About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>18 years of age
diagnosis of primary open-angle glaucoma
ability to perform visual field testing
capacity to provide informed consent to research protocol
Disqualifiers
diagnosis of secondary glaucoma or non-glaucomatous optic neuropathy
previous intraocular surgery (excluding cataract surgery and minimally invasive glaucoma surgery)
significant media opacity
pregnancy
Trial design
Single group
Treatments tested in this trial
Virtual Reality Visual Field (VR-VF)
DeviceBoth 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
Treatment groups
Trial outcomes
Primary outcomes
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)
Global indices of visual field loss
Mean deviation (MD) and pattern standard deviation (PSD) are measurements of global field loss produced by both devices.
Reliability Indices
Fixation losses, false positives, false negatives are recorded during each visual field test and reflect the reliability of the given test.
Secondary outcomes
Reliability over time
Assessed through examination of variation in global indices and point-wise threshold values
Patient satisfaction
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)
Sponsors and contacts
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