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

Duke University

Status: Enrolling

Conditions: Visual Field Defect, Peripheral

Treatments: Device: VisuALL; Device: Humphrey Visual Field

Study type: Interventional

Funder types: Other

Identifiers

NCT05150197

Pro00109426

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 4 to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients must be at least four (4) years old
• Cognitively normal (no developmental delay or syndrome)
• Be able to tolerate wearing the virtual reality goggles for at least 10 minutes
• Be able to provide informed consent of a parent/guardian (and assent if 12 years or older)
• Do not have any ocular diseases that could interfere with the visual field testing

Exclusion criteria

• Developmental delay
• Inability to obtain consent
• Inability to understand English

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Patient (pathology) group

Experimental group

Description:

This group will perform both the standard of care Humphrey Visual Field (HVF) and the VisuALL Virtual Reality Visual Field.

Treatment:

Device: Humphrey Visual Field

Device: VisuALL

Control group

Other group

Description:

This group will only perform the VisuALL Virtual Reality Visual Field.

Treatment:

Device: VisuALL