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

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 30, 2020

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.

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Test repeatability
    • Time Frame: 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 Measures

  • Ease of use and acceptability questionnaire
    • Time Frame: 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: 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?

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 50 Years

Investigator Details

  • Lead Sponsor
    • Queen’s University, Belfast
  • Collaborator
    • University of Sussex
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ruth Hogg, Principal Investigator – Queen’s University, Belfast
  • Overall Official(s)
    • Ruth E Hogg, PhD, Principal Investigator, Queen’s University, Belfast
  • Overall Contact(s)
    • Ruth Hogg, PhD, 02890971654, r.e.hogg@qub.ac.uk

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