Effectiveness of Ophthalmic Antiseptic Preparations

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Other)

Overall Status

Completed

CT.gov ID

NCT05974124

Collaborator

European School of Advanced Studies in Ophthalmology (Other)

Enrollment

Location

Arms

2.8

Actual Duration (Months)

24.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antiseptics Microbiota Conjunctiva	Device: Povidone-Iodine 0.66% Device: Chlorhexidine 0.02%	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 9, 2022

Actual Primary Completion Date :

Feb 3, 2023

Actual Study Completion Date :

Feb 3, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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