NCT00238862已完成不适用
Efficacy of Amniotic Membrane Transplantation and Autologous Serum in Treatment of Persistent Epithelial Defects
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Corneal re-epithelialization (= initial success)
研究概览
简要总结
Patients with persistent corneal epithelial defects who have not responded to conventional therapy will be randomized to treatment with either amniotic membrane transplantation or autologous serum 20%. Outcome measures will be (1) presence or absence of complete re-epithelialization within 28 days and (2) retention of intact epithelium for at least 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Corneal epithelial defect of more than 14 days that has not responded to conventional therapy
排除标准
- •Under age 18
- •Pregnant/lactating females
- •Patients with hemoglobin levels < 12 mg/ml
- •Patients with limbal stem cell deficiency
结局指标
主要结局
Corneal re-epithelialization (= initial success)
Persistent corneal re-epithelialization (= lasting success)
次要结局
未报告次要终点
研究者
研究点 (2)
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