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临床试验/NCT02911532
NCT02911532Unknown不适用

Tissue Engineering Conjunctiva Transplantation and Conjunctival Sac Formation for the Treatment of Pterygium and Atretoblepharia

Shandong Eye Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

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 epithelial defect size of the transplanted tissue engineering conjunctiva

研究概览

简要总结

The purpose of this study is to determine whether tissue engineering conjunctiva is effective in the treatment of pterygium and atretoblepharia.

详细描述

The most important area for research on the pterygium are the recurrence occurred after operation. Now the best way to prevent the recurrence is autologous conjunctival stem cell transplantation, but this way of operation can cause lack of conjunctiva and conjunctival scar, even may effect the later glaucoma surgery. For the atretoblepharia patients, amniotic membrane transplantation and autologous oral mucosa transplantation can not make effect to alleviate it. In this pilot project, investigators would like to study the effect of tissue engineering conjunctiva transplantation in the treatment of pterygium and tissue engineering conjunctiva transplantation combined with conjunctiva sac formation for the treatment of atretoblepharia. This will allow us to determine if useful data can be obtained, and if so, lead to further studies in various conjunctiva loss caused by trauma, infections, and so on.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary and recurrent pterygium patients,atretoblepharia patients
  • Voluntarily signed informed consent
  • No surgery and anesthesia contraindications.

排除标准

  • The patients combined systemic diseases
  • Reject study and follow visit
  • Patients don't accept the tissue engineering conjunctiva
  • Cannot tolerate surgery or anesthesia

研究组 & 干预措施

Optical Coherence tomography

Experimental

干预措施: Tissue engineering conjunctiva transplantation (Procedure)

结局指标

主要结局

The epithelial defect size of the transplanted tissue engineering conjunctiva

时间窗: the 7 days after operation

次要结局

未报告次要终点

研究者

发起方
Shandong Eye Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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