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

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ClinicalTrials.gov Identifier: NCT04010383
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : April 20, 2020
Sponsor:
Collaborator:
University of Bern
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Study Description
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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.


Condition or disease Intervention/treatment
Visual Field Tests Diagnostic Test: virtual reality perimeter

Study Design
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Study Type : Observational
Estimated Enrollment : 74 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device on Participants With Normal and Glaucomatous Visual Fields
Actual Study Start Date : August 2, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Diagnostic Test: virtual reality perimeter
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
 Diagnostic Test: virtual reality perimeter
Both groups will be examined with a standard automated perimeter as well as with the virtual reality perimeter.


Outcome Measures
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Primary Outcome Measures :
  1. non-inferiority estimation quality of mean defect (MD) measured in decibels (dB) between the virtual reality perimeter and the OCTOPUS 900 perimeter [ Time Frame: 2 weeks ]
    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
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010383


Contacts
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Contact: René G Höhn, Dr. med. +41 31 63 22501 rene.hoehn@insel.ch

Locations
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Switzerland
University Hospital Bern, Department of Ophthalmology Recruiting
Berne, Switzerland, 3010
Contact: René G Höhn, Dr. med.    0041316329717    rene.hoehn@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
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Principal Investigator: René G Höhn, Dr. med. Department of Ophthalmology, University Hospital Bern, Berne, Switzerland
More Information
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04010383    
Other Study ID Numbers: 2018-01902
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Perimetry
Virtual reality device