Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery
Information source: Queen's University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endophthalmitis
Intervention: gatifloxacin ophthalmic (ZYMAR) (Drug)
Sponsored by: Queen's University
Official(s) and/or principal investigator(s):
Sherif El-Defrawy, MD PhD FRCSC, Principal Investigator, Affiliation: Queen's University, Hotel Dieu Hospital, Kingston General Hospital
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
Official title: The Effect of Preoperative Topical Gatifloxacin on Anterior Chamber Sample Cultures After Cataract Surgery.
Study design: Prevention, Randomized, Open Label, Active Control, Single Group Assignment
Primary outcome: Difference in bacterial colony forming units (CFUs) between treatment (gatifloxacin) and no treatment group
Minimum age: N/A.
Maximum age: N/A.
- Cataract surgery on first eye (i. e., first cataract surgery.
- herpetic eye disease,
- corneal ulceration,
- severe blepharitis,
- past trauma to the eye,
- complicated cataract surgery (e. g., posterior capsule rupture),
- previous intraocular surgeries.
Locations and Contacts
Hotel Dieu Hospital, Kingston, Ontario K7L 5G2, Canada
Starting date: June 2006
Ending date: May 2007
Last updated: May 17, 2007