Implant the Corneal Stroma to the Diseased Cornea in Order to Cure Keratoconus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The best corrected visual acuity of the operated eye
研究概览
简要总结
The purpose of this study is to determine whether corneal stroma implantation is effective in the treatment of keratoconus.
详细描述
Keratoconus is a corneal disease with the progressive thinning of the central corneal stroma. The main treatment methods are corneal transplantation, corneal collagen cross-linking, etc. The effect of corneal collagen cross-linking is limited, and the lack of donor cornea is really a very big problem. In this pilot project, investigators would like to study whether corneal stroma implantation can increase the biomechanics of the cornea, which can, to some extent, delay the progress of keratoconus. This will allowed us to determine if useful data can be obtained, and if so, the donor cornea can be greatly saved.
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
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced and completed keratoconus patients
- •Voluntarily signed informed consent
- •No surgery and anesthesia contraindications
排除标准
- •Acute edema of cornea
- •Primary keratoconus patients
- •The patients combined systemic diseases
- •Reject study and follow visit
- •Cannot tolerate surgery or anesthesia
结局指标
主要结局
The best corrected visual acuity of the operated eye
时间窗: 12 months after operation
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
次要结局
- The biomechanics of the operated eye(12 months after operation)