跳至主要内容
临床试验/NCT00335231
NCT00335231撤回不适用

The Effect of Preoperative Topical Gatifloxacin on Anterior Chamber Sample Cultures After Cataract Surgery.

Queen's University1 个研究点 分布在 1 个国家开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Difference in bacterial colony forming units (CFUs) between treatment (gatifloxacin) and no treatment group

研究概览

简要总结

Postoperative endophthalmitis, a possible severe complication of cataract surgery, is an infection of the anterior chamber of the eye caused by bacterial contamination and colonization through surgical incisions. Bacteria are thought to originate mainly from the patient's skin and studies show that bacteria are commonly found in the anterior chamber following surgery. However, innate immune defences are usually able to control and eliminate bacterial growth before postoperative endophthalmitis occurs. Also, due to the low incidence of postoperative endophthalmitis, it is difficult to accurately evaluate preventative methods. This study will examine the efficacy of topical preoperative administration of gatifloxacin (a new fourth generation fluoroquinolone antibiotic) on reduction of bacterial contamination of the anterior chamber following cataract surgery. If the antibiotic is shown to lower bacteria count in cultures from anterior chamber fluid, it has the potential to lower the incidence of postoperative endophthalmitis.

Patients undergoing cataract surgery will be notified and asked to participate in the study by the physician in advance of the surgery, provided they do not possess any exclusion criteria. The participants will be randomly split into two groups; one group will receive topical application of gatifloxacin prior to surgery, while the other group will receive no eye drops. During surgery, a small sample of anterior chamber fluid will be removed from the eye and cultured in both broth and enrichment media for all subjects. Bacterial growth, i.e., colony forming units (CFUs), will be used as an indicator of the bacterial contamination of the fluid.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Cataract surgery on first eye (i.e., first cataract surgery.

排除标准

  • herpetic eye disease,
  • corneal ulceration,
  • severe blepharitis,
  • past trauma to the eye,
  • complicated cataract surgery (e.g., posterior capsule rupture),
  • previous intraocular surgeries.

研究组 & 干预措施

gatifloxacin

Experimental

one group will receive topical application of gatifloxacin prior to surgery,

干预措施: gatifloxacin ophthalmic (ZYMAR) (Drug)

结局指标

主要结局

Difference in bacterial colony forming units (CFUs) between treatment (gatifloxacin) and no treatment group

次要结局

  • Bacterial sensitivity
  • Patient comfort

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验