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

February 16, 2023 updated by: Brennan Eadie
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Victoria General Hopsital - Nova Scotia Health Authority
        • Contact:
      • Halifax, Nova Scotia, Canada, B3L 4W8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual field differential light sensitivity
Time Frame: 5 weeks
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
Time Frame: 5 weeks
Comparison of the reproducibility of sensitivity values estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brennan Eadie

Investigators

  • Principal Investigator: Brennan Eadie, MD, PhD, Nova Scotia Healthy Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

April 1, 2026

Study Completion (Anticipated)

April 1, 2026

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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