Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335231
Status:
WITHDRAWN
Last Update Posted:
2018-05-02
First Post:
2006-06-08
Brief Title:
Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
The Effect of Preoperative Topical Gatifloxacin on Anterior Chamber Sample Cultures After Cataract Surgery
Status:
WITHDRAWN
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Protocol changes underway Trial never started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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 ie colony forming units CFUs will be used as an indicator of the bacterial contamination of the fluid
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 ie colony forming units CFUs will be used as an indicator of the bacterial contamination of the fluid
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None