Eye AbnormalitiesNCT02539381
The Stroke Vision App: A Screening Tool for Visual Stroke
A study testing Formal Perimetry (Goldman or Octopus visual Field), Albert's visual inattention test and Star cancellation visual inattention test in people with Eye Abnormalities and Stroke, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Visual impairment can affect up to 70% of stroke survivors, but many do not have their vision adequately assessed in hospital. An unidentified visual defect can cause significant problems for recovery and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Abnormalities, Stroke
- What is being tested?
- Formal Perimetry (Goldman or Octopus visual Field), Albert's visual inattention test and Star cancellation visual inattention test
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Jan 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients referred to Visual Stroke Orthoptic Clinics
- All patients with stroke or stroke-like visual problems (for example, but not limited to bitemporal hemianopia caused by pituitary adenoma) referred to the neuro-ophthalmology clinics.
- Consent Provided
Who cannot join
- No spoken English
- Unable to provide consent
- Profound cortical blindness
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Gartnavel General Hospital
Glasgow, Scotland, G12 0YN
Christine McAlpine, MB ChB, 0141 211 4843, christine.mcalpine@ggc.scot.nhs.uk
About this study
Official title: Stroke Vision: A Screening Tool for the Assessment of Visual Impairments in Stroke Survivors
Visual impairment can affect up to 70% of stroke survivors, but many do not have their vision adequately assessed in hospital. An unidentified visual defect can cause significant problems for recovery and quality of life. The Stroke Vision app (an application currently scaled for a 10" Android tablet) has been developed to act as a screening tool for visual problems in stroke survivors; to help identify visual problems earlier and thereby improve rehabilitation outcomes. The app includes a suite of tests for assessing the patient's acuity, their visual fields and to aid in the identification of visual neglect / inattention. Furthermore, it includes educational information on visual stroke in order to better educate staff, patients and their carers. This study seeks to validate the novel digital assessments included in the Stroke Vision app against the current methods used for screening (clinical examination by confrontation field testing). Both screening measures will be compared with the gold standard methods for visual assessments, Octopus perimetry for fields and paper-based methods for visuospatial neglect
- Conditions
- Eye Abnormalities, Stroke
- Being tested
- Formal Perimetry (Goldman or Octopus visual Field), Albert's visual inattention test, Star cancellation visual inattention test, Visual field assessment to confrontation, Visual inattention assessment to bilateral stimuli
- Medical subject headings
- Eye Abnormalities, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formal Perimetry (Goldman or Octopus visual Field)Procedure or surgery
Albert's visual inattention testProcedure or surgery
Star cancellation visual inattention testProcedure or surgery
Visual field assessment to confrontationProcedure or surgery
Visual inattention assessment to bilateral stimuliProcedure or surgery
Digital tumbling E visual accuity assessmentDevice
Digital visual field assessmentDevice
Digital line crossing assessmentDevice
Digital shape cancellation assessmentDevice
| Study group | Role | What they receive |
|---|---|---|
| Gold Standard Assessments | Other | * Formal perimetry (Goldman or Octopus visual field)
* Albert's visual inattention test
* Star cancellation visual inattention test
* line bisection test
* These are performed as part of the routine assessment in the visual stroke orthoptic clinic and neuro-ophthalmology clinics.
* The time to perform the assessments or if the participant is unable to complete the assessment will be recorded.
* Researcher will record a score (0-10) to quantify the participant's compliance Receives: Procedure: Formal Perimetry (Goldman or Octopus visual Field); Procedure: Albert's visual inattention test; Procedure: Star cancellation visual inattention test |
| Usual Clinical Screening Practice | Other | * Visual field assessment to confrontation
* Visual inattention assessment to bilateral stimuli
* The time to perform the assessments or if the participant is unable to complete the assessment will be recorded.
* Researcher will record a score (0-10) to quantify the participant's compliance Receives: Procedure: Visual field assessment to confrontation; Procedure: Visual inattention assessment to bilateral stimuli |
| Stroke Vision App | Other | * Digital tumbling E visual accuity assessment
* Digital visual field assessment
* Digital line crossing assessment
* Digital shape cancellation assessment
* The time to perform the assessments or if the participant is unable to complete the assessment will be recorded.
* Researcher will record a score (0-10) to quantify the participant's compliance Receives: Device: Digital tumbling E visual accuity assessment; Device: Digital visual field assessment; Device: Digital line crossing assessment; Device: Digital shape cancellation assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Stroke Vision Tablet App to support assessment of visual field defects when compared with visual field assessment to confrontation in standard clinical practice
Visual field will be captured either by the Stroke Vision App or by confrontation. Visual field will be reported by assessors (blinded to referral and comparator assessment) as either defect present, no defect present or unable to test. Agreement between visual field assessment supported by the Stroke Vision App and visual field assessment to confrontation in standard clincial practice will be quantified by the Kappa statistic. Accuracy metrics of sensitivity/specificity/predictive values will also be reported.
