Trial Outcomes & Findings for Impact of Donor Diabetes on DMEK Success and Endothelial Cell Loss (NCT NCT05134480)
NCT ID: NCT05134480
Last Updated: 2026-04-16
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1097 participants
Primary outcome timeframe
1 year
Results posted on
2026-04-16
Participant Flow
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.
If a study participant received a study cornea from a donor with diabetes in one eye and a study cornea from a donor without diabetes in the fellow eye, the baseline characteristics collected at the time of enrollment of the first eye were counted in BOTH study arms (n=177). Thus 1097 participants were enrolled and 1274 participant characteristics are reported.
Unit of analysis: eyes
Participant milestones
| Measure |
Cornea From Donor With Diabetes
Participant will be assigned a cornea recovered from a donor with diabetes.
|
Cornea From Donor Without Diabetes
Participant will be assigned a cornea recovered from a donor without diabetes.
|
|---|---|---|
|
Overall Study
COMPLETED
|
474 491
|
750 875
|
|
Overall Study
NOT COMPLETED
|
18 18
|
32 37
|
|
Overall Study
STARTED
|
492 509
|
782 912
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The analysis was conducted at the eye (unit) level.
Baseline characteristics by cohort
| Measure |
Cornea From Donor Without Diabetes
n=912 Eyes
Participant will be assigned a cornea recovered from a donor without diabetes.
|
Cornea From Donor With Diabetes
n=509 Eyes
Participant will be assigned a cornea recovered from a donor with diabetes.
|
Total
n=1421 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=912 Eyes • The analysis was conducted at the eye (unit) level.
|
71 years
n=509 Eyes • The analysis was conducted at the eye (unit) level.
|
70 years
n=1421 Eyes • The analysis was conducted at the eye (unit) level.
|
|
Sex: Female, Male
Female
|
502 Eyes
n=912 Eyes • The analysis was conducted at the eye (unit) level.
|
301 Eyes
n=509 Eyes • The analysis was conducted at the eye (unit) level.
|
803 Eyes
n=1421 Eyes • The analysis was conducted at the eye (unit) level.
|
|
Sex: Female, Male
Male
|
410 Eyes
n=912 Eyes • The analysis was conducted at the eye (unit) level.
|
208 Eyes
n=509 Eyes • The analysis was conducted at the eye (unit) level.
|
618 Eyes
n=1421 Eyes • The analysis was conducted at the eye (unit) level.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Eyes
n=912 Eyes • The analysis was conducted at the eye (unit) level.
|
2 Eyes
n=509 Eyes • The analysis was conducted at the eye (unit) level.
|
3 Eyes
n=1421 Eyes • The analysis was conducted at the eye (unit) level.
|
|
Race (NIH/OMB)
Asian
|
3 Eyes
n=912 Eyes • The analysis was conducted at the eye (unit) level.
|
0 Eyes
n=509 Eyes • The analysis was conducted at the eye (unit) level.
|
3 Eyes
n=1421 Eyes • The analysis was conducted at the eye (unit) level.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Eyes
n=912 Eyes • The analysis was conducted at the eye (unit) level.
|
0 Eyes
n=509 Eyes • The analysis was conducted at the eye (unit) level.
|
1 Eyes
n=1421 Eyes • The analysis was conducted at the eye (unit) level.
|
|
Race (NIH/OMB)
Black or African American
|
23 Eyes
n=912 Eyes • The analysis was conducted at the eye (unit) level.
|
17 Eyes
n=509 Eyes • The analysis was conducted at the eye (unit) level.
|
40 Eyes
n=1421 Eyes • The analysis was conducted at the eye (unit) level.
|
|
Race (NIH/OMB)
White
|
882 Eyes
n=912 Eyes • The analysis was conducted at the eye (unit) level.
|
487 Eyes
n=509 Eyes • The analysis was conducted at the eye (unit) level.
|
1369 Eyes
n=1421 Eyes • The analysis was conducted at the eye (unit) level.
|
|
Race (NIH/OMB)
More than one race
|
2 Eyes
n=912 Eyes • The analysis was conducted at the eye (unit) level.
|
3 Eyes
n=509 Eyes • The analysis was conducted at the eye (unit) level.
|
5 Eyes
n=1421 Eyes • The analysis was conducted at the eye (unit) level.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Eyes
n=912 Eyes • The analysis was conducted at the eye (unit) level.
|
0 Eyes
n=509 Eyes • The analysis was conducted at the eye (unit) level.
|
0 Eyes
n=1421 Eyes • The analysis was conducted at the eye (unit) level.
|
|
Region of Enrollment
United States
|
912 Eyes
n=912 Eyes • The analysis was conducted at the eye (unit) level.
|
509 Eyes
n=509 Eyes • The analysis was conducted at the eye (unit) level.
|
1421 Eyes
n=1421 Eyes • The analysis was conducted at the eye (unit) level.
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Some participants had both eyes enrolled in the study and the eyes may have been assigned to the same or different study arms.
