Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation

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.

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Key information

Conditions

Endophthalmitis Following Cataract Surgery Cataract Endophthalmitis Eye Diseases Eye Infections Infections Lens Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oftalmologia Universitaria Ospedale Policlinico di Bari, Bari, BA, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IODIM

Device

Eye drops containing polyvinylpyrrolidone-Iodine (PVP-Iodine), hyaluronic acid and triglycerides

Primary outcomes

Variation of bacterial load of Positive Culture in Subjects Scheduled for Cataract Surgery

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ospedale Sacra Famiglia - Fatebenefratelli Erba

Other

Registry information

Official study title

Evaluation of Conjunctival Flora Alteration in Patients Undergoing Cataract Surgery

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2019
First posted: May 22, 2019
Registry last updated: May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed