Povidone-iodine Antisepsis for Strabismus Surgery (PASS)

This study has been completed.
Sponsor:
Collaborators:
Ludwig-Maximilians - University of Munich
University Medicine Greifswald
Free University Medical Center
Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Rotterdam Eye Hospital
Laurentius Hospital Roermond
Martin-Luther-Universität Halle-Wittenberg
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00461656
First received: April 17, 2007
Last updated: March 4, 2013
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Strabismus
Surgery
Endophthalmitis
Drug: Preoperative conjunctival irrigation with 5% or 1.25% PI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prospective, Randomized, Double-blind Comparison of 5 % Against 1.25 % Povidone-iodine Solution as Preoperative Antisepsis for Strabismus Surgery in Young Children

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • The difference in the mean numbers of bacterial colony forming units from pre-irrigation to post-irrigation with PI. [ Time Frame: Cultures taken during surgery, evaluated within 2 days postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Iodine excretion after surgery, assessed as urine iodine concentration per creatinine clearance. [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
  • Postoperative erosion of the cornea and corneal oedema. [ Time Frame: within 24 hours postoperatively ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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%
Detailed Description:

Background: Endophthalmitis after strabismus surgery in young children leads to blindness and loss of the affected eye. It is caused by conjunctival bacteria. PI solutions between 1% and 5% reduce the number of bacteria on the conjunctiva. The concentration used varies widely among clinics, from 1% to 5%. In vitro studies have shown that PI is paradoxically more effective at lower concentration, but in cataract surgery in elderly, 1% PI has been shown to be less effective than 5% PI. Dilution by tear fluid or binding of PI to proteins in tear fluid may lower its effectiveness. Since endophthalmitis after strabismus surgery especially affects young children and the bacterial flora of the conjunctiva in children is different from that in adults, the cataract PI study should be repeated in young children operated for strabismus.

Objective: 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.

Design: The study is a multi-centre, prospective, randomized-controlled, parallel-groups, assessor-blind (microbiological assessments), investigator-initiated trial.

Study population: All children under 6 years of age attending the 15 participating clinics for routine strabismus surgery will be eligible for the study at the point that a strabismus operation is planned. The clinics (5 Dutch, 10 German) will each recruit approximately 20 patients. The minimum sample size is 2 x 100 patients.

Intervention: Diluted PI, 1.25% or 5%, will be prepared in a sterile fashion, and distributed in single-use dispensers. These will be coded for randomization. Before initiation of surgery, children randomized to the 5% PI group will have their conjunctival fornices irrigated with 5 ml PI 5%. Children randomized to the 1.25% PI group will have their conjunctival fornices irrigated with 5 ml PI 1.25%. Conjunctiva cultures for aerobic and anaerobic bacteria will be obtained (1) after general anesthesia has been established, (2) 5-10 min after PI irrigation, (3) after reattachment of the eye muscles and (4) after closing the conjunctiva with sutures.

Primary outcome: The difference in the mean numbers of bacterial colony forming units (CFUs) from pre-irrigation (l) to post-irrigation with PI (2-4).

Secondary outcome: Iodine excretion after surgery, assessed as urine iodine concentration per creatinine clearance.

Postoperative erosion of the cornea and corneal oedema. Both of these have been described as side-effects of PI use.

Nature and extent of the burden and risks associated with participation:

Risks are limited to the act of taking the four bacterial cultures, as both 1.25% PI and 5% PI are approved preoperative antiseptic applications of PI and both are used, rather indiscriminately, by the university departments of ophthalmology participating in the study.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Children attending for routine strabismus surgery are eligible for the study. Criteria for inclusion:

  1. Children < 6 years of age
  2. undergoing surgery for strabismus for the first time, including any recession and/or resection surgery of the medial and/or lateral rectus muscles.
  3. willing to take part in all aspects of the study with written informed consent on the study participation of the child provided by the parents.

Exclusion Criteria:

  1. Any history or current condition of hypersensitivity to iodine
  2. Children on topical antibiotic within the last 30 days
  3. Children with signs of acute conjunctivitis, blepharitis, dacryocystitis or respiratory infection within the last 30 days
  4. Children with asthma or similar chronic, obstructive pulmonary disorder
  5. Insufficiently treated amblyopia, i.e. a difference between the visual acuities of both eyes larger than 1 LogMARline.
  6. Neurological or psychiatric disorder, medication, other eye disorder, decreased visual acuity caused by brain damage or trauma.
  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: NCT00461656

Locations
Germany
Ernst Moritz Arndt University
Greifswald, Germany, D-17487
Universitäts-Augenklinik
Magdeburg, Germany, D-39120
Universitäts-Augenklinik Ludwig-Maximilian University
Munich, Germany, D-80336
Netherlands
Dept. Ophthalmology Free University Medical Center
Amsterdam, Netherlands, NL-1007MB
Dept. Ophthalmology Academical Medical Center
Amsterdam, Netherlands, NL-1105AZ
Dept. Ophthalmology
Leiden, Netherlands, NL-2300RC
Dept. of Ophthalmology St. Laurentius Ziekenhuis
Roermond, Netherlands, NL-6040AX
Dept. of Ophthalmology Erasmus Medical Center
Rotterdam, Netherlands, NL3000CA
Rotterdam Eye Hospital
Rotterdam, Netherlands, 3011BH
Sponsors and Collaborators
Erasmus Medical Center
Ludwig-Maximilians - University of Munich
University Medicine Greifswald
Free University Medical Center
Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Rotterdam Eye Hospital
Laurentius Hospital Roermond
Martin-Luther-Universität Halle-Wittenberg
Investigators
Principal Investigator: Huibert J Simonsz, MD PhD Erasmus Medical Center
Principal Investigator: Herminia Miño de Kaspar, PhD Universitäts-Augenklinik Ludwig-Maximilian University Munich Germany
  More Information

Publications:

Responsible Party: Prof. H.J. Simonsz M.D., Erasmus Medical Center Rotterdam
ClinicalTrials.gov Identifier: NCT00461656     History of Changes
Other Study ID Numbers: ABR 14357
Study First Received: April 17, 2007
Last Updated: March 4, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Erasmus Medical Center:
Antiseptic
Povidone-Iodine

Additional relevant MeSH terms:
Endophthalmitis
Strabismus
Eye Infections
Infection
Eye Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Povidone
Iodine
Povidone-Iodine
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 28, 2014