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Clinical Trials/NCT02124603
NCT02124603
Completed
Not Applicable

Evaluation of Ocular Flora in Patients Undergoing Cataract Surgery. An Observational Study

SIFI SpA1 site in 1 country120 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disorders of the Eye Following Cataract Surgery
Sponsor
SIFI SpA
Enrollment
120
Locations
1
Primary Endpoint
Positive Culture in Subjects Scheduled for Cataract Surgery
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
October 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
SIFI SpA
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Positive Culture in Subjects Scheduled for Cataract Surgery

Time Frame: At least 14 days before surgery

Number of participants with positive culture at the screening visit

Secondary Outcomes

  • Antibiotic Susceptibility(At least 14 days before surgery)
  • Eradication Rate(Day of surgery)

Study Sites (1)

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