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Microbiological Evaluation of the Ocular Flora Before Cataract Surgery

Completed
Conditions
Disorders of the Eye Following Cataract Surgery
Registration Number
NCT02124603
Lead Sponsor
SIFI SpA
Brief Summary

The purpose of the present study is to elucidate the spectrum of ocular flora and their antimicrobial susceptibility profiles in patients undergoing routine cataract surgery.

Detailed Description

A conjunctival and palpebral swab will executed at least 14 days before routine cataract surgery. Isolates will be identified using standard microbiological protocols. In vitro susceptibility will be determined using a breakpoint minimal inhibitory concentrations. In case of positivity, the swab will be repeated the day of surgery. Topical antibiotic may be used in case of positivity at the discretion of the surgeon. Descriptive statistics will be calculated.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
Inclusion Criteria
  • Patients scheduled for cataract surgery
  • Age > 18 years
  • Any gender and race
  • Willing to sign informed consent
Exclusion Criteria
  • Any antibiotics within 3 months
  • Any ocular infection within 3 months

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Positive Culture in Subjects Scheduled for Cataract SurgeryAt least 14 days before surgery

Number of participants with positive culture at the screening visit

Secondary Outcome Measures
NameTimeMethod
Antibiotic SusceptibilityAt least 14 days before surgery

Isolated bacteria were tested for their in vitro susceptibility to commercially available ophthalmic antibiotics by the disk diffusion test and categorized as susceptible, intermediate or resistant.

Eradication RateDay of surgery

Number of participants having positive culture at the screening visit with bacterial eradication before surgery

Trial Locations

Locations (1)

Casa di Cura Di Stefano

🇮🇹

Catania, Italy

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