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ClinicalTrials.gov ID

NCT05030714

Lead Sponsor

Brennan EadieOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

120Estimated

Last Update Posted

Feb 21, 2023Actual

Start Date

Apr 2023Estimated

Primary Completion Date

Apr 2026Estimated

Completion Date

Apr 2026Estimated

Official Title

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

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.

• Glaucoma

• Visual Field Testing

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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

Primary Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Brennan EadieOTHER

eadie.brennan.d@gmail.com902-292-0873