StrabismusNCT04156763
Virtual Reality Test of Strabismus
An observational study of Strabismus, run by Julie Dawson at 1 site in United Kingdom.
Trial summary
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'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Strabismus
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jun 2020to 8 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Research participants will be recruited from the pool of patients presenting to the Eye department for their regular appointment.
Who may be able to join
- Patients with restrictive and paretic disturbances of ocular motility
Who cannot join
- Patients without capacity to consent
- Patients unwilling to participate
- Patients aged under 18
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Strabismus
- Keywords
- Strabismus Virtual Reality Prism Cover Test
- Medical subject headings
- Strabismus
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of agreement between the prism cover test and virtual reality headset-based test of ocular misalignment
The degree of agreement between the prism cover test and virtual reality headset-based test of ocular misalignment
Measured: 2 years
Secondary outcomes (1)
The subjective experience of the virtual reality headset-based test measured by questionnaire
The subjective experience of the virtual reality headset-based test measured by questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start22 Jun 2020
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Why it stopped: CI has left the trust
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrabismusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Dawson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156763
- Sponsor's protocol ID
- 268329 (100-06-19)
- Status last verified
- Dec 2023
- First submitted
- 6 Nov 2019
- Last updated
- 22 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Prism Cover Testing and a Virtual Reality Headset-based Test in the Objective Assessment of Ocular Deviation
- ClinicalTrials.gov ID
- NCT04156763
- Acronym / sponsor ID
- 268329 (100-06-19)
- Conditions
- Strabismus
- Keywords
- Strabismus Virtual Reality Prism Cover Test
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: CI has left the trust
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Julie DawsonUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Research participants will be recruited from the pool of patients presenting to the Eye department for their regular appointment.
Key inclusion criteria (1 listed)
- Patients with restrictive and paretic disturbances of ocular motility
Key exclusion criteria (3 listed)
- Patients without capacity to consent
- Patients unwilling to participate
- Patients aged under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
The subjective experience of the virtual reality headset-based test measured by questionnaire
Time frame: 2 years
Results and safety
The study was stopped early (reason given: CI has left the trust). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Strabismus, run by Julie Dawson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: CI has left the trust). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of agreement between the prism cover test and virtual reality headset-based test of ocular misalignment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.