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

April 17, 2007
March 4, 2013
September 2009
December 2012   (final data collection date for primary outcome measure)
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 ]
The difference in the mean numbers of bacterial colony forming units from pre-irrigation to post-irrigation with PI.
Complete list of historical versions of study NCT00461656 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Iodine excretion after surgery, assessed as urine iodine concentration per creatinine clearance.
  • Postoperative erosion of the cornea and corneal oedema.
Not Provided
Not Provided
 
Povidone-iodine Antisepsis for Strabismus Surgery
Prospective, Randomized, Double-blind Comparison of 5 % Against 1.25 % Povidone-iodine Solution as Preoperative Antisepsis for Strabismus Surgery in Young Children

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Strabismus
  • Surgery
  • Endophthalmitis
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%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
up to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands
 
NCT00461656
ABR 14357
No
Prof. H.J. Simonsz M.D., Erasmus Medical Center Rotterdam
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
Principal Investigator: Huibert J Simonsz, MD PhD Erasmus Medical Center
Principal Investigator: Herminia Miño de Kaspar, PhD Universitäts-Augenklinik Ludwig-Maximilian University Munich Germany
Erasmus Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP