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

Study Overview
=================
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.

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

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Diagnostic Test: Visual Field Testing


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Patients will perform visual field testing with the Humphrey Visual Field Analyzer and with the custom head-mounted device. | Diagnostic Test: Visual Field Testing<br>* Visual field testing using the protocol 24-2 and/or 10-2 Threshold Test<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |