Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,593
- 试验地点
- 2
- 主要终点
- Visual acuity
研究概览
简要总结
Endothelial keratoplasty is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. This technique offers many advantages compared with traditional full-thickness cornea transplants. Patients experience minimal change in glasses prescription and usually recover useful vision within weeks. Visual fluctuations are minimal during the healing process. The patient's cornea remains structurally intact and is more resistant to injury.
Endothelial keratoplasty is undergoing rapid and widespread adoption. Between 2005 and 2007, the number of corneas placed by US eye banks for endothelial keratoplasty increased ten-fold (2007 Eye Bank Association of America Annual Report). However, the procedure is less than 10 years old, and little is known about long term outcomes. Endothelial keratoplasty candidates at our center are invited to participate in an open enrollment, prospective study of the long-term outcomes of this procedure.
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
研究组 & 干预措施
Treatment
Endothelial keratoplasty procedure is performed.
干预措施: endothelial keratoplasty (Procedure)
结局指标
主要结局
Visual acuity
时间窗: 1, 3, 6, and 12 months and annually
次要结局
- Endothelial cell density(6 months, 12 months and annually)
- Intraocular pressure(1, 3, 6, 12 months and annually)
- Manifest refraction(1, 3, 6, 12 months and annually)
- corneal pachymetry(1, 3, 6, 12 months and annually)