Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision
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|ClinicalTrials.gov Identifier: NCT04281732|
Recruitment Status : Recruiting
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
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|
|Low Vision Retinitis Pigmentosa Stargardt Disease 1 Stargardt Disease 3 Stargardt Disease 4 Albinism||Device: Virtual Reality Headset based tests|
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 Type :||Observational|
|Estimated Enrollment :||20 participants|
|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 :||October 1, 2018|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
- Device: Virtual Reality Headset based tests
Visual task tests based on Oculus Rift
- 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.
- 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?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04281732
|Contact: Ruth Hogg, PhDemail@example.com|
|Contact: Lucie Dalton, BScfirstname.lastname@example.org|
|NI Clinical Research Facility||Recruiting|
|Belfast, Northern Ireland, United Kingdom, BT9 7AB|
|Contact: Ruth Hogg 028 90635018 email@example.com|
|Principal Investigator:||Ruth E Hogg, PhD||Queen's University, Belfast|