Diabetes endothelial keratoplasty study: impact of diabetes on corneal transplant success and cell loss

Ended Cooperative Agreement Awarded Last action

Award ID
UG1EY030030
Recipient
Awarding agency
Obligated
$10,700,024

Award facts

Assistance listing
93.867 Vision Research
Completion date
Funding
  • $9,868,730.00 Federal
  • $831,294.00 Non-federal
Place of performance
Tampa Palms, FL 33647, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
This proposal addresses a significant public health question: does diabetes, the 3RD leading cause of death in the united states (US), impact suitability of donor corneal tissue for transplantation? This question takes on increasing urgency as recent eye bank data suggests donors with diabetes now comprise about 30-35% of the cornea donor pool, a 50-72% increase in just over a decade. The impact of diabetes on keratoplasty outcomes remains unknown, with conflicting evidence from secondary or retrospective analyses of multiple clinical studies. Previous large clinical studies did not show a diabetic donor effect on penetrating keratoplasty (PKP) and descemet membrane endothelial keratoplasty (DMEK) graft success, yet our recent cornea preservation time study (CPTS) found the diabetic donor adversely affected graft outcomes following descemet stripping automated endothelial keratoplasty (DSAEK). Although current standard of care is to use diabetic donor corneas for all types of keratoplasties, some eye banks and surgeons are increasingly avoiding them for DMEK. As both the diabetic donor population and DMEK demand increases, a definitive superiority study evaluating effect of donor diabetes status on graft outcomes will allay and/or define these concerns. The diabetes endothelial keratoplasty study (DEKS) will address these important questions through a prospective masked clinical trial enrolling 1420 participant-eyes at 30 clinical sites and 15 eye banks across the US. The DEKS will determine if the 3-year graft success rate following DMEK performed with corneas from donors without diabetes is superior to the graft success rate with corneas from donors with diabetes. IT will also determine if the 3-year central endothelial cell loss (ECL) after DMEK with corneas from donors without diabetes is less than the central ECL when corneas from donors with diabetes are used. Lastly, the DEKS will explore the relationship of donor diabetes severity, as measured by eye bank-determined diabetes risk categorization scores, post- mortem HBA1C, and skin advanced glycation endproducts and oxidation markers, with DMEK graft outcomes 3 years postoperatively in corneas from diabetic donors. The DEKS could have a major impact on the targeted use of corneas from an increasing number of donors with diabetes with a range of disease severity in a donor pool that must continue to expand to meet the clinical demands of an aging population and DMEK growth.

Transactions

Action Federal Non-federal Date
Amendment $0 $0
Amendment Diabetes endothelial keratoplasty study (DEKS): impact of diabetes and other predictors on corneal transplant endothelial cell loss and success $675,389 $0
Amendment $675,389 $0
Amendment $0 $0
Amendment Diabetes endothelial keratoplasty study (DEKS): impact of diabetes and other predictors on corneal transplant endothelial cell loss and success $0 $0
Amendment $0 $0
Amendment $443,042 $0
Amendment $443,042 $0
Amendment $474,810 $0
Amendment $1,608,633 $0
Amendment $1,608,633 $0
Amendment $1,138,602 $0
Amendment $1,138,602 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $831,294 $0
Original award $831,294 $831,294
Show all 18

Subawards

Subrecipient Amount Awarded
Subrecipient not on record JCHR as the coordinating center and the Subrecipient as a clinical site will collaborate in the conduct of the clinical study Diabetes Endothelial… $31,196
Subrecipient not on record $36,003
Eye Centers Of Louisville PSC $37,345
Massachusetts Eye And Ear Infirmary $31,787
The University Of Chicago $31,160
Subrecipient not on record $30,624
Case Western Reserve University $30,075
Baylor College Of Medicine $31,888
University Of Miami JCHR as the coordinating center and the Subrecipient as a clinical site will collaborate in the conduct of the clinical study Diabetes Endothelial… $31,759
Subrecipient not on record JCHR as the coordinating center and the Subrecipient as a clinical site will collaborate in the conduct of the clinical study Diabetes Endothelial… $31,339
Chicago Cornea Consultants, LTD. JCHR as the coordinating center and the Subrecipient as a clinical site will collaborate in the conduct of the clinical study Diabetes Endothelial… $31,130
Indiana Lions Eye Bank Inc. JCHR as the data management and analysis center and the Subrecipient as an eye bank will collaborate in the conduct of the clinical study Diabetes Endothelial… $38,918
Subrecipient not on record JCHR as the coordinating center and the Subrecipient as a clinical site will collaborate in the conduct of the clinical study Diabetes Endothelial… $30,404
Subrecipient not on record JCHR as the coordinating center and the Subrecipient as a clinical site will collaborate in the conduct of the clinical study Diabetes Endothelial… $30,404
Minnesota Eye Consultants Pa JCHR as the coordinating center and the Subrecipient as a clinical site will collaborate in the conduct of the clinical study Diabetes Endothelial… $31,911
Visiongift JCHR as the data management and analysis center and the Subrecipient as an eye bank will collaborate in the conduct of the clinical study Diabetes Endothelial… $30,547
Show all 16

Quick answers

Who received award UG1EY030030?

UG1EY030030 was awarded to Jaeb Center For Health Research Foundation, Inc. by National Eye Institute (National Institutes of Health) on May 1, 2021.

How much is award UG1EY030030 worth?

$10,700,024 has been obligated on UG1EY030030: $9,868,730 in federal funding and $831,294 in non-federal funding.

On GovTribe

See this award's full record

  • Every transaction and subaward
  • The recipient's other awards and teaming partners
  • Similar grant awards
  • Ask GovTribe AI about this award
Try for free Login