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

Study Overview
=================
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.

Official Title
-----------------
Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device on Participants With Normal and Glaucomatous Visual Fields

Conditions
-----------------
Visual Field Tests

Intervention / Treatment
-----------------
* Diagnostic Test: virtual reality perimeter


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal visual field subjects<br>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 | Diagnostic Test: virtual reality perimeter<br>* Both groups will be examined with a standard automated perimeter as well as with the virtual reality perimeter.<br>|
| Glaucomatous subjects<br>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 | Diagnostic Test: virtual reality perimeter<br>* Both groups will be examined with a standard automated perimeter as well as with the virtual reality perimeter.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-inferiority estimation quality of mean defect (MD) measured in decibels (dB) between the virtual reality perimeter and the OCTOPUS 900 perimeter | 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. | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perimetry, Virtual reality device