Effectiveness of Ophthalmic Antiseptic Preparations

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status: Completed

Conditions: Conjunctiva; Antiseptics; Microbiota

Treatments: Device: Chlorhexidine 0.02%; Device: Povidone-Iodine 0.66%

Study type: Interventional

Funder types: Other

Identifiers

NCT05974124

OS1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Group A

Experimental group

Description:

Povidone-Iodine 0.66%

Treatment:

Device: Povidone-Iodine 0.66%

Group B

Experimental group

Description:

Chlorhexidine 0.02%

Treatment:

Device: Chlorhexidine 0.02%