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

Not Applicable

Not yet recruiting

• Conditions: Glaucoma
• Interventions: Diagnostic Test: Visual Field Testing

• Registration Number: NCT05030714
• Lead Sponsor: Brennan Eadie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21
• Study Start: 2023-04
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Visual Field Testing	Patients will perform visual field testing with the Humphrey Visual Field Analyzer and with the custom head-mounted device.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Victoria General Hopsital - Nova Scotia Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada

Eadie Technologies Inc.; 🇨🇦 Halifax, Nova Scotia, Canada