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

• Conditions: Glaucoma

• Registration Number: NCT04273438
• Lead Sponsor: Queen's University, Belfast

Brief Summary

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

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 Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-08-12
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-18
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-24
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean deviation (MD)	All statisitcal analysis will take place once all data collection has ended, average 1 year..	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.
Pattern Standard Deviation	All statisitcal analysis will take place once all data collection has ended, average 1 year..	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NI Clinical Research Facility; 🇬🇧 Belfast, Northern Ireland, United Kingdom