Measured: All assessments will be conducted following consent at standard clinical assessment visit
Accuracy of Stroke Vision Tablet App to support assessment of visual inattention defects when compared to visual inattention assessment to bilateral stimuli in standard clinical practice
Visual inattention tests will be conducted either by the Stroke Vision App or by inattention to bilateral stimuli in standard clinical practice. Inattention will be reported by assessors (blinded to referral and comparator assessment) as either defect present, no defect present or unable to test. Agreement between visual inattention assessment supported by the Stroke Vision App and inattention to bilateral stimuli in standard clincial practice will be quantified by the Kappa statistic. Accuracy metrics of sensitivity/specificity/predictive values will also be reported.
Measured: All assessments will be conducted following consent at standard clinical assessment visit
Secondary outcomes (2)
Accuracy of Stroke Vision Tablet App to support assessment of visual field defects when compared with "Gold standard" formal perimetry assessments
Visual field will be captured either by the Stroke Vision App or by formal perimetry assessments. Visual field will be reported by assessors (blinded to referral and comparator assessment) as either defect present, no defect present or unable to test. Agreement between visual field assessment supported by the Stroke Vision App and visual field assessment to formal perimetry will be quantified by the Kappa statistic. Accuracy metrics of sensitivity/specificity/predictive values will also be reported.
Measured: All assessments will be conducted following consent at standard clinical assessment visit
Accuracy of Stroke Vision Tablet App to support assessment of visual inattention defects when compared with "Gold standard" Albert's visual inattention test, Star cancellation visual inattention test, Line Bisection test
Visual inattention tests will be conducted either by the Stroke Vision App or by Gold standard" Albert's visual inattention test, Star cancellation visual inattention test, Line Bisection test conducted by a clinician. Inattention will be reported by assessors (blinded to referral and comparator assessment) as either defect present, no defect present or unable to test. Agreement between visual inattention assessment supported by the Stroke Vision App and "Gold standard" Albert's visual inattention test, Star cancellation visual inattention test, Line Bisection test will be quantified by the Kappa statistic. Accuracy metrics of sensitivity/specificity/predictive values will also be reported.
Measured: All assessments will be conducted following consent at standard clinical assessment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eye AbnormalitiesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine McAlpine, MBChB FRCP, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539381
- Sponsor's protocol ID
- GN15NE064
- Status last verified
- Aug 2015
- First submitted
- 16 Jul 2015
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Quinn TJ, Livingstone I, Weir A, Shaw R, Breckenridge A, McAlpine C, Tarbert CM. Accuracy and Feasibility of an Android-Based Digital Assessment Tool for Post Stroke Visual Disorders-The StrokeVision App. Front Neurol. 2018 Mar 28;9:146. doi: 10.3389/fneur.2018.00146. eCollection 2018.
PubMed 29643830
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Vision: A Screening Tool for the Assessment of Visual Impairments in Stroke Survivors
- ClinicalTrials.gov ID
- NCT02539381
- Acronym / sponsor ID
- GN15NE064
- Conditions
- Eye Abnormalities, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 3 Sep 2015 (estimated)
- 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.
Visual impairment can affect up to 70% of stroke survivors, but many do not have their vision adequately assessed in hospital. An unidentified visual defect can cause significant problems for recovery and quality of life. The Stroke Vision app (an application currently scaled for a 10" Android tablet) has been developed to act as a screening tool for visual problems in stroke survivors; to help identify visual problems earlier and thereby improve rehabilitation outcomes. The app includes a suite of tests for assessing the patient's acuity, their visual fields and to aid in the identification of visual neglect / inattention. Furthermore, it includes educational information on visual stroke in order to better educate staff, patients and their carers. This study seeks to validate the novel digital assessments included in the Stroke Vision app against the current methods used for screening (clinical examination by confrontation field testing). Both screening measures will be compared with the gold standard methods for visual assessments, Octopus perimetry for fields and paper-based methods for visuospatial neglect
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gold Standard Assessments | Other | Procedure: Formal Perimetry (Goldman or Octopus visual Field), Procedure: Albert's visual inattention test, Procedure: Star cancellation visual inattention test* Formal perimetry (Goldman or Octopus visual field) * Albert's visual inattention test * Star cancellation visual inattention test * line bisection test * These are performed as part of the routine assessment in the visual stroke orthoptic clinic and neuro-ophthalmology clinics. * The time to perform the assessments or if the participant is unable to complete the assessment will be recorded. * Researcher will record a score (0-10) to quantify the participant's compliance |
| Usual Clinical Screening Practice | Other | Procedure: Visual field assessment to confrontation, Procedure: Visual inattention assessment to bilateral stimuli* Visual field assessment to confrontation * Visual inattention assessment to bilateral stimuli * The time to perform the assessments or if the participant is unable to complete the assessment will be recorded. * Researcher will record a score (0-10) to quantify the participant's compliance |
| Stroke Vision App | Other | Device: Digital tumbling E visual accuity assessment, Device: Digital visual field assessment, Device: Digital line crossing assessment, Device: Digital shape cancellation assessment* Digital tumbling E visual accuity assessment * Digital visual field assessment * Digital line crossing assessment * Digital shape cancellation assessment * The time to perform the assessments or if the participant is unable to complete the assessment will be recorded. * Researcher will record a score (0-10) to quantify the participant's compliance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients referred to Visual Stroke Orthoptic Clinics
- All patients with stroke or stroke-like visual problems (for example, but not limited to bitemporal hemianopia caused by pituitary adenoma) referred to the neuro-ophthalmology clinics.
