Clinical Trial: Comparative Efficacy of Different Regimens of PVPI 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparative Efficacy of Two Different Regimens of Povidone-iodine 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of Sao Paulo

Current Primary Outcome: 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).


Original Primary Outcome: Number of positive 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).


Current Secondary Outcome: 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).


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: November 28, 2012
Date Started: May 2011
Date Completion:
Last Updated: January 23, 2017
Last Verified: January 2017