NCT04289571 Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
| NCT ID | NCT04289571 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | National Eye Institute (NEI) |
| Condition | Cone-Rod Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 165 participants |
| Start Date | 2023-07-25 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 165 participants in total. It began in 2023-07-25 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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....
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.
Contact & Investigator
Brett G Jeffrey, Ph.D.
PRINCIPAL INVESTIGATOR
National Eye Institute (NEI)
Frequently Asked Questions
Who can join the NCT04289571 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 120 Years, studying Cone-Rod Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04289571 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04289571 currently recruiting?
Yes, NCT04289571 is actively recruiting participants. Contact the research team at daniel.claus@nih.gov for enrollment information.
Where is the NCT04289571 trial being conducted?
This trial is being conducted at Bethesda, United States, Sydney, Australia.
Who is sponsoring the NCT04289571 clinical trial?
NCT04289571 is sponsored by National Eye Institute (NEI). The principal investigator is Brett G Jeffrey, Ph.D. at National Eye Institute (NEI). The trial plans to enroll 165 participants.