Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00707005
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Duration (Months): 2
• Patients Per Site Per Month: 52.4

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

• 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: Jun 1, 2008
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Outcome Measures

Primary Outcome Measures

1. Minimum inhibitory concentrations of commonly used antibiotics are determined using an E-test. [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Myopia patients scheduled for refractive surgery

Exclusion Criteria:

• Active keratitis

• Current treatment of antibiotics (systemic or topical)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00707005
• Other Study ID Numbers: 4-2008-0164
• First Posted: Jun 30, 2008
• Last Update Posted: Nov 1, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by , ,: antibiotic susceptibility; bacterial flora; fluoroquinolone; LASIK; refractive surgery
• Additional relevant MeSH terms: Keratitis; Disease Susceptibility

Study Results

No Results Posted as of Nov 1, 2016