Stroke Vision: A Screening Tool for the Assessment of Visual Impairments in Stroke Survivors
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •No spoken English
- •Unable to provide consent
- •Profound cortical blindness
研究组 & 干预措施
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
干预措施: Formal Perimetry (Goldman or Octopus visual Field) (Procedure)
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
干预措施: Albert's visual inattention test (Procedure)
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
干预措施: Star cancellation visual inattention test (Procedure)
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
干预措施: Visual inattention assessment to bilateral stimuli (Procedure)
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
干预措施: Visual field assessment to confrontation (Procedure)
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
干预措施: Digital line crossing assessment (Device)
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
干预措施: Digital shape cancellation assessment (Device)
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
干预措施: Digital tumbling E visual accuity assessment (Device)
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
干预措施: Digital visual field assessment (Device)
结局指标
主要结局
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
时间窗: 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.
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
时间窗: 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.
次要结局
- Accuracy of Stroke Vision Tablet App to support assessment of visual field defects when compared with "Gold standard" formal perimetry assessments(All assessments will be conducted following consent at standard clinical assessment visit)
- 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(All assessments will be conducted following consent at standard clinical assessment visit)