Clinical trial NCT00707005: Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients
Official title: Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Keratitis
Keywords: antibiotic susceptibility
bacterial flora
fluoroquinolone
LASIK
refractive surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2008-06-30
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Myopia patients scheduled for refractive surgery

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.

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 criteria: Inclusion Criteria:

* Myopia patients scheduled for refractive surgery

Exclusion Criteria:

* Active keratitis
* Current treatment of antibiotics (systemic or topical)

Primary outcomes:
measure: Minimum inhibitory concentrations of commonly used antibiotics are determined using an E-test.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
state: Kyoungkido
Study officials:
affiliation: Yonsei University
name: Kyoung Yul Seo, M.D.
role: STUDY_CHAIR
References:
citation: Mino de Kaspar H, Koss MJ, He L, Blumenkranz MS, Ta CN. Antibiotic susceptibility of preoperative normal conjunctival bacteria. Am J Ophthalmol. 2005 Apr;139(4):730-3. doi: 10.1016/j.ajo.2004.10.007.