Status:
RECRUITING
Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Cone-Rod Degeneration
Rod-Cone Degeneration
Eligibility:
All Genders
5-120 years
Phase:
PHASE1
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 env...
Detailed Description
Objective: Designing clinical trials for advanced retinal disease represents an especially difficult challenge due to the lack of suitable outcome measures. Clinical measures such as visual field and ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- To be eligible, the following inclusion criteria must be met.
- For the NEI site: Participant must be five years of age or older.
- For the USyd site: Participant must be thirteen (13) years of age or older.
- Participant (or legal guardian) must understand and be willing to sign the protocol s informed consent document.
- Participant must be able to cooperate with the testing required for this study.
- 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.
- For healthy volunteers only:
- 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.
- Participant is in another investigational study and actively receiving study therapy.
- 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:
- 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).
- Participants with Retinal Disease Only
- 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.
Exclusion
Key Trial Info
Start Date :
July 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT04289571
Start Date
July 25 2023
End Date
December 31 2030
Last Update
August 1 2025
Active Locations (2)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
2
University of Sydney
Sydney, Australia