- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04156763
Virtual Reality Test of Strabismus
A Comparison of Prism Cover Testing and a Virtual Reality Headset-based Test in the Objective Assessment of Ocular Deviation
Strabismus, or squint, describes any misalignment of the eyes, and can affect both children and adults. As a result, the images of the outside world conveyed to the brain from the two eyes do not correspond, which can result in diplopia, or 'double vision'. As well as impacting on a patient's functionality, strabismus can have cosmetic and psychosocial ramifications. Furthermore, if left untreated in childhood, strabismus can lead to life-long visual impairment, despite best spectacle correction.
Current treatment is guided by the exact nature of the strabismus and the patient's age; options include spectacle prescription to correct underlying refractive error, use of prisms to control deviation, or in certain cases, surgery. In order to investigate the size and type of strabismus present, and determine the best management, tests of ocular deviation are performed in Eye Clinics.
Quantitative objective assessment of the angle of horizontal and vertical strabismus is currently performed using the prism cover test - the patient is asked to look at a fixation target, and prisms of increasing power are placed in front of one eye until the ocular deviation is neutralised (i.e. there is no movement of the eyes to take up fixation). The test can provide accurate numerical recordings to aid in monitoring and surgical planning.
However, the prism cover test requires a range of different prisms, the presence of a near and distance fixation target, a trained examiner, and a patient able to fixate at an appropriate target without moving their head for the duration of the test. In this study, it will be investigated whether a virtual reality headset-based test can produce comparable measurements of ocular deviation to the traditional prism cover test, without the need for prisms, or control of head posture.
Study Overview
Status
Conditions
Detailed Description
Purpose
- To establish whether a virtual reality headset-based test can produce accurate and reliable data on ocular deviation in those with disturbances of ocular motility, by comparing its performance to those of established tests of ocular deviation currently in use in clinical practice (prism cover test).
- To assess the practicality, and subjective experience of a virtual reality headset- based Lancaster red-green test, using questionnaire surveys
Background
Strabismus, or squint, describes any misalignment of the eyes, and can affect both children and adults. As a result, the images of the outside world conveyed to the brain from the two eyes do not correspond, which can result in diplopia, or 'double vision'. As well as impacting on a patient's functionality, strabismus can have cosmetic and psychosocial ramifications. Furthermore, if left untreated in childhood, strabismus can lead to life-long visual impairment, despite best spectacle correction.
Current treatment is guided by the exact nature of the strabismus and the patient's age; options include spectacle prescription to correct underlying refractive error, use of prisms to control deviation, or in certain cases, surgery. In order to investigate the size and type of strabismus present, and determine the best management, tests of ocular deviation are performed in Eye Clinics.
Quantitative objective assessment of the angle of horizontal and vertical strabismus is currently performed using the prism cover test - the patient is asked to look at a fixation target, and prisms of increasing power are placed in front of one eye until the ocular deviation is neutralised (i.e. there is no movement of the eyes to take up fixation). The test can provide accurate numerical recordings to aid in monitoring and surgical planning.
However, the prism cover test requires a range of different prisms, the presence of a near and distance fixation target, a trained examiner, and a patient able to fixate at an appropriate target without moving their head for the duration of the test. In this study, it will be investigated whether a virtual reality headset-based test can produce comparable measurements of ocular deviation to the traditional prism cover test, without the need for prisms, or control of head posture.
Design and Methodology
Research participants will be recruited from the pool of patients presenting to the Eye department for their regular appointment.
Those who meet the inclusion criteria will have the study explained to them by a member of the research team in the department, and given a leaflet to read about the study. Should they wish to take part, they will have verbal and written consent taken, and then undergo two tests:
- Prism cover test
- Virtual reality headset-based test
Each test will last approximately 10 minutes. At the end of the two tests, they will be asked to fill in a questionnaire on their experience of the tests. They will require no additional visits to clinic as part of enrolling in the study.
Statistical Analysis
The angles of deviation of the eyes will be extracted from each of the three tests, and Bland Altman analysis will be applied to the data to check for agreement.
The subjective experience of the virtual reality headset-based Lancaster red-green test measured by the questionnaire, and compared to the subjective experience of the two established tests of ocular deviation using a paired t-test.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Norfolk
-
Norwich, Norfolk, United Kingdom, NR4 7UY
- Norfolk & Norwich University Hospitals NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
• Patients with restrictive and paretic disturbances of ocular motility
Exclusion criteria:
- Patients without capacity to consent
- Patients unwilling to participate
- Patients aged under 18
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The degree of agreement between the prism cover test and virtual reality headset-based test of ocular misalignment
Time Frame: 2 years
|
The degree of agreement between the prism cover test and virtual reality headset-based test of ocular misalignment
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The subjective experience of the virtual reality headset-based test measured by questionnaire
Time Frame: 2 years
|
The subjective experience of the virtual reality headset-based test measured by questionnaire
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 268329 (100-06-19)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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