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出境医 / 临床实验 / Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device

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

Study Description
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
Layout table for study information
Study Type : Observational
Actual Enrollment : 70 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
Actual Primary Completion Date : November 1, 2020
Actual Study Completion Date : December 30, 2020
Arms and Interventions
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
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
Layout table for eligibility information
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

Locations
Layout table for location information
Switzerland
University Hospital Bern, Department of Ophthalmology
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
Layout table for investigator information
Principal Investigator: René G Höhn, Dr. med. Department of Ophthalmology, University Hospital Bern, Berne, Switzerland
Tracking Information
First Submitted Date July 3, 2019
First Posted Date July 8, 2019
Last Update Posted Date March 1, 2021
Actual Study Start Date August 2, 2019
Actual Primary Completion Date November 1, 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 Completed
Actual Enrollment
 (submitted: February 26, 2021) 		70
Original Estimated Enrollment
 (submitted: July 3, 2019) 		74
Actual Study Completion Date December 30, 2020
Actual Primary Completion Date November 1, 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 information is only displayed when the study is recruiting subjects
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 February 2021

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