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

Visual Field Tests Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04010383
• Other study ID #: 2018-01902
• Status: Completed
• Start date: August 2, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 30, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Bern, Department of Ophthalmology	Berne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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