Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients

Bacterial Keratitis Clinical Trial

Official title:

Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707005
• Other study ID #: 4-2008-0164
• Status: Completed
• Phase: N/A
• First received: June 26, 2008
• Last updated: October 30, 2016
• Start date: June 2008
• Est. completion date: August 2008

Study information

• Verified date: October 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Myopia patients scheduled for refractive surgery

Exclusion Criteria:

• Active keratitis

• Current treatment of antibiotics (systemic or topical)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacterial Keratitis
• Disease Susceptibility
• Keratitis

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System	Seoul	Kyoungkido

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Miño 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum inhibitory concentrations of commonly used antibiotics are determined using an E-test.		3 months	No