The Stroke Vision App: A Screening Tool for Visual Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02539381
• Other study ID #: GN15NE064
• Status: Recruiting
• Phase: N/A
• First received: July 16, 2015
• Last updated: August 31, 2015
• Start date: July 2015
• Est. completion date: January 2016

Study information

• Verified date: August 2015
• Source: NHS Greater Glasgow and Clyde
• Contact: Christine McAlpine, MBChB FRCP
• Phone: 44-141-211-4843
• Email: christine.mcalpine[@]ggc.scot.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Eye Abnormalities
• Stroke

Intervention

Procedure:
• 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

Device:
• Digital tumbling E visual accuity assessment

• Digital visual field assessment

• Digital line crossing assessment

• Digital shape cancellation assessment

Locations

Country	Name	City	State
United Kingdom	Gartnavel General Hospital	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patients completing Gold standard vision assessments		All assessments will be conducted following consent at standard clinical assessment visit	No
Other	Proportion of patients competing usual clinical practice vision assessments		All assessments will be conducted following consent at standard clinical assessment visit	No
Other	Proportion of patients competing Stroke vision app assessments		All assessments will be conducted following consent at standard clinical assessment visit	No
Other	Time to complete Gold standard vision assessments		All assessments will be conducted following consent at standard clinical assessment visit	No
Other	Time to complete usual clinical practice vision assessments		All assessments will be conducted following consent at standard clinical assessment visit	No
Other	Time to complete Stroke vision app assessments		All assessments will be conducted following consent at standard clinical assessment visit	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No