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Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation

Primary Purpose

Endophthalmitis Following Cataract Surgery

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
IODIM
Sponsored by
Ospedale Sacra Famiglia - Fatebenefratelli Erba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endophthalmitis Following Cataract Surgery focused on measuring Cataract, Endophthalmitis, Microbiological evaluation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Oftalmologia Universitaria Ospedale Policlinico di Bari
  • Ospedale Sacra Famiglia Fatebenefratelli
  • Clinica Oculistica Azienda Ospedaliero-Universitaria, Presidio Ospedaliero G. Rodolico
  • Centro di Microchirurgia Ambulatoriale di Monza
  • Casa di Cura Villa Valeria di Roma
  • Ospedale San Carlo di Nancy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients undergoing routine cataract surgery

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 8, 2019
Last Updated
May 20, 2019
Sponsor
Ospedale Sacra Famiglia - Fatebenefratelli Erba
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1. Study Identification

Unique Protocol Identification Number
NCT03958292
Brief Title
Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation
Official Title
Evaluation of Conjunctival Flora Alteration in Patients Undergoing Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
October 29, 2018 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ospedale Sacra Famiglia - Fatebenefratelli Erba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endophthalmitis Following Cataract Surgery
Keywords
Cataract, Endophthalmitis, Microbiological evaluation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients undergoing routine cataract surgery
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
IODIM
Intervention Description
Eye drops containing polyvinylpyrrolidone-Iodine (PVP-Iodine), hyaluronic acid and triglycerides
Primary Outcome Measure Information:
Title
Variation of bacterial load of Positive Culture in Subjects Scheduled for Cataract Surgery
Description
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.
Time Frame
Three days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Oftalmologia Universitaria Ospedale Policlinico di Bari
City
Bari
State/Province
BA
ZIP/Postal Code
70120
Country
Italy
Facility Name
Ospedale Sacra Famiglia Fatebenefratelli
City
Erba
State/Province
Como
ZIP/Postal Code
22036
Country
Italy
Facility Name
Clinica Oculistica Azienda Ospedaliero-Universitaria, Presidio Ospedaliero G. Rodolico
City
Catania
State/Province
CT
ZIP/Postal Code
95123
Country
Italy
Facility Name
Centro di Microchirurgia Ambulatoriale di Monza
City
Monza
State/Province
MB
ZIP/Postal Code
20900
Country
Italy
Facility Name
Casa di Cura Villa Valeria di Roma
City
Roma
State/Province
RM
ZIP/Postal Code
00141
Country
Italy
Facility Name
Ospedale San Carlo di Nancy
City
Roma
State/Province
RM
ZIP/Postal Code
00165
Country
Italy

12. IPD Sharing Statement

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Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation

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