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Feasibility of Visual Field Testing With a Virtual Reality Headset

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748654
Recruitment Status : Not yet recruiting
First Posted : November 21, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Brennan Eadie, Nova Scotia Health Authority

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glaucoma Diagnostic Test: Visual Field Testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Feasibility of Visual Field Testing With a Virtual Reality Headset
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748654


Contacts
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Contact: Brennan Eadie, MD, PhD 902-292-0873 eadie.brennan.d@gmail.com

Sponsors and Collaborators
Brennan Eadie
Investigators
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Principal Investigator: Brennan Eadie, MD, PhD Nova Scotia Health Authority
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Responsible Party: Brennan Eadie, Assistant Professor, Department of Ophthalmology, Dalhousie University and Nova Scotia Health Authority; MD, PhD, FRCSC, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03748654    
Other Study ID Numbers: E001
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases