Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00335231
Recruitment Status : Withdrawn (Protocol changes underway. Trial never started)
First Posted : June 9, 2006
Last Update Posted : May 2, 2018
Information provided by (Responsible Party):
Queen's University

June 8, 2006
June 9, 2006
May 2, 2018
June 2006
June 2013   (Final data collection date for primary outcome measure)
Difference in bacterial colony forming units (CFUs) between treatment (gatifloxacin) and no treatment group
Same as current
Complete list of historical versions of study NCT00335231 on Archive Site
  • Bacterial sensitivity
  • Patient comfort
Same as current
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Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery
The Effect of Preoperative Topical Gatifloxacin on Anterior Chamber Sample Cultures After Cataract Surgery.

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.

Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Drug: gatifloxacin ophthalmic (ZYMAR)
  • Experimental: gatifloxacin
    one group will receive topical application of gatifloxacin prior to surgery,
    Intervention: Drug: gatifloxacin ophthalmic (ZYMAR)
  • No Intervention: no eye drops
    this group will receive no eye drops.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • uveitis,
  • herpetic eye disease,
  • corneal ulceration,
  • severe blepharitis,
  • past trauma to the eye,
  • complicated cataract surgery (e.g., posterior capsule rupture),
  • previous intraocular surgeries.
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
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Queen's University
Queen's University
Not Provided
Principal Investigator: Sherif El-Defrawy, MD PhD FRCSC Queen's University, Hotel Dieu Hospital, Kingston General Hospital
Queen's University
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP