Effectiveness of Ophthalmic Antiseptic Preparations

August 2, 2023 updated by: Vito Romano, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Topical Ophthalmic Antiseptics and Reduction of Ocular Surface Bacterial Load Before Cataract Surgery: a Randomized Clinical Trial

The aim of this clinical trial is to evaluate the effectiveness of two topical antiseptics, povidone-iodine (PVI) and chlorhexidine (CHX), in reducing conjunctival bacterial flora.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

70 patients undergoing cataract surgery were enrolled and randomly divided in two arms: 35 patients used PVI 0.66% 4 times daily starting 3 days before surgery; 35 patients used CHX 0.02% with the same posology. The contralateral eye was considered as control. Conjunctival swabs were collected in both eyes at the baseline (T0) and after three days of treatment (T1) all before cataract surgery. Conjunctival bacterial load has been evaluated through a molecular based method at T0 and T1 and compared to the control eye.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing cataract surgery
  • 18 years of age or older

Exclusion Criteria:

  • Reported allergy or hypersensitivity to iodine or chlorhexidine
  • Active ocular infection
  • Contraindication to surgery
  • Pregnant women
  • Patients residing in nursing homes or prison
  • Patients who used antibiotic, antiviral or antifungal eye drops in the week preceding the intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Povidone-Iodine 0.66%
Device: Povidone-Iodine 0.66%
Povidone-iodine 0.66% eye drops were instilled 4 times daily for 3 days before cataract surgery in the eye to be operated on. The contralateral eye was considered as control and received no treatment.
Experimental: Group B
Chlorhexidine 0.02%
Device: Chlorhexidine 0.02%
Chlorhexidine 0.02% eye drops were instilled 4 times daily for 3 days before cataract surgery in the eye to be operated on. The contralateral eye was considered as control and received no treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conjunctival composition
Time Frame: 3 days. Conjunctival swabs were taken at baseline and after 3 days of treatment.
Molecular based method: 16S rRNA gene was sequenced to evaluate ocular microbiota
3 days. Conjunctival swabs were taken at baseline and after 3 days of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient pain score
Time Frame: Day 3: after 3 days of treatment
Numerical rating scale, from 0 to 10
Day 3: after 3 days of treatment
Compliance of the patients
Time Frame: Day 3: after 3 days of treatment
Questionnaire about patients' compliance
Day 3: after 3 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Collaborators

European School of Advanced Studies in Ophthalmology

Investigators

  • Principal Investigator: Vito Romano, MD, Università degli Studi di Brescia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2022

Primary Completion (Actual)

February 3, 2023

Study Completion (Actual)

February 3, 2023

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD that underlie results in a publication

IPD Sharing Time Frame

After completion of the study

IPD Sharing Access Criteria

Upon approval of individual sharing request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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