Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation

Study Overview
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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.

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.

Official Title
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Evaluation of Conjunctival Flora Alteration in Patients Undergoing Cataract Surgery

Conditions
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Endophthalmitis Following Cataract Surgery

Intervention / Treatment
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* Device: IODIM


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing routine cataract surgery<br>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<br>* Eye drops containing polyvinylpyrrolidone-Iodine (PVP-Iodine), hyaluronic acid and triglycerides<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Three days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Endophthalmitis, Microbiological evaluation