Corneal Endothelial DecompensationDEKSNCT05134480
Impact of Donor Diabetes on DMEK Success and Endothelial Cell Loss
A study testing Descemet membrane endothelial keratoplasty in people with Corneal Endothelial Decompensation and Fuchs' Endothelial Dystrophy, run by Case Western Reserve University at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Corneal Endothelial Decompensation, Fuchs' Endothelial Dystrophy
- 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
- 1,097 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jan 2022to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 19Show fewer
- 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
- Presence of vitreous in the anterior chamber
- 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 minimally invasive glaucoma surgery (MIGS) or trabeculectomy 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
- Intraocular pressure <8 mmHg
- Topical Rho kinase inhibitor, including netarsudil, used within 1 month prior to study entry and anticipated during the course of the study
- Fellow eye enrolled in the DEKS that has met study-criteria for graft failure.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Verdier Eye Center
Grand Rapids, Michigan, 49546
Price Vision Group
Indianapolis, Indiana, 46260
About this study
Official title: Diabetes Endothelial Keratoplasty Study (DEKS): Impact of Diabetes on Corneal Transplant Success and Endothelial Cell Loss
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.
Read the detailed description
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.
- 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
cornea transplant procedure to replace dysfunctional endothelial cell layer
| Study group | Role | What they receive |
|---|---|---|
| Cornea from donor with diabetes | Active comparator | Participant eye will be assigned a cornea recovered from a donor with diabetes. Receives: Procedure: Descemet membrane endothelial keratoplasty |
| Cornea from donor without diabetes | Active comparator | Participant eye will be assigned a cornea recovered from a donor without diabetes. Receives: Procedure: Descemet membrane endothelial keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
Endothelial Cell Density
Central corneal endothelial cell density assessed with specular microscopy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start21 Jan 2022
- Primary completion15 Jul 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Corneal Endothelial DecompensationStudies 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
- Model description
- Prospective, randomized, double-masked (participant and clinical site) clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,097 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Jaeb Center for Health Research, National Eye Institute (NEI)
- Responsible party
- Principal investigator, Jonathan Lass, MD, Case Western Reserve University
- Investigators
- Jonathan Lass, MD, Study chair, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134480
- Sponsor's protocol ID
- DEKS
- Other IDs
- 1UG1EY030039-01A1, 1UG1EY030030-01A1
- Acronym
- DEKS
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2021
- Last updated
- 16 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Price MO, Szczotka-Flynn LB, Bauza CE, Reed ZW, Benetz BA, Greiner MA, Verdier DD, Soper MC, Titus MS, Monnier VM, Arafah BM, Kollman C, Beck RW, Lass JH; Writing Committee for the Diabetes Endothelial Keratoplasty Study Group. Diabetes Endothelial Keratoplasty Study: Methods and Impact on the Use of Corneas From Donors With Diabetes for Descemet Membrane Endothelial Keratoplasty. Cornea. 2026 Mar 1;45(3):312-321. doi: 10.1097/ICO.0000000000003776. Epub 2025 Jan 9.
PubMed 39808526Price FW Jr, Szczotka-Flynn LB, Price MO, Bauza CE, Reed ZW, Arafah BM, Greiner MA, Johnson PJ, Keeler DB, Mian SI, Patel SV, Pramanik S, Soper MC, Terry MA, Titus MS, Verdier DD, Kollman C, Beck RW, Lass JH; Diabetes Endothelial Keratoplasty Study Group. Donor Diabetes and 1-Year Descemet Membrane Endothelial Keratoplasty Success Rate: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 Dec 1;143(12):1043-1051. doi: 10.1001/jamaophthalmol.2025.4253.
PubMed 41105094Lass JH, Benetz BA, Verdier DD, Szczotka-Flynn LB, Bauza CE, Reed ZW, Greiner MA, Mian SI, Patel SV, Pramanik S, Price FW Jr, Soper MC, Terry MA, Titus MS, Kollman C, Beck RW, Price MO; Diabetes Endothelial Keratoplasty Study Group. Endothelial Cell Loss 1 Year After Successful DMEK in the Diabetes Endothelial Keratoplasty Study: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 Dec 1;143(12):1053-1060. doi: 10.1001/jamaophthalmol.2025.4261.
PubMed 41105099Greiner MA, Monnier VM, Arafah BM, Szczotka-Flynn LB, Benetz BA, Bailey RJ, Gal RL, Kollman C, Baratz KH, Huffman JM, Jurkunas UV, Ketcherside CS, Price FW Jr, Schmidt GA, Schoenberg ED, Soper MC, Tenkman LR, Verdier DD, Nelson D, Sell DR, Beck RW, Price MO, Lass JH; Diabetes Endothelial Keratoplasty Study Group. Diabetes Severity in Cornea Donors and 1-Year Outcomes in Recipients in the Diabetes Endothelial Keratoplasty Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2026 Oct 8:e264253. doi: 10.1001/jamaophthalmol.2026.4253. Online ahead of print.
