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

Nova Scotia Health Authority (NSHA)

Status: Enrolling

Conditions: Glaucoma Open-Angle

Treatments: Device: Virtual Reality Visual Field (VR-VF)

Study type: Interventional

Funder types: Other

Identifiers

NCT07063537

1030608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Visual Field Testing

Experimental group

Description:

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

Treatment:

Device: Virtual Reality Visual Field (VR-VF)