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NCT04289571 · ClinicalTrials.gov registry record · Phase 1
Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
A Phase 1 study of Cone-Rod Degeneration and Rod-Cone Degeneration, sponsored by National Eye Institute (NEI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 165
- Enrollment target
- 2
- Study locations
NCT04289571 is a Phase 1 study of Cone-Rod Degeneration and Rod-Cone Degeneration that is actively recruiting participants, run by National Eye Institute (NEI). The registered enrollment target is 165 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT04289571, a Phase 1 study of Cone-Rod Degeneration and Rod-Cone Degeneration, is actively recruiting participants, sponsored by National Eye Institute (NEI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 165 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- DIAGNOSTIC_TEST VR Mobility Tool
Study Locations (2)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Other
- University of Sydney - Sydney
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2023-07-25 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04289571
The ClinicalTrials.gov registry entry for NCT04289571 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cone-Rod Degeneration appearing as the primary indexed condition, and to 1 intervention - of which VR Mobility Tool is the first listed.
NCT04289571 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Other.
Frequently Asked Questions
What is clinical trial NCT04289571 about?
NCT04289571 is a clinical study titled "Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease". 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 acc...
What is the current status of trial NCT04289571?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 165 participants. The study started on 2023-07-25. Estimated completion is 2030-12-31.
What conditions does trial NCT04289571 study?
This clinical trial studies the following conditions: Cone-Rod Degeneration, Rod-Cone Degeneration.
What interventions are being tested in trial NCT04289571?
The interventions under investigation include: VR Mobility Tool (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04289571?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04289571 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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