NCT00491049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2007

Completed
Last Updated

June 25, 2007

Status Verified

June 1, 2007

First QC Date

June 21, 2007

Last Update Submit

June 21, 2007

Conditions

Conjunctival Bacterial Flora

Keywords

prophylaxisintraocular surgeryendophthalmitisantibiotic

Outcome Measures

Primary Outcomes (1)

  • Rate of culture positive results in thioglycolate broth from conjunctival swabs at defined time points

    maximum 7 days before surgery until conclusion of surgery

Secondary Outcomes (1)

  • 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.

    maximum 7 days before surgery until concluison of surgery

Interventions

0.5% levofloxacin eye dropsDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing surgery for cataract, glaucoma or vitrectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augenklinik der LMU

Munich, Bavaria, 80336, Germany

Location

Related Publications (6)

  • Speaker MG, Milch FA, Shah MK, Eisner W, Kreiswirth BN. Role of external bacterial flora in the pathogenesis of acute postoperative endophthalmitis. Ophthalmology. 1991 May;98(5):639-49; discussion 650. doi: 10.1016/s0161-6420(91)32239-5.

    PMID: 2062496BACKGROUND

  • Bannerman TL, Rhoden DL, McAllister SK, Miller JM, Wilson LA. The source of coagulase-negative staphylococci in the Endophthalmitis Vitrectomy Study. A comparison of eyelid and intraocular isolates using pulsed-field gel electrophoresis. Arch Ophthalmol. 1997 Mar;115(3):357-61. doi: 10.1001/archopht.1997.01100150359008.

    PMID: 9076208BACKGROUND

  • Ta CN, Egbert PR, Singh K, Shriver EM, Blumenkranz MS, Mino De Kaspar H. Prospective randomized comparison of 3-day versus 1-hour preoperative ofloxacin prophylaxis for cataract surgery. Ophthalmology. 2002 Nov;109(11):2036-40; discussion 2040-1. doi: 10.1016/s0161-6420(02)01236-8.

    PMID: 12414411BACKGROUND

  • De Kaspar HM, Chang RT, Shriver EM, Singh K, Egbert PR, Blumenkranz MS, Ta CN. Three-day application of topical ofloxacin reduces the contamination rate of microsurgical knives in cataract surgery: a prospective randomized study. Ophthalmology. 2004 Jul;111(7):1352-5. doi: 10.1016/j.ophtha.2003.10.032.

    PMID: 15234136BACKGROUND

  • Mino de Kaspar H, Chang RT, Singh K, Egbert PR, Blumenkranz MS, Ta CN. Prospective randomized comparison of 2 different methods of 5% povidone-iodine applications for anterior segment intraocular surgery. Arch Ophthalmol. 2005 Feb;123(2):161-5. doi: 10.1001/archopht.123.2.161.

    PMID: 15710810BACKGROUND

  • Mino de Kaspar H, Kreutzer TC, Aguirre-Romo I, Ta CN, Dudichum J, Bayrhof M, Klauss V, Kampik A. A prospective randomized study to determine the efficacy of preoperative topical levofloxacin in reducing conjunctival bacterial flora. Am J Ophthalmol. 2008 Jan;145(1):136-142. doi: 10.1016/j.ajo.2007.08.031. Epub 2007 Nov 8.

    PMID: 17996212DERIVED

Related Links

MeSH Terms

Conditions

Endophthalmitis

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye Diseases

Study Officials

  • Herminia Mino de Kapsar, PhD

    Augenklinik der LMU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 21, 2007

First Posted

June 25, 2007

Study Start

September 1, 2004

Study Completion

April 1, 2005

Last Updated

June 25, 2007

Record last verified: 2007-06

Locations

DE(1)