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OpenTrials
Completed

NCT Number: NCT02124603

Microbiological Evaluation of the Ocular Flora Before Cataract Surgery

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.

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Key information

Conditions

Disorders of the Eye Following Cataract Surgery Cataract Disease Attributes Disease Susceptibility Eye Diseases Lens Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Casa di Cura Di Stefano

Catania, 95100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

SIFI SpA

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 28, 2014
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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