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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing routine cataract surgery | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IODIM | Device | Eye drops containing polyvinylpyrrolidone-Iodine (PVP-Iodine), hyaluronic acid and triglycerides |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oftalmologia Universitaria Ospedale Policlinico di Bari | Bari | BA | 70120 | Italy | ||
| Ospedale Sacra Famiglia Fatebenefratelli |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D009877 | Endophthalmitis |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D015817 | Eye Infections |
| D007239 | Infections |
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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.
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| Erba |
| Como |
| 22036 |
| Italy |
| Clinica Oculistica Azienda Ospedaliero-Universitaria, Presidio Ospedaliero G. Rodolico | Catania | CT | 95123 | Italy |
| Centro di Microchirurgia Ambulatoriale di Monza | Monza | MB | 20900 | Italy |
| Casa di Cura Villa Valeria di Roma | Roma | RM | 00141 | Italy |
| Ospedale San Carlo di Nancy | Roma | RM | 00165 | Italy |