Clinical trial NCT05150197: Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease
Official title: Virtual Reality Visual Field Testing as an Alternative to Standard Automated Perimetry in Childhood Eye Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Visual Field Defect, Peripheral
Keywords: Virtual Reality Visual Field
Glaucoma
Neuro-ophthalmology
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean deviation results of visual field parameters
timeFrame: During office visit, approximately 30 minutes
measure: Pattern standard deviation results of visual field parameters
timeFrame: During office visit, approximately 30 minutes
measure: Sensitivity results of visual field parameters
timeFrame: During office visit, approximately 30 minutes
Secondary outcomes:
measure: Percent of times that scotomas were visualized as measured by visual field tests
timeFrame: During office visit, approximately 30 minutes
measure: Percent of participants stating satisfaction as measured by questionnaire
timeFrame: During office visit, approximately 5 minutes
measure: Percent of patients able to use VisuALL home testing as measured by device reading
timeFrame: One month, 1-2 tests per week
measure: Percent of patients able to use VisuALL in-office testing as measured by patient observation
timeFrame: During office visit, approximately 30 minutes
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Sharon F Freedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Razeghinejad R, Gonzalez-Garcia A, Myers JS, Katz LJ. Preliminary Report on a Novel Virtual Reality Perimeter Compared With Standard Automated Perimetry. J Glaucoma. 2021 Jan 1;30(1):17-23. doi: 10.1097/IJG.0000000000001670.
citation: Montelongo M, Gonzalez A, Morgenstern F, Donahue SP, Groth SL. A Virtual Reality-Based Automated Perimeter, Device, and Pilot Study. Transl Vis Sci Technol. 2021 Mar 1;10(3):20. doi: 10.1167/tvst.10.3.20.