Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Duration of corneal complete epithelial healing in days.
研究概览
简要总结
The corneal collagen cross linking is currently used in the treatment of keratoconus but this procedure has also a sterilizing non-specific effect on bacteria and fungus. So the corneal cross linking in association with the antibiotic treatment could result in a reduction of the duration of epithelial complete healing of the cornea.
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
- 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
- •Infectious bacterial or fungal keratitis with : size > 2mm or within the central corneal area ( 3mm of the visual axis ) or with a reaction in anterior chamber.
- •Being major responsible.
- •Agreement in writing to participate in the study.
- •Being affiliated to a national insurance scheme.
排除标准
- •Present an infectious keratitis without all the previous criteria.
- •Herpes or acanthamoeba keratitis
- •preperforated or perforated cornea.
- •General criteria:
- •Pregnant woman.
- •Minors(miners).
- •Adults under guardianship.
- •Patient can not be followed during 3 necessary months.
- •French speaking patient.
- •Unaffiliated patient in a national insurance scheme.
- •HIV infected patients
研究组 & 干预措施
antibiotic treatment alone
干预措施: antibiotic treatment (Drug)
Crosslinking + Antibiotic
The procedure of the cross linking is standard:combined riboflavin(Ricrolin®)-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 or 5.4 joule/cm2 for a 30-minute exposure irradiation of the cornea.
Patients are checked every days during the hospitalisation and one week, one month and 3 months after the hospitalisation.
干预措施: Crosslinking (Device)
Crosslinking + Antibiotic
The procedure of the cross linking is standard:combined riboflavin(Ricrolin®)-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 or 5.4 joule/cm2 for a 30-minute exposure irradiation of the cornea.
Patients are checked every days during the hospitalisation and one week, one month and 3 months after the hospitalisation.
干预措施: antibiotic treatment (Drug)
结局指标
主要结局
Duration of corneal complete epithelial healing in days.
时间窗: 3 months
次要结局
- Gain of visual acuity(3 months)
- Size of the corneal scar(3months)
- Corneal thinning(3 months)