Effect of Donor Diabetes and Other Factors on Corneal Transplant Endothelial Cell Loss and Success at 5 Years (DEKS)

Case Western Reserve University

Status: Begins enrollment in 2 months

Conditions: Corneal Endothelial Decompensation; Fuchs Endothelial Corneal Dystrophy

Treatments: Procedure: Descemet membrane endothelial keratoplasty

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07217249

5UG1EY030030-05 (U.S. NIH Grant/Contract)

1UG1EY037206-01 (U.S. NIH Grant/Contract)

DEKS 5-year Extension Study

Details and patient eligibility

About

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.

Enrollment: 570 estimated patients

Sex: All

Ages: 30 to 93 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing to return to the study site for follow up at 3 and 5 years after a Descemet membrane endothelial keratoplasty procedure
• Fluent in English or Spanish
• Willing to have fingerstick blood sample collected to determine HbA1c level
• Participated and completed 12-month follow-up in the DEKS study for one or both eyes or a DEKS participant that had a study eye regraft prior to the 12-month visit.

Exclusion criteria

• Lack cognitive capacity such that consent could not be provided.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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570 participants in 2 patient groups

Assigned cornea from a donor without diabetes

Active Comparator group

Description:

Eyes assigned to this arm receive a cornea from a donor without diabetes and undergo Descemet membrane endothelial keratoplasty.

Treatment:

Procedure: Descemet membrane endothelial keratoplasty

Assigned cornea from a donor with diabetes

Active Comparator group

Description:

Eyes assigned to this arm receive a cornea from a donor with diabetes for Descemet membrane endothelial keratoplasty.

Treatment:

Procedure: Descemet membrane endothelial keratoplasty