Feasibility of Visual Field Testing With a Virtual Reality Headset

NCT03748654 | Suspended

• 1 other identifier: E001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Visual field differential light sensitivity threshold

  Comparison of differential light sensitivity threshold estimated with the Humphrey Field Analyzer and the Virtual Reality headset

  Three weeks

Secondary Outcomes (1)

• Reproducibility of sensitivity values

  Three weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Diagnostic Test: Visual Field Testing

Interventions

Visual Field Testing DIAGNOSTIC_TEST

Visual field test using the protocol 24-2 Threshold Test

Single Arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Presence of non-glaucomatous pathology that could influence the visual field test, such as media opacities.
• 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.

Sponsors & Collaborators

• Brennan Eadie: lead

Study Sites (1)

Victoria General Hopsital - Nova Scotia Health Authority

Halifax, Nova Scotia, B3H2Y9, Canada

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Visual Fields

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Study Officials

• Brennan Eadie, MD, PhD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Ophthalmology, Dalhousie University and Nova Scotia Health Authority; MD, PhD, FRCSC

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 21, 2018
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

CA (1)