Comparative Efficacy of Different Regimens of PVPI 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Comparative Efficacy of Two Different Regimens of Povidone-iodine 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora|
- Number of positive cultures after treatment in both groups [ Time Frame: At 30-minute study period, a conjunctival sac swab will be obtained ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: Yes ]Corneal paquimetry will be performed before and after procedure using OcuScan Alcon RXP (Alcon, Fortworth, Texas).
- Difference in corneal keratitis score between groups. [ Time Frame: At 35-minute study period. ] [ Designated as safety issue: Yes ]Patients will be submitted to a slit-lamp examination to verify for corneal epithelium toxicity.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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.
Studies have demonstrated that the external bacterial flora of the patients in most cases is the actual source of infection. The objective of antisepsis is to eliminate or significantly reduce the number of microorganisms in the surgical field at the time of surgery. The eyelids and the conjunctiva are considered to be quite common sources of bacteria that can lead to endophthalmitis. Thus, it is believed that by reducing the number and growth of bacteria on the ocular surface and adnexa before surgery, the risk of postoperative infection would be lower. Povidone-iodine 5% eye drops has been used in preoperative cataract surgery to prevent endophthalmitis and is the standard prophylactic action in preventing postoperative endophthalmitis being widely compared with other antibiotic eye drops and their associations. The standard procedure of prophylaxis of postoperative endophthalmitis corresponds to applying a single drop of povidone-iodine 2min before any intraocular surgical procedure. However, few studies have assessed the effectiveness of povidone-iodine 5% eye drops using different dosing regimens to achieve the best bactericidal effect. The aim of this study is to investigate different dosages with respect to the use of povidone-iodine drops to optimize the effectiveness of the agent, ensuring the best exogenous endophthalmitis prophylaxis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739920
|Contact: Leticia F Barroso, MD||+55 16 email@example.com|
|Clinics Hospital of Ribeirão Preto||Recruiting|
|Ribeirão Preto, São Paulo, Brazil, 14048-900|
|Contact: Leticia F Barroso, MD +55 16 3602-2523 firstname.lastname@example.org|
|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|