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

NCT ID: NCT05150197

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-19

Study Completion Date

2026-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Visual Field Defect, Peripheral

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient (pathology) group

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

Group Type EXPERIMENTAL

VisuALL

Intervention Type DEVICE

Virtual Reality Visual Field Device

Humphrey Visual Field

Intervention Type DEVICE

Standard of care Visual Field test

Control group

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

Group Type OTHER

VisuALL

Intervention Type DEVICE

Virtual Reality Visual Field Device

Interventions

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VisuALL

Virtual Reality Visual Field Device

Intervention Type DEVICE

Humphrey Visual Field

Standard of care Visual Field test

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharon F Freedman, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sharon F Freedman, MD

Role: CONTACT

(919) 681-3937

Facility Contacts

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Samuel A Alvarez-Falcon, MD

Role: primary

919-684-0560

References

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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.

Reference Type BACKGROUND
PMID: 32941320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34003954 (View on PubMed)

Other Identifiers

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Pro00109426

Identifier Type: -

Identifier Source: org_study_id

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