Clinical trial NCT03958292: Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation
Official title: Evaluation of Conjunctival Flora Alteration in Patients Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endophthalmitis Following Cataract Surgery
Keywords: Cataract
Endophthalmitis
Microbiological evaluation
Lead sponsor: Ospedale Sacra Famiglia - Fatebenefratelli Erba
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Variation of bacterial load of Positive Culture in Subjects Scheduled for Cataract Surgery
timeFrame: Three days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Oftalmologia Universitaria Ospedale Policlinico di Bari
state: BA
city: Erba
country: Italy
facility: Ospedale Sacra Famiglia Fatebenefratelli
state: Como
city: Catania
country: Italy
facility: Clinica Oculistica Azienda Ospedaliero-Universitaria, Presidio Ospedaliero G. Rodolico
state: CT
city: Monza
country: Italy
facility: Centro di Microchirurgia Ambulatoriale di Monza
state: MB
city: Roma
country: Italy
facility: Casa di Cura Villa Valeria di Roma
state: RM
city: Roma
country: Italy
facility: Ospedale San Carlo di Nancy
state: RM
Study officials:
References: