NCT04258787招募中不适用
Evaluating Corneal Edema in Fuchs' Endothelial Dystrophy Using Optical Coherence Tomography
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Corneal Stromal Edema/Haze
研究概览
简要总结
This is an observational study using optical coherence tomography (OCT) technology to quantify corneal edema in Fuchs' endothelial dystrophy and predict refractive shift from resolving corneal edema after surgical treatments.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Damaged or diseased corneal endothelium from Fuchs' or PBK
- •Willingness to commit to required study visits
排除标准
- •Prior Endothelial Keratoplasty (EK) or any other surgery except uncomplicated cataract surgery
- •Presence of a condition that increases the probability for treatment failure (e.g., heavily vascularized cornea, uncontrolled uveitis)
- •Other primary endothelial dysfunction conditions (e.g., posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy, iridocorneal endothelial syndrome)
- •Central sub-epithelial or stromal scarring that could impact post-operative clarity assessment
- •Peripheral anterior synechiae in the angle greater than 3 clock hours
- •Uncontrolled glaucoma
- •Visually significant optic nerve or macular pathology
结局指标
主要结局
Corneal Stromal Edema/Haze
时间窗: up to 2 years
OCT will be used to measure corneal stromal edema/haze (in microns) in participants with Fuchs' or PBK
Corneal Epithelial Edema/Haze
时间窗: up to 2 years
OCT will be used to measure corneal epithelial edema/haze (in microns) in participants with Fuchs' or PBK
次要结局
未报告次要终点
研究者
David Huang
Principal Investigator
Oregon Health and Science University
研究点 (1)
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