The Effects on Betadine 5% Penetration When Using Lidocaine 2% Jelly Versus Topical Tetracaine 0.5% for Topical Phacoemulsification Cataract Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs
研究概览
简要总结
The purpose of this study is to determine if there is a difference on the penetration of betadine 5% when using lidocaine 2% jelly versus topical tetracaine 0.5% in topical cataract surgery. This will be assessed comparing bacterial colony count and species by taking swabs from the eye surface before and after the topical anesthesia has been administered.
详细描述
The purpose of this research study is to show that using Lidocaine2% jelly before surgery as an anesthetic (keep you from feeling touch or pain) for cataract surgery does not block the antiseptic (cleans and kills germs) effect of Betadine5%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •greater or equal to 18 years old
- •uni- or bi-lateral visually significant cataracts
排除标准
- •hypersensitivity to betadine5%, topical tetracaine0.5%, or lidocaine2% jelly
- •pregnancy
研究组 & 干预措施
Tetracaine 0.5% drop
Tetracaine 0.5% drop of betadine will be used on the operative eye after Tetracaine has been administered
干预措施: tetracaine 0.5% (Drug)
Lidocaine 2% Jelly
Lidocaine 2% Jelly drop of betadine will be used on the operative eye after Lidocaine 2% Jelly has been administered
干预措施: Lidocaine 2% Jelly (Drug)
结局指标
主要结局
Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs
时间窗: (1) Pre-antibiotics swab, and (2) Post-study medication (pre surgery)
Within 3 hours from time of culture acquisition, the samples will be vortexed for 30 seconds and 100µl aliquots will be plated onto 5% sheep blood and chocolate agar plates. These plates will be incubated with 5% carbon dioxide at 35˚ C for 72 hours. After 72 hours all plates will be read for colony count and identification of all isolates will be performed using routine microbiological methods. The natural log of bacterial bacterial colony count will be used for the outcome measure.
Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs
时间窗: (1) Pre-antibiotics swab and (2) Post-study medication (pre surgery)
次要结局
未报告次要终点
研究者
Joseph Selem
Principle Investigator
Hermann Eye Center