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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Sao Paulo
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
  Purpose

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.


Condition Intervention Phase
Eye Infections
Other: Povidone-iodine
Other: Saline Solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparative Efficacy of Two Different Regimens of Povidone-iodine 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Other Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Povidone-iodine
1 drop of povidone-iodine 5% will be instilled at time zero, 20-minute and 28-minute study period.
Other: Povidone-iodine
Povidone iodine 5% drop will be instilled into conjunctival sac.
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%.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739920

Contacts
Contact: Leticia F Barroso, MD +55 16 3602-2523 leticiafbarroso@gmail.com

Locations
Brazil
Clinics Hospital of Ribeirão Preto Recruiting
Ribeirão Preto, São Paulo, Brazil, 14048-900
Contact: Leticia F Barroso, MD    +55 16 3602-2523    leticiafbarroso@gmail.com   
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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
  More Information

No publications provided

Responsible Party: Leticia Fernandes Barroso, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01739920     History of Changes
Other Study ID Numbers: 2516/2010, 2010/17350-6
Study First Received: November 28, 2012
Last Updated: November 28, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Povidone-Iodine
Ophthalmic Solutions
Endophthalmitis
Preoperative procedures

Additional relevant MeSH terms:
Eye Infections
Infection
Eye Diseases
Povidone
Ophthalmic Solutions
Iodine
Cadexomer iodine
Povidone-Iodine
Pharmaceutical Solutions
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014