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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05150197
Enrollment
1000
Registered
2021-12-09
Start date
2022-01-19
Completion date
2028-07-01
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Field Defect, Peripheral

Keywords

Virtual Reality Visual Field, Glaucoma, Neuro-ophthalmology

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.

Interventions

DEVICEVisuALL

Virtual Reality Visual Field Device

DEVICEHumphrey Visual Field

Standard of care Visual Field test

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 21 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mean deviation results of visual field parametersDuring office visit, approximately 30 minutesMean deviation of the visual field is one score measured in decibels calculated from device reading
Pattern standard deviation results of visual field parametersDuring office visit, approximately 30 minutesPattern standard deviation of the visual field is one score calculated from device reading
Sensitivity results of visual field parametersDuring office visit, approximately 30 minutesSensitivities are the results of each space in the visual field measured in decibels

Secondary

MeasureTime frameDescription
Percent of times that scotomas were visualized as measured by visual field testsDuring office visit, approximately 30 minutes
Percent of participants stating satisfaction as measured by questionnaireDuring office visit, approximately 5 minutes12 questions with strongly disagree to strongly agree
Percent of patients able to use VisuALL in-office testing as measured by patient observationDuring office visit, approximately 30 minutes
Percent of patients able to use VisuALL home testing as measured by device readingDuring office visit, 30 minutesHome testing will be done in a few patients that demonstrate facility with the device

Countries

United States

Contacts

CONTACTSharon F Freedman, MD
sharon.freedman@duke.edu(919) 681-3937
PRINCIPAL_INVESTIGATORSharon F Freedman, MD

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026