updated 31 March 2026

What this trial tests

Phase 1 trial testing VR Mobility Tool in Cone-Rod Degeneration in 165 participants. Currently enrolling.

Timeline

25 July 2023

Primary endpoint
31 December 2030

31 December 2030

Quick facts

Lead sponsor	National Eye Institute (NEI)
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	165
Start date	25 July 2023
Primary completion	31 December 2030
Estimated completion	31 December 2030
Sites	2 locations across United States, Australia

Drugs / interventions tested

• VR Mobility Tool

Conditions studied

• Cone-Rod Degeneration — all drugs for Cone-Rod Degeneration →
• Rod-Cone Degeneration — all drugs for Rod-Cone Degeneration →

Sponsor

National Eye Institute (NEI)

Who can join

Adults 5 to 120, any sex, with Cone-Rod Degeneration or Rod-Cone Degeneration. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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....

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Therapeutic landscape for inherited ocular diseases: Current and emerging therapies.
   Chan HW, Oh J, Leroy B. · · 2023 · cited 8× · PMID 36722513 · DOI 10.4103/singaporemedj.smj-2022-179