Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation

Ospedale Sacra Famiglia - Fatebenefratelli Erba

Status: Completed

Conditions: Endophthalmitis Following Cataract Surgery

Treatments: Device: IODIM

Study type: Interventional

Funder types: Other

Identifiers

NCT03958292

OSFFE_OCU_IO18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

Patients undergoing routine cataract surgery

Experimental group

Description:

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.

Treatment:

Device: IODIM