Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery

This study has suspended participant recruitment.
(Protocol changes underway.)
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00335231
First received: June 8, 2006
Last updated: May 17, 2007
Last verified: May 2006
  Purpose

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.


Condition Intervention
Endophthalmitis
Drug: gatifloxacin ophthalmic (ZYMAR)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Preoperative Topical Gatifloxacin on Anterior Chamber Sample Cultures After Cataract Surgery.

Resource links provided by NLM:


Further study details as provided by Queen's University:

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

Secondary Outcome Measures:
  • Bacterial sensitivity
  • Patient comfort

Estimated Enrollment: 30
Study Start Date: June 2006
Estimated Study Completion Date: May 2007
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335231

Locations
Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Sherif El-Defrawy, MD PhD FRCSC Queen's University, Hotel Dieu Hospital, Kingston General Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00335231     History of Changes
Other Study ID Numbers: QUEENS-SRE-3
Study First Received: June 8, 2006
Last Updated: May 17, 2007
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Post-cataract surgery endophthalmitis

Additional relevant MeSH terms:
Cataract
Endophthalmitis
Capsule Opacification
Lens Diseases
Eye Diseases
Eye Infections
Infection
Gatifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014