This trial is active, not recruiting.

Condition eye infections
Treatments povidone-iodine, saline solution
Phase phase 4
Sponsor University of Sao Paulo
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date February 2011
End date November 2014
Trial size 80 participants
Trial identifier NCT01739920, 2010/17350-6, 2516/2010


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
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)
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.
saline solution
1 drop of saline solution 0.9% will be instilled into conjunctival sac.

Primary Outcomes

Number of positive cultures after treatment in both groups
time frame: At 30-minute study period, a conjunctival sac swab will be obtained

Secondary Outcomes

Difference in corneal thickness change between groups.
time frame: At 35-minute study period.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Comparative Efficacy of Two Different Regimens of Povidone-iodine 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora
Principal investigator Rodrigo Jorge, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Sao Paulo.