A Phase 4 interventional study of Povidone-iodine and Saline Solution in Eye Infections, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-25.
Sponsored by University of Sao Paulo · Phase 4, Interventional, and Prevention
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.
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.
34 studies on the registry are indexed under Eye Infections; 4 are open to participants now.
This study's enrollment of 124 is close to the median of 116 across 21 interventional studies indexed under Eye Infections.
Browse Eye Infections studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
1 drop of povidone-iodine 5% will be instilled at time zero, 20-minute and 28-minute study period.
Other: Povidone-iodine
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%.
Other: Povidone-iodine · Other: Saline Solution
Povidone iodine 5% drop will be instilled into conjunctival sac.
1 drop of saline solution 0.9% will be instilled into conjunctival sac.
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).
Time frame: At 30-minute study period, a conjunctival sac swab will be obtained
Difference in corneal thickness change between groups.
Corneal paquimetry will be performed before and after procedure using OcuScan Alcon RXP (Alcon, Fortworth, Texas).
Time frame: At 35-minute study period.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo