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

Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device on Participants With Normal and Glaucomatous Visual Fields

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04010383
Enrollment
70
Registered
2019-07-08
Start date
2019-08-02
Completion date
2020-12-30
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Field Tests

Keywords

Perimetry, Virtual reality device

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.

Interventions

DIAGNOSTIC_TESTvirtual reality perimeter

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

Sponsors

University of Bern
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes

Inclusion 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

*

Design outcomes

Primary

MeasureTime frameDescription
non-inferiority estimation quality of mean defect (MD) measured in decibels (dB) between the virtual reality perimeter and the OCTOPUS 900 perimeter2 weeksThe 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026