Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision

Retinitis Pigmentosa Clinical Trial

Official title:

Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04281732
• Other study ID #: 17/NI/0002
• 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

Purpose:

To validate a newly developed battery of performance-based tests of visual function to be presented using virtual reality. The tests are intended as potential outcome measures for clinical trials of treatments of eye disease: they measure visual performance in patients with low vision on visual tasks that a relevant for daily life.

Description:

Aims of the Research Project:

1. To validate a new virtual reality (VR)-based battery of performance-based tests of visual function that are relevant for patients' daily lives.

2. To quantify the reproducibility of the performance-based tests.

3. To gather acceptability and ease-of-use data from patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2020
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Male and female participants

2. Age 20-50

3. Bilateral sight impairment due to Stargardt's disease, retinitis pigmentosa or albinism.

4. Sight impairment criteria are as follows:

• Visual acuity of 3 / 60 to 6 / 60 with a full field of vision.

• Visual acuity of up to 6 / 24 with a moderate reduction of field of vision

Exclusion Criteria:

1. Any physical impairment that would make use of the virtual reality headset difficult or unsafe.

2. A history of vertigo or dizziness.

Related Conditions & MeSH terms

• Albinism
• Low Vision
• Macular Degeneration
• Retinitis
• Retinitis Pigmentosa
• Stargardt Disease 1
• Stargardt Disease 3
• Stargardt Disease 4
• Vision, Low

Intervention

Device:
• Virtual Reality Headset based tests
Visual task tests based on Oculus Rift

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	Test repeatability	Bland and Altman analysis will be used to investigate the repeatability of the tests between visit 1 and visit 2.	All statistical analysis will take place once all data collection has ended, average 1 year.
Secondary	Ease of use and acceptability questionnaire	Modified from Tay et al, Br J Ophthalmol 2004;88:719-720; Ask the following questions for virtual reality test: Was the test comfortable? If no- How?; Was the test too long?; How did you find the test? Would you describe it as easy or difficult? If you found it difficult- how?; How would you feel if you knew you had to perform this test at every clinic appointment?; Do you have any other comments about the test?	Responses from all participants will be collated and summarised at the end of the study, average 1 year.