Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation

Not Applicable

Completed

• Conditions: Endophthalmitis Following Cataract Surgery
• Interventions: Device: IODIM

• Registration Number: NCT03958292
• Lead Sponsor: Ospedale Sacra Famiglia - Fatebenefratelli Erba

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.

Study Timeline

• Study Start: 2018-01-08
• Primary Completion: 2018-10-29
• Study Completion: 2019-03-30
• Status Verified: 2019-05
• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-20
• Last Update Submitted: 2019-05-20
• Study First Posted: 2019-05-22
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing routine cataract surgery	IODIM	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Oftalmologia Universitaria Ospedale Policlinico di Bari; 🇮🇹 Bari, BA, Italy

Ospedale Sacra Famiglia Fatebenefratelli; 🇮🇹 Erba, Como, Italy

Centro di Microchirurgia Ambulatoriale di Monza; 🇮🇹 Monza, MB, Italy

Casa di Cura Villa Valeria di Roma; 🇮🇹 Roma, RM, Italy

Clinica Oculistica Azienda Ospedaliero-Universitaria, Presidio Ospedaliero G. Rodolico; 🇮🇹 Catania, CT, Italy

Ospedale San Carlo di Nancy; 🇮🇹 Roma, RM, Italy