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Diabetes Endothelial Keratoplasty Study: Impact of Diabetes on Corneal Transplant Success and Cell Loss

Award Number: UG1EY030030
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2021
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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Diabetes Endothelial Keratoplasty Study: Impact of Diabetes on Corneal Transplant Success and Cell Loss - PROJECT SUMMARY 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $474,810 )
2024	2024	JAEB CENTER FOR HEALTH RESEARCH FOUNDATION, INC.	15310 AMBERLY DR STE 350	TAMPA	FL	33647	HILLSBOROUGH	USA	Vision Research	000	4	5/13/2024	NON-COMPETING CONTINUATION	$474,810
														Subtotal = $474,810

Issue Date FY: 2023 ( Subtotal = $1,608,633 )
2023	2023	JAEB CENTER FOR HEALTH RESEARCH FOUNDATION, INC.	15310 AMBERLY DR STE 350	TAMPA	FL	33647	HILLSBOROUGH	USA	Vision Research	000	3	6/2/2023	NON-COMPETING CONTINUATION	$1,608,633
														Subtotal = $1,608,633

Issue Date FY: 2022 ( Subtotal = $1,138,602 )
2022	2022	JAEB CENTER FOR HEALTH RESEARCH FOUNDATION, INC.	15310 AMBERLY DR STE 350	TAMPA	FL	33647	HILLSBOROUGH	USA	Vision Research	001	2	6/13/2022	NON-COMPETING CONTINUATION	$1,138,602
2022	2021	JAEB CENTER FOR HEALTH RESEARCH FOUNDATION, INC.	15310 AMBERLY DR STE 350	TAMPA	FL	33647	HILLSBOROUGH	USA	Vision Research	000	1	6/10/2022	NEW	$0
														Subtotal = $1,138,602

Issue Date FY: 2021 ( Subtotal = $831,294 )
2021	2021	JAEB CENTER FOR HEALTH RESEARCH FOUNDATION, INC.	15310 AMBERLY DR STE 350	TAMPA	FL	33647	HILLSBOROUGH	USA	Vision Research	000	1	4/21/2021	NEW	$831,294
														Subtotal = $831,294

Grand Total All Awards = $4,053,339

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Diabetes Endothelial Keratoplasty Study: Impact of Diabetes on Corneal Transplant Success and Cell Loss

Award Number: UG1EY030030

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/01/2021

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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