Feasibility of Visual Field Testing With a Virtual Reality Headset

NCT ID: NCT03748654

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Single Arm

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

Group Type EXPERIMENTAL

Visual Field Testing

Intervention Type DIAGNOSTIC_TEST

Visual field test using the protocol 24-2 Threshold Test

Interventions

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Visual Field Testing

Visual field test using the protocol 24-2 Threshold Test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brennan Eadie

OTHER

Sponsor Role lead

Responsible Party

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Brennan Eadie

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

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Brennan Eadie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

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Victoria General Hopsital - Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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E001

Identifier Type: -

Identifier Source: org_study_id

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