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

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ClinicalTrials.gov Identifier: NCT01739920
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Eye Infections Other: Povidone-iodine Other: Saline Solution Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, 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
Actual Study Start Date : May 2011
Primary Completion Date : October 2014
Study Completion Date : April 2015

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Proportion of negative cultures after treatment in both groups [ Time Frame: At 30-minute study period, a conjunctival sac swab will be obtained ]
    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 :
  1. Difference in corneal thickness change between groups. [ Time Frame: At 35-minute study period. ]
    Corneal paquimetry will be performed before and after procedure using OcuScan Alcon RXP (Alcon, Fortworth, Texas).

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739920

Clinics Hospital of Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil, 14048-900
Sponsors and Collaborators
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
More Information

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 ( Other Grant/Funding Number: Fundação de Amparo à Pesquisa do Estado de São Paulo )
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017

Keywords provided by Leticia Fernandes Barroso, University of Sao Paulo:
Ophthalmic Solutions
Preoperative procedures

Additional relevant MeSH terms:
Eye Infections
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes