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

Not Applicable

Recruiting

• Conditions: Visual Field Defect, Peripheral
• Interventions: Device: VisuALL; Device: Humphrey Visual Field

• Registration Number: NCT05150197
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-09
• Study Start: 2022-01-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	VisuALL	This group will only perform the VisuALL Virtual Reality Visual Field.
Patient (pathology) group	Humphrey Visual Field	This group will perform both the standard of care Humphrey Visual Field (HVF) and the VisuALL Virtual Reality Visual Field.
Patient (pathology) group	VisuALL	This group will perform both the standard of care Humphrey Visual Field (HVF) and the VisuALL Virtual Reality Visual Field.

Primary Outcome Measures

Name	Time	Method
Mean deviation results of visual field parameters	During office visit, approximately 30 minutes	Mean deviation of the visual field is one score measured in decibels calculated from device reading
Pattern standard deviation results of visual field parameters	During office visit, approximately 30 minutes	Pattern standard deviation of the visual field is one score calculated from device reading
Sensitivity results of visual field parameters	During office visit, approximately 30 minutes	Sensitivities are the results of each space in the visual field measured in decibels

Secondary Outcome Measures

Name	Time	Method
Percent of patients able to use VisuALL in-office testing as measured by patient observation	During office visit, approximately 30 minutes
Percent of participants stating satisfaction as measured by questionnaire	During office visit, approximately 5 minutes	12 questions with strongly disagree to strongly agree
Percent of times that scotomas were visualized as measured by visual field tests	During office visit, approximately 30 minutes
Percent of patients able to use VisuALL home testing as measured by device reading	One month, 1-2 tests per week	Home testing will be done in a few patients that demonstrate facility with device

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States