Viewing Study NCT02124603


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Study NCT ID: NCT02124603
Status: COMPLETED
Last Update Posted: 2016-01-18
First Post: 2014-04-23
Is Gene Therapy: True
Has Adverse Events: True

Brief Title: Microbiological Evaluation of the Ocular Flora Before Cataract Surgery
Sponsor: SIFI SpA
Organization:

Study Overview

Official Title: Evaluation of Ocular Flora in Patients Undergoing Cataract Surgery. An Observational Study
Status: COMPLETED
Status Verified Date: 2015-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: