A prospective, randomized, double-blind comparison of 5 % against 1 % povidone-iodine solution in preoperative antisepsis for strabismus surgery in young children.

• Conditions: Endophthalmitis (E) after strabismus surgery (S) leading to blindness is caused by eyelid and conjunctival bacteria. Povidone-iodine(PI) solutions between 1% and 5% reduce the number of bacteria on the conjunctiva and the incidence of E after S. In cataract surgery 5% PI was shown to be more effective than 1% PI in decreasing the conjunctival bacterial flora. As E after S especially afflicts younger children this study is to compare ocular antisepsis achieved by 5% PI vs 1.25% PI in children.; MedDRA version: 8.1Level: PTClassification code 10049924Term: Infection prophylaxis

• Registration Number: EUCTR2006-004811-22-NL
• Lead Sponsor: Erasmus Medical Center Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Demonstration of superiority of either 5% or 1.25% PI as preoperative antiseptic, measured by pre-operative and intraoperative bacterial cultures;Secondary Objective: Reduce the incidence of postoperative endophthamitis after strabismus surgery by half.;Primary end point(s): Conjunctiva cultures (both eyes by T0 and T1) of aerobic and anaerobic bacteria will be obtained at time points T0 – to T4 (T0: baseline, T1: surgery: before PI-, T2: after PI-irrigation, T3: after reattachment of eye muscles, T4: at the end of surgery) specified in the study design. The number of bacterial colonies cultured on agar from each smear is counted.<br>The difference in the mean numbers of bacterial colony forming units (CFUs) from pre-irrigation (T0, T1) to post-irrigation (T2, T3, T4) is then compared between the groups.<br>The species of bacterial colonies from each swab is determined and listed in a descriptive manner.