NCT05030714

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Brennan Eadie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Visual Field Testing	Visual field testing using the protocol 24-2 and/or 10-2 Threshold Test

Timeline

• Start date: 2023-04-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2021-09-01
• Last updated: 2023-02-21

Locations

2 sites across 1 country: Canada