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Acrylate Intraocular Lenses in Cataract Surgery of Uveitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00403832
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : July 28, 2010
Sponsor:
Information provided by:
St. Franziskus Hospital

Tracking Information
First Submitted Date  ICMJE November 24, 2006
First Posted Date  ICMJE November 27, 2006
Last Update Posted Date July 28, 2010
Study Start Date  ICMJE August 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2006)
  • visual acuity
  • cell deposits on anterior IOL surface
  • posterior capsular opacification
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acrylate Intraocular Lenses in Cataract Surgery of Uveitis Patients
Official Title  ICMJE Comparison of Two Different Acrylate Intraocular Lenses in Cataract Surgery in Patients With Non-infectious Uveitis
Brief Summary Cataract is a common complication in uveitis patients. Cataract operations with intraocular lens implantation are difficult in these patients because of complication due to the biocompatibility of the intraocular lens. In this study, uveal and capsular biocompatibility of two widely used acrylate intraocular lenses are compared.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Uveitis
  • Cataract
Intervention  ICMJE Device: intraocular lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb)
Study Arms  ICMJE Not Provided
Publications * Roesel M, Heinz C, Koch JM, Heiligenhaus A. Comparison of orbital floor triamcinolone acetonide and oral prednisolone for cataract surgery management in patients with non-infectious uveitis. Graefes Arch Clin Exp Ophthalmol. 2010 May;248(5):715-20. doi: 10.1007/s00417-009-1269-1. Epub 2010 Jan 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 24, 2006)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • non infectious uveitis
  • no active inflammation
  • significant visual disturbance related to lens opacification

Exclusion Criteria:

  • vitreous opacification
  • ocular hypertension/glaucoma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00403832
Other Study ID Numbers  ICMJE 05-2911
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE St. Franziskus Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arnd Heiligenhaus, Md Phd Department of Ophthalmology at St.-FranziskusHospital Münster
PRS Account St. Franziskus Hospital
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP