跳至主要内容
临床试验/NCT01307527
NCT01307527Unknown不适用

Riboflavin Corneal Crosslinking for Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type VI

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2011年3月3日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
1
试验地点
1
主要终点
Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI

研究概览

简要总结

Brittle Cornea Syndrome and Ehlers-Danlos Syndrome (EDS) type VI are rare collagen-connective tissue disorders that predispose affected individuals to the development of perforated corneas from the mildest of eye trauma or even spontaneously. Clinical studies evaluating riboflavin-corneal crosslinking have found that it dramatically increases corneal rigidity. Given the success and safety of riboflavin crosslinking, the investigators believe that it can increase the corneal stability in patients affected these disseases, preventing perforation. It is furthermore possible, that riboflavin crosslinking will allow corneal transplants to successfully be performed on blind eyes that have already perforated and opacified. The purpose of the study is to determine whether corneal crosslinking can be safely performed on individuals with Brittle Cornea Syndrome or Ehlers-Danlos Syndrome type VI.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult Patient with:
  • Genetic diagnosis of either Brittle Cornea Syndrome or EDS-VI, and
  • Personal History of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma or
  • Immediate family member with history of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma

排除标准

  • Any patient that is deemed to be unable to fully cooperate during the crosslinking procedure

结局指标

主要结局

Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI

时间窗: 3 Months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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