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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04273438
• Other study ID #: 16/NI/0251
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Queen's University, Belfast
• Contact: Ruth Hogg, PhD
• Phone: 02890971654
• Email: r.e.hogg[@]qub.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Visual field testing using Oculus Rift and Humphrey Visual Field Perimeter
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
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.

Locations

Country	Name	City	State
United Kingdom	NI Clinical Research Facility	Belfast	Northern Ireland

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University, Belfast	University of Sussex

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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..
Primary	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	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..