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

• ClinicalTrials.gov Identifier: NCT04010383
• Recruitment Status: Completed
• First Posted: July 8, 2019
• Last Update Posted: March 1, 2021
• Sponsor: University Hospital Inselspital, Berne
• 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: 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
• 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

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

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