Clinical trial NCT00461656: Povidone-iodine Antisepsis for Strabismus Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Strabismus
Surgery
Endophthalmitis
Keywords: Antiseptic
Povidone-Iodine
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
name: University Medicine Greifswald
name: Free University Medical Center
name: Leiden University Medical Center
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Rotterdam Eye Hospital
name: Laurentius Hospital Roermond
name: Martin-Luther-Universität Halle-Wittenberg
First posted: 2007-04-18
Enrollment: 70
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

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. 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:

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. a difference between the visual acuities of both eyes larger than 1 LogMARline.
6. Neurological or psychiatric disorder, medication, other eye disorder, decreased visual acuity caused by brain damage or trauma.

Primary outcomes:
measure: The difference in the mean numbers of bacterial colony forming units from pre-irrigation to post-irrigation with PI.
timeFrame: Cultures taken during surgery, evaluated within 2 days postoperatively
Secondary outcomes:
measure: Iodine excretion after surgery, assessed as urine iodine concentration per creatinine clearance.
timeFrame: 24 hours postoperatively
measure: Postoperative erosion of the cornea and corneal oedema.
timeFrame: within 24 hours postoperatively
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Ernst Moritz Arndt University
city: Magdeburg
country: Germany
facility: Universitäts-Augenklinik
city: Munich
country: Germany
facility: Universitäts-Augenklinik Ludwig-Maximilian University
city: Amsterdam
country: Netherlands
facility: Dept. Ophthalmology Free University Medical Center
city: Amsterdam
country: Netherlands
facility: Dept. Ophthalmology Academical Medical Center
city: Leiden
country: Netherlands
facility: Dept. Ophthalmology
city: Roermond
country: Netherlands
facility: Dept. of Ophthalmology St. Laurentius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Rotterdam Eye Hospital
city: Rotterdam
country: Netherlands
facility: Dept. of Ophthalmology Erasmus Medical Center
Study officials:
affiliation: Erasmus Medical Center
name: Huibert J Simonsz, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitäts-Augenklinik Ludwig-Maximilian University Munich Germany
name: Herminia Miño de Kaspar, PhD
role: PRINCIPAL_INVESTIGATOR
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