Suppression of Graft Rejection Using Mixed Component Cornea in the High-risk Keratoplasty，A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The rate of corneal graft rejection at 12 months
研究概览
简要总结
Because of the immunologically privileged nature of the cornea, the graft rejection rate is less than 10% for low-risk keratoplasty. But when the cornea performed 2 or more quadrants of corneal neovascularization after ocular trauma or infection, the graft rejection rate is more than 65%, it is called high-risk keratoplasty.
This study will observe the graft survival of high-risk corneal transplantation using mixed component cornea from different donors.
详细描述
Ocular trauma or infection lead to corneal limbal stem cell deficiency and central corneal opacification which could only be treated by central penetrating keratoplasty and limbal transplantation, but the rejection rate is very high. In clinical, we found that limbal transplantation combined with central penetrating keratoplasty from different donors can keep the graft transparent for a long time, this result also be found in organ transplantation, multiple donor organ transplantation could reduce rejection risk in liver and kidney transplantation. Therefore, it is speculated that there are different MHC antigens from different donors, which cause different reactions after transplantation. Because there are a large number of Langerhans cells， abundant blood vessels and lymphatic in the limbal, so the rejection occurs early and severely. Continuous and intense limbal rejection leads to the depletion of recipient T cells, lead to the immune tolerance of another donor's central corneal tissue. In this project, central penetrating keratoplasty and limbal transplantation from different donors will be carried out and the graft survival of high-risk corneal transplantation will be observed in clinical, to find a new method for high-risk corneal transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Central corneal opacity involving full layer
- •Corneal neovascularization in two or more quadrants
- •Patients must be willing and able to return for scheduled follow-up examinations for 12 months after surgery
- •Ages：18 -70 Years
排除标准
- •Central corneal opacity not involving the endothelial layer
- •Less than two quadrants of corneal neovascularization
- •History of Stevens-Johnson syndrome or Sjogren's syndrome
- •Severe eyelid and conjunctival scar
- •Loss of vision in contralateral eye
- •Pregnant and lactating women
研究组 & 干预措施
Single graft corneal transplantation
Limbal transplantation combined with central penetrating keratoplasty from single donors.
干预措施: Limbal transplantation combined with central penetrating keratoplasty (Procedure)
Dual graft corneal transplantation
Limbal transplantation combined with central penetrating keratoplasty from different donors.
干预措施: Limbal transplantation combined with central penetrating keratoplasty (Procedure)
结局指标
主要结局
The rate of corneal graft rejection at 12 months
时间窗: 12 months
The rejection index of corneal transplantation will be observed by slit lamp after surgery
次要结局
- The changes of corneal thickness depth(baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months)
- The rate of presence of goblet cells containing conjunctival epithelium on the corneal surface by impression cytology(baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months)
- The changes of best corrected visual acuity(Before surgery, 1 week, 1 month, 3 months, 6 months, 12 months)
- Reconstruction of corneal limbal(baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months)
- Endothelial Cell Density(baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months)