Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device
NCT04010383 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70
Last updated 2021-03-01
Summary
It is hypothesized that performing VF measurements with a Virtual Reality headset using similar testing strategies as implemented in conventional perimeters, allow for a non-inferior quality in VF acquisitions. The results of this study will show if valid measurements of such devices in human subjects can be obtained.
The primary endpoint of this study is the non-inferiority estimation quality of participant's mean defect (MD) measured in decibel (dB) between the head-mounted display and an OCTOPUS perimeter using the dynamic strategy (DS) for participants with normal or glaucomatous visual field. The MD is a clinical measure for the average loss of visual function calculated from the visual field of a participant.
Conditions
- Visual Field Tests
Interventions
- DIAGNOSTIC_TEST
-
virtual reality perimeter
Both groups will be examined with a standard automated perimeter as well as with the virtual reality perimeter.
Sponsors & Collaborators
-
University of Bern
collaborator OTHER -
Insel Gruppe AG, University Hospital Bern
lead OTHER
Principal Investigators
-
René G Höhn, Dr. med. · Department of Ophthalmology, University Hospital Bern, Berne, Switzerland
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-08-02
- Primary Completion
- 2020-11-01
- Completion
- 2020-12-30
Countries
- Switzerland
Study Locations
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