Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation

Ospedale Sacra Famiglia - Fatebenefratelli Erba140 enrolled

Overview

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.

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

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

140

Conditions

Endophthalmitis Following Cataract Surgery

Interventions

IODIMDEVICE

Eye drops containing polyvinylpyrrolidone-Iodine (PVP-Iodine), hyaluronic acid and triglycerides

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (6)

Oftalmologia Universitaria Ospedale Policlinico di Bari

Bari, BA, Italy

Ospedale Sacra Famiglia Fatebenefratelli

Erba, Como, Italy

Clinica Oculistica Azienda Ospedaliero-Universitaria, Presidio Ospedaliero G. Rodolico

Catania, CT, Italy

Centro di Microchirurgia Ambulatoriale di Monza

Monza, MB, Italy

Outcomes

Primary Outcomes

Variation of bacterial load of Positive Culture in Subjects Scheduled for Cataract Surgery

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.

Time frame: Three days of treatment

Data from ClinicalTrials.gov

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