Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rejection evaluation
研究概览
简要总结
This study is to develop a lamellar keratoplasty method for corneal ulcer using acellular corneal matrix (ACM) and to make an analysis among patients for its therapeutic effect.
详细描述
Infections, chemical injury, and other diseases result in acute or chronic corneal ulcer, which may damage corneal stroma and may lead to permanent corneal scars and blindness. Corneal transplantation is standard method for corneal ulcer, but severe shortage of donor corneas limits its application. Acellular porcine corneal matrix is similar to the native cornea, especially with the biological property and microstructure. Recently, this matrix has been proved to be safe when transplanted to animal subjects and will not be rejected by the recipient. In animal lamellar keratoplasty experiments, acellular corneal matrix showed that they can integrate into the corneal wound bed and help reconstruction of the lamellar integrity of corneal stroma. This study will investigate its healing effect on human corneal ulcer. It will provide a potential corneal substitute for this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 75 yrs.
- •Corneal ulcer.
- •Informed consent.
排除标准
- •Corneal perforation.
- •Other ocular diseases.
- •The presence of systemic connective tissue diseases
- •Severe allergic constitution
- •Pregnancy
- •The presence of chronic disease, such as significant cardiovascular illness
- •The patients who received clinical experiments for other medicine or medical devices within 3 months prior to the transplantation.
- •Any patient that is not suitable for recruitment, in the judgment of the investigator.
结局指标
主要结局
Rejection evaluation
时间窗: 30 days following transplantation
次要结局
- Corneal wound healing(90 days following transplantation)
