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

NCT ID: NCT01739920

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-04-30

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.

Conditions

Eye Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Povidone-iodine

1 drop of povidone-iodine 5% will be instilled at time zero, 20-minute and 28-minute study period.

Group Type: EXPERIMENTAL

Povidone-iodine

Intervention Type: OTHER

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

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%.

Group Type: ACTIVE_COMPARATOR

Povidone-iodine

Intervention Type: OTHER

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

Saline Solution

Intervention Type: OTHER

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

Interventions

Povidone-iodine

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

Intervention Type: OTHER

Saline Solution

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Leticia Fernandes Barroso

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo Jorge, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Leticia F Barroso, MD

Role: PRINCIPAL_INVESTIGATOR

Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP

Locations

Clinics Hospital of Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

2010/17350-6

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2516/2010

Identifier Type: -

Identifier Source: org_study_id