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

Visual Field Defect, Peripheral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05150197
• Other study ID #: Pro00109426
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: Samuel A Alvarez, MD
• Phone: 919-684-0560
• Email: samuel.alvarez544[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Visual Field Defect, Peripheral

Intervention

Device:
• VisuALL
Virtual Reality Visual Field Device
• Humphrey Visual Field
Standard of care Visual Field test

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Percent of times that scotomas were visualized as measured by visual field tests		During office visit, approximately 30 minutes
Secondary	Percent of participants stating satisfaction as measured by questionnaire	12 questions with strongly disagree to strongly agree	During office visit, approximately 5 minutes
Secondary	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
Secondary	Percent of patients able to use VisuALL in-office testing as measured by patient observation		During office visit, approximately 30 minutes