Microbiological Evaluation of the Ocular Flora Before Cataract Surgery

Disorders of the Eye Following Cataract Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02124603
• Other study ID #: 041SI
• Status: Completed
• Phase: N/A
• First received: April 23, 2014
• Last updated: December 15, 2015
• Start date: April 2014
• Est. completion date: October 2014

Study information

• Verified date: December 2015
• Source: SIFI SpA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cataract
• Disorders of the Eye Following Cataract Surgery

Locations

Country	Name	City	State
Italy	Casa di Cura Di Stefano	Catania

Sponsors (1)

Lead Sponsor	Collaborator
SIFI SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Culture in Subjects Scheduled for Cataract Surgery	Number of participants with positive culture at the screening visit	At least 14 days before surgery	No
Secondary	Antibiotic Susceptibility	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.	At least 14 days before surgery	No
Secondary	Eradication Rate	Number of participants having positive culture at the screening visit with bacterial eradication before surgery	Day of surgery	No