NCT00642044Unknown不适用
Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Keratometry
研究概览
简要总结
Cross-linking of the cornea increases the mechanical and biochemical stability of the stromal tissue. The purpose of this study is to assess the effectiveness of riboflavin-ultraviolet light induced cross-linking of corneal collagen in improving visual acuity and reducing progression of keratoconus in the Brazilian population.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 35 years.
- •Diagnosis of Keratoconus.
- •Progression of Ametropia.
- •Written informed consent.
排除标准
- •Corneal Thickness < 395 micra at thinnest point.
- •Other active ocular disease than keratectasia.
- •Cornea Guttata.
- •Previous ocular surgery.
- •Pregnancy.
- •Known sensitivity to riboflavin.
结局指标
主要结局
Keratometry
时间窗: 3 months
BSCVA (Best spectacle corrected visual acuity)
时间窗: 3 months
次要结局
- Endothelial cell count(3 months)
研究者
研究点 (2)
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