Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Keratoconus progression
研究概览
简要总结
Background: Corneal cross linking is a procedure that induces collagen cross linking of the corneal stroma due to release of reactive oxygen radicals upon activation of topically applied riboflavine A by UVA exposure. This procedure might be capable of reducing keratocouns progression.
Purpose: Although there are no randomised controlled trials on the effectiveness of corneal cross linking for the treatment of keratoconus it gains more and more importance in the general clinical setting. Therefore, the investigators started such randomised, placebo controlled, double blinded, multicenter trial to find out if this treatment is as effective as it promises to be.
Methods: Randomised, placebo controlled, double blinded, multicenter trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only early Keratoconus (Contact lens fitting)
- •Progression of Ametropia.
- •Corneal thickness > 450µm
排除标准
- •Further ophthalmic diseases
- •History of ocular surgery
- •Pregnancy, brest feeding
- •Allergy against Riboflavin
- •End stage Keratoconus
结局指标
主要结局
Keratoconus progression
时间窗: 3 years
Endothelial cell loss
时间窗: 3 years
次要结局
未报告次要终点
研究者
D Dr. Philip Maier
PD Dr. med.
University Hospital Freiburg