At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective, Randomized, Double-blind Comparison of 5 % Against 1.25 % Povidone-iodine Solution as Preoperative Antisepsis for Strabismus Surgery in Young Children
In Brief
A Phase 4 clinical trial evaluating Preoperative conjunctival irrigation with 5% or 1.25% PI for Strabismus and 2 related conditions. Completed, enrolled 70 participants across 9 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Before initiation of surgery, children will have their conjunctival fornices irrigated with 5 ml PI 5% or with 5 ml PI 1.25%