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

Queen's University, Belfast20 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Low Vision Retinitis Pigmentosa Stargardt Disease 1 Stargardt Disease 3 Stargardt Disease 4 Albinism

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Test repeatability

Bland and Altman analysis will be used to investigate the repeatability of the tests between visit 1 and visit 2.

Time frame: All statistical analysis will take place once all data collection has ended, average 1 year.

Secondary Outcomes

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: 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?

Time frame: Responses from all participants will be collated and summarised at the end of the study, average 1 year.

Central Contacts

Ruth Hogg, PhD

CONTACT

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

Lucie Dalton, BSc