Antibiotic Susceptibility of Conjunctival Bacterial Isola... | NCT00707005

Studies
Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients

NCT00707005

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Nov 1, 2016Estimated

Enrollment

105Actual

Phase

Not provided

Conditions

Bacterial Keratitis

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Jun 26, 2008

First Submission Date that Met QC Criteria

Jun 26, 2008

First Posted Date

Jun 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2016

Last Update Posted Date

Nov 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

105Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Myopia patients scheduled for refractive surgery

Exclusion Criteria:

Active keratitis
Current treatment of antibiotics (systemic or topical)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Myopia patients scheduled for refractive surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyoung Yul Seo, M.D.	Yonsei University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei University Health System		Seoul	Kyoungkido	120-752	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15808182	Background	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.