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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
| KKS Netzwerk | NETWORK |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients in this arm randomly receive a corneal graft cultured in a serum free culture medium |
|
| 2 | Active Comparator | Patients in this arm randomly receive a corneal graft cultured in a serum supplemented culture medium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal transplantation | Procedure | Full thickness penetrating keratoplasty |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is the endothelial cell density of the corneal grafts prior to and after the transplantation procedure | The measurment will be performed prior to and 1, 4, 12, 24, 36, 48 and 60 months after the transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary study outcomes are immune mediated graft rejection, non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation. | 1,4,12, 24, 36, 48 and 60 month after the transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katrin Engelmann, MD | Contact | + 49 371 333 33230 | k.engelmann@skc.de | |
| Simo Murovski, MD | Contact | + 49 371 6000020 | s.murovski@poliklinik-chemnitz.de |
| Name | Affiliation | Role |
|---|---|---|
| Katrin Engelmann, MD | Klinikum Chemnitz GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augenklinik, Klinikum Chemnitz gGmbH | Chemnitz | Saxony | 091116 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11760044 | Background | Hempel B, Bednarz J, Engelmann K. Use of a serum-free medium for long-term storage of human corneas. Influence on endothelial cell density and corneal metabolism. Graefes Arch Clin Exp Ophthalmol. 2001 Oct;239(10):801-5. doi: 10.1007/s004170100364. | |
| 11734511 | Background | Bednarz J, Doubilei V, Wollnik PC, Engelmann K. Effect of three different media on serum free culture of donor corneas and isolated human corneal endothelial cells. Br J Ophthalmol. 2001 Dec;85(12):1416-20. doi: 10.1136/bjo.85.12.1416. |
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| Corneal transplantation |
| Procedure |
Full thickness penetrating keratoplasty |
|
| Universitäts Augenklinik | Halle | Saxony-Anhalt | 06120 | Germany |
|
| 11450479 | Background | Uphoff J, Bednarz J, Engelmann K. [Follow-up of endothelial cell density after perforating keratoplasty. Effect of donor and recipient-related factors]. Ophthalmologe. 2001 Jun;98(6):550-4. doi: 10.1007/s003470170117. German. |
| 11520760 | Background | Moller-Pedersen T, Hartmann U, Moller HJ, Ehlers N, Engelmann K. Evaluation of potential organ culture media for eye banking using human donor corneas. Br J Ophthalmol. 2001 Sep;85(9):1075-9. doi: 10.1136/bjo.85.9.1075. |
| 11760040 | Background | Moller-Pedersen T, Hartmann U, Ehlers N, Engelmann K. Evaluation of potential organ culture media for eye banking using a human corneal endothelial cell growth assay. Graefes Arch Clin Exp Ophthalmol. 2001 Oct;239(10):778-82. doi: 10.1007/s004170100354. |
| ID | Term |
|---|---|
| D005642 | Fuchs' Endothelial Dystrophy |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D016039 | Corneal Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |
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