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

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.

Study Overview

• Status: Completed
• Conditions: Visual Field Tests
• Intervention / Treatment: Diagnostic test: virtual reality perimeter

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Switzerland
  • Berne, Switzerland, 3010
    • University Hospital Bern, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population consists of glaucoma patients and patients with normal visual fields respecting the inclusion/exclusion criteria. There is no restriction in ethnicity.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: virtual reality perimeter; Both groups will be examined with a standard automated perimeter as well as with the virtual reality perimeter.
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; Age range 40 - 80 years	Diagnostic test: virtual reality perimeter; Both groups will be examined with a standard automated perimeter as well as with the virtual reality perimeter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
non-inferiority estimation quality of mean defect (MD) measured in decibels (dB) between the virtual reality perimeter and the OCTOPUS 900 perimeter	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.	2 weeks

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: University of Bern
• Investigators: Principal Investigator: René G Höhn, Dr. med., Department of Ophthalmology, University Hospital Bern, Berne, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2019
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Perimetry; Virtual reality device
• Other Study ID Numbers: 2018-01902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No