NCT05835869招募中不适用
Electrophysiological and Morphofunctional Changes of Retina and Choroid Vascularization After Carotid Endarterectomy, a Pilot Study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Functional retinal changes
研究概览
简要总结
The aim of the study is to evaluate changes in retinal function by means of electro-functional examinations of the retina and to associate them with any changes in chorioretinal vascular density occurring in the ipsilateral eye after carotid revascularization surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •age >18 years old
- •Carotid stenosis diagnosis with indication to perform carotid endarterectomy
- •informed consent form signing
排除标准
- •age <18 years old
- •recurrent intraocular inflammation
- •retinal disease
- •optic neuropathy, optic nerve drusen, opacity of the dioptric means in the pre- or post-operative period that prevents the acquisition of high-resolution images
- •unstable fixation
- •spheric refractive error > +/- 6 D spheric and/or +/- 3 D cylinder
- •history of prior ocular surgery
- •refusal of signing informed consent form
结局指标
主要结局
Functional retinal changes
时间窗: 1 week and 3 months
To evaluate rate of pattern electroretinography/pattern visual evoked potential improvement in both eyes before and after carotid endarterectomy
次要结局
- Retinal vascular density changes(1 week and 3 months)
研究者
研究点 (2)
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