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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-02

Study Completion Date

2020-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Visual Field Tests

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

virtual reality perimeter

Intervention Type DIAGNOSTIC_TEST

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

virtual reality perimeter

Intervention Type DIAGNOSTIC_TEST

Both groups will be examined with a standard automated perimeter as well as with the virtual reality perimeter.

Interventions

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virtual reality perimeter

Both groups will be examined with a standard automated perimeter as well as with the virtual reality perimeter.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes