Head-Mounted Visual Field Testing Device for Glaucoma

Recruiting at 1 trial location

Overseen By Brennan Eadie, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brennan Eadie

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Brennan Eadie, MD, PhD

Principal Investigator

Nova Scotia Healthy Authority

Eligibility Criteria

This trial is for individuals who can consent and have had a visual field test indicating normal or varying degrees of glaucomatous damage. It excludes those with anxiety disorders, severe vertigo, certain past eye surgeries (except cataract surgery), pregnancy, seizure disorders, extreme refractive errors, inability to make informed decisions, significant eye opacity, cardiac pacemakers or similar devices.

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

I understand the study and agree to participate.

Exclusion Criteria

Cardiac pacemaker or other implantable devices

Anxiety disorder

Significant media opacity

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Testing

Participants perform visual field testing with both the Humphrey Visual Field Analyzer and the custom head-mounted device, followed by a questionnaire on comfort and satisfaction.

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for any delayed responses or feedback after the testing phase.

2 weeks

Treatment Details

Interventions

• Visual Field Testing

Trial Overview The study tests a new head-mounted device for visual field testing against the standard Humphrey Visual Field Analyzer in patients with different stages of glaucoma. Each participant will use both devices over five weekly visits and complete questionnaires on comfort and satisfaction.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Brennan Eadie

Lead Sponsor

Trials

2

Recruited

150+