Using virtual reality to assess mobility in people with retinal disease

An Observational Cross-Sectional Study of Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease

This study is testing a virtual reality tool to see if it can help people with retinal diseases, aged 5 and older, understand their mobility challenges while navigating obstacle courses.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 5 Years to 120 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 2 sites (Bethesda, Maryland and 1 other locations)
• Trial ID: NCT04289571 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate a virtual reality (VR) tool designed to assess mobility in individuals with retinal diseases such as cone-rod and rod-cone degeneration. Participants, aged 5 and older, will navigate through obstacle courses in a VR environment while their mobility is tracked. The study will involve 2-3 clinic visits where participants will also complete medical history exams and questionnaires about their vision and mobility challenges. The goal is to determine if the VR tool can serve as a reliable measure of functional vision and document changes over time.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 5 and older with retinal diseases affecting their vision, as well as healthy volunteers aged 13 and older.

Not a fit: Patients who are currently participating in another investigational study or unable to comply with study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more accurate and effective way to assess mobility in patients with retinal diseases, potentially improving their quality of life.

How similar studies have performed: While the use of virtual reality in clinical assessments is emerging, this specific approach to measuring mobility in retinal disease is novel and has not been extensively tested in prior studies.

Eligibility criteria

* 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.

Where this trial is running

Bethesda, Maryland and 1 other locations

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
• University of Sydney — Sydney, Australia (Recruiting)

Study contacts

• Principal investigator: Brett G Jeffrey, Ph.D. — National Eye Institute (NEI)
• Study coordinator: Daniel W Claus, R.N.

Conditions Cone-Rod Degeneration; Rod-Cone Degeneration; Eye; BCVA; OCT