Stroke Clinical Trial
Official title:
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
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
United Kingdom | Gartnavel General Hospital | Glasgow | Scotland |
Lead Sponsor | Collaborator |
---|---|
NHS Greater Glasgow and Clyde |
United Kingdom,
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 |
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