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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Leticia Fernandes Barroso, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01739920
First received: November 28, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted

November 28, 2012
November 28, 2012
February 2011
October 2013   (final data collection date for primary outcome measure)
Number of positive cultures after treatment in both groups [ Time Frame: At 30-minute study period, a conjunctival sac swab will be obtained ] [ Designated as safety issue: No ]
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).
Same as current
No Changes Posted
Difference in corneal thickness change between groups. [ Time Frame: At 35-minute study period. ] [ Designated as safety issue: Yes ]
Corneal paquimetry will be performed before and after procedure using OcuScan Alcon RXP (Alcon, Fortworth, Texas).
Same as current
Difference in corneal keratitis score between groups. [ Time Frame: At 35-minute study period. ] [ Designated as safety issue: Yes ]
Patients will be submitted to a slit-lamp examination to verify for corneal epithelium toxicity.
Same as current
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Eye Infections
  • 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.
  • Experimental: Povidone-iodine
    1 drop of povidone-iodine 5% will be instilled at time zero, 20-minute and 28-minute study period.
    Intervention: Other: Povidone-iodine
  • 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%.
    Interventions:
    • Other: Povidone-iodine
    • Other: Saline Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
October 2014
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Leticia F Barroso, MD +55 16 3602-2523 leticiafbarroso@gmail.com
Brazil
 
NCT01739920
2516/2010, 2010/17350-6
No
Leticia Fernandes Barroso, University of Sao Paulo
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Rodrigo Jorge, MD, PhD University of São Paulo
Principal Investigator: Leticia F Barroso, MD Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
University of Sao Paulo
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP