Fuchs Dystrophy Clinical Trials

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Diabetes Endothelial Keratoplasty Study (DEKS): Impact of Diabetes and Other Predictors on Corneal Transplant Endothelial Cell Loss and Success

Status: Enrolling_by_invitation
Location: See all (14) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 93
Healthy Volunteers: f
View:

• 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.

Locations
United States
Georgia
Georgia Eye Partners
Atlanta
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Indiana
Price Vision Group
Indianapolis
Kansas
Kansas City Eye Clinic
Overland Park
Maryland
Mid-Atlantic Cornea Consultants
Baltimore
The Wilmer Eye Institute/Johns Hopkins
Baltimore
Michigan
University of Michigan/Kellogg Eye Center
Ann Arbor
Verdier Eye Center
Grand Rapids
Minnesota
Minnesota Eye Consultants
Bloomington
Mayo Clinic
Rochester
Associated Eye Care
Stillwater
Missouri
Moyes Eye Center
Kansas City
Oregon
Legacy Devers Eye Institute
Portland
Pennsylvania
Ophthalmic Partners
Bala-cynwyd
Time Frame
Start Date: 2025-12-03
Completion Date: 2030-04-30
Participants
Target number of participants: 570
Treatments
Active_comparator: Assigned cornea from a donor without diabetes
Eyes assigned to this arm receive a cornea from a donor without diabetes and undergo Descemet membrane endothelial keratoplasty.
Active_comparator: Assigned cornea from a donor with diabetes
Eyes assigned to this arm receive a cornea from a donor with diabetes for Descemet membrane endothelial keratoplasty.
Related Therapeutic Areas
Sponsors
Collaborators: National Eye Institute (NEI)
Leads: Case Western Reserve University

This content was sourced from clinicaltrials.gov