Comparison Of Two Corticosteroid Dosing Regimens For Prevention Of Corneal Transplant Rejection Episodes After Descemet's Membrane Endothelial Keratoplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Number of Eyes With Immunologic Graft Rejection Episodes
研究概览
简要总结
The purpose of this study is to compare two different commonly used steroid dosing regimens after Descemet's membrane endothelial keratoplasty (DMEK) transplant surgery. The investigators hope to determine if one is more effective at preventing rejection or if both are equally effective.
详细描述
Graft rejection is one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used after transplant surgery. The steroid eye drop dosing regimen varies from surgeon to surgeon, because no studies have been done to determine the optimum dosing regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fluorometholone 0.1% Solution
Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.
干预措施: Fluorometholone (Drug)
Prednisolone acetate 1% Solution
Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
干预措施: Prednisolone acetate (Drug)
结局指标
主要结局
Number of Eyes With Immunologic Graft Rejection Episodes
时间窗: Within 1 year
次要结局
- Number of Eyes With Intraocular Pressure (IOP) Elevation(one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK)