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Sponsors and Collaborators: |
Klinikum Chemnitz gGmbH German Research Foundation Koordinierungszentrum für klinische Studien Dresden |
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Information provided by: | Klinikum Chemnitz gGmbH |
ClinicalTrials.gov Identifier: | NCT00623584 |
The goal of this clinical trial is to compare the quality of corneal grafts cultured in a serum-free culture medium with a defined composition versus corneal grafts cultured in a standard serum supplemented culture medium transplanted in patients with decompensated corneal dystrophy
Condition | Intervention |
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Fuch's Endothelial Dystrophy Pseudophakic Bullous Keratopathy |
Procedure: Corneal transplantation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | In Vitro and Clinical Comparison of Corneal Grafts Cultured in Serum Free Medium or Standard Serum Supplemented Medium in Patients With Degeneration of the Corneal Endothelium |
Estimated Enrollment: | 60 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Patients in this arm randomly receive a corneal graft cultured in a serum free culture medium
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Procedure: Corneal transplantation
Full thickness penetrating keratoplasty
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2: Active Comparator
Patients in this arm randomly receive a corneal graft cultured in a serum supplemented culture medium
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Procedure: Corneal transplantation
Full thickness penetrating keratoplasty
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The primary objective of this clinical trial is to test the equivalence of the quality of the corneal grafts cultured under serum free conditions to corneal grafts cultured in the Minimal Essential Medium supplemented with 2% fetal calf serum, based on a parallel comparison of the endothelial cell density of paired corneal grafts deriving from single donors at different time points before and after the grafting procedure. In addition, the safety of the clinical use of corneal grafts cultured in both media will be determined. The graft survival rate during the follow-up period will be quantified in regard to immune mediated graft rejection and non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation.
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Katrin Engelmann, MD | + 49 371 333 33230 | k.engelmann@skc.de |
Contact: Simo Murovski, MD | + 49 371 333 31022 | s.murovski@skc.de |
Germany, Sachsen-Anhalt | |
Universitäts Augenklinik | Recruiting |
Halle (Saale), Sachsen-Anhalt, Germany, 06120 | |
Contact: Gernot Duncker, MD +49 345 557 1878 gernot.duncker@medizin.uni-halle.de | |
Contact: Timm Bredehorn, MD + 49 345 557 1575 timm.bredehorn@dso.de | |
Germany, Saxony | |
Augenklinik, Klinikum Chemnitz gGmbH | Not yet recruiting |
Chemnitz, Saxony, Germany, 091116 | |
Contact: Katrin Engelmann, MD + 49 371 333 33230 k.engelmann@skc.de | |
Contact: Simo Murovski, MD + 49 371 333 31022 s.murovski@skc.de | |
Sub-Investigator: Simo Murovski, MD | |
Principal Investigator: Katrin Engelmann, MD |
Responsible Party: | Eye Clinic Chemnitz ( Prof. Dr. med. Katrin Engelmann ) |
Study ID Numbers: | SKC001SFM08 |
Study First Received: | February 13, 2008 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00623584 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
penetrating keratoplasty corneal transplantation corneal grafting corneal grafts |
culture media corneal culturing in vitro culturing |
Corneal Diseases Corneal Dystrophy Fuchs' Endothelial 1 Genetic Diseases, Inborn Corneal Dystrophy Corneal Dystrophies, Hereditary |
Eye Diseases Fuchs' Endothelial Dystrophy Corneal Edema Eye Diseases, Hereditary Edema |
Corneal Diseases Genetic Diseases, Inborn Corneal Dystrophies, Hereditary Eye Diseases |
Fuchs' Endothelial Dystrophy Corneal Edema Eye Diseases, Hereditary |