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A prospective, randomized, double-blind comparison of 5 % against 1.25 % povidone-iodine solution in preoperative antisepsis for strabismus surgery in young children.

A prospective, randomized, double-blind comparison of 5 % against 1.25 % povidone-iodine solution in preoperative antisepsis for strabismus surgery in young children. - 1.25% vs 5% povidone-iodine antisepsis for strabismus surgery in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30444
Enrollment
100
Registered
2007-09-05
Start date
2009-09-18
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

strabismus squint

Interventions

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

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: (1) Children

Exclusion criteria

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 (or equivalent in preverbal children).

Design outcomes

Secondary

MeasureTime frame
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.

Primary

MeasureTime frame
The difference in the mean numbers of bacterial colony forming units (CFUs) from pre-irrigation (l) to post-irrigation with PI (2-4).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)