Clinical trial NCT01739920: Comparative Efficacy of Different Regimens of PVPI 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora
Official title: Comparative Efficacy of Two Different Regimens of Povidone-iodine 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eye Infections
Keywords: Povidone-Iodine
Ophthalmic Solutions
Endophthalmitis
Preoperative procedures
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2012-12-04
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of negative cultures after treatment in both groups
timeFrame: At 30-minute study period, a conjunctival sac swab will be obtained
Secondary outcomes:
measure: Difference in corneal thickness change between groups.
timeFrame: At 35-minute study period.
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Clinics Hospital of Ribeirão Preto
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Rodrigo Jorge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
name: Leticia F Barroso, MD
role: PRINCIPAL_INVESTIGATOR
References: