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

Study Overview
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Brief Summary
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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.

Official Title
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Virtual Reality Visual Field Testing as an Alternative to Standard Automated Perimetry in Childhood Eye Disease

Conditions
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Visual Field Defect, Peripheral

Intervention / Treatment
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* Device: VisuALL
* Device: Humphrey Visual Field


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be 17 years or younger, OR patients from 18-21 years of age must have been diagnosed with their condition prior to their 18th birthday 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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient (pathology) group<br>This group will perform both the standard of care Humphrey Visual Field (HVF) and the VisuALL Virtual Reality Visual Field. | Device: VisuALL<br>* Virtual Reality Visual Field Device<br>Device: Humphrey Visual Field<br>* Standard of care Visual Field test<br>|
| Other: Control group<br>This group will only perform the VisuALL Virtual Reality Visual Field. | Device: VisuALL<br>* Virtual Reality Visual Field Device<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality Visual Field, Glaucoma, Neuro-ophthalmology