Donor Diabetes Impact on Corneal Transplant Success

(DEKS Trial)

Recruiting at 1 trial location

Overseen By Loretta Szczotka-Flynn, OD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Must not be taking: Rho kinase inhibitors

Disqualifiers: Pregnancy, Cognitive impairment, Uncontrolled glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

1420 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot use topical Rho kinase inhibitors, like netarsudil, within 1 month before joining the study and during the study.

What data supports the effectiveness of the treatment Descemet membrane endothelial keratoplasty?

Research suggests that Descemet membrane endothelial keratoplasty (DMEK) may have a lower risk of rejection and better long-term survival compared to other similar procedures, like Descemet stripping endothelial keratoplasty (DSEK). This indicates that DMEK could be a more effective treatment option for corneal transplants. ^{1 2 3 4 5}

Is Descemet membrane endothelial keratoplasty (DMEK) generally safe for humans?

Descemet membrane endothelial keratoplasty (DMEK) is generally considered safe, but there are potential complications such as transplant dehiscence (separation) and increased eye pressure, which can often be managed with additional treatments. Immune rejection is less common compared to other similar procedures, but using steroid eye drops is recommended to prevent it. ^{1 6 7 8 9}

How is Descemet membrane endothelial keratoplasty (DMEK) different from other treatments for corneal transplant?

Descemet membrane endothelial keratoplasty (DMEK) is unique because it involves transplanting only the innermost layer of the cornea, which is the Descemet membrane and its attached endothelial cells, making it less invasive and potentially leading to faster recovery and better vision compared to other corneal transplant methods that replace more layers of the cornea. ^{1 3 10 11 12}

Research Team

Jonathan Lass, MD

Principal Investigator

Case Western Reserve University

Eligibility Criteria

This trial is for adults aged 30-90 with Fuchs' Dystrophy or corneal endothelial decompensation, who need a cornea transplant and can return for follow-ups. They must speak English/Spanish, have certain types of intraocular lenses if present, and be willing to test for diabetes. Exclusions include uncontrolled glaucoma, low eye pressure, pregnancy plans before surgery, cognitive impairment preventing consent, use of specific eye drops within a month prior to the study or conditions likely leading to transplant failure.

Inclusion Criteria

I have swelling in my eye after cataract surgery.

I have an eye recommended for DMEK surgery, scheduled within 5 to 90 days after joining.

My previous cornea transplant surgery was unsuccessful.

Exclusion Criteria

I have swelling in my cornea due to missing lens, with or without a specific corneal disease.

I have a rare eye condition affecting the cornea.

Pregnant or planning to become pregnant prior to the DMEK study surgery

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a cornea transplant from either a donor with or without diabetes

8 weeks

Multiple visits for surgery and initial post-operative care

Follow-up

Participants are monitored for graft success and endothelial cell density

1 year

Regular visits for specular microscopy and clinical assessments

Treatment Details

Interventions

• Descemet membrane endothelial keratoplasty

Trial Overview The trial tests whether donor diabetes affects success rates and cell loss in cornea transplants using Descemet membrane endothelial keratoplasty (DMEK). Participants will receive either a diabetic or non-diabetic donor's cornea randomly and will be evaluated after one year.

Participant Groups

Group I: Cornea from donor with diabetes Active Control 1 Intervention

Participant will be assigned a cornea recovered from a donor with diabetes.

Group II: Cornea from donor without diabetes Active Control 1 Intervention

Participant will be assigned a cornea recovered from a donor without diabetes.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

Jaeb Center for Health Research

Collaborator

Trials

162

Recruited

36,200+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Donor and Recipient Diabetes Status on Descemet Membrane Endothelial Keratoplasty Adherence and Survival. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Five-Year Graft Survival of Descemet Membrane Endothelial Keratoplasty (EK) versus Descemet Stripping EK and the Effect of Donor Sex Matching. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Graft survival of diabetic versus nondiabetic donor tissue after initial keratoplasty. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Causes of primary donor failure in descemet membrane endothelial keratoplasty. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

DMEK outcomes using nondiabetic grafts for recipients with diabetes mellitus. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Diabetes mellitus increases risk of unsuccessful graft preparation in Descemet membrane endothelial keratoplasty: a multicenter study. [2014]

7. Brazil pubmed.ncbi.nlm.nih.gov

The relationship between systemic disorders and anatomical outcomes after Descemet membrane endothelial keratoplasty. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Efficacy, Efficiency, and Cell Viability of a Novel Descemet Membrane Endothelial Keratoplasty Graft Preparation Device, DescePrep, in Nondiabetic and Diabetic Human Donor Corneas. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

[Complications of Descemet's membrane endothelial keratoplasty]. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Type II Diabetes Mellitus Causes Extracellular Matrix Alterations in the Posterior Cornea That Increase Graft Thickness and Rigidity. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

The effect of donor diabetes history on graft failure and endothelial cell density 10 years after penetrating keratoplasty. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Impact of Donor Age on Corneal Endothelium-Descemet Membrane Layer Scroll Formation. [2018]