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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Visual field point-wise threshold values [Срок оценки: Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)]
• Global indices of visual field loss [Срок оценки: Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)]
• Reliability Indices [Срок оценки: Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)]

Вторичные конечные точки (2)

• Reliability over time [Срок оценки: Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)]
• Patient satisfaction [Срок оценки: Questionnaire completed at the end of each testing session, following the completion of both visual field tests (throughout study enrolment, average 2 months)]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Канада · 1 центр

• Eadie Technologies Inc — Halifax

Публикации

• 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

Идентификаторы

NCT: NCT07063537 · 1030608

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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