Effectiveness of Ophthalmic Antiseptic Preparations

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Antiseptics, Microbiota, Conjunctiva

Intervention / Treatment
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* Device: Povidone-Iodine 0.66%
* Device: Chlorhexidine 0.02%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Povidone-Iodine 0.66% | Device: Povidone-Iodine 0.66%<br>* 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.<br>|
| Experimental: Group B<br>Chlorhexidine 0.02% | Device: Chlorhexidine 0.02%<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient pain score | Numerical rating scale, from 0 to 10 | Day 3: after 3 days of treatment | 
| Compliance of the patients | Questionnaire about patients' compliance | Day 3: after 3 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Povidone-iodine, Chlorhexidine, Preoperative, Antiseptics, Conjunctival bacterial flora