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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG1EY037206-01 | U.S. NIH Grant/Contract | View source | |
| 5UG1EY030030-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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This multi-center clinical trial is designed to assess the association of diabetes in a cornea donor with transplant success and loss of endothelial cells 5 years following Descemet membrane endothelial keratoplasty (DMEK). Study eyes are assigned to receive either a cornea from a donor without diabetes or a cornea from a donor with diabetes in a masked fashion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assigned cornea from a donor without diabetes | Active Comparator | Eyes assigned to this arm receive a cornea from a donor without diabetes and undergo Descemet membrane endothelial keratoplasty. |
|
| Assigned cornea from a donor with diabetes | Active Comparator | Eyes assigned to this arm receive a cornea from a donor with diabetes for Descemet membrane endothelial keratoplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Descemet membrane endothelial keratoplasty | Procedure | Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in central corneal endothelial cell density 5 years after Descemet membrane endothelial keratoplasty. | Central corneal endothelial cell density will be assessed by specular microscopy at 3 and 5 years after Descemet membrane endothelial keratoplasty and the results will be compared with the baseline donor endothelial cell density assessed at the eye bank that provided the donor tissue. | Subjects are followed for 5 years after corneal transplantation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Lass, MD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Eye Partners | Atlanta | Georgia | 30189 | United States | ||
| Price Vision Group |
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| Indianapolis |
| Indiana |
| 46260 |
| United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Kansas City Eye Clinic | Overland Park | Kansas | 66204 | United States |
| Mid-Atlantic Cornea Consultants | Baltimore | Maryland | 21204 | United States |
| The Wilmer Eye Institute/Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| University of Michigan/Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
| Verdier Eye Center | Grand Rapids | Michigan | 49546 | United States |
| Minnesota Eye Consultants | Bloomington | Minnesota | 55431 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Associated Eye Care | Stillwater | Minnesota | 55082 | United States |
| Moyes Eye Center | Kansas City | Missouri | 64154 | United States |
| Legacy Devers Eye Institute | Portland | Oregon | 97210 | United States |
| Ophthalmic Partners | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| 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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