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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Virtual Reality Headset based tests


Participation Criteria
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Eligibility Criteria
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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: 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: Any physical impairment that would make use of the virtual reality headset difficult or unsafe. A history of vertigo or dizziness.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Virtual Reality Headset based tests|Visual task tests based on Oculus Rift|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Quality of life