Effectiveness of Ophthalmic Antiseptic Preparations

NCT ID: NCT05974124

Last Updated: 2023-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-09

Study Completion Date

2023-02-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Antiseptics Microbiota Conjunctiva

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomised to instill either povidone-iodine eye drops (35 patients) or chlorhexidine (35 patients) in the eye to be operated on. The contralateral eye was considered as control and received no antiseptic prophylaxis.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A

Povidone-Iodine 0.66%

Group Type EXPERIMENTAL

Povidone-Iodine 0.66%

Intervention Type DEVICE

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.

Group B

Chlorhexidine 0.02%

Group Type EXPERIMENTAL

Chlorhexidine 0.02%

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European School of Advanced Studies in Ophthalmology

OTHER

Sponsor Role collaborator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Vito Romano

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vito Romano, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Brescia

Locations

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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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OS1

Identifier Type: -

Identifier Source: org_study_id

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