Determining the Clinical Utility of Using Virtual Reality Headsets to Assess Visual Function in Those With Glaucoma.

To validate a new virtual reality (VR) based visual field test against the gold standard clinical perimetry test (Humphrey Visual field test 24-2).

Study Overview

• Status: Unknown
• Conditions: Glaucoma
• Intervention / Treatment: Device: Visual field testing using Oculus Rift and Humphrey Visual Field Perimeter; Device: Visual Field Testing using HUmphrey 24-3 Perimeter

Detailed Description

Perimetry (or visual field testing) is a vision test used to evaluate a patient's peripheral vision. It involves a patient fixating on a central target and pressing a button when they see a spot of light in their peripheral vision. It is an important way of deciding whether Glaucoma is progressing or not. Next generation virtual reality (VR) technologies offer an exciting new way of conducting perimetry in either a clinical or home environment, allowing more affordable and more frequent monitoring of disease progression in glaucoma, and an easier and more comfortable experience for patients. The investigators propose to create a perimetry test using a commercially available head mounted display for VR, and to assess its accuracy in glaucoma patients in relation to standard automated perimetry.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT9 7AB
      • Recruiting
      • NI Clinical Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Professor Azuara-Blanco will identify participants who meet the criteria from his NHS clinics at the Shankill Health and Well-being Centre. He is part of both the direct care team and also a co-investigator on this application. Opportunistic sampling will be used to ensure that different severity levels of visual field deficit will be represented within the sample. Identification of potential participants will involve reviewing their patient records.

Description

Inclusion Criteria:

- Patients with a clinical diagnosis of glaucoma with repeatable defects on standard automated perimetry.

Exclusion Criteria:

• Presence of other ocular disease which impacts vision such as age-related macular degeneration or diabetic retinopathy.
• Any physical limitation that would make the participant unable to place their head in the head-rest to perform Humphrey Perimetry (Eg some patients with arthritic or neck problems are unable to use the headrests of ophthalmic devices).
• Any cognitive impairment that would limit their ability to perform perimetry or a history of vertigo/dizziness.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean deviation (MD)	Mean deviation in decibels (dB), this is a standard summary measure generated by all perimetric tests and is considered to represent generalised loss of visual function.	All statisitcal analysis will take place once all data collection has ended, average 1 year..
Pattern Standard Deviation	Pattern standard deviation in decibels (dB), this is a standard summary measure generated by all perimetric tests and is considered to represent localised loss of visual function.	All statisitcal analysis will take place once all data collection has ended, average 1 year..

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeatbility of both devices	Bland and Altman plots and intra-class correlation coefficients will be generated for both tests for visit 1 vs visit 2 data.	All statisitcal analysis will take place once all data collection has ended, average 1 year..

Collaborators and Investigators

• Sponsor: Queen's University, Belfast
• Collaborators: University of Sussex

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Virtual Reality; Perimetry; Visual field testing
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 16/NI/0251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No