Glaucoma Open-AngleNCT07063537
Feasibility, Accuracy, and Reproducibility of Virtual Reality Visual Field Testing in Patients With Glaucoma
A study testing Virtual Reality Visual Field (VR-VF) in people with Glaucoma Open-Angle, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma Open-Angle
- What is being tested?
- Virtual Reality Visual Field (VR-VF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 14 Dec 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- diagnosis of primary open-angle glaucoma
- ability to perform visual field testing
- capacity to provide informed consent to research protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Eadie Technologies Inc
Halifax, Nova Scotia, B3L1N3
Lynn Murphy, 19024072380, lynn@eadietech.com
Reann Post, BSc, 9029560601, reann.post@dal.ca
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Glaucoma Open-Angle
- Being tested
- Virtual Reality Visual Field (VR-VF)
- Keywords
- Virtual Reality, Visual Field, Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual Reality Visual Field (VR-VF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)
Secondary outcomes (2)
Reliability over time
Assessed through examination of variation in global indices and point-wise threshold values
Measured: Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)
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)
Measured: Questionnaire completed at the end of each testing session, following the completion of both visual field tests (throughout study enrolment, average 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start14 Dec 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Glaucoma Open-AngleStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will perform both a Humphrey visual field test and a virtual reality based visual field test.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brennan Eadie, Nova Scotia Health Authority
- Investigators
- Brennan Eadie, MD, PhD, FRCSC, Principal investigator, Nova Scotia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063537
- Sponsor's protocol ID
- 1030608
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19492005Selvan 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.
PubMed 38036608Glen 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.
PubMed 24413347Tham 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.
PubMed 24974815
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07063537
- Acronym / sponsor ID
- 1030608
- Conditions
- Glaucoma Open-Angle
- Keywords
- Virtual Reality, Visual Field, Glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 14 Dec 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will perform both a Humphrey visual field test and a virtual reality based visual field test.
| Arm | Type | Receives |
|---|---|---|
| Visual Field Testing | Experimental | Device: Virtual Reality Visual Field (VR-VF)Participants will perform both a virtual reality-based visual field test and a standard Humphrey visual field test for both eyes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years of age
- diagnosis of primary open-angle glaucoma
- ability to perform visual field testing
- capacity to provide informed consent to research protocol
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Visual Field Testing |
Primary outcome
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)
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.
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.
2 secondary outcomes
Reliability over time
Time frame: Measured during each visual field test on visits 1 through 5 (throughout study completion, average 2 months)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 19492005Canadian 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.
- Background: PubMed 38036608Selvan 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.
- Background: PubMed 24413347Glen 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.
- Background: PubMed 24974815Tham 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.
- Individual participant dataSharing planned: No
Related trials for Glaucoma Open-Angle
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brennan Eadie, MD, PhD, FRCSC principal investigator
Nova Scotia Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Visual Field (VR-VF) in people with Glaucoma Open-Angle, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reann Post, BSc (19029560601, reann.post@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07063537, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.