Prospective, Randomized, Double-blind Comparison of 5 % Against 1.25 % Povidone-iodine Solution as Preoperative Antisepsis for Strabismus Surgery in Young Children (PASS)

NCT00461656 Phase 4 COMPLETED

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.

Details

Lead sponsor	Erasmus Medical Center
Phase	Phase 4
Status	COMPLETED
Enrolment	70
Start date	2009-09
Completion	2012-12

Conditions

• Strabismus
• Surgery
• Endophthalmitis

Interventions

• Preoperative conjunctival irrigation with 5% or 1.25% PI

Primary outcomes

• The difference in the mean numbers of bacterial colony forming units from pre-irrigation to post-irrigation with PI. — Cultures taken during surgery, evaluated within 2 days postoperatively

Countries

Germany, Netherlands