Effect of Corneal Preservation Time on Long-Term Graft Success
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,174
- 试验地点
- 79
- 主要终点
- Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery
研究概览
简要总结
The purpose of this study is to determine if the 3-year graft failure rate following endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14 days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or fewer days are used.
详细描述
When the donor cornea is removed from the person who died, it is prepared for transplantation by an eye bank. The donor cornea is placed into a liquid that helps preserve the cornea until it is transplanted. The Food and Drug Administration (FDA) has approved storage of the cornea in this liquid for up to 14 days before the transplant. The purpose of this study is to see if the length of time the donor cornea is kept in the preservation liquid before the transplant affects the likelihood of the transplant being successful. We will follow participants for 3 years after transplant to see if there are any differences in transplant success or in the number of transplanted endothelial cells (the layer of cells that line the undersurface of the cornea) on the corneas that were preserved for 7 days or less compared to those preserved between 8 and 14 days. We have no reason to believe that there is any greater risk for transplant failure with either preservation time group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery
时间窗: Study eye will be assessed for this outcome for 3 years following surgery
Graft failure, defined as the occurrence of one of the following within 3 years of surgery: * Regrafting of the study eye for any reason * Cornea which remains cloudy without clearing, according to the following: 1. cloudy cornea on the first postoperative day which does not clear within 8 weeks OR 2. cloudy cornea which was initially clear postoperatively but becomes and remains cloudy for 3 months without clearing.
Endothelial Cell Density (ECD)
时间窗: 3 years from surgery
Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery.
次要结局
未报告次要终点
研究者
Jonathan Lass, MD
Charles I Thomas Professor, Dept. of Ophthalmology & Visual Sciences,
Case Western Reserve University