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

NCT04010383 | Completed

• 1 other identifier: 2018-01902
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Field Tests

Keywords

Perimetry; Virtual reality device

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

virtual reality perimeter DIAGNOSTIC_TEST

Both groups will be examined with a standard automated perimeter as well as with the virtual reality perimeter.

Glaucomatous subjects; normal visual field subjects

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

University Hospital Bern, Department of Ophthalmology

Bern, 3010, Switzerland

Location

Study Officials

• René G Höhn, Dr. med.

  Department of Ophthalmology, University Hospital Bern, Berne, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 8, 2019
• Study Start: August 2, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 30, 2020
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)