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

Not Applicable

Recruiting

• Conditions: Glaucoma Open-Angle

• Registration Number: NCT07063537
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-12-14
• Study First Submitted: 2025-06-20
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Primary Completion: 2025-10
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Global indices of visual field loss	Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)	Mean deviation (MD) and pattern standard deviation (PSD) are measurements of global field loss produced by both devices.
Reliability Indices	Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)	Fixation losses, false positives, false negatives are recorded during each visual field test and reflect the reliability of the given test.
Visual field point-wise threshold values	Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)	Both the VR visual field and HFA produce threshold light sensitivity values measured in decibels (db) at the same locations in space (e.g., 24-2 protocol with stimuli 6 degrees apart at locations up to 30 degrees from central fixation)

Secondary Outcome Measures

Name	Time	Method
Reliability over time	Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)	Assessed through examination of variation in global indices and point-wise threshold values
Patient satisfaction	Questionnaire completed at the end of each testing session, following the completion of both visual field tests (throughout study enrolment, average 2 months)	Patient experience questionnaires will assess the perceived difficulty of performing the test (very difficult, somewhat difficult, neither difficult nor easy, somewhat easy, or very easy), patient comfort during the test (very uncomfortable, somewhat uncomfortable, neutral, somewhat comfortable, or very comfortable), and patient preference between the two devices (conventional visual field test, VR visual field test, or no preference)

Trial Locations

Locations (1)

Eadie Technologies Inc; 🇨🇦 Halifax, Nova Scotia, Canada