Phase 1 Study of Applying Fibrin Glue in Patients With Corneal Ulcer or Patients Requiring Wound Closure by Suture
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- cure of the diseases
研究概览
简要总结
This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries, which includes pterygium surgery, corneal melting/perforation, Gunderson's flap, conjunctival laceration, and muscle/clinical/filtering surgery.
详细描述
This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries. The inclusion criteria are:
- ocular surface disease which may need amniotic membrane transplantation (corneal pro epithelization, pterygium surgery, etc)
- infectious or noninfectious corneal ulcer with perforation less than 3 mm
- conjunctival transplantation/suture
- corneal surgeries which can be treated by conventional suture technique or application with cyanoacrylic acid tissue glues.
Informed consents will be obtained from the patients before applications. After surgeries, topical steroids and antibiotics will be used, and therapeutic contact lens will be used. The patients will be followed up for at least three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ocular surface diseases, which are expected to be treated by tissue fibrin glues
排除标准
- •Pregnancy
- •Children younger than 3 years old
研究组 & 干预措施
1
Use of fibrin glue after corneal surgery or transplantation
干预措施: tissue fibrin glue application (Tisseel) (Drug)
结局指标
主要结局
cure of the diseases
时间窗: 1week, 2 weeks, 3 weeks, 4 weeks
次要结局
- integrity of the ocular surface(1week, 2 weeks, 3 weeks, 4 weeks)
- visual acuity(1week, 2 weeks, 3 weeks, 4 weeks)