Skip to main content
OpenTrials
Completed

NCT Number: NCT04010383

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bern, Department of Ophthalmology

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Written informed consent

Inclusion criteria

for normal visual field subjects:

  • Cataract yes or no
  • Age range 40 - 80 years- normal visual field (MD: < +2 dB)
  • Refractive error within ±5 dpt. spherical equivalent
  • Astigmatism of < -3 dpt.
  • Visual acuity of ≥0.3 logMar (decimal ≥0.5)
  • Experience in perimetry (history of at least one perimetry examination)
  • False positive or negative errors each less than 20% in each examination

Inclusion criteria

for glaucomatous subjects:

  • Primary open-angle/ pseudoexfoliation/ primary angle-closure glaucoma
  • Early to moderate visual field loss (MD: +2 to +12 dB)
  • Refractive error within ±5 dpt. spherical equivalent
  • Astigmatism of < -3 dpt.
  • Visual acuity of ≥0.3 logMar (decimal ≥0.5)
  • Experience in perimetry (history of at least one perimetry examination)
  • False positive or negative errors each less than 20% in each examination
  • Cataract yes or no

Exclusion criteria

  • Exclusion criteria are subjects younger than 40 and older than 80 years
  • Inability to follow the procedure
  • Insufficient knowledge of project language
  • The history of other ocular diseases than glaucoma or cataract or other conditions that might affect visual field testing (e.g. pituitary lesions, demyelinating diseases).
  • Any history of epilepsy

Treatment and study plan

virtual reality perimeter

Diagnostic Test

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

Primary outcomes

  1. non-inferiority estimation quality of mean defect (MD) measured in decibels (dB) between the virtual reality perimeter and the OCTOPUS 900 perimeter

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • University of Bern

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 8, 2019
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.