Clinical trial NCT04010383: Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device
Official title: Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device on Participants With Normal and Glaucomatous Visual Fields
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Field Tests
Keywords: Perimetry
Virtual reality device
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2019-07-08
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: non-inferiority estimation quality of mean defect (MD) measured in decibels (dB) between the virtual reality perimeter and the OCTOPUS 900 perimeter
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: University Hospital Bern, Department of Ophthalmology
Study officials:
affiliation: Department of Ophthalmology, University Hospital Bern, Berne, Switzerland
name: René G Höhn, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: