Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation

Endophthalmitis Following Cataract Surgery Clinical Trial

Official title:

Evaluation of Conjunctival Flora Alteration in Patients Undergoing Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958292
• Other study ID #: OSFFE_OCU_IO18
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: May 2019
• Source: Ospedale Sacra Famiglia - Fatebenefratelli Erba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 30, 2019
• Est. primary completion date: October 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Endophthalmitis
• Endophthalmitis Following Cataract Surgery

Intervention

Device:
• IODIM
Eye drops containing polyvinylpyrrolidone-Iodine (PVP-Iodine), hyaluronic acid and triglycerides

Locations

Country	Name	City	State
Italy	Oftalmologia Universitaria Ospedale Policlinico di Bari	Bari	BA
Italy	Clinica Oculistica Azienda Ospedaliero-Universitaria, Presidio Ospedaliero G. Rodolico	Catania	CT
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	Ospedale San Carlo di Nancy	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Sacra Famiglia - Fatebenefratelli Erba

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of bacterial load of Positive Culture in Subjects Scheduled for Cataract Surgery	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.	Three days of treatment