Clinical trial NCT02539381: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Eye Abnormalities
Stroke
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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


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

Primary outcomes:
measure: 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
timeFrame: All assessments will be conducted following consent at standard clinical assessment visit
measure: 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
timeFrame: All assessments will be conducted following consent at standard clinical assessment visit
Secondary outcomes:
measure: Accuracy of Stroke Vision Tablet App to support assessment of visual field defects when compared with "Gold standard" formal perimetry assessments
timeFrame: All assessments will be conducted following consent at standard clinical assessment visit
measure: 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
timeFrame: All assessments will be conducted following consent at standard clinical assessment visit
Other outcomes:
measure: Proportion of patients completing Gold standard vision assessments
timeFrame: All assessments will be conducted following consent at standard clinical assessment visit
measure: Proportion of patients competing usual clinical practice vision assessments
timeFrame: All assessments will be conducted following consent at standard clinical assessment visit
measure: Proportion of patients competing Stroke vision app assessments
timeFrame: All assessments will be conducted following consent at standard clinical assessment visit
measure: Time to complete Gold standard vision assessments
timeFrame: All assessments will be conducted following consent at standard clinical assessment visit
measure: Time to complete usual clinical practice vision assessments
timeFrame: All assessments will be conducted following consent at standard clinical assessment visit
measure: Time to complete Stroke vision app assessments
timeFrame: All assessments will be conducted following consent at standard clinical assessment visit
Locations:
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
state: Scotland
Study officials:
affiliation: NHS Greater Glasgow & Clyde
name: Christine McAlpine, MBChB FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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.