Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05150197
Status
Recruiting
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Conditions

  • Visual Field Defect, Peripheral

Eligibility Criteria

Sex
ALL
Age
4 Years - 21 Years
Healthy Volunteers
Accepted

Interventions

  • VisuALL — DEVICE
    Virtual Reality Visual Field Device
  • Humphrey Visual Field — DEVICE
    Standard of care Visual Field test

Study Details

The purpose of this study is to test a new way of measuring the peripheral vision (called a visual field test) using a device which can be worn as goggles rather than being a large instrument the patient must sit at. This new visual field test (called VisuALL) is an FDA-approved virtual reality system which has been used in adults and children. This study will compare the performance of the VisuALL to the standard testing for peripheral vision, which is called the Humphrey Visual Field (HVF) test. The study will recruit both healthy children, as well children and young adults who have eye conditions which require visual field testing as part of their standard care. The test will be performed on a day when the child or young adult already has a scheduled eye appointment as standard care. The test does not touch the eyes or require any eye drops to be given, and there is no known risk associated with the test itself. There may be a risk of loss of confidentiality. Participating in this study will require approximately 30 minutes, has no extra cost associated with it, and will be compensated by a parking pass for the day of the visit. There are no direct benefits for participants. Selected participants will be also be given training and then loaned a home VisuALL system to allow home visual field testing. If your child is selected, additional information would be provided.

Key Dates

Start date
Jan 19, 2022
Status verified
May 2026
Primary completion
Jun 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Patient (pathology) group
    This group will perform both the standard of care Humphrey Visual Field (HVF) and the VisuALL Virtual Reality Visual Field.
  • Other: Control group
    This group will only perform the VisuALL Virtual Reality Visual Field.

Primary Outcome Measure

Mean deviation results of visual field parameters [ Time Frame: During office visit, approximately 30 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27705
Nikita Piryani, MD
[email protected]
2624081232

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By research site
Duke University Medical Center· Durham, NC

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