Phase 4 Study on Effectiveness of Topical 0.5% Levofloxacin on Reduction of Preoperative Conjunctival Flora in Patients Scheduled for Intraocular Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Rate of culture positive results in thioglycolate broth from conjunctival swabs at defined time points
研究概览
简要总结
The purpose of this study is to determine whether additional topical application of 0.5% levofloxacin is more effective in reducing the load of the conjunctival bacterial flora in patients scheduled for intraocular surgery than preoperative irrigation of the conjunctiva with povidone iodine alone.
详细描述
Endophthalmitis is serious complication of intraocular surgery. Previous studies have shown that the most common sources of bacteria causing endophthalmitis are the patients eyelid and conjunctival bacteria. [1, 2] The risk of postoperative endophthalmitis may be reduced by eliminating bacteria from the ocular surface at the time of the surgery.
The current standard for endophthalmitis prophylaxis at Ludwig-Maximilians-University in Munich, Germany is the irrigation of the conjunctival fornices with 1% povidone-iodine (PVI) prior to surgery. In general, patients do not receive topical antibiotic prior to surgery.
Ta and co-workers have demonstrated that a three-day application of topical ofloxacin resulted in less conjunctival cultures obtained before and after surgery compared to an application of antibiotic given one hour prior to surgery.[3] Furthermore, the same research group showed that the contamination rate of the microsurgical knives used during surgery decreased from 26% to 5% (P = 0.028) with a three day application of ofloxacin compared to a one-hour application.[4] The goal of the current proposal is to determine if we can improve on the current standard of endophthalmitis prophylaxis at Ludwig-Maximilians-University by using topical 5% levofloxacin prior to surgery. Given that the rate of endophthalmitis is quite low, we will use conjunctival bacterial flora and anterior chamber aqueous contamination rate as surrogate markers to determine the effectiveness of topical levofloxacin in reducing or eliminating bacteria from the ocular surface at the time of the surgery. The results of this prospective-randomized control trial may radically change the current practice of endophthalmitis prophylaxis, and levofloxacin may play a critical role in preventing postoperative endophthalmitis.
Study Protocol:
One hundred and forty patients will be randomized to control group and a study group:
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
- Double
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 surgery for cataract, glaucoma or vitrectomy
排除标准
- •Patients who report to be allergic to levofloxacin or iodine
- •Patients on topical antibiotic within the last 30 days
- •Patients with acute conjunctivitis, blepharitis or dacryocystitis
- •Patients under age of 18 years
结局指标
主要结局
Rate of culture positive results in thioglycolate broth from conjunctival swabs at defined time points
时间窗: maximum 7 days before surgery until conclusion of surgery
次要结局
- Numbers of colony forming units (CFUs) found on solid media. Specimens were cultured aerobically and micro-aerobically on blood agar plates and anaerobically on chocolate agar plates and CFUs were determined on each plate using a magnifying glass.(maximum 7 days before surgery until concluison of surgery)