Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Superficial Vascular Complexes Vessel Density
研究概览
简要总结
This study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.
详细描述
A growing body of research indicates that abnormal ocular microvascular features may serve as a novel biomarker reflecting the severity of underlying cardiovascular, neurodegenerative, and microvascular disease. Since blood flow to the retina is predominantly supplied by the internal carotid artery (ICA), we hypothesized that ocular microvasculature and structure changes may reflect the disease status or therapeutic effects in patients with carotid artery stenosis.
Optical coherence tomography angiography (OCTA) is a novel, non-invasive imaging modality that can be a reliable tool for the qualitative and quantitative assessments of ocular vessels during various ocular pathological or physiological changes. Recent studies have also demonstrated the ability of OCTA to quantify retinal microvascular changes in monitoring cardiovascular risk.
This study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.In this study, the patients with carotid artery stenosis and control group will receive a series of cerebral and ocular examinations including the most important cerebral CT perfusion (CTP) and OCTA. After that, the cerebral and ocular data between the two groups will be compared. Also, the preoperative and postoperative data acquired will be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of carotid artery stenosis
- •Age-gender-race-matched controls
排除标准
- •age <18 years
- •intraocular pressure (IOP) >21 mmHg
- •VA >logMAR 1.0
- •spherical equivalent (SE) between >1.00 or < -6.00 D
- •other serious eye diseases which may affect OCTA results including diabetic retinopathy, hypertensive retinopathy, retinal vascular occlusion, age-related macular degeneration, and uveitis
- •major intraocular surgery performed in the past 6 months or a history of laser photocoagulation or intravitreal injection
- •glaucoma or first-degree relatives with a history of glaucoma; and
- •any disease that might cause poor scan quality (image quality <6).
结局指标
主要结局
Superficial Vascular Complexes Vessel Density
时间窗: Difference of vessel density in each group at baseline
superficial vascular complexes vessel density of Optical Coherence Tomography Angiography
Choriocapillaris Vessel Density
时间窗: Difference of vessel density in each group at baseline
choriocapillaris vessel density of Optical Coherence Tomography Angiography
Radical Peripapillary Capillaries Vessel Density
时间窗: Difference of vessel density in each group at baseline
Radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography（OCTA）
Deep Vascular Complexes Vessel Density
时间窗: Difference of vessel density in each group at baseline
deep vascular complexes vessel density of Optical Coherence Tomography Angiography
次要结局
- Changes of Superficial Vascular Complexes Vessel Density(baseline and 4 days after carotid artery procedure)
- Changes of Retinal Nerve Fiber Layer(baseline and 4 days after carotid artery procedure)
- Changes of Deep Vascular Complexes Vessel Density(baseline and 4 days after carotid artery procedure)
- Change of Difference of Mean Transit Time(dMTT)(baseline and 4 days after carotid artery procedure)
- Change of the Ratio of Cerebral Blood Flow(rCBF)(baseline and 4 days after carotid artery procedure)
- Changes of Radical Peripapillary Capillaries Vessel Density(baseline and 4 days after carotid artery procedure)