PASS: Povidone-iodine Antisepsis for Strabismus Surgery

Sponsor

Erasmus Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00461656

Collaborator

Ludwig-Maximilians - University of Munich (Other), University Medicine Greifswald (Other), Free University Medical Center (Other), Leiden University Medical Center (Other), Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other), Rotterdam Eye Hospital (Other), Laurentius Hospital Roermond (Other), Martin-Luther-Universität Halle-Wittenberg (Other)

Enrollment

Locations

Duration (Months)

7.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Strabismus Surgery Endophthalmitis	Drug: Preoperative conjunctival irrigation with 5% or 1.25% PI	Phase 4

Detailed Description

Background: Endophthalmitis after strabismus surgery in young children leads to blindness and loss of the affected eye. It is caused by conjunctival bacteria. PI solutions between 1% and 5% reduce the number of bacteria on the conjunctiva. The concentration used varies widely among clinics, from 1% to 5%. In vitro studies have shown that PI is paradoxically more effective at lower concentration, but in cataract surgery in elderly, 1% PI has been shown to be less effective than 5% PI. Dilution by tear fluid or binding of PI to proteins in tear fluid may lower its effectiveness. Since endophthalmitis after strabismus surgery especially affects young children and the bacterial flora of the conjunctiva in children is different from that in adults, the cataract PI study should be repeated in young children operated for strabismus.

Objective: 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.

Design: The study is a multi-centre, prospective, randomized-controlled, parallel-groups, assessor-blind (microbiological assessments), investigator-initiated trial.

Study population: All children under 6 years of age attending the 15 participating clinics for routine strabismus surgery will be eligible for the study at the point that a strabismus operation is planned. The clinics (5 Dutch, 10 German) will each recruit approximately 20 patients. The minimum sample size is 2 x 100 patients.

Intervention: 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 the 5% PI group will have their conjunctival fornices irrigated with 5 ml PI 5%. Children randomized to the 1.25% PI group will have their conjunctival fornices irrigated with 5 ml PI 1.25%. Conjunctiva cultures for aerobic and anaerobic bacteria will be obtained (1) after general anesthesia has been established, (2) 5-10 min after PI irrigation, (3) after reattachment of the eye muscles and (4) after closing the conjunctiva with sutures.

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

Secondary outcome: 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.

Nature and extent of the burden and risks associated with participation:

Risks are limited to the act of taking the four bacterial cultures, as both 1.25% PI and 5% PI are approved preoperative antiseptic applications of PI and both are used, rather indiscriminately, by the university departments of ophthalmology participating in the study.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Iodine excretion after surgery, assessed as urine iodine concentration per creatinine clearance. [24 hours postoperatively]
Postoperative erosion of the cornea and corneal oedema. [within 24 hours postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children attending for routine strabismus surgery are eligible for the study. Criteria for inclusion:

Children < 6 years of age
undergoing surgery for strabismus for the first time, including any recession and/or resection surgery of the medial and/or lateral rectus muscles.
willing to take part in all aspects of the study with written informed consent on the study participation of the child provided by the parents.

Exclusion Criteria:

Any history or current condition of hypersensitivity to iodine
Children on topical antibiotic within the last 30 days
Children with signs of acute conjunctivitis, blepharitis, dacryocystitis or respiratory infection within the last 30 days
Children with asthma or similar chronic, obstructive pulmonary disorder
Insufficiently treated amblyopia, i.e. a difference between the visual acuities of both eyes larger than 1 LogMARline.
Neurological or psychiatric disorder, medication, other eye disorder, decreased visual acuity caused by brain damage or trauma.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Ernst Moritz Arndt University	Greifswald	Germany	D-17487
2	Universitäts-Augenklinik	Magdeburg	Germany	D-39120
3	Universitäts-Augenklinik Ludwig-Maximilian University	Munich	Germany	D-80336
4	Dept. Ophthalmology Free University Medical Center	Amsterdam	Netherlands	NL-1007MB
5	Dept. Ophthalmology Academical Medical Center	Amsterdam	Netherlands	NL-1105AZ
6	Dept. Ophthalmology	Leiden	Netherlands	NL-2300RC
7	Dept. of Ophthalmology St. Laurentius Ziekenhuis	Roermond	Netherlands	NL-6040AX
8	Rotterdam Eye Hospital	Rotterdam	Netherlands	3011BH
9	Dept. of Ophthalmology Erasmus Medical Center	Rotterdam	Netherlands	NL3000CA

Sponsors and Collaborators

Erasmus Medical Center
Ludwig-Maximilians - University of Munich
University Medicine Greifswald
Free University Medical Center
Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Rotterdam Eye Hospital
Laurentius Hospital Roermond
Martin-Luther-Universität Halle-Wittenberg

Investigators

Principal Investigator: Huibert J Simonsz, MD PhD, Erasmus Medical Center
Principal Investigator: Herminia Miño de Kaspar, PhD, Universitäts-Augenklinik Ludwig-Maximilian University Munich Germany