Microbiological Evaluation of the Ocular Flora Before Cataract Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by SIFI SpA
Sponsor:
Information provided by (Responsible Party):
SIFI SpA
ClinicalTrials.gov Identifier:
NCT02124603
First received: April 23, 2014
Last updated: April 25, 2014
Last verified: April 2014
  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:
  • Characterization of the ocular flora [ Time Frame: At least 14 days before surgery ] [ Designated as safety issue: No ]
    Isolated organisms will be identified and characterized


Secondary Outcome Measures:
  • Eradication rate [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    In case of positive swab at the screening visit, bacteria eradication will be evaluated before surgery


Other Outcome Measures:
  • Antibiotic susceptibility [ Time Frame: At least 14 days before surgery ] [ Designated as safety issue: No ]
    Select isolates recovered will be tested for antibiotic susceptibility to netilmicin, tobramycin, chloramphenicol, ofloxacin, levofloxacin, moxifloxacin, azithromycin , meticillin, cefuroxime and vancomycin.


Biospecimen Retention:   Samples Without DNA

Conjunctival and palpebral swab of the eye undergoing surgery


Estimated Enrollment: 100
Study Start Date: April 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02124603

Contacts
Contact: Marcello Santocono, MD santocono.m@alice.it

Locations
Italy
Casa di Cura Di Stefano Recruiting
Catania, Italy, 95100
Contact: Antonio Gerace       info@distefanovelona.com   
Principal Investigator: Marcello Santocono, MD         
Sponsors and Collaborators
SIFI SpA
Investigators
Principal Investigator: Marcello Santocono, MD Casa Di Cura Di Stefano Catania (Italy)
  More Information

No publications provided

Responsible Party: SIFI SpA
ClinicalTrials.gov Identifier: NCT02124603     History of Changes
Other Study ID Numbers: 041SI
Study First Received: April 23, 2014
Last Updated: April 25, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by SIFI SpA:
cataract
prophylaxis
susceptibility

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 23, 2014