GlaucomaNCT03748654
Feasibility of Visual Field Testing With a Virtual Reality Headset
A study testing Visual Field Testing in people with Glaucoma, run by Brennan Eadie at 1 site in Canada.
Trial summary
This study aim to determine the feasibility of using a virtual reality (VR) headset (HTC Vive) to test the visual field. The VR headset test will be compared to a conventional visual field test, using the Humphrey Field Analyzer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Visual Field Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Previous visual field test with Humphrey Field Analyzer indicating normal field, early glaucomatous field damage, or advanced glaucomatous field damage, according to Canadian Glaucoma Society Guidelines.
- Ability to understand and consent to the study.
Who cannot join
- Presence of non-glaucomatous pathology that could influence the visual field test, such as media opacities.
- Previous intraocular surgery less than 6 months from inclusion.
- Difficulty to execute a reliable visual field test.
- Potential contra-indications to use of virtual reality headset, including: anxiety disorder, pregnancy, seizure disorder, cardiac pacemaker or other implantable device, severe vertigo or balance disturbance.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Victoria General Hopsital - Nova Scotia Health Authority
Halifax, Nova Scotia, B3H2Y9
About this study
This study aim to determine the feasibility of using a virtual reality (VR) headset (HTC Vive) to test the visual field. The VR headset test will be compared to a conventional visual field test, using the Humphrey Field Analyzer. The investigators will include 10 healthy patients without visual field defect, 10 patients with early glaucomatous visual field defect, and 10 patients with advanced visual field defect. Each patient will perform the conventional test twice and the VR headset test 4 times, divided in 3 visits within a 2 month period. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and VR tests will be similar.
- Conditions
- Glaucoma
- Being tested
- Visual Field Testing
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Field TestingDiagnostic test
Visual field test using the protocol 24-2 Threshold Test
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Patients will perform visual field testing with the Humphrey Field Analyzer and with the Virtual Reality Headset Receives: Diagnostic Test: Visual Field Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual field differential light sensitivity threshold
Comparison of differential light sensitivity threshold estimated with the Humphrey Field Analyzer and the Virtual Reality headset
Measured: Three weeks
Secondary outcomes (1)
Reproducibility of sensitivity values
Comparison of the reproducibility of sensitivity values estimated with the Humphrey Field Analyzer and the Virtual Reality headset
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brennan Eadie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brennan Eadie, Nova Scotia Health Authority
- Investigators
- Brennan Eadie, MD, PhD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748654
- Sponsor's protocol ID
- E001
- Status last verified
- Jul 2021
- First submitted
- 16 Nov 2018
- Last updated
- 2 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Visual Field Testing With a Virtual Reality Headset
- ClinicalTrials.gov ID
- NCT03748654
- Acronym / sponsor ID
- E001
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brennan EadieUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 21 Nov 2018 (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.
This study aim to determine the feasibility of using a virtual reality (VR) headset (HTC Vive) to test the visual field. The VR headset test will be compared to a conventional visual field test, using the Humphrey Field Analyzer. The investigators will include 10 healthy patients without visual field defect, 10 patients with early glaucomatous visual field defect, and 10 patients with advanced visual field defect. Each patient will perform the conventional test twice and the VR headset test 4 times, divided in 3 visits within a 2 month period. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and VR tests will be similar.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Diagnostic Test: Visual Field TestingPatients will perform visual field testing with the Humphrey Field Analyzer and with the Virtual Reality Headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previous visual field test with Humphrey Field Analyzer indicating normal field, early glaucomatous field damage, or advanced glaucomatous field damage, according to Canadian Glaucoma Society Guidelines.
- Ability to understand and consent to the study.
Key exclusion criteria (4 listed)
- Presence of non-glaucomatous pathology that could influence the visual field test, such as media opacities.
- Previous intraocular surgery less than 6 months from inclusion.
- Difficulty to execute a reliable visual field test.
- Potential contra-indications to use of virtual reality headset, including: anxiety disorder, pregnancy, seizure disorder, cardiac pacemaker or other implantable device, severe vertigo or balance disturbance.
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 |
|---|---|---|
| Visual Field TestingVisual field test using the protocol 24-2 Threshold Test | Diagnostic test | Single Arm |
Primary outcome
Visual field differential light sensitivity threshold
Time frame: Three weeks
Comparison of differential light sensitivity threshold estimated with the Humphrey Field Analyzer and the Virtual Reality headset
1 secondary outcome
Reproducibility of sensitivity values
Time frame: Three weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
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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. This study is not recruiting at the moment.
Brennan Eadie, MD, PhD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Field Testing in people with Glaucoma, run by Brennan Eadie 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 2 inclusion and 4 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: paused, as of the sponsor's last update on 2 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual field differential light sensitivity threshold (time frame: Three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2021.