A prospective, randomized, double-blind comparison of 5 % against 1.25 % povidone-iodine solution in preoperative antisepsis for strabismus surgery in young children.
- Conditions
- strabismus squint10030061
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
(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.
(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 (or equivalent in preverbal children).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The difference in the mean numbers of bacterial colony forming units (CFUs)<br /><br>from pre-irrigation (l) to post-irrigation with PI (2-4).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Iodine excretion after surgery, assessed as urine iodine concentration per<br /><br>creatinine clearance.<br /><br>Postoperative erosion of the cornea and corneal oedema. Both of these have been<br /><br>described as side-effects of PI use. </p><br>