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Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00707005
First Posted: June 30, 2008
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  Purpose
The purpose of this study is to determine the in vitro antibiotic susceptibility patterns of conjunctival bacterial flora isolated preoperatively from patients undergoing refractive surgery.

Condition
Bacterial Keratitis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Minimum inhibitory concentrations of commonly used antibiotics are determined using an E-test. [ Time Frame: 3 months ]

Biospecimen Retention:   Samples Without DNA
Conjunctival swab samples

Enrollment: 105
Study Start Date: June 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:
Laser in situ keratomileusis (LASIK) is the most commonly performed refractive surgical procedure for the correction of ametropia worldwide. Infectious keratitis, although rare, is a potentially devastating complication of LASIK, and it can lead to horrifying outcomes. Previous studies on antibiotic susceptibility of preoperative ocular bacterial flora focused primarily on intraocular surgeries with particular interests in endophthalmitis. This study was aimed at refractive surgeries with special interest in infectious keratitis after LASIK. Intraocular surgeries for cataract, glaucoma or retinal disease are performed mostly on aged patients at a large hospital on an inpatient or outpatient basis; however, most refractive surgeries are performed on young, healthy people in private clinics on an outpatient basis. The patient populations are therefore quite different between these two types of surgery. The aim of this study is to determine the in vitro antibiotic susceptibility patterns of conjunctival bacterial flora isolated preoperatively from patients undergoing refractive surgery at an outpatient laser surgery clinic. Preoperative conjunctival swab samples are directly inoculated in culture media at the bedside before topical anesthetic or antibiotic application. Blood agar, chocolate agar, thioglycolate broth, Sabouraud dextrose agar, and Ogawa media are used for bacterial, fungal and mycobacterial cultures. Minimum inhibitory concentrations (MICs) of ofloxacin (OFX), levofloxacin (LEV), gatifloxacin (GAT), moxifloxacin (MOX), gemifloxacin (GEM) and other commonly used antibiotics are determined using an E-test.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Myopia patients scheduled for refractive surgery
Criteria

Inclusion Criteria:

  • Myopia patients scheduled for refractive surgery

Exclusion Criteria:

  • Active keratitis
  • Current treatment of antibiotics (systemic or topical)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707005


Locations
Korea, Republic of
Yonsei University Health System
Seoul, Kyoungkido, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Study Chair: Kyoung Yul Seo, M.D. Yonsei University
  More Information

Publications:
Responsible Party: Kyoung Yul Seo M.D., Yonsei University Health System
ClinicalTrials.gov Identifier: NCT00707005     History of Changes
Other Study ID Numbers: 4-2008-0164
First Submitted: June 26, 2008
First Posted: June 30, 2008
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Yonsei University:
antibiotic susceptibility
bacterial flora
fluoroquinolone
LASIK
refractive surgery

Additional relevant MeSH terms:
Disease Susceptibility
Keratitis
Disease Attributes
Pathologic Processes
Corneal Diseases
Eye Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents