Povidone-iodine Antisepsis for Strabismus Surgery

Summary

The purpose of this study is to compare the efficacy of 5 % vs. 1.25 % povidone-iodine (PI) as preoperative antiseptic prior to strabismus surgery in children as a prophylaxis of endophthalmitis. Given the low rate of endophthalmitis the conjunctival bacterial flora rate is used as surrogate marker to determine the effectiveness of topical PI in reducing or eliminating bacteria from the ocular surface at the time of the surgery. Secondary objective is a reduction of the incidence of postoperative endophthalmitis after strabismus surgery in young children.

Conditions

• Strabismus
• Surgery
• Endophthalmitis

Interventions

DRUG

Preoperative conjunctival irrigation with 5% or 1.25% PI

Before initiation of surgery, children will have their conjunctival fornices irrigated with 5 ml PI 5% or with 5 ml PI 1.25%

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• University Medicine Greifswald

  collaborator OTHER

• Free University Medical Center

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Rotterdam Eye Hospital

  collaborator UNKNOWN

• Laurentius Hospital Roermond

  collaborator UNKNOWN

• Martin-Luther-Universität Halle-Wittenberg

  collaborator OTHER

• Erasmus Medical Center

  lead OTHER

Principal Investigators

• Huibert J Simonsz, MD PhD · Erasmus Medical Center

• Herminia Miño de Kaspar, PhD · Universitäts-Augenklinik Ludwig-Maximilian University Munich Germany

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2012-12-31

Completion

2012-12-31

Countries

• Germany
• Netherlands

Study Locations