Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00707005
First received: June 26, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Conjunctival swab samples


Estimated Enrollment: 110
Study Start Date: May 2008
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: July 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707005

Contacts
Contact: Kyoung Yul Seo, M.D. 822-2228-3580 seoky@yuhs.ac
Contact: Jae Lim Chung, M.D. 822-2228-3588 jlchung@yuhs.ac

Locations
Korea, Republic of
Yonsei University Health System Recruiting
Seoul, Kyoungkido, Korea, Republic of, 120-752
Contact: Kyoung Yul Seo, M.D.    822-2228-3580    seoky@yuhs.ac   
Contact: Jae Lim Chung, M.D    822-2228-3588    jlchung@yuhs.ac   
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
Study First Received: June 26, 2008
Last Updated: June 26, 2008
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Disease Susceptibility
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 18, 2014