Back to resultsAcrylate Intraocular Lenses in Cataract Surgery of Uveitis Patients
Primary Purpose
Uveitis, Cataract
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
intraocular lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb)
Sponsored by
About this trial
This is an interventional treatment trial for Uveitis
Eligibility Criteria
Inclusion Criteria:
- non infectious uveitis
- no active inflammation
- significant visual disturbance related to lens opacification
Exclusion Criteria:
- vitreous opacification
- ocular hypertension/glaucoma
Sites / Locations
- Department of Ophthalmology at St.-Franziskus Hospital
Outcomes
Primary Outcome Measures
visual acuity
cell deposits on anterior IOL surface
posterior capsular opacification
Secondary Outcome Measures
Full Information
NCT ID
NCT00403832
First Posted
November 24, 2006
Last Updated
July 26, 2010
Sponsor
St. Franziskus Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00403832
Brief Title
Acrylate Intraocular Lenses in Cataract Surgery of Uveitis Patients
Official Title
Comparison of Two Different Acrylate Intraocular Lenses in Cataract Surgery in Patients With Non-infectious Uveitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
St. Franziskus Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
intraocular lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb)
Primary Outcome Measure Information:
Title
visual acuity
Title
cell deposits on anterior IOL surface
Title
posterior capsular opacification
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non infectious uveitis
no active inflammation
significant visual disturbance related to lens opacification
Exclusion Criteria:
vitreous opacification
ocular hypertension/glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnd Heiligenhaus, Md Phd
Organizational Affiliation
Department of Ophthalmology at St.-FranziskusHospital Münster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology at St.-Franziskus Hospital
City
Münster
ZIP/Postal Code
48145
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
20082200
Citation
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.
Results Reference
derived
Links:
URL
http://www.uveitis-zentrum.de
Description
Related Info
Learn more about this trial
Acrylate Intraocular Lenses in Cataract Surgery of Uveitis Patients
We'll reach out to this number within 24 hrs