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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:
Participants will perform both a standard and a VR based visual field test at each visit, for a total of 5 visits.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visual Field Testing | Experimental | Participants will perform both a virtual reality-based visual field test and a standard Humphrey visual field test for both eyes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Visual Field (VR-VF) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual field point-wise threshold values | 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) | Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months) |
| Global indices of visual field loss | Mean deviation (MD) and pattern standard deviation (PSD) are measurements of global field loss produced by both devices. | Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months) |
| Reliability Indices | Fixation losses, false positives, false negatives are recorded during each visual field test and reflect the reliability of the given test. | Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Reliability over time | Assessed through examination of variation in global indices and point-wise threshold values | Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months) |
| Patient satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reann Post, BSc | Contact | 19029560601 | reann.post@dal.ca | |
| Lynn Murphy | Contact | 19024072380 | lynn@eadietech.com |
| Name | Affiliation | Role |
|---|---|---|
| Brennan Eadie, MD, PhD, FRCSC | Nova Scotia Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eadie Technologies Inc | Recruiting | Halifax | Nova Scotia | B3L1N3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19492005 | Background | 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. | |
| 38036608 |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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All participants will perform both a Humphrey visual field test and a virtual reality based visual field test.
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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)
| Questionnaire completed at the end of each testing session, following the completion of both visual field tests (throughout study enrolment, average 2 months) |
| 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. |
| 24413347 | Background | 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. |
| 24974815 | Background | 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. |