The Stroke Vision App: A Screening Tool for Visual Stroke

Study Overview
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Brief Summary
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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

Official Title
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Stroke Vision: A Screening Tool for the Assessment of Visual Impairments in Stroke Survivors

Conditions
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Eye Abnormalities, Stroke

Intervention / Treatment
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* Procedure: Formal Perimetry (Goldman or Octopus visual Field)
* Procedure: Albert's visual inattention test
* Procedure: Star cancellation visual inattention test
* Procedure: Visual field assessment to confrontation
* Procedure: Visual inattention assessment to bilateral stimuli
* Device: Digital tumbling E visual accuity assessment
* Device: Digital visual field assessment
* Device: Digital line crossing assessment
* Device: Digital shape cancellation assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: No spoken English Unable to provide consent Profound cortical blindness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Gold Standard Assessments<br>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 | Procedure: Formal Perimetry (Goldman or Octopus visual Field)<br> <br> Procedure: Albert's visual inattention test<br> <br> Procedure: Star cancellation visual inattention test<br> <br> |
| Other: Usual Clinical Screening Practice<br>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 | Procedure: Visual field assessment to confrontation<br> <br> Procedure: Visual inattention assessment to bilateral stimuli<br> <br> |
| Other: Stroke Vision App<br>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 | Device: Digital tumbling E visual accuity assessment<br> <br> Device: Digital visual field assessment<br> <br> Device: Digital line crossing assessment<br> <br> Device: Digital shape cancellation assessment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | All assessments will be conducted following consent at standard clinical assessment visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | All assessments will be conducted following consent at standard clinical assessment visit |