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The Stroke Vision App: A Screening Tool for Visual Stroke

Not Applicable
Conditions
Eye Abnormalities
Stroke
Interventions
Procedure: Formal Perimetry (Goldman or Octopus visual Field)
Device: Digital tumbling E visual accuity assessment
Procedure: Visual field assessment to confrontation
Device: Digital visual field assessment
Procedure: Albert's visual inattention test
Procedure: Visual inattention assessment to bilateral stimuli
Procedure: Star cancellation visual inattention test
Device: Digital line crossing assessment
Device: Digital shape cancellation assessment
Registration Number
NCT02539381
Lead Sponsor
NHS Greater Glasgow and Clyde
Brief 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. 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

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
62
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Gold Standard AssessmentsFormal Perimetry (Goldman or Octopus visual Field)* 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
Gold Standard AssessmentsStar 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
Stroke Vision AppDigital tumbling E visual accuity 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
Stroke Vision AppDigital visual field 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
Gold Standard AssessmentsAlbert's 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 PracticeVisual field assessment to confrontation* 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
Usual Clinical Screening PracticeVisual 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 AppDigital line crossing 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
Stroke Vision AppDigital 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
Primary Outcome Measures
NameTimeMethod
Accuracy of Stroke Vision Tablet App to support assessment of visual field defects when compared with visual field assessment to confrontation in standard clinical practiceAll 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 practiceAll 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.

Secondary Outcome Measures
NameTimeMethod
Accuracy of Stroke Vision Tablet App to support assessment of visual field defects when compared with "Gold standard" formal perimetry assessmentsAll assessments will be conducted following consent at standard clinical assessment visit

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.

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 testAll 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 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.

Trial Locations

Locations (1)

Gartnavel General Hospital

🇬🇧

Glasgow, Scotland, United Kingdom

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