The Stroke Vision App: A Screening Tool for Visual Stroke

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

Study Overview

• Status: Unknown
• Conditions: Stroke; Eye Abnormalities
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 0YN
      • Recruiting
      • Gartnavel General Hospital
      • Contact: Christine McAlpine, MB ChB; Phone Number: 0141 211 4843; Email: christine.mcalpine@ggc.scot.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Gold Standard Assessments; 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); Procedure: Albert's visual inattention test; Procedure: Star cancellation visual inattention test
OTHER: Usual Clinical Screening Practice; 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; Procedure: Visual inattention assessment to bilateral stimuli
OTHER: Stroke Vision App; 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; Device: Digital visual field assessment; Device: Digital line crossing assessment; Device: Digital shape cancellation assessment

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Proportion of patients completing Gold standard vision assessments	All assessments will be conducted following consent at standard clinical assessment visit
Proportion of patients competing usual clinical practice vision assessments	All assessments will be conducted following consent at standard clinical assessment visit
Proportion of patients competing Stroke vision app assessments	All assessments will be conducted following consent at standard clinical assessment visit
Time to complete Gold standard vision assessments	All assessments will be conducted following consent at standard clinical assessment visit
Time to complete usual clinical practice vision assessments	All assessments will be conducted following consent at standard clinical assessment visit
Time to complete Stroke vision app assessments	All assessments will be conducted following consent at standard clinical assessment visit

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Investigators: Principal Investigator: Christine McAlpine, MBChB FRCP, NHS Greater Glasgow & Clyde

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ANTICIPATED): January 1, 2016
• Study Completion (ANTICIPATED): January 1, 2016

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (ESTIMATE): September 3, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): September 3, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Congenital Abnormalities; Stroke; Eye Abnormalities
• Other Study ID Numbers: GN15NE064