- Consent Provided
Key exclusion criteria (3 listed)
- No spoken English
- Unable to provide consent
- Profound cortical blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formal Perimetry (Goldman or Octopus visual Field) | Procedure or surgery | Gold Standard Assessments |
| Albert's visual inattention test | Procedure or surgery | Gold Standard Assessments |
| Star cancellation visual inattention test | Procedure or surgery | Gold Standard Assessments |
| Visual field assessment to confrontation | Procedure or surgery | Usual Clinical Screening Practice |
| Visual inattention assessment to bilateral stimuli | Procedure or surgery | Usual Clinical Screening Practice |
| Digital tumbling E visual accuity assessment | Device | Stroke Vision App |
| Digital visual field assessment | Device | Stroke Vision App |
| Digital line crossing assessment | Device | Stroke Vision App |
| Digital shape cancellation assessment | Device | Stroke Vision App |
Primary outcome
Accuracy of Stroke Vision Tablet App to support assessment of visual field defects when compared with visual field assessment to confrontation in standard clinical practice
Time frame: All assessments will be conducted following consent at standard clinical assessment visit
Visual field will be captured either by the Stroke Vision App or by confrontation. Visual field will be reported by assessors (blinded to referral and comparator assessment) as either defect present, no defect present or unable to test. Agreement between visual field assessment supported by the Stroke Vision App and visual field assessment to confrontation in standard clincial practice will be quantified by the Kappa statistic. Accuracy metrics of sensitivity/specificity/predictive values will also be reported.
Accuracy of Stroke Vision Tablet App to support assessment of visual inattention defects when compared to visual inattention assessment to bilateral stimuli in standard clinical practice
Time frame: All assessments will be conducted following consent at standard clinical assessment visit
Visual inattention tests will be conducted either by the Stroke Vision App or by inattention to bilateral stimuli in standard clinical practice. Inattention will be reported by assessors (blinded to referral and comparator assessment) as either defect present, no defect present or unable to test. Agreement between visual inattention assessment supported by the Stroke Vision App and inattention to bilateral stimuli in standard clincial practice will be quantified by the Kappa statistic. Accuracy metrics of sensitivity/specificity/predictive values will also be reported.
2 secondary outcomes
Accuracy of Stroke Vision Tablet App to support assessment of visual field defects when compared with "Gold standard" formal perimetry assessments
Time frame: All assessments will be conducted following consent at standard clinical assessment visit
Accuracy of Stroke Vision Tablet App to support assessment of visual inattention defects when compared with "Gold standard" Albert's visual inattention test, Star cancellation visual inattention test, Line Bisection test
Time frame: All assessments will be conducted following consent at standard clinical assessment visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
- Derived from this study: PubMed 29643830Quinn TJ, Livingstone I, Weir A, Shaw R, Breckenridge A, McAlpine C, Tarbert CM. Accuracy and Feasibility of an Android-Based Digital Assessment Tool for Post Stroke Visual Disorders-The StrokeVision App. Front Neurol. 2018 Mar 28;9:146. doi: 10.3389/fneur.2018.00146. eCollection 2018.
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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.
Christine McAlpine, MBChB FRCP principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formal Perimetry (Goldman or Octopus visual Field), Albert's visual inattention test and Star cancellation visual inattention test in people with Eye Abnormalities and Stroke, run by NHS Greater Glasgow and Clyde 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 3 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: status not confirmed, as of the sponsor's last update on 3 Sep 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine McAlpine, MBChB FRCP (44-141-211-4843, christine.mcalpine@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Stroke Vision Tablet App to support assessment of visual field defects when compared with visual field assessment to confrontation in standard clinical practice (time frame: All assessments will be conducted following consent at standard clinical assessment visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02539381, which also lists 1 linked publication.
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 3 Sep 2015.