Effectiveness of Topical 0.5% Levofloxacin to Reduce the Conjunctival Bacterial Flora Before Intraocular Surgery
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|ClinicalTrials.gov Identifier: NCT00491049|
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : June 25, 2007
|First Submitted Date ICMJE||June 21, 2007|
|First Posted Date ICMJE||June 25, 2007|
|Last Update Posted Date||June 25, 2007|
|Study Start Date ICMJE||September 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Rate of culture positive results in thioglycolate broth from conjunctival swabs at defined time points [ Time Frame: maximum 7 days before surgery until conclusion of surgery ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||Numbers of colony forming units (CFUs) found on solid media. Specimens were cultured aerobically and micro-aerobically on blood agar plates and anaerobically on chocolate agar plates and CFUs were determined on each plate using a magnifying glass. [ Time Frame: maximum 7 days before surgery until concluison of surgery ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Effectiveness of Topical 0.5% Levofloxacin to Reduce the Conjunctival Bacterial Flora Before Intraocular Surgery|
|Official Title ICMJE||Phase 4 Study on Effectiveness of Topical 0.5% Levofloxacin on Reduction of Preoperative Conjunctival Flora in Patients Scheduled for Intraocular Surgery|
|Brief Summary||The purpose of this study is to determine whether additional topical application of 0.5% levofloxacin is more effective in reducing the load of the conjunctival bacterial flora in patients scheduled for intraocular surgery than preoperative irrigation of the conjunctiva with povidone iodine alone.|
Endophthalmitis is serious complication of intraocular surgery. Previous studies have shown that the most common sources of bacteria causing endophthalmitis are the patients eyelid and conjunctival bacteria. [1, 2] The risk of postoperative endophthalmitis may be reduced by eliminating bacteria from the ocular surface at the time of the surgery.
The current standard for endophthalmitis prophylaxis at Ludwig-Maximilians-University in Munich, Germany is the irrigation of the conjunctival fornices with 1% povidone-iodine (PVI) prior to surgery. In general, patients do not receive topical antibiotic prior to surgery.
Ta and co-workers have demonstrated that a three-day application of topical ofloxacin resulted in less conjunctival cultures obtained before and after surgery compared to an application of antibiotic given one hour prior to surgery. Furthermore, the same research group showed that the contamination rate of the microsurgical knives used during surgery decreased from 26% to 5% (P = 0.028) with a three day application of ofloxacin compared to a one-hour application. The goal of the current proposal is to determine if we can improve on the current standard of endophthalmitis prophylaxis at Ludwig-Maximilians-University by using topical 5% levofloxacin prior to surgery. Given that the rate of endophthalmitis is quite low, we will use conjunctival bacterial flora and anterior chamber aqueous contamination rate as surrogate markers to determine the effectiveness of topical levofloxacin in reducing or eliminating bacteria from the ocular surface at the time of the surgery. The results of this prospective-randomized control trial may radically change the current practice of endophthalmitis prophylaxis, and levofloxacin may play a critical role in preventing postoperative endophthalmitis.
One hundred and forty patients will be randomized to control group and a study group:
Five minutes prior to surgery both groups will receive topical povidone-iodine (10%) to scrub the periorbital area and 1% PVI to irrigate the conjunctiva (standard protocol). Patients will be draped in a sterile fashion and surgery will be initiated.
Conjunctival cultures for aerobic and anaerobic bacteria will be obtained at the following time-points:
• T0: (Baseline) at the day of the first interview (one week before surgery), prior to any application of antibiotic or povidone-iodine. Samples will be taken from both conjunctivas.
At every step, samples are taken from the conjunctiva with a standard dissolving Ca-alginate swab (Sanofi-Pasteur, Germany). The moistened swab should be taken via one rotational swipe over the lower conjunctiva without touching the lid or eyelashes. Additionally anterior chamber aqueous fluid will be obtained immediately before and after surgery. The cannulas (2x) used for the aspiration will be cultured in a separate broth culture, too.
- Patients undergoing surgery for cataract, glaucoma or vitrectomy.
The results of this study may revolutionize the standard of endophthalmitis prophylaxis. It could be that the application of topical levofloxacin 5%, four times a day for one or three days prior to surgery, significantly reduce or eliminate bacteria from the ocular surface. Hence, topical levofloxacin may have a critical role in preventing postoperative endophthalmitis.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Condition ICMJE||Conjunctival Bacterial Flora|
|Intervention ICMJE||Drug: 0.5% levofloxacin eye drops|
|Study Arms ICMJE||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Actual Enrollment ICMJE||Same as current|
|Actual Study Completion Date ICMJE||April 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages ICMJE||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Germany|
|Removed Location Countries|
|NCT Number ICMJE||NCT00491049|
|Other Study ID Numbers ICMJE||LevoProMUC03|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Ludwig-Maximilians - University of Munich|
|Collaborators ICMJE||Santen Gmbh|
|PRS Account||Ludwig-Maximilians - University of Munich|
|Verification Date||June 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP