NCT04010383

Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device

Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device on Participants With Normal and Glaucomatous Visual Fields

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DIAGNOSTIC_TEST	virtual reality perimeter	Both groups will be examined with a standard automated perimeter as well as with the virtual reality perimeter.

Timeline

• Start date: 2019-08-02
• Primary completion: 2020-11-01
• Completion: 2020-12-30
• First posted: 2019-07-08
• Last updated: 2021-03-01

Locations

1 site across 1 country: Switzerland