Feasibility of Visual Field Testing With a Virtual Reality Headset

Sponsor

Brennan Eadie (Other)

Overall Status

Suspended

CT.gov ID

NCT03748654

Collaborator

(none)

Enrollment

Location

Arm

17.9

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aim to determine the feasibility of using a virtual reality (VR) headset (HTC Vive) to test the visual field. The VR headset test will be compared to a conventional visual field test, using the Humphrey Field Analyzer. The investigators will include 10 healthy patients without visual field defect, 10 patients with early glaucomatous visual field defect, and 10 patients with advanced visual field defect. Each patient will perform the conventional test twice and the VR headset test 4 times, divided in 3 visits within a 2 month period. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and VR tests will be similar.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Diagnostic Test: Visual Field Testing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Feasibility of Visual Field Testing With a Virtual Reality Headset

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm Patients will perform visual field testing with the Humphrey Field Analyzer and with the Virtual Reality Headset	Diagnostic Test: Visual Field Testing Visual field test using the protocol 24-2 Threshold Test

Arm

Intervention/Treatment

Experimental: Single Arm

Patients will perform visual field testing with the Humphrey Field Analyzer and with the Virtual Reality Headset

Diagnostic Test: Visual Field Testing

Visual field test using the protocol 24-2 Threshold Test

Outcome Measures

Primary Outcome Measures

Visual field differential light sensitivity threshold [Three weeks]
Comparison of differential light sensitivity threshold estimated with the Humphrey Field Analyzer and the Virtual Reality headset

Secondary Outcome Measures

Reproducibility of sensitivity values [Three weeks]
Comparison of the reproducibility of sensitivity values estimated with the Humphrey Field Analyzer and the Virtual Reality headset

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Previous visual field test with Humphrey Field Analyzer indicating normal field, early glaucomatous field damage, or advanced glaucomatous field damage, according to Canadian Glaucoma Society Guidelines.
Ability to understand and consent to the study.

Exclusion Criteria:

Presence of non-glaucomatous pathology that could influence the visual field test, such as media opacities.
Previous intraocular surgery less than 6 months from inclusion.
Difficulty to execute a reliable visual field test.
Potential contra-indications to use of virtual reality headset, including: anxiety disorder, pregnancy, seizure disorder, cardiac pacemaker or other implantable device, severe vertigo or balance disturbance.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Victoria General Hopsital - Nova Scotia Health Authority	Halifax	Nova Scotia	Canada	B3H2Y9

Sponsors and Collaborators

Brennan Eadie

Investigators

Principal Investigator: Brennan Eadie, MD, PhD, Nova Scotia Health Authority

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brennan Eadie, Assistant Professor, Department of Ophthalmology, Dalhousie University and Nova Scotia Health Authority; MD, PhD, FRCSC, Nova Scotia Health Authority

ClinicalTrials.gov Identifier:

NCT03748654

Other Study ID Numbers:

E001

First Posted:

Nov 21, 2018

Last Update Posted:

Aug 2, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glaucoma

Study Results

No Results Posted as of Aug 2, 2021