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Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study

Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05030714
Enrollment
120
Registered
2021-09-01
Start date
2023-04-30
Completion date
2026-04-30
Last updated
2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

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.

Interventions

DIAGNOSTIC_TESTVisual Field Testing

Visual field testing using the protocol 24-2 and/or 10-2 Threshold Test

Sponsors

Brennan Eadie
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Visual field differential light sensitivity5 weeksComparison of differential light sensitivity threshold estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.

Secondary

MeasureTime frameDescription
Reproducibility of sensitivity values5 weeksComparison of the reproducibility of sensitivity values estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.

Countries

Canada

Contacts

Primary ContactBrennan Eadie, MD, PhD
eadie.brennan.d@gmail.com902-292-0873

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026