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Completed

NCT Number: NCT01739920

Comparative Efficacy of Different Regimens of PVPI 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinics Hospital of Ribeirão Preto

Ribeirão Preto, São Paulo, 14048-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Povidone-Iodine

Other

Povidone iodine 5% drop will be instilled into conjunctival sac.

Saline solution

Other

1 drop of saline solution 0.9% will be instilled into conjunctival sac.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Dec 4, 2012
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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