Povidone-iodine Antisepsis for Strabismus Surgery

NCT00461656 | Completed Phase 4

• 1 other identifier: ABR 14357
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 9

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.

Conditions

Strabismus; Surgery; Endophthalmitis

Keywords

Antiseptic; Povidone-Iodine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Interventions

Preoperative conjunctival irrigation with 5% or 1.25% PI DRUG

Before initiation of surgery, children will have their conjunctival fornices irrigated with 5 ml PI 5% or with 5 ml PI 1.25%

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (9)

Ernst Moritz Arndt University

Greifswald, D-17487, Germany

Location

Universitäts-Augenklinik

Magdeburg, D-39120, Germany

Location

Universitäts-Augenklinik Ludwig-Maximilian University

Munich, D-80336, Germany

Location

Dept. Ophthalmology Free University Medical Center

Amsterdam, NL-1007MB, Netherlands

Location

Dept. Ophthalmology Academical Medical Center

Amsterdam, NL-1105AZ, Netherlands

Location

Dept. Ophthalmology

Leiden, NL-2300RC, Netherlands

Location

Dept. of Ophthalmology St. Laurentius Ziekenhuis

Roermond, NL-6040AX, Netherlands

Location

Rotterdam Eye Hospital

Rotterdam, 3011BH, Netherlands

Location

Dept. of Ophthalmology Erasmus Medical Center

Rotterdam, NL3000CA, Netherlands

Location

Related Publications (25)

• Anderson RL, Vess RW, Carr JH, Bond WW, Panlilio AL, Favero MS. Investigations of intrinsic Pseudomonas cepacia contamination in commercially manufactured povidone-iodine. Infect Control Hosp Epidemiol. 1991 May;12(5):297-302. doi: 10.1086/646342.

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• Bannerman TL, Rhoden DL, McAllister SK, Miller JM, Wilson LA. The source of coagulase-negative staphylococci in the Endophthalmitis Vitrectomy Study. A comparison of eyelid and intraocular isolates using pulsed-field gel electrophoresis. Arch Ophthalmol. 1997 Mar;115(3):357-61. doi: 10.1001/archopht.1997.01100150359008.

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• Berkelman RL, Holland BW, Anderson RL. Increased bactericidal activity of dilute preparations of povidone-iodine solutions. J Clin Microbiol. 1982 Apr;15(4):635-9. doi: 10.1128/jcm.15.4.635-639.1982.

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• Binder CA, Mino de Kaspar H, Klauss V, Kampik A. [Preoperative infection prophylaxis with 1% polyvidon-iodine solution based on the example of conjunctival staphylococci]. Ophthalmologe. 1999 Oct;96(10):663-7. doi: 10.1007/s003470050471. German.

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• Caldwell DR, Kastl PR, Cook J, Simon J. Povidone-iodine: its efficacy as a preoperative conjunctival and periocular preparation. Ann Ophthalmol. 1984 Jun;16(6):577, 580.

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• Carothers TS, Coats DK, McCreery KM, Rossman SN, Wilson P, Wu TG, Paysse EA. Quantification of incidental needle and suture contamination during strabismus surgery. Binocul Vis Strabismus Q. 2003;18(2):75-9.

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• Ciulla TA, Starr MB, Masket S. Bacterial endophthalmitis prophylaxis for cataract surgery: an evidence-based update. Ophthalmology. 2002 Jan;109(1):13-24. doi: 10.1016/s0161-6420(01)00899-5.

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• Dereklis DL, Bufidis TA, Tsiakiri EP, Palassopoulos SI. Preoperative ocular disinfection by the use of povidone-iodine 5%. Acta Ophthalmol (Copenh). 1994 Oct;72(5):627-30. doi: 10.1111/j.1755-3768.1994.tb07191.x.

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• Ferguson AW, Scott JA, McGavigan J, Elton RA, McLean J, Schmidt U, Kelkar R, Dhillon B. Comparison of 5% povidone-iodine solution against 1% povidone-iodine solution in preoperative cataract surgery antisepsis: a prospective randomised double blind study. Br J Ophthalmol. 2003 Feb;87(2):163-7. doi: 10.1136/bjo.87.2.163.

  PMID: 12543744 BACKGROUND

• Grimes SR, Hollsten D, Nauschuetz WF, Whiddon RG, Trevino SB. Effect of povidone-iodine irrigation on the preoperative chemical preparation of the eye. Mil Med. 1992 Mar;157(3):111-3.

  PMID: 1603399 BACKGROUND

• Katosova LK. [The features of Haemophilus influenza and Streptococcus pneumoniae carriage and the comparative characteristics of strains isolated from healthy children and from patients with acute and chronic respiratory infections]. Zh Mikrobiol Epidemiol Immunobiol. 1994 Aug-Sep;Suppl 1:55-60. Russian.

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• Khashu M, Chessex P, Chanoine JP. Iodine overload and severe hypothyroidism in a premature neonate. J Pediatr Surg. 2005 Feb;40(2):E1-4. doi: 10.1016/j.jpedsurg.2004.10.028.

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• Lacey RW, Catto A. Action of povidone-iodine against methicillin-sensitive and -resistant cultures of Staphylococcus aureus. Postgrad Med J. 1993;69 Suppl 3(818):S78-83.

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• Mino de Kaspar H, Chang RT, Singh K, Egbert PR, Blumenkranz MS, Ta CN. Prospective randomized comparison of 2 different methods of 5% povidone-iodine applications for anterior segment intraocular surgery. Arch Ophthalmol. 2005 Feb;123(2):161-5. doi: 10.1001/archopht.123.2.161.

  PMID: 15710810 BACKGROUND

• Olitsky SE, Vilardo M, Awner S, Reynolds JD. Needle sterility during strabismus surgery. J AAPOS. 1998 Jun;2(3):151-2. doi: 10.1016/s1091-8531(98)90006-4.

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• Recchia FM, Baumal CR, Sivalingam A, Kleiner R, Duker JS, Vrabec TR. Endophthalmitis after pediatric strabismus surgery. Arch Ophthalmol. 2000 Jul;118(7):939-44.

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• Roberts SM, Severin GA, Lavach JD. Antibacterial activity of dilute povidone-iodine solutions used for ocular surface disinfection in dogs. Am J Vet Res. 1986 Jun;47(6):1207-10.

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• Zamora JL. Chemical and microbiologic characteristics and toxicity of povidone-iodine solutions. Am J Surg. 1986 Mar;151(3):400-6. doi: 10.1016/0002-9610(86)90477-0.

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MeSH Terms

Conditions

Strabismus; Endophthalmitis

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Eye Infections; Infections

Study Officials

• Huibert J Simonsz, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Herminia Miño de Kaspar, PhD

  Universitäts-Augenklinik Ludwig-Maximilian University Munich Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 18, 2007
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 5, 2013

Record last verified: 2011-07

Locations

NL (6); DE (3)