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