NCT07063537

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

June 20, 2025

Last Update Submit

July 2, 2025

Conditions

Keywords

Virtual RealityVisual FieldGlaucoma

Outcome Measures

Primary Outcomes (3)

  • 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)

Secondary Outcomes (2)

  • Reliability over time

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

  • Patient satisfaction

    Questionnaire completed at the end of each testing session, following the completion of both visual field tests (throughout study enrolment, average 2 months)

Study Arms (1)

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.

Device: Virtual Reality Visual Field (VR-VF)

Interventions

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

Visual Field Testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eadie Technologies Inc

Halifax, Nova Scotia, B3L1N3, Canada

RECRUITING

Related Publications (4)

  • 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: 19492005BACKGROUND
  • 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: 38036608BACKGROUND
  • 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: 24413347BACKGROUND
  • 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: 24974815BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Brennan Eadie, MD, PhD, FRCSC

    Nova Scotia Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reann Post, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: All participants will perform both a Humphrey visual field test and a virtual reality based visual field test.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FRCSC. Assistant Professor, Glaucoma Division; Department of Ophthalmology and Visual Sciences. Dalhousie University

Study Record Dates

First Submitted

June 20, 2025

First Posted

July 14, 2025

Study Start

December 14, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations