Retinal Vessel Leakage in Cerebral Small Vessel Disease: a Sub-study of the Mild Stroke Study 3
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Retinal vessel leakage by automated segmentation
研究概览
简要总结
The goal of this observational study is to learn about leakage from retinal vessels in cerebral small vessel disease. The main questions it aims to answer are:
- Does retinal vessel leakage occur in cerebral small vessel disease?
- If it does, is the severity of retinal vessel leakage similar to the severity of cerebral small vessel disease generally?
Participants will be tested using fluorescein angiography. This involves an intravenous injection of fluorescent dye, and is a very sensitive way to find leakage from retinal blood vessels.
Participants will have already had brain scans and other examinations and tests to measure the severity of their cerebral small vessel disease. Our new retinal images will complement the information from these previous tests.
详细描述
Cerebral small vessel disease (SVD) is a common cause of stroke and dementia. The molecular causes are unclear, limiting new therapies. Breakdown of the blood-brain barrier (BBB) is characteristic and may damage brain tissue. However, specialist MRI scans to measure BBB breakdown are expensive and time-consuming.
In contrast, measuring leakage from retinal blood vessels is relatively simple. The blood-retina barrier is very similar to the BBB, and SVD is likely to damage retinal and brain blood vessels in the same way. If so, then retinal angiography could be used to study SVD pathogenesis and measure the effect of new treatments with much greater resolution and lower cost than MRI.
We have three aims:
- Test the feasibility of fluorescein angiography in people with SVD
- Discover if retinal vessel leakage occurs people with SVD
- Discover whether the severity of retinal vessel leakage is associated with clinical features of SVD
We will recruit participants from a well-established cohort of people with SVD - the Mild Stroke Study 3 (MSS3).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Membership in the Mild Stroke Study 3 cohort
- •Contrast enhanced MRI within 12 months
- •Clear optical media in both eyes, as assessed by study investigator
- •Best corrected visual acuity (near vision) ≥N36
排除标准
- •Any condition known to cause retinal leakage (i.e., worse than background diabetic retinopathy, retinal vein occlusion, active uveitis, wet age-related macular degeneration, malignant hypertension)
- •Previous treatment for retinal leakage (retinal laser, intravitreal anti-VEGF)
- •Recent eye surgery
- •Shallow anterior chambers as assessed by torch test
- •Pregnancy, renal failure
- •Severe dementia
- •Known allergy to fluorescein
- •History of allergy such as food or drug induced urticaria or history of bronchial asthma
- •Any other severe or acute medical or psychiatric conditions
- •Inability to give informed consent
结局指标
主要结局
Retinal vessel leakage by automated segmentation
时间窗: within one angiogram
The presence and severity of retinal vessel leakage will be measured for each eye in terms of change in pixel brightness over the duration of the angiogram.
Retinal vessel leakage by manual grading
时间窗: within one angiogram
The presence and severity of retinal vessel leakage will be measured using an manual ordinal grading scale
次要结局
- Baseline blood-brain barrier breakdown(Within one MRI scan)
- Change in white matter hyperintensity (WMH) volume adjusted for brain volume(Difference in MRI scans up to 5 years prior)
- Baseline number of leakage hotspots(Within one MRI scan)
- Fazekas score(Within one MRI scan)
- Baseline average leakage in deep grey matter(Within one MRI scan)
- White matter hyperintensity (WMH) volume adjusted for brain volume(Within one MRI scan)
- Change in Fazekas score(Difference in MRI scans up to 5 years prior)
- Baseline average leakage in white matter hyperintensities(Within one MRI scan)