GlaucomaNCT05030714
Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study
A study testing Visual Field Testing in people with Glaucoma, run by Brennan Eadie at 2 sites in Canada.
Trial summary
This proof-of-concept study aims to determine the feasibility and effectiveness of using a custom head-mounted device for visual field testing. The novel head-mounted device, with custom software, will be compared to a conventional visual field test: The Humphrey Visual 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
- 120 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2023to Apr 2026
- 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, moderate glaucomatous field damage, or advanced glaucomatous field damage.
- Ability to understand and consent to the study.
Who cannot join
- Diagnosis of secondary glaucoma
- Diagnosis of non-glaucomatous optic neuropathy or other significant ophthalmic diagnosis that could limit vision (ex. age-related macular degeneration)
- Significant media opacity
- Previous intraocular surgery other than cataract surgery
- Anxiety disorder
- Pregnancy
Show all 11Show fewer
- Seizure disorder
- Cardiac pacemaker or other implantable devices
- Severe vertigo or balance disturbance
- Refractive error greater than +4 diopters and less than -6 diopters spherical equivalent
- Inability to demonstrate competence to make informed decision regarding study participation
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Victoria General Hopsital - Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9
Brennan Eadie, MD, PhD, 902-292-0873, eadie.brennan.d@gmail.com
Eadie Technologies Inc.
Halifax, Nova Scotia, B3L 4W8
Brennan Eadie, MD, PhD, 902-292-0873, eadie.brennan.d@gmail.com
About this study
This proof-of-concept study aims to determine the feasibility and effectiveness of using a custom head-mounted device for visual field testing. The novel head-mounted device, with custom software, will be compared to a conventional visual field test: The Humphrey Visual Field Analyzer. The investigators will include 30 healthy normal patients, 30 glaucoma suspects, 30 patients with moderate glaucoma, and 30 patients with advanced glaucoma (total: 120 patients). Each patient will perform the conventional test and the head-mounted device visual field test during the study visit, with the order (i.e., which device the patient starts with) being randomized. After the two tests, the patient will fill out a questionnaire to gather information regarding patient comfort and satisfaction. This will repeat each week for 5 weeks, for a total of 5 study visits. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and head-mounted device 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 testing using the protocol 24-2 and/or 10-2 Threshold Test
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Patients will perform visual field testing with the Humphrey Visual Field Analyzer and with the custom head-mounted device. 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
Comparison of differential light sensitivity threshold estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.
Measured: 5 weeks
Secondary outcomes (1)
Reproducibility of sensitivity values
Comparison of the reproducibility of sensitivity values estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study startApr 2023 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 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 Healthy Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030714
- Sponsor's protocol ID
- E002
- Status last verified
- Feb 2023
- First submitted
- 23 Aug 2021
- Last updated
- 21 Feb 2023
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT05030714
- Acronym / sponsor ID
- E002
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Brennan EadieUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 1 Sep 2021 (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 proof-of-concept study aims to determine the feasibility and effectiveness of using a custom head-mounted device for visual field testing. The novel head-mounted device, with custom software, will be compared to a conventional visual field test: The Humphrey Visual Field Analyzer. The investigators will include 30 healthy normal patients, 30 glaucoma suspects, 30 patients with moderate glaucoma, and 30 patients with advanced glaucoma (total: 120 patients). Each patient will perform the conventional test and the head-mounted device visual field test during the study visit, with the order (i.e., which device the patient starts with) being randomized. After the two tests, the patient will fill out a questionnaire to gather information regarding patient comfort and satisfaction. This will repeat each week for 5 weeks, for a total of 5 study visits. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and head-mounted device will be similar.
Study design
- Primary purpose
- Other
- 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 Visual Field Analyzer and with the custom head-mounted device. |
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, moderate glaucomatous field damage, or advanced glaucomatous field damage.
- Ability to understand and consent to the study.
Key exclusion criteria (11 listed)
- Diagnosis of secondary glaucoma
- Diagnosis of non-glaucomatous optic neuropathy or other significant ophthalmic diagnosis that could limit vision (ex. age-related macular degeneration)
- Significant media opacity
- Previous intraocular surgery other than cataract surgery
- Anxiety 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 |
|---|---|---|
| Visual Field TestingVisual field testing using the protocol 24-2 and/or 10-2 Threshold Test | Diagnostic test | Single Arm |
Primary outcome
Visual field differential light sensitivity
Time frame: 5 weeks
Comparison of differential light sensitivity threshold estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.
1 secondary outcome
Reproducibility of sensitivity values
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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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 Healthy Authority
2 sites 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 2 sites 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 11 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: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Brennan Eadie, MD, PhD (902-292-0873, eadie.brennan.d@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual field differential light sensitivity (time frame: 5 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 21 Feb 2023.