Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Arm Patients will perform visual field testing with the Humphrey Visual Field Analyzer and with the custom head-mounted device. |
Diagnostic Test: Visual Field Testing
Visual field testing using the protocol 24-2 and/or 10-2 Threshold Test
|
Outcome Measures
Primary Outcome Measures
- Visual field differential light sensitivity [5 weeks]
Comparison of differential light sensitivity threshold estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.
Secondary Outcome Measures
- Reproducibility of sensitivity values [5 weeks]
Comparison of the reproducibility of sensitivity values estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Previous visual field test with Humphrey Field Analyzer indicating normal field, early glaucomatous field damage, moderate glaucomatous field damage, or advanced glaucomatous field damage.
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Ability to understand and consent to the study.
Exclusion Criteria:
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Diagnosis of secondary glaucoma
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Diagnosis of non-glaucomatous optic neuropathy or other significant ophthalmic diagnosis that could limit vision (ex. age-related macular degeneration)
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Significant media opacity
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Previous intraocular surgery other than cataract surgery
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Anxiety disorder
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Pregnancy
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Seizure disorder
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Cardiac pacemaker or other implantable devices
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Severe vertigo or balance disturbance
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Refractive error greater than +4 diopters and less than -6 diopters spherical equivalent
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Inability to demonstrate competence to make informed decision regarding study participation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Victoria General Hopsital - Nova Scotia Health Authority | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 2 | Eadie Technologies Inc. | Halifax | Nova Scotia | Canada | B3L 4W8 |
Sponsors and Collaborators
- Brennan Eadie
Investigators
- Principal Investigator: Brennan Eadie, MD, PhD, Nova Scotia Healthy Authority
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E002