Evaluation of Conjunctival Flora Alteration in Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 11
- 主要终点
- Variation of bacterial load of Positive Culture in Subjects Scheduled for Cataract Surgery
研究概览
简要总结
The purpose of the present study is to elucidate the qualitative and quantitative variation of ocular flora after treatment with eyedrops containing 0.6% povidone-iodine in the eye of patients undergoing routine cataract surgery.
详细描述
Two conjunctival swabs will be executed at 3 days before and at the day of routine cataract surgery in each eye of patients undergoing routine cataract surgery. After the collection of the first conjunctival swab a three-days treatment with eyedrops containing 0.6% povidone-iodine in the eye undergoing routine cataract surgery will be performed. Bacterial isolates will be identified by using standard microbiological protocols and total bacterial load will be determined at the two different time points. In vitro susceptibility testing to determine methicillin resistance in isolated Staphylococcus species will be performed. Controlateral eye of each patient will be used as control. Descriptive statistics will be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Males and females aged between 40 and 80 years
- •Patients who are candidates for cataract extraction
排除标准
- •Males and females under 40 years and over 80 years
- •Previous diseases of the eye, ocular surface and thyroid disease
- •Known hypersensitivity to the product
- •Presence of autoimmune diseases
- •Pregnancy or breast-feeding
- •Participation in other clinical studies
研究组 & 干预措施
Patients undergoing routine cataract surgery
Two eye drops containing PVP-Iodine instillation in the eye undergoing cataract surgery three times for three days before surgery.
Each patient was evaluated for conjunctival flora variation by means of two conjunctival swabs before starting the treatment and at the end of the treatment before the surgery.
干预措施: IODIM (Device)
结局指标
主要结局
Variation of bacterial load of Positive Culture in Subjects Scheduled for Cataract Surgery
时间窗: Three days of treatment
Variation/Eradication of bacterial load in participants with positive culture at the screening visit. This variation/Eradication will be recorded at pre-surgical visit by means of a second collection of a conjunctival swab and culture analysis. This outcome will be assessed by comparing the number of participants undergoing eradication of their initial bacterial load or decrease of bacterial load after treatment.
次要结局
未报告次要终点