跳至主要内容
临床试验/NCT06233409
NCT06233409招募中不适用

A Novel Sandwich Technique of Minimally Invasive Keratoplasty for Corneal Perforation

Tianjin Eye Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
A Novel Sandwich Technique for Corneal Perforation

研究概览

简要总结

The goal of this type of study to describe a new sandwich technique of minimally invasive keratoplasty (STMIK) by using SMILE-extracted lenticules for treatment corneal perforation and effectiveness.

The main question[s] it aims to answer are: 1.Corneal perforations require urgent attendances for prompt treatments. How can we restore the integrity of the eyeball as soon as possible, reduce complications, and restore vision in the case of lack of corneal material according to the conditions that may be obtained.

2.In China, nearly 1 million lenticules are obtained through all-femtosecond surgery every year. How to reuse and turn waste into precious materials for clinical application is an important study.

Participants will understand and signed the informed consent to take this new method for the treatment of their corneal perforations disease, which will obtain good results, but there may be a certain risk of complications.The main tasks participants will be asked to cooperate as required.The clinical eye check includes the test of includes visual acuity, slit lamp, anterior segment phase, anterior segment OCT and IOP.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with corneal perforation who are willing to undergo treatment with this new technique;
  • The size of cornea perforation was ≦ 3mm

排除标准

  • The size of cornea perforation was >3mm
  • Patients with corneal perforation who were unwilling to be treated with this new technique.
  • Patients who could not be followed up regularly.

结局指标

主要结局

A Novel Sandwich Technique for Corneal Perforation

时间窗: one year

By sandwiching the corneal lenticules interlamellar implantation, STMIK as an alternative novel treatment and effective procedure that provides an option to restore the corneal integrity and improve vision in patients with corneal perforations.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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