Fuchs Endothelial Corneal DystrophyDEKSNCT07217249
Effect of Donor Diabetes and Other Factors on Corneal Transplant Endothelial Cell Loss and Success at 5 Years
A study testing Descemet membrane endothelial keratoplasty in people with Fuchs Endothelial Corneal Dystrophy and Corneal Endothelial Decompensation, run by Case Western Reserve University at 14 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 93 years
- Conditions the study is for
- Fuchs Endothelial Corneal Dystrophy, Corneal Endothelial Decompensation
- What is being tested?
- Descemet membrane endothelial keratoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 14 sitesUnited States
- Study dates
- 3 Dec 2025to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 93 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Lack cognitive capacity such that consent could not be provided.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites
University of Michigan/Kellogg Eye Center
Ann Arbor, Michigan, 48105
Georgia Eye Partners
Atlanta, Georgia, 30189
Ophthalmic Partners
Bala-Cynwyd, Pennsylvania, 19004
Mid-Atlantic Cornea Consultants
Baltimore, Maryland, 21204
The Wilmer Eye Institute/Johns Hopkins
Baltimore, Maryland, 21287
Minnesota Eye Consultants
Bloomington, Minnesota, 55431
Verdier Eye Center
Grand Rapids, Michigan, 49546
Price Vision Group
Indianapolis, Indiana, 46260
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Moyes Eye Center
Kansas City, Missouri, 64154
Kansas City Eye Clinic
Overland Park, Kansas, 66204
Legacy Devers Eye Institute
Portland, Oregon, 97210
Mayo Clinic
Rochester, Minnesota, 55905
Associated Eye Care
Stillwater, Minnesota, 55082
About this study
Official title: Diabetes Endothelial Keratoplasty Study (DEKS): Impact of Diabetes and Other Predictors on Corneal Transplant Endothelial Cell Loss and Success
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.
- Being tested
- Descemet membrane endothelial keratoplasty
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descemet membrane endothelial keratoplastyProcedure or surgery
Replacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea.
| Study group | Role | What they receive |
|---|---|---|
| Assigned cornea from a donor without diabetes | Active comparator | Eyes assigned to this arm receive a cornea from a donor without diabetes and undergo Descemet membrane endothelial keratoplasty. Receives: Procedure: Descemet membrane endothelial keratoplasty |
| Assigned cornea from a donor with diabetes | Active comparator | Eyes assigned to this arm receive a cornea from a donor with diabetes for Descemet membrane endothelial keratoplasty. Receives: Procedure: Descemet membrane endothelial keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in central corneal endothelial cell density 5 years after Descemet membrane endothelial keratoplasty.
Central corneal endothelial cell density will be assessed by specular microscopy at 3 and 5 years after Descemet membrane endothelial keratoplasty and the results will be compared with the baseline donor endothelial cell density assessed at the eye bank that provided the donor tissue.
Measured: Subjects are followed for 5 years after corneal transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start3 Dec 2025
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs Endothelial Corneal DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Jonathan Lass, MD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217249
- Sponsor's protocol ID
- DEKS 5-year Extension Study
- Other IDs
- 1UG1EY037206-01, 5UG1EY030030-05
- Acronym
- DEKS
- Status last verified
- Feb 2026
- First submitted
- 13 Oct 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Endothelial Keratoplasty Study (DEKS): Impact of Diabetes and Other Predictors on Corneal Transplant Endothelial Cell Loss and Success
- ClinicalTrials.gov ID
- NCT07217249
- Acronym / sponsor ID
- DEKS / DEKS 5-year Extension Study
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assigned cornea from a donor without diabetes | Active comparator | Procedure: Descemet membrane endothelial keratoplastyEyes assigned to this arm receive a cornea from a donor without diabetes and undergo Descemet membrane endothelial keratoplasty. |
| Assigned cornea from a donor with diabetes | Active comparator | Procedure: Descemet membrane endothelial keratoplastyEyes assigned to this arm receive a cornea from a donor with diabetes for Descemet membrane endothelial keratoplasty. |
Who may qualify
- Ages
- 30 to 93 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Lack cognitive capacity such that consent could not be provided.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Descemet membrane endothelial keratoplastyReplacement of the recipient corneal endothelial and Descemet membrane with healthy tissue from a donor cornea. | Procedure or surgery | Assigned cornea from a donor with diabetes, Assigned cornea from a donor without diabetes |
Primary outcome
Change in central corneal endothelial cell density 5 years after Descemet membrane endothelial keratoplasty.
Time frame: Subjects are followed for 5 years after corneal transplantation.
Central corneal endothelial cell density will be assessed by specular microscopy at 3 and 5 years after Descemet membrane endothelial keratoplasty and the results will be compared with the baseline donor endothelial cell density assessed at the eye bank that provided the donor tissue.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Related trials for Fuchs Endothelial Corneal Dystrophy
Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, Fuchs Dystrophy
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingPhase 2
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Fuchs
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Lass, MD principal investigator
Case Western Reserve University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Descemet membrane endothelial keratoplasty in people with Fuchs Endothelial Corneal Dystrophy and Corneal Endothelial Decompensation, run by Case Western Reserve University at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in central corneal endothelial cell density 5 years after Descemet membrane endothelial keratoplasty. (time frame: Subjects are followed for 5 years after corneal transplantation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.