Official Title: “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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Single Group Assignment

Intervention(s) in this Clinical Trial

• Drug: gatifloxacin ophthalmic (ZYMAR)

Primary Measures

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

Secondary Measures

• Bacterial sensitivity
• Patient comfort

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Queen's University

Overall Clinical Trial Officials and Contacts

Sherif El-Defrawy, MD PhD FRCSC Principal Investigator Queen's University, Hotel Dieu Hospital, Kingston General Hospital  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00335231

Study ID Number: QUEENS-SRE-3

ClinicalTrials.gov Identifier: NCT00335231

Health Authority: Canada: Health Canada