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

Completed

• Conditions: Visual Field Tests
• Interventions: Diagnostic Test: virtual reality perimeter

• Registration Number: NCT04010383
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-08
• Study Start: 2019-08-02
• Primary Completion: 2020-11-01
• Study Completion: 2020-12-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-26
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
normal visual field subjects	virtual reality perimeter	* 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
Glaucomatous subjects	virtual reality perimeter	* 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

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Bern, Department of Ophthalmology; 🇨🇭 Berne, Switzerland