Feasibility of Visual Field Testing With a Virtual Reality Headset

July 26, 2021 updated by: Brennan Eadie
This study aim to determine the feasibility of using a virtual reality (VR) headset (HTC Vive) to test the visual field. The VR headset test will be compared to a conventional visual field test, using the Humphrey Field Analyzer. The investigators will include 10 healthy patients without visual field defect, 10 patients with early glaucomatous visual field defect, and 10 patients with advanced visual field defect. Each patient will perform the conventional test twice and the VR headset test 4 times, divided in 3 visits within a 2 month period. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and VR tests will be similar.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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 Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H2Y9
        • Victoria General Hopsital - Nova Scotia Health Authority

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previous visual field test with Humphrey Field Analyzer indicating normal field, early glaucomatous field damage, or advanced glaucomatous field damage, according to Canadian Glaucoma Society Guidelines.
  • Ability to understand and consent to the study.

Exclusion Criteria:

  • Presence of non-glaucomatous pathology that could influence the visual field test, such as media opacities.
  • Previous intraocular surgery less than 6 months from inclusion.
  • Difficulty to execute a reliable visual field test.
  • Potential contra-indications to use of virtual reality headset, including: anxiety disorder, pregnancy, seizure disorder, cardiac pacemaker or other implantable device, severe vertigo or balance disturbance.

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: Device Feasibility
  • 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 Field Analyzer and with the Virtual Reality Headset
Diagnostic test: Visual Field Testing
Visual field test using the protocol 24-2 Threshold Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual field differential light sensitivity threshold
Time Frame: Three weeks
Comparison of differential light sensitivity threshold estimated with the Humphrey Field Analyzer and the Virtual Reality headset
Three weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reproducibility of sensitivity values
Time Frame: Three weeks
Comparison of the reproducibility of sensitivity values estimated with the Humphrey Field Analyzer and the Virtual Reality headset
Three 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 Health 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)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 19, 2018

First Posted (Actual)

November 21, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E001

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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