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

NCT04273438 | Unknown

• 1 other identifier: 16/NI/0251
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Glaucoma

Keywords

Perimetry; Virtual Reality; Visual field testing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Repeatbility of both devices

  All statisitcal analysis will take place once all data collection has ended, average 1 year..

Interventions

Visual field testing using Oculus Rift and Humphrey Visual Field Perimeter DEVICE

Glaucoma patients at Queen's University, Belfast, will be invited to undergo both Visual field testing using the Oculus Rift and the gold-standard Humphrey 24-2 (Carl Zeiss Meditec, Dublin, CA) at two visits, and evaluating consistency for detecting visual field impairments.

Visual Field Testing using HUmphrey 24-3 Perimeter DEVICE

Glaucoma patients at Queen's University, Belfast, will be invited to undergo both Visual field testing using the Oculus Rift and the gold-standard Humphrey 24-2 (Carl Zeiss Meditec, Dublin, CA) at two visits, and evaluating consistency for detecting visual field impairments.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• University of Sussex: collaborator

Study Sites (1)

NI Clinical Research Facility

Belfast, Northern Ireland, BT9 7AB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Ruth E Hogg, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Hogg, PhD

CONTACT

02890971654; r.e.hogg@qub.ac.uk

Lucie Dalton, BSc

CONTACT

l.dalton@qub.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: February 18, 2020
• Study Start: October 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)