An interventional study of Descemet membrane endothelial keratoplasty in Corneal Endothelial Decompensation and Fuchs' Endothelial Dystrophy, sponsored by Case Western Reserve University. Completed at 2 sites in United States. Open to participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Treatment
This double-masked multi-center trial will evaluate the association of diabetes in the cornea donor with transplant success and loss of endothelial cells through 1 year 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.
This study will address concerns about the suitability of corneas from donors with diabetes for use with DMEK through a prospective, masked, multi-center clinical trial in which the donor corneas are assigned by diabetes status in the same distribution proportion (2:1 distribution of tissue from donors without diabetes to tissue from donors with diabetes) currently used in the USA. The DEKS will assess graft success and endothelial cell density through 1 year following DMEK to determine whether the surgical success rate with corneas from donors with well characterized diabetes (including post-mortem hemoglobin A1c (HbA1c) and advanced glycation end products (AGE) testing) is inferior to the rate with donors without diabetes. The investigators hypothesize that the majority of donor corneas from individuals with diabetes will be suitable, but that a portion of donors with a higher diabetes severity scale, and/or poorer control based on HbA1c will have a greater risk for graft failure and endothelial cell loss. This study will also examine collected skin biopsies to determine whether high levels of AGE biomarkers in donor skin tissue - which quantifies disease severity over many years (and possibly coupled with elevated HbA1c levels) - is associated with greater risk for graft failure and cell loss. This novel approach to characterization of donor tissue can provide a paradigm shift in the risk assessment of transplanted corneas from diabetic donors. The effect of recipient diabetes on keratoplasty success and cell loss will also be studied in a rigorous manner to determine the potential combined effect of donor and recipient diabetes status.
In summary, this study is designed to determine if non-diabetic donor corneas are superior to diabetic donor corneas in terms of both graft success and endothelial cell density outcomes, with an additional specific aim to determine whether donors with a higher diabetes severity scale, and/or poorer control based on HbA1c are driving the effect. This study will also determine whether a high AGE/A1c metric is also associated with the potential superiority finding and establish a novel composite score (severity score, HbA1c and AGE/A1c) based on these metrics that can be used to identify high versus low risk diabetic donors. This distinction may enable eye banks to potentially utilize the majority of donors with diabetes for EK surgery, while excluding the severely affected donors with diabetes.
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.
This study's enrollment of 1,097 is above the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →Case Western Reserve University is the lead sponsor of 160 studies on the registry; 28 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participant Inclusion Criteria:
Has a condition related to endothelial dysfunction which will be treated by DMEK. Eligible indications for DMEK include:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant eye will be assigned a cornea recovered from a donor with diabetes.
Procedure: Descemet membrane endothelial keratoplasty
Participant eye will be assigned a cornea recovered from a donor without diabetes.
Procedure: Descemet membrane endothelial keratoplasty
cornea transplant procedure to replace dysfunctional endothelial cell layer
Graft Failure
Graft failure is defined as the occurrence of one of the following: a graft which requires replacement for any reason or the recipient cornea remains cloudy after surgery without clearing for 8 weeks or longer
Time frame: 1 year
Endothelial Cell Density
Central corneal endothelial cell density assessed with specular microscopy
Time frame: 1 year
Eligible recipients were aged 30 to 90 years old and scheduled to have Descemet membrane endothelial keratoplasty to treat a low to moderate risk condition including Fuchs endothelial corneal dystrophy (FECD), pseudophakic corneal edema, or failed DSAEK or DMEK.
| Milestone | Cornea From Donor With Diabetes | Cornea From Donor Without Diabetes |
|---|---|---|
| Started | 492 | 782 |
| Completed | 474 | 750 |
| Not completed | 18 | 32 |
Graft failure is defined as the occurrence of one of the following: a graft which requires replacement for any reason or the recipient cornea remains cloudy after surgery without clearing for 8 weeks or longer
| eyes | Cornea From Donor Without Diabetes | Cornea From Donor With Diabetes |
|---|---|---|
| Graft Failure | 32 | 15 |
Central corneal endothelial cell density assessed with specular microscopy
| cells/mm2 | Cornea From Donor Without Diabetes | Cornea From Donor With Diabetes |
|---|---|---|
| Endothelial Cell Density | 1927 ± 498 | 1920 ± 496 |
Collected over from enrollment until end of follow-up, up to 15 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cornea From Donor With Diabetes | 7/912 (0.8%) | 4/912 (0.4%) | 402/912 (44.1%) |
| Cornea From Donor Without Diabetes | 4/509 (0.8%) | 2/509 (0.4%) | 224/509 (44%) |
| Event | Cornea From Donor With Diabetes | Cornea From Donor Without Diabetes |
|---|---|---|
| Vitreous hemorrhage/choroidal effusionsEye disorders | 0/912 | 1/509 |
| Corneal keratitisEye disorders | 0/912 | 1/509 |
| Retinal detachmentEye disorders | 1/912 | 0/509 |
| Herpes simplex viral keratitisEye disorders | 1/912 | 0/509 |
| Pseudoendophthalmitis (likely cytomegalovirus keratouveitis)Eye disorders | 1/912 | 0/509 |
| Deep vein thrombosisBlood and lymphatic system disorders | 1/912 | 0/509 |
| Event | Cornea From Donor With Diabetes | Cornea From Donor Without Diabetes |
|---|---|---|
| Postoperative air or gas injection to promote graft attachmentEye disorders | 172/912 | 98/509 |
| Intraocular pressure > 25 mm HgEye disorders | 147/912 | 86/509 |
| Clouded recipient stroma noted at any timepointEye disorders | 114/912 | 76/509 |
| Surgical complicationsEye disorders | 52/912 | 26/509 |
Analyses were conducted at the eye level.
| Age, Continuous(years) | Cornea From Donor Without Diabetes | Cornea From Donor With Diabetes | Total |
|---|---|---|---|
| Median | 70 (65 to 75) | 71 (66 to 76) | 70 (65 to 76) |
| Sex: Female, Male(Eyes) | Cornea From Donor Without Diabetes | Cornea From Donor With Diabetes | Total |
|---|---|---|---|
| Female | 502 | 301 | 803 |
| Male | 410 | 208 | 618 |
| Race (NIH/OMB)(Eyes) | Cornea From Donor Without Diabetes | Cornea From Donor With Diabetes | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 2 | 3 |
| Asian | 3 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 23 | 17 | 40 |
| White | 882 | 487 | 1369 |
| More than one race | 2 | 3 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Eyes) | Cornea From Donor Without Diabetes | Cornea From Donor With Diabetes | Total |
|---|---|---|---|
| United States | 912 | 509 | 1421 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data collected for this study will be analyzed and stored at the Jaeb Center for Health Research. After the study is completed, the de-identified, archived data will be made publicly available. Further, some data and images may be requested and shared with other researchers under a Data Use Agreement as a limited data set, since other than date of collection, there are no other identifiable elements. No additional identifying information shall be provided in a manner that would make the human subjects readily identifiable.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be made available indefinitely after publication of the study results, which is anticipated by July, 2030.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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