Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery

Endophthalmitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00335231
• Other study ID #: QUEENS-SRE-3
• Status: Withdrawn
• Phase: N/A
• Start date: June 2006
• Est. completion date: June 2013

Study information

• Verified date: April 2018
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Endophthalmitis

Intervention

Drug:
• gatifloxacin ophthalmic (ZYMAR)

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in bacterial colony forming units (CFUs) between treatment (gatifloxacin) and no treatment group
Secondary	Bacterial sensitivity
Secondary	Patient comfort