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

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Eye Infections

Treatments: Other: Povidone-iodine; Other: Saline Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01739920

2010/17350-6 (Other Grant/Funding Number)

2516/2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups

Povidone-iodine

Experimental group

Description:

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

Treatment:

Other: Povidone-iodine

Povidone-iodine and Saline Solution

Active Comparator group

Description:

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%.

Treatment:

Other: Povidone-iodine

Other: Saline Solution