Status:
COMPLETED
Povidone-iodine Antisepsis for Strabismus Surgery
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Ludwig-Maximilians - University of Munich
University Medicine Greifswald
Conditions:
Strabismus
Surgery
Eligibility:
All Genders
Up to 5 years
Phase:
PHASE4
Brief 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. Give...
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...
Eligibility Criteria
Inclusion
- Children attending for routine strabismus surgery are eligible for the study. Criteria for inclusion:
- Children \< 6 years of age
- undergoing surgery for strabismus for the first time, including any recession and/or resection surgery of the medial and/or lateral rectus muscles.
- 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
- Any history or current condition of hypersensitivity to iodine
- Children on topical antibiotic within the last 30 days
- Children with signs of acute conjunctivitis, blepharitis, dacryocystitis or respiratory infection within the last 30 days
- Children with asthma or similar chronic, obstructive pulmonary disorder
- Insufficiently treated amblyopia, i.e. a difference between the visual acuities of both eyes larger than 1 LogMARline.
- Neurological or psychiatric disorder, medication, other eye disorder, decreased visual acuity caused by brain damage or trauma.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00461656
Start Date
September 1 2009
End Date
December 1 2012
Last Update
March 5 2013
Active Locations (9)
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1
Ernst Moritz Arndt University
Greifswald, Germany, D-17487
2
Universitäts-Augenklinik
Magdeburg, Germany, D-39120
3
Universitäts-Augenklinik Ludwig-Maximilian University
Munich, Germany, D-80336
4
Dept. Ophthalmology Free University Medical Center
Amsterdam, Netherlands, NL-1007MB