NCT02020044Unknown不适用
Prospective Clinical Study on Postoperative Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Visual acuity (change from baseline)
研究概览
简要总结
The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Male or female aged 18 or older
- •Scheduled to undergo endothelial keratoplasty
- •Able to provide written informed consent.
排除标准
- •Age less than 18 years
结局指标
主要结局
Visual acuity (change from baseline)
时间窗: 1, 3, 6, and 12 months and annually
次要结局
- Endothelial cell density (change from baseline)(1, 3, 6, and 12 months and annually)
- Intraocular pressure (change from baseline)(1, 3, 6, and 12 months and annually)
- Manifest refraction (change from baseline)(1, 3, 6, 12 months and annually)
- corneal pachymetry (change from baseline)(1, 3, 6, 12 months and annually)
- Quality of Life, NEI-VFQ 25 (change from baseline)(3, 12 months, annualy)
- corneal topography (change from baseline)(1, 3, 6, and 12 months and annually)
- Anterior Segment OCT of cornea and anterior chamber angle (change from baseline)(1, 3, 6, and 12 months and annually)
- postoperative Medication (change from baseline)(1,3,6 and 12 months and annually)
- Histological Sample of Recipient's Descemet Membrane(intraoperative)
研究者
Necip Torun
Necip, Torun, MD
Charite University, Berlin, Germany
研究点 (2)
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