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

NCT ID: NCT05030714

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-30

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single Arm

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

Group Type EXPERIMENTAL

Visual Field Testing

Intervention Type DIAGNOSTIC_TEST

Visual field testing using the protocol 24-2 and/or 10-2 Threshold Test

Interventions

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Visual Field Testing

Visual field testing using the protocol 24-2 and/or 10-2 Threshold Test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brennan Eadie

OTHER

Sponsor Role lead

Responsible Party

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Brennan Eadie

Assistant Professor, Department of Ophthalmology, Dalhousie University and Nova Scotia Health Authority; MD, PhD, FRCSC

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Brennan Eadie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Healthy Authority

Locations

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Victoria General Hopsital - Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Site Status

Eadie Technologies Inc.

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Central Contacts

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Brennan Eadie, MD, PhD

Role: CONTACT

902-292-0873

Facility Contacts

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Brennan Eadie, MD, PhD

Role: primary

902-292-0873

Brennan Eadie, MD, PhD

Role: primary

902-292-0873

Other Identifiers

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E002

Identifier Type: -

Identifier Source: org_study_id

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