Phase I Study of Xenogenic Keratoplasty From Porcine Cornea in the Treatment of Infectious Corneal Ulcer
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of rejection in three months after keratoplasty
研究概览
简要总结
Acellular porcine cornea is a valid substitution for human cornea because of its similar biological structure, corneal superficial curvature and good histocompatibility toward human. Facing the lack of human cornea donor, it is hypothesised that using acellular lamellar porcine cornea as an alternative of lamellar human cornea to treat infectious corneal ulcer.
详细描述
Acellular porcine cornea eligibility criteria:
- fresh porcine cornea,
- porcine cornea keeping transparent without scar, neovascularization or corneal ulcer,
- porcine cornea keeping integrative corneal epithelium and endothelium,
- acellular porcine cornea keeping transparent.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe infectious corneal ulcer
- •The ulcers can not be controlled with existing antibiotics eye drops or medicine after 1 week treatment
- •The infected corneas have risks of penetrating
- •The depth of ulcers are less than 400um
- •The bridge of the ulcers is away from corneal limbal more than 1mm
- •Patients aged 18 or older
- •Patients able and willing to sign the informed consent form
排除标准
- •Patients with severe infectious corneal ulcer in stable stage
- •Patients with corneal ulcers after viruses infection, such as herpes simplex virus
- •Patients with corneal ulcers from non-infectious factors, such as toxicity, burn or immunological inflammation
- •The ulcers are not cover pupil zone and will not result in visional defect in future
- •The depth of ulcer is less than 50um
- •Patients has history of keratoplasty surgery
结局指标
主要结局
Rate of rejection in three months after keratoplasty
时间窗: three months after lamellar keratoplasty
1. Rate of epithelium rejection Epithelial rejection performances: 1.1 epithelium edema, OR 1.2 epithelium opacity, OR 1.3 epithelial rejection line. 2. Rate of stroma rejection Stroma rejection performances: 2.1 stroma edema, OR 2.2 stroma opacity, OR 2.3 suture loosing.
次要结局
- Density of regenerative sub-epithelial nerve plex, stromal nerve and stromal keratocytes in vivo confocal microscopy(one year)
研究者
Zuguo Liu
Dean of Xiamen University Medical School
Xiamen University