Feasibility, Accuracy, and Reproducibility of Virtual Reality Visual Field Testing in Patients With Glaucoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality Visual Field (VR-VF).
- Who it may be relevant to
- Registry conditions: Glaucoma Open-Angle. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Accuracy and Reproducibility of Visual Field Testing Using a Virtual Reality Head-Mounted Device for Patients With Early, Moderate, and Advanced Glaucoma
Overview
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.
Interventions
- Device 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
Primary outcome measures
- Visual field point-wise threshold values [Time frame: Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)]
- Global indices of visual field loss [Time frame: Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)]
- Reliability Indices [Time frame: Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)]
Secondary outcome measures (2)
- Reliability over time [Time frame: Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)]
- Patient satisfaction [Time frame: Questionnaire completed at the end of each testing session, following the completion of both visual field tests (throughout study enrolment, average 2 months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Canada · 1 center
- Eadie Technologies Inc — Halifax
Publications
- Canadian Ophthalmological Society Glaucoma Clinical Practice Guideline Expert Committee; Canadian Ophthalmological Society. Canadian Ophthalmological Society evidence-based clinical practice guidelines for the management of glaucoma in the adult eye. Can J Ophthalmol. 2009;44 Suppl 1:S7-93. doi: 10.3129/cjo44s1. No abstract available. English, French. PMID 19492005
- Selvan K, Mina M, Abdelmeguid H, Gulsha M, Vincent A, Sarhan A. Virtual reality headsets for perimetry testing: a systematic review. Eye (Lond). 2024 Apr;38(6):1041-1064. doi: 10.1038/s41433-023-02843-y. Epub 2023 Nov 30. PMID 38036608
- Glen FC, Baker H, Crabb DP. A qualitative investigation into patients' views on visual field testing for glaucoma monitoring. BMJ Open. 2014 Jan 10;4(1):e003996. doi: 10.1136/bmjopen-2013-003996. PMID 24413347
- Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26. PMID 24974815
Identifiers
NCT: NCT07063537 · 1030608