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

Sponsor

Queen's University, Belfast (Other)

Overall Status

Unknown status

CT.gov ID

NCT04281732

Collaborator

University of Sussex (Other)

Enrollment

Location

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Vision Retinitis Pigmentosa Stargardt Disease 1 Stargardt Disease 3 Stargardt Disease 4 Albinism	Device: Virtual Reality Headset based tests

Detailed Description

Aims of the Research Project:

To validate a new virtual reality (VR)-based battery of performance-based tests of visual function that are relevant for patients' daily lives.
To quantify the reproducibility of the performance-based tests.
To gather acceptability and ease-of-use data from patients.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Sep 30, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

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

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: 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?

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Male and female participants
Age 20-50
Bilateral sight impairment due to Stargardt's disease, retinitis pigmentosa or albinism.
Sight impairment criteria are as follows: