Microbiological Evaluation of the Ocular Flora Before Cataract Surgery

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. Identifier: NCT02124603
Recruitment Status : Completed
First Posted : April 28, 2014
Results First Posted : September 29, 2015
Last Update Posted : January 18, 2016
Information provided by (Responsible Party):

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.

Condition or disease
Disorders of the Eye Following 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.

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Ocular Flora in Patients Undergoing Cataract Surgery. An Observational Study
Study Start Date : April 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

single group
Patients undergone cataract surgery

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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

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

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

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 identifier (NCT number): NCT02124603

Casa di Cura Di Stefano
Catania, Italy, 95100
Sponsors and Collaborators
Principal Investigator: Marcello Santocono, MD Casa Di Cura Di Stefano Catania (Italy)

Responsible Party: SIFI SpA Identifier: NCT02124603     History of Changes
Other Study ID Numbers: 041SI
First Posted: April 28, 2014    Key Record Dates
Results First Posted: September 29, 2015
Last Update Posted: January 18, 2016
Last Verified: December 2015

Keywords provided by SIFI SpA:

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases