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

NCT04010383 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2021-03-01

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04010383 on ClinicalTrials.gov