Eye Infections Clinical Trial
Official title:
Comparative Efficacy of Two Different Regimens of Povidone-iodine 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora
Verified date | January 2017 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present study intends to assess the efficacy of 3 drops of 5% povidone-iodine (PVPI) eyedrops in reducing the bacterial flora in a conjunctival sac fundus compared to the standard procedure consisting of the application of 1 PVPI eyedrop 2 min before any intraocular surgical procedure.
Status | Completed |
Enrollment | 124 |
Est. completion date | April 2015 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - No systemic or ocular infection; - Absence of auto-imune disease or immunosuppressive therapy; - No use of systemic or topic antibiotics in the last 30 days; - No previous ocular surgery or trauma in the study eye in the last 30 days; - No history of allergy to povidone iodine; - Signed informed consent. Exclusion Criteria: - Presence of blepharitis, ectropion, entropion, trichiasis or distichiasis; - Diabetes Mellitus; - Any systemic condition that, at the discretion of the investigators, would facilitate or contribute to infection, such as influenza; - Inability to understand and sign the informed consent. |
Country | Name | City | State |
---|---|---|---|
Brazil | Clinics Hospital of Ribeirão Preto | Ribeirão Preto | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of negative cultures after treatment in both groups | Conjunctival swab will be obtained five minutes before and 30 minutes after the first povidone iodine drop will be instilled into the conjunctival sac of study eye. Conjunctival swabs were incubated aerobically in enriched Thioglycolate liquid medium (meat broth) and in three solid culture media (Agar Chocolate, Trypticase Soy Agar with 5% sheep blood, and Agar Sabouraud). | At 30-minute study period, a conjunctival sac swab will be obtained | |
Secondary | Difference in corneal thickness change between groups. | Corneal paquimetry will be performed before and after procedure using OcuScan Alcon RXP (Alcon, Fortworth, Texas). | At 35-minute study period. |
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