Recruiting
Phase 1

Virtual Reality

Sponsor:

National Eye Institute (NEI)

Code:

NCT04289571

Conditions

Cone-Rod Degeneration

Rod-Cone Degeneration

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Accepted

Interventions

VR Mobility Tool

Study Details

Brief summary:

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....

Conditions

Cone-Rod Degeneration

Rod-Cone Degeneration

Study ID

NCT04289571

Start date

Jul 25, 2023

Status verified date

Aug 6, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

To be eligible, the following inclusion criteria must be met.

1. For the NEI site: Participant must be five years of age or older.
2. For the USyd site: Participant must be thirteen (13) years of age or older.
3. Participant (or legal guardian) must understand and be willing to sign the protocol s informed consent document.
4. Participant must be able to cooperate with the testing required for this study.
5. 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.
6. For healthy volunteers only:

1. 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.

1. Participant is in another investigational study and actively receiving study therapy.
2. 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:

1. 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).
2. Participants with Retinal Disease Only

1. 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.

Study Design

Enrollment

165 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Participants

Participants with retinal disease, healthy volunteers

Interventions

VR Mobility Tool

Participant 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.

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 and Locations

Central contacts

Daniel W Claus, R.N.

(301) 451-1621daniel.claus@nih.gov

Brett G Jeffrey, Ph.D.

(301) 402-2391jeffreybg@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

National Eye Institute (NEI)

Last update posted

Aug 10, 2026

Last verified

Aug 6, 2026

Keywords

  • Cone-Rod Degeneration
  • Rod-Cone Degeneration
  • Eye
  • BCVA
  • OCT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Eye Institute (NEI) on 2026-08-10.