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CompletedNCT00707005Updated Nov 1, 2016

Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients

An observational study in Bacterial Keratitis, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2016-11-01.

Sponsored by Yonsei University · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
105
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Bacterial Keratitis

Keywords

  • antibiotic susceptibility
  • bacterial flora
  • fluoroquinolone
  • LASIK
  • refractive surgery
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In context

Keratitis

126 studies on the registry are indexed under Keratitis; 15 are open to participants now.

This study's enrollment of 105 is close to the median of 100 across 37 observational studies indexed under Keratitis.

Browse Keratitis studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Myopia patients scheduled for refractive surgery

Inclusion criteria

  • Myopia patients scheduled for refractive surgery

Exclusion criteria

Exclusion Criteria:

  • Active keratitis
  • Current treatment of antibiotics (systemic or topical)
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Study design

Time perspective
Prospective
Enrollment
105 participants (actual)
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

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

    Time frame: 3 months

07

Study locations

1 site
  • Yonsei University Health System
    Seoul, Kyoungkido 120-752, Korea, Republic of
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References and documents

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. PubMed 15808182 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00707005
Lead sponsor
Yonsei University
First posted
Jun 30, 2008
Start date
Jun 2008
Primary completion
Aug 2008
Completion
Aug 2008
Last update
Nov 1, 2016

Study contacts

Kyoung Yul Seo, M.D.
study chair · Yonsei University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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