Topical Ophthalmic Antiseptics and Reduction of Ocular Surface Bacterial Load Before Cataract Surgery: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Conjunctival composition
研究概览
简要总结
The aim of this clinical trial is to evaluate the effectiveness of two topical antiseptics, povidone-iodine (PVI) and chlorhexidine (CHX), in reducing conjunctival bacterial flora.
详细描述
70 patients undergoing cataract surgery were enrolled and randomly divided in two arms: 35 patients used PVI 0.66% 4 times daily starting 3 days before surgery; 35 patients used CHX 0.02% with the same posology. The contralateral eye was considered as control. Conjunctival swabs were collected in both eyes at the baseline (T0) and after three days of treatment (T1) all before cataract surgery. Conjunctival bacterial load has been evaluated through a molecular based method at T0 and T1 and compared to the control eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients undergoing cataract surgery
- •18 years of age or older
排除标准
- •Reported allergy or hypersensitivity to iodine or chlorhexidine
- •Active ocular infection
- •Contraindication to surgery
- •Pregnant women
- •Patients residing in nursing homes or prison
- •Patients who used antibiotic, antiviral or antifungal eye drops in the week preceding the intervention
结局指标
主要结局
Conjunctival composition
时间窗: 3 days. Conjunctival swabs were taken at baseline and after 3 days of treatment.
Molecular based method: 16S rRNA gene was sequenced to evaluate ocular microbiota
次要结局
- Patient pain score(Day 3: after 3 days of treatment)
- Compliance of the patients(Day 3: after 3 days of treatment)
研究者
Vito Romano
Professor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia