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The Stroke Vision App: A Screening Tool for Visual Stroke

Primary Purpose

Eye Abnormalities, Stroke

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
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
Digital tumbling E visual accuity assessment
Digital visual field assessment
Digital line crossing assessment
Digital shape cancellation assessment
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Eye Abnormalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gartnavel General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Gold Standard Assessments

Usual Clinical Screening Practice

Stroke Vision App

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 16, 2015
Last Updated
August 31, 2015
Sponsor
NHS Greater Glasgow and Clyde
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1. Study Identification

Unique Protocol Identification Number
NCT02539381
Brief Title
The Stroke Vision App: A Screening Tool for Visual Stroke
Official Title
Stroke Vision: A Screening Tool for the Assessment of Visual Impairments in Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Abnormalities, Stroke

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gold Standard Assessments
Arm Type
Other
Arm Description
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
Arm Title
Usual Clinical Screening Practice
Arm Type
Other
Arm Description
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
Arm Title
Stroke Vision App
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Formal Perimetry (Goldman or Octopus visual Field)
Intervention Type
Procedure
Intervention Name(s)
Albert's visual inattention test
Intervention Type
Procedure
Intervention Name(s)
Star cancellation visual inattention test
Intervention Type
Procedure
Intervention Name(s)
Visual field assessment to confrontation
Intervention Type
Procedure
Intervention Name(s)
Visual inattention assessment to bilateral stimuli
Intervention Type
Device
Intervention Name(s)
Digital tumbling E visual accuity assessment
Intervention Type
Device
Intervention Name(s)
Digital visual field assessment
Intervention Type
Device
Intervention Name(s)
Digital line crossing assessment
Intervention Type
Device
Intervention Name(s)
Digital shape cancellation assessment
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
All assessments will be conducted following consent at standard clinical assessment visit
Title
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
Description
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.
Time Frame
All assessments will be conducted following consent at standard clinical assessment visit
Secondary Outcome Measure Information:
Title
Accuracy of Stroke Vision Tablet App to support assessment of visual field defects when compared with "Gold standard" formal perimetry assessments
Description
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.
Time Frame
All assessments will be conducted following consent at standard clinical assessment visit
Title
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
Description
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.
Time Frame
All assessments will be conducted following consent at standard clinical assessment visit
Other Pre-specified Outcome Measures:
Title
Proportion of patients completing Gold standard vision assessments
Time Frame
All assessments will be conducted following consent at standard clinical assessment visit
Title
Proportion of patients competing usual clinical practice vision assessments
Time Frame
All assessments will be conducted following consent at standard clinical assessment visit
Title
Proportion of patients competing Stroke vision app assessments
Time Frame
All assessments will be conducted following consent at standard clinical assessment visit
Title
Time to complete Gold standard vision assessments
Time Frame
All assessments will be conducted following consent at standard clinical assessment visit
Title
Time to complete usual clinical practice vision assessments
Time Frame
All assessments will be conducted following consent at standard clinical assessment visit
Title
Time to complete Stroke vision app assessments
Time Frame
All assessments will be conducted following consent at standard clinical assessment visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine McAlpine, MBChB FRCP
Phone
44-141-211-4843
Email
christine.mcalpine@ggc.scot.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine McAlpine, MBChB FRCP
Organizational Affiliation
NHS Greater Glasgow & Clyde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gartnavel General Hospital
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine McAlpine, MB ChB
Phone
0141 211 4843
Email
christine.mcalpine@ggc.scot.nhs.uk

12. IPD Sharing Statement

Citations:
PubMed Identifier
29643830
Citation
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.
Results Reference
derived

Learn more about this trial

The Stroke Vision App: A Screening Tool for Visual Stroke

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