- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00335231
Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 5G2
- Hotel Dieu Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: gatifloxacin
one group will receive topical application of gatifloxacin prior to surgery,
|
|
No Intervention: no eye drops
this group will receive no eye drops.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Difference in bacterial colony forming units (CFUs) between treatment (gatifloxacin) and no treatment group
|
Secondary Outcome Measures
Outcome Measure |
---|
Bacterial sensitivity
|
Patient comfort
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sherif El-Defrawy, MD PhD FRCSC, Queen's University, Hotel Dieu Hospital, Kingston General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Eye Diseases
- Lens Diseases
- Eye Infections
- Cataract
- Capsule Opacification
- Endophthalmitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Pharmaceutical Solutions
- Ophthalmic Solutions
- Gatifloxacin
Other Study ID Numbers
- QUEENS-SRE-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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