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

NCT05150197 | Recruiting DMC FDA Device

• 1 other identifier: Pro00109426
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Field Defect, Peripheral

Keywords

Virtual Reality Visual Field; Glaucoma; Neuro-ophthalmology

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

  During office visit, approximately 5 minutes

• Percent of patients able to use VisuALL home testing as measured by device reading

  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

Study Arms (2)

Patient (pathology) group

EXPERIMENTAL

This group will perform both the standard of care Humphrey Visual Field (HVF) and the VisuALL Virtual Reality Visual Field.

Device: VisuALL; Device: Humphrey Visual Field

Control group

OTHER

This group will only perform the VisuALL Virtual Reality Visual Field.

Device: VisuALL

Interventions

VisuALL DEVICE

Virtual Reality Visual Field Device

Control group; Patient (pathology) group

Humphrey Visual Field DEVICE

Standard of care Visual Field test

Patient (pathology) group

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Developmental delay
• Inability to obtain consent
• Inability to understand English

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 32941320 BACKGROUND

• 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.

  PMID: 34003954 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Sharon F Freedman, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon F Freedman, MD

CONTACT

(919) 681-3937; sharon.freedman@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 9, 2021
• Study Start: January 19, 2022
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)