Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease
ConditionVisual Field Defect, Peripheral
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-21
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Developmental delay
Inability to obtain consent
Inability to understand English
Trial design
Design model
Parallel
Treatments tested in this trial
VisuALL
DeviceVirtual Reality Visual Field Device
Humphrey Visual Field
DeviceStandard of care Visual Field test
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Patient (pathology) groupExperimental treatment 2 interventions
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Mean deviation results of visual field parameters
Mean deviation of the visual field is one score measured in decibels calculated from device reading
Time frame
During office visit, approximately 30 minutes2
Pattern standard deviation results of visual field parameters
Pattern standard deviation of the visual field is one score calculated from device reading
Time frame
During office visit, approximately 30 minutes3
Sensitivity results of visual field parameters
Sensitivities are the results of each space in the visual field measured in decibels
Time frame
During office visit, approximately 30 minutesSecondary outcomes
1
Percent of times that scotomas were visualized as measured by visual field tests
Time frame
During office visit, approximately 30 minutes2
Percent of participants stating satisfaction as measured by questionnaire
12 questions with strongly disagree to strongly agree
Time frame
During office visit, approximately 5 minutes3
Percent of patients able to use VisuALL in-office testing as measured by patient observation
Time frame
During office visit, approximately 30 minutes4
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 the device
Time frame
During office visit, 30 minutesSponsors and contacts
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Source ClinicalTrials.gov