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

University of Sao Paulo124 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

124

Conditions

Eye Infections

Interventions

Povidone-iodineOTHER

Povidone iodine 5% drop will be instilled into conjunctival sac.

Saline SolutionOTHER

1 drop of saline solution 0.9% will be instilled into conjunctival sac.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinics Hospital of Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.