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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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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