Impact of Donor Diabetes on DMEK Success and Endothelial Cell Loss (DEKS)

Overview

About this study

The objectives of this study are to determine if the 1-year graft success rate following DMEK performed with corneas from donors without diabetes is superior to the graft success rate with cornea donors with diabetes, to determine if the 1-year central endothelial cell loss (ECL) following DMEK performed with corneas from donors without diabetes is superior to the central ECL when corneas from donors with diabetes are used, nd to explore the relationship of severity of diabetes in the donor, as measured by eye bank-determined diabetes risk categorization scores, post-mortem hemoglobin A1c (HbA1c), and skin advanced glycation endproducts (AGE) and oxidation markers, with 1-year graft outcomes (i.e., graft success and ECL) following DMEK in corneas from donors with diabetes.

The association of diabetes in the cornea donor with transplant success and loss of endothelial cells one year following Descemet membrane endothelial keratoplasty (DMEK) will be evaluated in a double-masked multi-center trial in which study eyes will be assigned to receive either a cornea from a donor without diabetes or a cornea from a donor with diabetes.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Participant:

  • Age range 30- < 91 years with minimum life expectancy of at least 1 year.
  • Willingness to return to study site for follow up at 1 month and 1 year.
  • Fluent in English or Spanish.
  • Willingness to have fingerstick blood sample collected to determine HbA1c level at entry and at 1 year. If determined to be diabetic at baseline, participant will be advised to seek medical care.

Inclusion Criteria - Study Eye:

  • Clinically recommended for DMEK, and able to schedule DMEK between 5 to 90 days after enrollment.
  • Presence of a condition related to endothelial dysfunction which will be treated by DMEK.  Eligible indications for DMEK include:
    • Presence of Fuchs endothelial corneal dystrophy (FECD) meeting at least one of the following:
    • Phakic FECD with or without cataract;
    • Triple procedure including DMEK for FECD, cataract extraction and posterior chamber intraocular lens implantation (IOL) is allowed;
    • Pseudophakic FECD with posterior capsule supported, sulcus supported, or scleral-fixated posterior chamber IOL b. Pseudophakic corneal edema with posterior capsule supported, sulcus supported, or scleral-fixated posterior chamber IOL without FECD;
    • Failed Descemet stripping automated endothelial keratoplasty (DSAEK) or DMEK without exclusionary criteria, as described below.

Exclusion Criteria:

  • Pregnant or planning to become pregnant prior to the DMEK study surgery, based on verbal report.
  • Lack cognitive capacity such that consent could not be provided.
  • Presence of a condition that has a high probability for failure (e.g., failed penetrating keratoplasty, uncontrolled uveitis).
  • Stromal vascularization that will impede assessment of recipient stroma clarity.
  • Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy.
  • Indication for surgery that is not suitable for DMEK (e.g, keratoconus, stromal dystrophies and scars).
  • Aphakic corneal edema with or without FECD.
  • Anterior chamber IOL in study eye prior to DMEK or planned placement of anterior chamber IOL during DMEK.
  • Planned IOL exchange of an anterior chamber IOL with a posterior chamber IOL in study eye at time of study DMEK.
  • Pre-operative central sub-epithelial or stromal scarring that could impact post-operative recipient stromal clarity assessment.
  • Presence of anterior synechiae.
  • Peripheral anterior synechiae in the angle greater than a total of three clock hours.
  • Uncontrolled glaucoma with or without prior filtering surgery, tube shunt placement, or MIGS. Uncontrolled glaucoma is defined as intraocular pressure > 25mm Hg.
  • Controlled glaucoma with prior tube shunt placement for glaucoma (controlled glaucoma with MIGS is allowed).
  • Fellow eye visual acuity < 20/200 due to an ocular condition other than a cornea disease that would be a candidate for DMEK.
  • IOP < 8 mmHg.
  • Topical Rho kinase inhibitor, including Rhopressa, used within 1 month prior to study entry and anticipated during the course of the study.

Eligibility last updated 5/18/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sanjay Patel, M.D.

Open for enrollment

Contact information:

Emily Treichel

(507) 284-8558

Treichel.Emily@mayo.edu

More information

Publications

Publications are currently not available
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