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
Outcome measures
| Measure |
Cornea From Donor Without Diabetes
n=912 eyes
Participant will be assigned a cornea recovered from a donor without diabetes.
|
Cornea From Donor With Diabetes
n=509 eyes
Participant will be assigned a cornea recovered from a donor with diabetes.
|
|---|---|---|
|
Graft Failure
|
32 eyes
|
15 eyes
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Endothelial cell density analyses included only eyes classified as a graft success at one year with analyzable 1-year specular microscopic image sets obtained 304 to 464 days post-operatively.
Central corneal endothelial cell density assessed with specular microscopy
Outcome measures
| Measure |
Cornea From Donor Without Diabetes
n=710 eyes
Participant will be assigned a cornea recovered from a donor without diabetes.
|
Cornea From Donor With Diabetes
n=393 eyes
Participant will be assigned a cornea recovered from a donor with diabetes.
|
|---|---|---|
|
Endothelial Cell Density
|
1927 cells/mm2
Standard Deviation 498
|
1920 cells/mm2
Standard Deviation 496
|
Adverse Events
Cornea From Donor With Diabetes
Serious events: 4 serious events
Other events: 402 other events
Deaths: 7 deaths
Cornea From Donor Without Diabetes
Serious events: 2 serious events
Other events: 224 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Cornea From Donor With Diabetes
n=912 participants at risk
Participant will be assigned a cornea recovered from a donor with diabetes.
Descemet membrane endothelial keratoplasty: cornea transplant procedure to replace dysfunctional endothelial cell layer
|
Cornea From Donor Without Diabetes
n=509 participants at risk
Participant will be assigned a cornea recovered from a donor without diabetes.
Descemet membrane endothelial keratoplasty: cornea transplant procedure to replace dysfunctional endothelial cell layer
|
|---|---|---|
|
Eye disorders
Retinal detachment
|
0.11%
1/912 • Number of events 1 • from enrollment until end of follow-up, up to 15 months
|
0.00%
0/509 • from enrollment until end of follow-up, up to 15 months
|
|
Eye disorders
Herpes simplex viral keratitis
|
0.11%
1/912 • Number of events 1 • from enrollment until end of follow-up, up to 15 months
|
0.00%
0/509 • from enrollment until end of follow-up, up to 15 months
|
|
Eye disorders
Pseudoendophthalmitis (likely cytomegalovirus keratouveitis)
|
0.11%
1/912 • Number of events 1 • from enrollment until end of follow-up, up to 15 months
|
0.00%
0/509 • from enrollment until end of follow-up, up to 15 months
|
|
Eye disorders
Vitreous hemorrhage/choroidal effusions
|
0.00%
0/912 • from enrollment until end of follow-up, up to 15 months
|
0.20%
1/509 • Number of events 1 • from enrollment until end of follow-up, up to 15 months
|
|
Blood and lymphatic system disorders
Deep vein thrombosis
|
0.11%
1/912 • Number of events 1 • from enrollment until end of follow-up, up to 15 months
|
0.00%
0/509 • from enrollment until end of follow-up, up to 15 months
|
|
Eye disorders
Corneal keratitis
|
0.00%
0/912 • from enrollment until end of follow-up, up to 15 months
|
0.20%
1/509 • Number of events 1 • from enrollment until end of follow-up, up to 15 months
|
Other adverse events
| Measure |
Cornea From Donor With Diabetes
n=912 participants at risk
Participant will be assigned a cornea recovered from a donor with diabetes.
Descemet membrane endothelial keratoplasty: cornea transplant procedure to replace dysfunctional endothelial cell layer
|
Cornea From Donor Without Diabetes
n=509 participants at risk
Participant will be assigned a cornea recovered from a donor without diabetes.
Descemet membrane endothelial keratoplasty: cornea transplant procedure to replace dysfunctional endothelial cell layer
|
|---|---|---|
|
Eye disorders
Clouded recipient stroma noted at any timepoint
|
12.5%
114/912 • Number of events 114 • from enrollment until end of follow-up, up to 15 months
|
14.9%
76/509 • Number of events 76 • from enrollment until end of follow-up, up to 15 months
|
|
Eye disorders
Postoperative air or gas injection to promote graft attachment
|
18.9%
172/912 • Number of events 172 • from enrollment until end of follow-up, up to 15 months
|
19.3%
98/509 • Number of events 98 • from enrollment until end of follow-up, up to 15 months
|
|
Eye disorders
Surgical complications
|
5.7%
52/912 • Number of events 52 • from enrollment until end of follow-up, up to 15 months
|
5.1%
26/509 • Number of events 26 • from enrollment until end of follow-up, up to 15 months
|
|
Eye disorders
Intraocular pressure > 25 mm Hg
|
16.1%
147/912 • Number of events 147 • from enrollment until end of follow-up, up to 15 months
|
16.9%
86/509 • Number of events 86 • from enrollment until end of follow-up, up to 15 months
|
Additional Information
Jonathan Lass, MD
University Hospitals Cleveland Medical Center
Phone: 216-952-2000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place