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NCT Number: NCT07063537

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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)

    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)

  2. 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)

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

  3. Reliability Indices

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

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

Secondary outcomes

  1. Reliability over time

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

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

  2. 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)

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Lynn Murphy

CONTACT

[email protected]

19024072380

Reann Post, BSc

CONTACT

[email protected]

19029560601

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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