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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05030714
• Other study ID #: E002
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: April 2026

Study information

• Verified date: February 2023
• Source: Nova Scotia Health Authority
• Contact: Brennan Eadie, MD, PhD
• Phone: 902-292-0873
• Email: eadie.brennan.d[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Diagnostic Test:
• Visual Field Testing
Visual field testing using the protocol 24-2 and/or 10-2 Threshold Test

Locations

Country	Name	City	State
Canada	Eadie Technologies Inc.	Halifax	Nova Scotia
Canada	Victoria General Hopsital - Nova Scotia Health Authority	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Brennan Eadie

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual field differential light sensitivity	Comparison of differential light sensitivity threshold estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.	5 weeks
Secondary	Reproducibility of sensitivity values	Comparison of the reproducibility of sensitivity values estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.	5 weeks