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Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients

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ClinicalTrials.gov Identifier: NCT00707005
Recruitment Status : Completed
First Posted : June 30, 2008
Last Update Posted : November 1, 2016
Sponsor:
Information provided by:
Yonsei University

Brief Summary:
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 or disease
Bacterial Keratitis

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.

Study Type : Observational
Actual Enrollment : 105 participants
Time Perspective: Prospective
Official Title: Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients
Study Start Date : June 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics




Primary Outcome Measures :
  1. 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


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Ages Eligible for Study:   Child, Adult, Older Adult
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)

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

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 Posted: June 30, 2008    Key Record Dates
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