Topical 0.03% Tacrolimus Versus Systemic Mycophenolate Mofetil for Preventing Graft Rejection After Repeat Keratoplasty: One-year Results of a Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- graft rejection
研究概览
简要总结
Purpose: To compare the efficacy of topical 0.03% tacrolimus with systemic mycophenolate mofetil (MMF) in preventing corneal allograft rejection after repeat keratoplasty.
Design: Prospective, randomized clinical trial Introduction: Repeat keratoplasty continues to be an important indication for corneal transplantation in many centers, and it accounts for up to 41% (varying from 6% to 41%) of all keraptoplasty cases performed.
Methods: This study will enroll all patients who are candidate for repeat keratoplasty after a failed penetrating keratoplasty. Group 1 will receive MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months, and group 2 will receive topical 0.03 % tacrolimus 3 times a day for 12 months. All patients are treated with topical and oral corticosteroids postoperatively. The participants are observed closely for signs of graft rejection, and the rates of rejection-free graft survival are calculated and compared between the two groups at postoperative month 12
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all patients who are scheduled for repeat corneal transplantation following failed primary penetrating keratoplasty (PK )
排除标准
- •uncontrolled increase in intraocular pressure
- •active herpetic keratitis and corneal ulcer
- •limbal stem cell deficiency
- •a history of limbal stem cell transplantation
- •age less than 18 years
- •pregnancy, a history of malignant disorders
- •abnormal liver or kidney function
- •the presence of poorly controlled systemic hypertension
- •diabetes mellitus
- •systemic infections
- •active peptic ulcer disease
- •any gastrointestinal disorders led to patient exclusion
研究组 & 干预措施
usage mycophenolate mofetil
干预措施: prescribe mycophenolate mofetil(MMF) (Drug)
usage tacrolimus
干预措施: prescribe topical 0.03 % tacrolimus (Drug)
结局指标
主要结局
graft rejection
时间窗: 12 months
clinical examination
次要结局
未报告次要终点
研究者
Zahra Rabbani Khah
Head of ophthalmic research center
Shahid Beheshti University of Medical Sciences