Endophthalmitis Following Cataract Surgery
Conditions
Keywords
Cataract, Endophthalmitis, Microbiological evaluation
Brief summary
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
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.
Interventions
DEVICEIODIM
Eye drops containing polyvinylpyrrolidone-Iodine (PVP-Iodine), hyaluronic acid and triglycerides
Sponsors
Ospedale Sacra Famiglia - Fatebenefratelli Erba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of bacterial load of Positive Culture in Subjects Scheduled for Cataract Surgery | 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. |
Countries
Italy
Outcome results
None listed