Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation

May 20, 2019 updated by: Ospedale Sacra Famiglia - Fatebenefratelli Erba

Evaluation of Conjunctival Flora Alteration in Patients Undergoing Cataract Surgery

The purpose of the present study is to elucidate the qualitative and quantitative variation of ocular flora after treatment with eyedrops containing 0.6% povidone-iodine in the eye of patients undergoing routine cataract surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two conjunctival swabs will be executed at 3 days before and at the day of routine cataract surgery in each eye of patients undergoing routine cataract surgery. After the collection of the first conjunctival swab a three-days treatment with eyedrops containing 0.6% povidone-iodine in the eye undergoing routine cataract surgery will be performed. Bacterial isolates will be identified by using standard microbiological protocols and total bacterial load will be determined at the two different time points. In vitro susceptibility testing to determine methicillin resistance in isolated Staphylococcus species will be performed. Controlateral eye of each patient will be used as control. Descriptive statistics will be calculated.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BA
      • Bari, BA, Italy, 70120
        • Oftalmologia Universitaria Ospedale Policlinico di Bari
    • CT
      • Catania, CT, Italy, 95123
        • Clinica Oculistica Azienda Ospedaliero-Universitaria, Presidio Ospedaliero G. Rodolico
    • Como
      • Erba, Como, Italy, 22036
        • Ospedale Sacra Famiglia Fatebenefratelli
    • MB
      • Monza, MB, Italy, 20900
        • Centro di Microchirurgia Ambulatoriale di Monza
    • RM
      • Roma, RM, Italy, 00141
        • Casa di Cura Villa Valeria di Roma
      • Roma, RM, Italy, 00165
        • Ospedale San Carlo di Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent
  • Males and females aged between 40 and 80 years
  • Patients who are candidates for cataract extraction

Exclusion Criteria:

  • Males and females under 40 years and over 80 years
  • Previous diseases of the eye, ocular surface and thyroid disease
  • Known hypersensitivity to the product
  • Presence of autoimmune diseases
  • Pregnancy or breast-feeding
  • Participation in other clinical studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients undergoing routine cataract surgery

Two eye drops containing PVP-Iodine instillation in the eye undergoing cataract surgery three times for three days before surgery.

Each patient was evaluated for conjunctival flora variation by means of two conjunctival swabs before starting the treatment and at the end of the treatment before the surgery.
Device: IODIM
Eye drops containing polyvinylpyrrolidone-Iodine (PVP-Iodine), hyaluronic acid and triglycerides

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of bacterial load of Positive Culture in Subjects Scheduled for Cataract Surgery
Time Frame: Three days of treatment
Variation/Eradication of bacterial load in participants with positive culture at the screening visit. This variation/Eradication will be recorded at pre-surgical visit by means of a second collection of a conjunctival swab and culture analysis. This outcome will be assessed by comparing the number of participants undergoing eradication of their initial bacterial load or decrease of bacterial load after treatment.
Three days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Sacra Famiglia - Fatebenefratelli Erba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Actual)

October 29, 2018

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSFFE_OCU_IO18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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