Antiseptics, Conjunctiva, Microbiota
Conditions
Keywords
Povidone-iodine, Chlorhexidine, Preoperative, Antiseptics, Conjunctival bacterial flora
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.
Interventions
DEVICEPovidone-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.
DEVICEChlorhexidine 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.
Sponsors
European School of Advanced Studies in Ophthalmology
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed