Comparative Efficacy of Different Regimens of PVPI 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora
|ClinicalTrials.gov Identifier: NCT01739920|
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : January 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Eye Infections||Other: Povidone-iodine Other: Saline Solution||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Comparative Efficacy of Two Different Regimens of Povidone-iodine 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora|
|Actual Study Start Date :||May 2011|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||April 2015|
1 drop of povidone-iodine 5% will be instilled at time zero, 20-minute and 28-minute study period.
Povidone iodine 5% drop will be instilled into conjunctival sac.
Active Comparator: Povidone-iodine and Saline Solution
1 drop of saline solution 0.9% will be instilled at time zero and 20-minute. At 28-minute will be instilled 1 drop of Povidone-iodine 5%.
Povidone iodine 5% drop will be instilled into conjunctival sac.Other: Saline Solution
1 drop of saline solution 0.9% will be instilled into conjunctival sac.
- Proportion of negative cultures after treatment in both groups [ Time Frame: At 30-minute study period, a conjunctival sac swab will be obtained ]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).
- Difference in corneal thickness change between groups. [ Time Frame: At 35-minute study period. ]Corneal paquimetry will be performed before and after procedure using OcuScan Alcon RXP (Alcon, Fortworth, Texas).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739920
|Clinics Hospital of Ribeirão Preto|
|Ribeirão Preto, São Paulo, Brazil, 14048-900|
|Principal Investigator:||Rodrigo Jorge, MD, PhD||University of São Paulo|
|Principal Investigator:||Leticia F Barroso, MD||Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP|