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

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.

Study Overview

• Status: Recruiting
• Conditions: Visual Field Defect, Peripheral
• Intervention / Treatment: Device: VisuALL; Device: Humphrey Visual Field

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samuel A Alvarez, MD; Phone Number: 919-684-0560; Email: samuel.alvarez544@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University Medical Center
      • Contact: Samuel A Alvarez-Falcon, MD; Phone Number: 919-684-0560; Email: samuel.alvarez544@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Sharon F Freedman, MD, Duke University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Accurate field testing without the stress
• Comparison of a Virtual-Reality Perimeter to Standard Humphrey Visual Field in Normal Children

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Glaucoma; Virtual Reality Visual Field; Neuro-ophthalmology
• Additional Relevant MeSH Terms: Eye Diseases
• Other Study ID Numbers: Pro00109426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes