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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority

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 volunteers

Qualifiers

>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

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Visual Field TestingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)
2

Global indices of visual field loss

Mean deviation (MD) and pattern standard deviation (PSD) are measurements of global field loss produced by both devices.

Time frame
Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)
3

Reliability Indices

Fixation losses, false positives, false negatives are recorded during each visual field test and reflect the reliability of the given test.

Time frame
Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)

Secondary outcomes

1

Reliability over time

Assessed through examination of variation in global indices and point-wise threshold values

Time frame
Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)
2

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)

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.