PubMed 42848388Price MO, Szczotka-Flynn LB, Reed ZW, Gal RL, Brandsdorfer AM, Greenwood MD, Greiner MA, Jurkunas UV, Koo EH, Majmudar PA, Phillips PM, Price FW Jr, Srikumaran D, Veldman PB, Verdier DD, Beck RW, Lass JH; Diabetes Endothelial Keratoplasty Study Group. Factors Associated with Successful Descemet Membrane Endothelial Keratoplasty in the Diabetes Endothelial Keratoplasty Study. Ophthalmology. 2026 Jul 28:S0161-6420(26)00526-9. doi: 10.1016/j.ophtha.2026.07.022. Online ahead of print.
PubMed 42521031
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Endothelial Keratoplasty Study (DEKS): Impact of Diabetes on Corneal Transplant Success and Endothelial Cell Loss
- ClinicalTrials.gov ID
- NCT05134480
- Acronym / sponsor ID
- DEKS / DEKS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,097 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- Jaeb Center for Health Research, National Eye Institute (NEI)
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Posted 16 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double-masked (participant and clinical site) clinical trial
| Arm | Type | Receives |
|---|---|---|
| Cornea from donor with diabetes | Active comparator | Procedure: Descemet membrane endothelial keratoplastyParticipant eye will be assigned a cornea recovered from a donor with diabetes. |
| Cornea from donor without diabetes | Active comparator | Procedure: Descemet membrane endothelial keratoplastyParticipant eye will be assigned a cornea recovered from a donor without diabetes. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (19 listed)
- 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.
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 keratoplastycornea transplant procedure to replace dysfunctional endothelial cell layer | Procedure or surgery | Cornea from donor with diabetes, Cornea from donor without diabetes |
Primary outcome
Graft Failure
Time frame: 1 year
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
1 secondary outcome
Endothelial Cell Density
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39808526Price MO, Szczotka-Flynn LB, Bauza CE, Reed ZW, Benetz BA, Greiner MA, Verdier DD, Soper MC, Titus MS, Monnier VM, Arafah BM, Kollman C, Beck RW, Lass JH; Writing Committee for the Diabetes Endothelial Keratoplasty Study Group. Diabetes Endothelial Keratoplasty Study: Methods and Impact on the Use of Corneas From Donors With Diabetes for Descemet Membrane Endothelial Keratoplasty. Cornea. 2026 Mar 1;45(3):312-321. doi: 10.1097/ICO.0000000000003776. Epub 2025 Jan 9.
- Results publication: PubMed 41105094Price FW Jr, Szczotka-Flynn LB, Price MO, Bauza CE, Reed ZW, Arafah BM, Greiner MA, Johnson PJ, Keeler DB, Mian SI, Patel SV, Pramanik S, Soper MC, Terry MA, Titus MS, Verdier DD, Kollman C, Beck RW, Lass JH; Diabetes Endothelial Keratoplasty Study Group. Donor Diabetes and 1-Year Descemet Membrane Endothelial Keratoplasty Success Rate: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 Dec 1;143(12):1043-1051. doi: 10.1001/jamaophthalmol.2025.4253.
- Results publication: PubMed 41105099Lass JH, Benetz BA, Verdier DD, Szczotka-Flynn LB, Bauza CE, Reed ZW, Greiner MA, Mian SI, Patel SV, Pramanik S, Price FW Jr, Soper MC, Terry MA, Titus MS, Kollman C, Beck RW, Price MO; Diabetes Endothelial Keratoplasty Study Group. Endothelial Cell Loss 1 Year After Successful DMEK in the Diabetes Endothelial Keratoplasty Study: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 Dec 1;143(12):1053-1060. doi: 10.1001/jamaophthalmol.2025.4261.
- Derived from this study: PubMed 42848388Greiner MA, Monnier VM, Arafah BM, Szczotka-Flynn LB, Benetz BA, Bailey RJ, Gal RL, Kollman C, Baratz KH, Huffman JM, Jurkunas UV, Ketcherside CS, Price FW Jr, Schmidt GA, Schoenberg ED, Soper MC, Tenkman LR, Verdier DD, Nelson D, Sell DR, Beck RW, Price MO, Lass JH; Diabetes Endothelial Keratoplasty Study Group. Diabetes Severity in Cornea Donors and 1-Year Outcomes in Recipients in the Diabetes Endothelial Keratoplasty Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2026 Oct 8:e264253. doi: 10.1001/jamaophthalmol.2026.4253. Online ahead of print.
- Derived from this study: PubMed 42521031Price MO, Szczotka-Flynn LB, Reed ZW, Gal RL, Brandsdorfer AM, Greenwood MD, Greiner MA, Jurkunas UV, Koo EH, Majmudar PA, Phillips PM, Price FW Jr, Srikumaran D, Veldman PB, Verdier DD, Beck RW, Lass JH; Diabetes Endothelial Keratoplasty Study Group. Factors Associated with Successful Descemet Membrane Endothelial Keratoplasty in the Diabetes Endothelial Keratoplasty Study. Ophthalmology. 2026 Jul 28:S0161-6420(26)00526-9. doi: 10.1016/j.ophtha.2026.07.022. Online ahead of print.
- Individual participant dataSharing planned: 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.
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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. This study is not recruiting at the moment.
Jonathan Lass, MD study chair
Case Western Reserve University
2 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 Corneal Endothelial Decompensation and Fuchs' Endothelial Dystrophy, run by Case Western Reserve University at 2 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 0 inclusion and 19 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: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 16 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Graft Failure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05134480, which also lists 5 linked publications.
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 16 Apr 2026.