Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients

October 30, 2016 updated by: Yonsei University

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- Kyoungkido
  - Seoul, Kyoungkido, Korea, Republic of, 120-752
    - Yonsei University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Myopia patients scheduled for refractive surgery

Description

Inclusion Criteria:

Myopia patients scheduled for refractive surgery

Exclusion Criteria:

Active keratitis
Current treatment of antibiotics (systemic or topical)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Minimum inhibitory concentrations of commonly used antibiotics are determined using an E-test. Time Frame: 3 months	3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

Study Chair: Kyoung Yul Seo, M.D., Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

June 26, 2008

First Submitted That Met QC Criteria