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An Observational Cross-Sectional Study of Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
Sponsor study identifier
Secondary identifiers
interventional
165
2 countries
2
Study Start
July 25, 2023
Actual (reported)Primary Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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....
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 27, 2020
Actual (reported)February 28, 2020
Actual (reported)July 25, 2023
Actual (reported)December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Examine the correlation between VR mobility test parameters(e.g., accuracy, task time) and the mobility score from a PRO questionnaire/s.
Three months
Determination of the brightest background at which participants who experience photoaversion can navigate the VR maze.
Three months
Sensitivity of VR mobility test parameters to the presence and severity of retinal disease.
Three Months
Learning effect on and test-retest variability of the VR test parameters.
Three Months
Effect of prior game play
Three Months
Feasibility of the tool
Three Months
Participants with retinal disease, healthy volunteers
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
University of Sydney
Sydney, Australia
Brett G Jeffrey, Ph.D.
National Eye Institute (NEI)
First Submitted
February 27, 2020
First Posted
February 28, 2020
Study Start
July 25, 2023
Actual (reported)Primary Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 10, 2026
Record last verified: 2026-08-06
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Source: ClinicalTrials.gov.
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