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

Eye Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739920
• Other study ID #: 2516/2010
• Secondary ID: 2010/17350-6
• Status: Completed
• Phase: Phase 4
• First received: November 28, 2012
• Last updated: January 23, 2017
• Start date: May 2011
• Est. completion date: April 2015

Study information

• Verified date: January 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eye Infections

Intervention

Other:
• Povidone-iodine
Povidone iodine 5% drop will be instilled into conjunctival sac.
• Saline Solution
1 drop of saline solution 0.9% will be instilled into conjunctival sac.

Locations

Country	Name	City	State
Brazil	Clinics Hospital of Ribeirão Preto	Ribeirão Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.