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

Brennan Eadie

Status: Not yet enrolling

Conditions: Glaucoma

Treatments: Diagnostic Test: Visual Field Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT05030714

E002

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Single Arm

Experimental group

Description:

Patients will perform visual field testing with the Humphrey Visual Field Analyzer and with the custom head-mounted device.

Treatment:

Diagnostic Test: Visual Field Testing