Effectiveness of Ophthalmic Antiseptic Preparations

NCT05974124 | Completed

• 1 other identifier: OS1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antiseptics; Microbiota; Conjunctiva

Keywords

Povidone-iodine; Chlorhexidine; Preoperative; Antiseptics; Conjunctival bacterial flora

Outcome Measures

Primary Outcomes (1)

• Conjunctival composition

  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 Outcomes (2)

• Patient pain score

  Day 3: after 3 days of treatment

• Compliance of the patients

  Day 3: after 3 days of treatment

Study Arms (2)

Group A

EXPERIMENTAL

Povidone-Iodine 0.66%

Device: Povidone-Iodine 0.66%

Group B

EXPERIMENTAL

Chlorhexidine 0.02%

Device: Chlorhexidine 0.02%

Interventions

Povidone-Iodine 0.66% 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 A

Chlorhexidine 0.02% 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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing cataract surgery
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead
• European School of Advanced Studies in Ophthalmology: collaborator

Study Sites (1)

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Study Officials

• Vito Romano, MD

  Università degli Studi di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: November 9, 2022
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After completion of the study
• Access Criteria: Upon approval of individual sharing request

Locations

IT (1)