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Clinical Trials/EUCTR2006-004811-22-NL
EUCTR2006-004811-22-NL
Active, not recruiting
Not Applicable

A prospective, randomized, double-blind comparison of 5 % against 1 % povidone-iodine solution in preoperative antisepsis for strabismus surgery in young children.

Erasmus Medical Center Rotterdam0 sites250 target enrollmentApril 4, 2008
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ConditionsEndophthalmitis (E) after strabismus surgery (S) leading to blindness is caused by eyelid and conjunctival bacteria. Povidone-iodine(PI) solutions between 1% and 5% reduce the number of bacteria on the conjunctiva and the incidence of E after S. In cataract surgery 5% PI was shown to be more effective than 1% PI in decreasing the conjunctival bacterial flora. As E after S especially afflicts younger children this study is to compare ocular antisepsis achieved by 5% PI vs 1.25% PI in children.MedDRA version: 8.1Level: PTClassification code 10049924Term: Infection prophylaxis
DrugsBetaisodona (TM) Lösung (= 10% povidone iodine solution to be diluted to 5%)Betaisodona (TM) Lösung (= 10% povidone iodine solution to be diluted to 1.25%)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endophthalmitis (E) after strabismus surgery (S) leading to blindness is caused by eyelid and conjunctival bacteria. Povidone-iodine(PI) solutions between 1% and 5% reduce the number of bacteria on the conjunctiva and the incidence of E after S. In cataract surgery 5% PI was shown to be more effective than 1% PI in decreasing the conjunctival bacterial flora. As E after S especially afflicts younger children this study is to compare ocular antisepsis achieved by 5% PI vs 1.25% PI in children.
Sponsor
Erasmus Medical Center Rotterdam
Enrollment
250
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 4, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Erasmus Medical Center Rotterdam

Eligibility Criteria

Inclusion Criteria

  • •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\.Children willing to take part in all aspects of the study and written informed consent on the study participation of the child provided by the parents.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

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. visual acuity must be equal in both eyes or not differ by more than 1 LogMAR line.

Outcomes

Primary Outcomes

Not specified

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