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Microbiological Evaluation of the Ocular Flora Before Cataract Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02124603
First Posted: April 28, 2014
Last Update Posted: January 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
SIFI SpA
  Purpose
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.

Condition
Disorders of the Eye Following Cataract Surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Ocular Flora in Patients Undergoing Cataract Surgery. An Observational Study

Resource links provided by NLM:


Further study details as provided by SIFI SpA:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Antibiotic Susceptibility [ Time Frame: At 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 Rate [ Time Frame: Day of surgery ]
    Number of participants having positive culture at the screening visit with bacterial eradication before surgery


Biospecimen Retention:   Samples Without DNA
Conjunctival and palpebral swab of the eye undergoing surgery

Enrollment: 120
Study Start Date: April 2014
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
single group
Patients undergone 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing routine cataract surgery
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02124603


Locations
Italy
Casa di Cura Di Stefano
Catania, Italy, 95100
Sponsors and Collaborators
SIFI SpA
Investigators
Principal Investigator: Marcello Santocono, MD Casa Di Cura Di Stefano Catania (Italy)
  More Information

Responsible Party: SIFI SpA
ClinicalTrials.gov Identifier: NCT02124603     History of Changes
Other Study ID Numbers: 041SI
First Submitted: April 23, 2014
First Posted: April 28, 2014
Results First Submitted: July 20, 2015
Results First Posted: September 29, 2015
Last Update Posted: January 18, 2016
Last Verified: December 2015

Keywords provided by SIFI SpA:
cataract
prophylaxis
susceptibility

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases