Feasibility, Accuracy, and Reproducibility of Virtual Reality Visual Field Testing in Patients With Glaucoma

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-14

Study Completion Date

2025-10-31

Brief Summary

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The goal of this clinical trial is to evaluate the feasibility of using virtual reality based visual field testing to monitor glaucoma in a clinical setting. This will be done through comparison of a virtual reality (VR) based device to the current gold standard Ziess Humphrey Field Analyzer (HFA). The main questions the study aims to answer are:

* Can both devices produce similar results in terms of detecting visual field defects and progression?
* Does the stage (early, moderate, advanced) of glaucoma impact results between the two devices?

Participants will perform both a standard and a VR based visual field test at each visit, for a total of 5 visits.

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Detailed Description

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The proposed study aims to evaluate the global and pointwise accuracy and reproducibility of a virtual reality (VR) based visual field testing system on a Pico VR platform in direct comparison to the current standard Zeiss Humphrey Field Analyzer (HFA) in glaucoma patients with various levels of decreased visual field sensitivities. Specifically, we aim to evaluate (1) if both devices produce similar global and pointwise threshold values; (2) the reproducibility of threshold values across the entire tested visual field; (3) whether the stage of glaucoma impacts the accuracy and reproducibility between the two devices; (4) whether scotomas exhibit similar threshold sensitives and reproducibility between the two devices; and (5) differences in reported reliability indices between the two devices.

Each participant will perform visual field testing for both eyes using both the VR visual field system and HFA (order randomized). Five separate sessions (both tests for each patient; both eyes) will be conducted, at least 24 hours apart. Patients will also be asked to fill out a questionnaire to qualitatively evaluate their perception of each visual field test.

Conditions

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Glaucoma Open-Angle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will perform both a Humphrey visual field test and a virtual reality based visual field test.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Visual Field Testing

Participants will perform both a virtual reality-based visual field test and a standard Humphrey visual field test for both eyes.

Group Type EXPERIMENTAL

Virtual Reality Visual Field (VR-VF)

Intervention Type DEVICE

Both devices administer a standard visual field test. The Humphrey is the gold standard desk top model and the VR-VF is a virtual reality headset designed to deliver visual field testing

Interventions

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Virtual Reality Visual Field (VR-VF)

Both devices administer a standard visual field test. The Humphrey is the gold standard desk top model and the VR-VF is a virtual reality headset designed to deliver visual field testing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* \>18 years of age
* diagnosis of primary open-angle glaucoma
* ability to perform visual field testing
* capacity to provide informed consent to research protocol

Exclusion Criteria

* diagnosis of secondary glaucoma or non-glaucomatous optic neuropathy
* previous intraocular surgery (excluding cataract surgery and minimally invasive glaucoma surgery)
* significant media opacity
* pregnancy
* seizure disorder
* cardiac pacemaker/other implantable device
* severe vertigo/balance disorder

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No