ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery

This study has been suspended.
( Protocol changes underway. )

Sponsored by: Queen's University
Information provided by: Queen's University
ClinicalTrials.gov Identifier: NCT00335231
  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)

MedlinePlus related topics:   Cataract   

ChemIDplus related topics:   Gatifloxacin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Single Group Assignment
Official Title:   The Effect of Preoperative Topical Gatifloxacin on Anterior Chamber Sample Cultures After Cataract Surgery.

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

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


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

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

Study placed in the following topic categories:
Bacterial Infections
Mycoses
Eye Infections, Bacterial
Uveitis
Eye Diseases
Cataract
Eye Infections
Endophthalmitis
Suppuration
Lens Diseases
Gatifloxacin

Additional relevant MeSH terms:
Anti-Infective Agents
Uveal Diseases
Therapeutic Uses
Uveitis, Suppurative
Eye Infections, Fungal
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 14, 2008




Links to all studies - primarily for crawlers