EUCTR2006-004811-22-NL进行中（未招募）不适用
A prospective, randomized, double-blind comparison of 5 % against 1 % povidone-iodine solution in preoperative antisepsis for strabismus surgery in young children.
Erasmus Medical Center Rotterdam0 个研究点目标入组 250 人开始时间: 2008年4月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Children < 6 years of age
- •2.undergoing surgery for strabismus for the first time, including any recession and/or resection surgery of the medial and/or lateral rectus muscles.
- •3.Children willing to take part in all aspects of the study and written informed consent on the study participation of the child provided by the parents.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Any history or current condition of hypersensitivity to iodine
- •2.Children on topical antibiotic within the last 30 days
- •3.Children with signs of acute conjunctivitis, blepharitis, dacryocystitis or respiratory infection within the last 30 days
- •4.Children with asthma or similar chronic, obstructive pulmonary disorder
- •5.Insufficiently treated amblyopia, i.e. visual acuity must be equal in both eyes or not differ by more than 1 LogMAR line.
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