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The Stroke Vision App: A Screening Tool for Visual Stroke

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ClinicalTrials.gov Identifier: NCT02539381
Recruitment Status : Unknown
Verified August 2015 by NHS Greater Glasgow and Clyde.
Recruitment status was:  Recruiting
First Posted : September 3, 2015
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Eye Abnormalities Stroke 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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Stroke Vision: A Screening Tool for the Assessment of Visual Impairments in Stroke Survivors
Study Start Date : July 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
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
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
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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.


Other Outcome Measures:
  1. Proportion of patients completing Gold standard vision assessments [ Time Frame: All assessments will be conducted following consent at standard clinical assessment visit ]
  2. Proportion of patients competing usual clinical practice vision assessments [ Time Frame: All assessments will be conducted following consent at standard clinical assessment visit ]
  3. Proportion of patients competing Stroke vision app assessments [ Time Frame: All assessments will be conducted following consent at standard clinical assessment visit ]
  4. Time to complete Gold standard vision assessments [ Time Frame: All assessments will be conducted following consent at standard clinical assessment visit ]
  5. Time to complete usual clinical practice vision assessments [ Time Frame: All assessments will be conducted following consent at standard clinical assessment visit ]
  6. Time to complete Stroke vision app assessments [ Time Frame: All assessments will be conducted following consent at standard clinical assessment visit ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539381


Contacts
Contact: Christine McAlpine, MBChB FRCP 44-141-211-4843 christine.mcalpine@ggc.scot.nhs.uk

Locations
United Kingdom
Gartnavel General Hospital Recruiting
Glasgow, Scotland, United Kingdom, G12 0YN
Contact: Christine McAlpine, MB ChB    0141 211 4843    christine.mcalpine@ggc.scot.nhs.uk   
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Investigators
Principal Investigator: Christine McAlpine, MBChB FRCP NHS Greater Glasgow & Clyde

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02539381     History of Changes
Other Study ID Numbers: GN15NE064
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Stroke
Eye Abnormalities
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Congenital Abnormalities