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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
Sponsor:
Collaborator:
Santen Gmbh
Information provided by:
Ludwig-Maximilians - University of Munich

Tracking Information
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
 (submitted: June 21, 2007)
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
 (submitted: June 21, 2007)
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
 
Descriptive Information
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.
Detailed Description

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.[3] 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.[4] 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.

Study Protocol:

One hundred and forty patients will be randomized to control group and a study group:

  • Control group: no antibiotic (70 patients). Standard protocol at the Department of Ophthalmology, Munich.
  • Study group I: topical 0.5% levofloxacin four times per day for one day prior to surgery. In addition, one drop of topical levofloxacin is given three times with five minutes intervals, one hour prior to surgery (70 patients).

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.

  • T1: On the morning of the surgery, but prior to final treatment during the last hour before surgery. At this time, patients in both study groups will have received topical levofloxacin (one day and three days before surgery) treatment; patients in the control group will not have received any treatment with antibiotic. Samples will be taken also from both conjunctiva.
  • T2: Immediately before surgery, 5-10 min after PVI scrub and PVI irrigation for both the control and study group, but only on the conjunctiva of surgery eye. In addition of sample of anterior chamber aqueous fluid is taken from the surgery eye by the responsible surgeon.
  • T3: At the conclusion of surgery, again from the conjunctiva and the anterior chamber fluid of the surgery eye.

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.

Inclusion criteria:

- Patients undergoing surgery for cataract, glaucoma or vitrectomy.

Exclusion criteria:

  • Patients who report to be allergic to levofloxacin or iodine
  • Patients on topical antibiotic within the last 30 days
  • Patients with acute conjunctivitis, blepharitis or dacryocystitis
  • Patients under age of 18 years

Summary:

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
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Conjunctival Bacterial Flora
Intervention  ICMJE Drug: 0.5% levofloxacin eye drops
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2007)
140
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing surgery for cataract, glaucoma or vitrectomy

Exclusion Criteria:

  • Patients who report to be allergic to levofloxacin or iodine
  • Patients on topical antibiotic within the last 30 days
  • Patients with acute conjunctivitis, blepharitis or dacryocystitis
  • Patients under age of 18 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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  
 
Administrative Information
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
Investigators  ICMJE
Principal Investigator: Herminia Mino de Kapsar, PhD Augenklinik der LMU
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