Back to resultsFeasibility of Visual Field Testing With a Virtual Reality Headset
Primary Purpose
Glaucoma
Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Visual Field Testing
Sponsored by
About this trial
This is an interventional device feasibility trial for Glaucoma
Eligibility 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.
Sites / Locations
- Victoria General Hopsital - Nova Scotia Health Authority
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Patients will perform visual field testing with the Humphrey Field Analyzer and with the Virtual Reality Headset
Outcomes
Primary Outcome Measures
Visual field differential light sensitivity threshold
Comparison of differential light sensitivity threshold estimated with the Humphrey Field Analyzer and the Virtual Reality headset
Secondary Outcome Measures
Reproducibility of sensitivity values
Comparison of the reproducibility of sensitivity values estimated with the Humphrey Field Analyzer and the Virtual Reality headset
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03748654
Brief Title
Feasibility of Visual Field Testing With a Virtual Reality Headset
Official Title
Feasibility of Visual Field Testing With a Virtual Reality Headset
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Suspended
Why Stopped
COVID-19
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brennan Eadie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Patients will perform visual field testing with the Humphrey Field Analyzer and with the Virtual Reality Headset
Intervention Type
Diagnostic Test
Intervention Name(s)
Visual Field Testing
Intervention Description
Visual field test using the protocol 24-2 Threshold Test
Primary Outcome Measure Information:
Title
Visual field differential light sensitivity threshold
Description
Comparison of differential light sensitivity threshold estimated with the Humphrey Field Analyzer and the Virtual Reality headset
Time Frame
Three weeks
Secondary Outcome Measure Information:
Title
Reproducibility of sensitivity values
Description
Comparison of the reproducibility of sensitivity values estimated with the Humphrey Field Analyzer and the Virtual Reality headset
Time Frame
Three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brennan Eadie, MD, PhD
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria General Hopsital - Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2Y9
Country
Canada
12. IPD Sharing Statement
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Feasibility of Visual Field Testing With a Virtual Reality Headset
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