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

• Conditions: Retinitis Pigmentosa; Stargardt Disease 4; Stargardt Disease 3; Low Vision; Stargardt Disease 1; Albinism

• Registration Number: NCT04281732
• Lead Sponsor: Queen's University, Belfast

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-08-12
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-21
• Last Update Submitted: 2020-02-21
• Study First Posted: 2020-02-24
• Last Update Posted: 2020-02-24
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Test repeatability	All statistical analysis will take place once all data collection has ended, average 1 year.	Bland and Altman analysis will be used to investigate the repeatability of the tests between visit 1 and visit 2.

Secondary Outcome Measures

Name	Time	Method
Ease of use and acceptability questionnaire	Responses from all participants will be collated and summarised at the end of the study, average 1 year.	Modified from Tay et al, Br J Ophthalmol 2004;88:719-720; Ask the following questions for virtual reality test: 1. Was the test comfortable? If no- How?; 2. Was the test too long?; 3. How did you find the test? Would you describe it as easy or difficult? If you found it difficult- how?; 4. How would you feel if you knew you had to perform this test at every clinic appointment?; 5. Do you have any other comments about the test?

Trial Locations

Locations (1)

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