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

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

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.

Study Overview

• Status: Completed
• Conditions: Eye Infections
• Intervention / Treatment: Other: Povidone-iodine; Other: Saline Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14048-900
      • Clinics Hospital of Ribeirão Preto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Povidone-iodine; 1 drop of povidone-iodine 5% will be instilled at time zero, 20-minute and 28-minute study period.	Other: Povidone-iodine; Povidone iodine 5% drop will be instilled into conjunctival sac.
Active Comparator: Povidone-iodine and Saline Solution; 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; Povidone iodine 5% drop will be instilled into conjunctival sac.; Other: Saline Solution; 1 drop of saline solution 0.9% will be instilled into conjunctival sac.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At 30-minute study period, a conjunctival sac swab will be obtained

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in corneal thickness change between groups.	Corneal paquimetry will be performed before and after procedure using OcuScan Alcon RXP (Alcon, Fortworth, Texas).	At 35-minute study period.

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Rodrigo Jorge, MD, PhD, University of Sao Paulo; Principal Investigator: Leticia F Barroso, MD, Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: November 28, 2012
• First Submitted That Met QC Criteria: November 28, 2012
• First Posted (Estimate): December 4, 2012

Study Record Updates

• Last Update Posted (Estimate): January 25, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Povidone-Iodine; Ophthalmic Solutions; Endophthalmitis; Preoperative procedures
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Eye Infections; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: 2516/2010; 2010/17350-6 (Other Grant/Funding Number: Fundação de Amparo à Pesquisa do Estado de São Paulo)