Status:
COMPLETED
Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University of Bern
Conditions:
Visual Field Tests
Eligibility:
All Genders
40-80 years
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 acq...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04010383
Start Date
August 2 2019
End Date
December 30 2020
Last Update
March 1 2021
Active Locations (1)
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1
University Hospital Bern, Department of Ophthalmology
Bern, Switzerland, 3010