Descemet Membrane Endothelial Keratoplasty for Fuchs' Dystrophy

(DEKS Trial)

Not yet recruiting at 4 trial locations

Overseen By Jonathan Lass, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Cognitive impairment

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

Compensation: Varies

Number of Visits: 3

Duration: Surgery and immediate recovery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a cornea donor's diabetes status affects the success of Descemet membrane endothelial keratoplasty (DMEK), a surgery for treating Fuchs' dystrophy, where the inner cornea layer deteriorates. Participants will receive a cornea from either a donor with diabetes or one without, and researchers will compare the results. Ideal candidates include those who participated in a previous related study and are willing to return for follow-ups. As an unphased study, this trial allows participants to contribute to important research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Descemet membrane endothelial keratoplasty is safe?

Research has shown that Descemet membrane endothelial keratoplasty (DMEK) is a safe treatment for corneal issues. Studies have found that DMEK is effective, and patients typically recover smoothly. Most people experience improved vision after the surgery.

Evidence also suggests that serious side effects are rare. In some studies, patients' best-corrected vision ranged from 20/21 to 20/31 over several months of follow-up, indicating that most patients enjoy good vision results without major problems.

In this trial, the cornea may come from donors with or without diabetes. However, past research confirms that the main treatment, DMEK, has a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Descemet membrane endothelial keratoplasty (DMEK) is unique because it involves transplanting only the innermost layer of the cornea, which can lead to faster recovery and better visual outcomes compared to traditional corneal transplant methods like penetrating keratoplasty. Researchers are excited about this approach because it uses corneas from both diabetic and non-diabetic donors to see if donor health impacts the success of the surgery. This could pave the way for more flexible donor criteria and potentially increase the availability of suitable corneas for patients with Fuchs' Dystrophy.

What evidence suggests that this trial's treatments could be effective for Fuchs' Dystrophy?

Research has shown that Descemet membrane endothelial keratoplasty (DMEK) effectively treats Fuchs' Dystrophy, a condition affecting the cornea, the clear front part of the eye. Studies have found that DMEK can significantly improve vision, with about 90% of patients experiencing better sight after the procedure. Compared to other treatments, DMEK yields superior results, with many patients achieving vision of 20/40 or better. The procedure is also considered safe, making it a common treatment for this eye condition. In this trial, participants will receive a cornea from either a donor with diabetes or a donor without diabetes, allowing for a comparison of outcomes based on donor characteristics. ^{6 7 8 9 10}

Who Is on the Research Team?

Jonathan Lass, MD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for patients with corneal conditions like Fuchs' Dystrophy or endothelial decompensation. It's not specified who can't join, but typically, participants should be in stable health and meet specific eye health criteria set by the study.

Inclusion Criteria

I am willing to visit the study site for follow-ups 3 and 5 years after my eye surgery.

I am fluent in English or Spanish.

Willing to have fingerstick blood sample collected to determine HbA1c level

Exclusion Criteria

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Descemet membrane endothelial keratoplasty with corneas from donors with or without diabetes

Surgery and immediate recovery

Follow-up

Participants are monitored for changes in central corneal endothelial cell density

5 years

Specular microscopy assessments at 3 and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Descemet membrane endothelial keratoplasty

Trial Overview The trial tests if donor diabetes affects the success of a cornea transplant called Descemet membrane endothelial keratoplasty (DMEK) after 5 years. Patients receive a cornea from either a non-diabetic or diabetic donor randomly.

How Is the Trial Designed?

Group I: Assigned cornea from a donor with diabetes Active Control 1 Intervention

Eyes assigned to this arm receive a cornea from a donor with diabetes for Descemet membrane endothelial keratoplasty.

Group II: Assigned cornea from a donor without diabetes Active Control 1 Intervention

Eyes assigned to this arm receive a cornea from a donor without diabetes and undergo Descemet membrane endothelial keratoplasty.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10230002/

Outcomes of Descemet's membrane endothelial keratoplasty ... This was 4.4% in a study of 45 eyes that underwent DMEK triple,[22] with graft detachment and rebubbling rates of 35.6% and 33.3%, respectively.

2. bmjophth.bmj.com bmjophth.bmj.com/content/9/1/e001725

Descemet Endothelial Thickness Comparison Trial II ... Although Descemet membrane endothelial keratoplasty (DMEK) has an excellent risk profile and visual outcomes and is currently the standard of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03275896

Evaluation of the Efficacy of Descemet Membrane ... Evaluation of the Efficacy of Descemet Membrane Transplantation for the Treatment of Fuchs' Endothelial Dystrophy. Conditions. Fuchs' Endothelial Dystrophy.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0161642023005328

Descemet Stripping Automated Endothelial Keratoplasty ... Visual acuity improved in most patients (90%) with all 3 surgical methods. However, DMEK and phacoemulsification plus DSAEK reached higher levels of visual ...

5. nature.com nature.com/articles/eye2008393

Descemet membrane endothelial keratoplasty (DMEK) for ... On average, historic cohort studies on PK for Fuchs endothelial dystrophy report a visual outcome of 20/40 or better at 1 year in only 40–50% of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28923499/

Descemet Membrane Endothelial Keratoplasty: Safety and ... The evidence reviewed supports DMEK as a safe and effective treatment for endothelial failure. With respect to visual recovery time, visual outcomes, and ...

7. aaojournal.org aaojournal.org/article/S0161-6420(17)32521-6/fulltext

Descemet Membrane Endothelial Keratoplasty: Safety and ... After DMEK surgery, the mean best-corrected visual acuity (BCVA) ranged from 20/21 to 20/31, with follow-up ranging from 5.7 to 68 months.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161642017325216

Descemet Membrane Endothelial Keratoplasty: Safety and ... To review the published literature on the safety and outcomes of Descemet membrane endothelial keratoplasty (DMEK) for the surgical treatment of corneal ...

9. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(22)00017-3/fulltext

Predicting Corneal Improvement after Descemet ... To develop a model to predict corneal improvement after Descemet membrane endothelial keratoplasty (DMEK) for Fuchs endothelial corneal dystrophy (FECD) from ...

10. journals.lww.com journals.lww.com/10.1097/ICO.0000000000003019

Five-Year Safety and Efficacy of Femtosecond Laser ... The purpose of this study was to evaluate 5-year safety and efficacy outcomes of femtosecond-enabled Descemet membrane endothelial keratoplasty (F-DMEK) in ...