Povidone-iodine Antisepsis for Strabismus Surgery

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Free University Medical Center; Laurentius Hospital Roermond; Leiden University Medical Center; Ludwig-Maximilians - University of Munich; Martin-Luther-Universität Halle-Wittenberg; Rotterdam Eye Hospital; University Medicine Greifswald
• Treatments: Iodine; Povidone; Povidone-Iodine

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.