Effectiveness of Ophthalmic Antiseptic Preparations

Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05974124
• Other study ID #: OS1
• Status: Completed
• Phase: N/A
• Start date: November 9, 2022
• Est. completion date: February 3, 2023

Study information

• Verified date: August 2023
• Source: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 3, 2023
• Est. primary completion date: February 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Microbiota

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia	Brescia

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia	European School of Advanced Studies in Ophthalmology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient pain score	Numerical rating scale, from 0 to 10	Day 3: after 3 days of treatment
Secondary	Compliance of the patients	Questionnaire about patients' compliance	Day 3: after 3 days of treatment