Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2019-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endophthalmitis Following Cataract Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Each patient has self-control of the IODIM treatment in the eye undergoing to cataract surgery with the contralateral eye. Microbiological studies will be performed by means of conjunctival swabs evaluation.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

IODIM

Intervention Type DEVICE

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

Interventions

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IODIM

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No