Effectiveness of Ophthalmic Antiseptic Preparations

Not Applicable

Completed

• Conditions: Conjunctiva; Microbiota; Antiseptics
• Interventions: Device: Povidone-Iodine 0.66%; Device: Chlorhexidine 0.02%

• Registration Number: NCT05974124
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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.

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 Timeline

• Study Start: 2022-11-09
• Primary Completion: 2023-02-03
• Study Completion: 2023-02-03
• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-07-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-02
• Study First Posted: 2023-08-03
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Povidone-Iodine 0.66%	Povidone-Iodine 0.66%
Group B	Chlorhexidine 0.02%	Chlorhexidine 0.02%

Primary Outcome Measures

Name	Time	Method
Conjunctival composition	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia; 🇮🇹 Brescia, Italy