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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04281732
Enrollment
20
Registered
2020-02-24
Start date
2018-10-01
Completion date
2020-12-31
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Virtual Reality, Quality of life

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.

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

DEVICEVirtual Reality Headset based tests

Visual task tests based on Oculus Rift

Sponsors

University of Sussex
CollaboratorOTHER
Queen's University, Belfast
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Test repeatabilityAll 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

MeasureTime frameDescription
Ease of use and acceptability questionnaireResponses 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: 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?

Countries

United Kingdom

Contacts

Primary ContactRuth Hogg, PhD
r.e.hogg@qub.ac.uk02890971654
Backup ContactLucie Dalton, BSc
l.dalton@qub.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026