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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

Tracking Information
First Submitted Date July 3, 2019
First Posted Date July 8, 2019
Last Update Posted Date April 20, 2020
Actual Study Start Date August 2, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device
Official Title Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device on Participants With Normal and Glaucomatous Visual Fields
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Visual Field Tests
Intervention Diagnostic Test: virtual reality perimeter
Both groups will be examined with a standard automated perimeter as well as with the virtual reality perimeter.
Study Groups/Cohorts
  • 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
    Intervention: Diagnostic Test: 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
    Intervention: Diagnostic Test: virtual reality perimeter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 3, 2019)
74
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: René G Höhn, Dr. med. +41 31 63 22501 rene.hoehn@insel.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04010383
Other Study ID Numbers 2018-01902
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital Inselspital, Berne
Study Sponsor University Hospital Inselspital, Berne
Collaborators University of Bern
Investigators
Principal Investigator: René G Höhn, Dr. med. Department of Ophthalmology, University Hospital Bern, Berne, Switzerland
PRS Account University Hospital Inselspital, Berne
Verification Date April 2020