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

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Visual Field Tests

Treatments: Diagnostic Test: virtual reality perimeter

Study type: Observational

Funder types: Other

Identifiers

NCT04010383

2018-01902

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

70 participants in 2 patient groups

normal visual field subjects

Description:

* 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

Treatment:

Diagnostic Test: virtual reality perimeter

Glaucomatous subjects

Description:

* 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

Treatment:

Diagnostic Test: virtual reality perimeter