Donor Diabetes Impact on Corneal Transplant Success
(DEKS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how diabetes in cornea donors might affect the success of corneal transplants, with a focus on Descemet membrane endothelial keratoplasty (DMEK). Participants will receive a cornea from either a donor with diabetes or a donor without diabetes, and researchers will assess each group's progress over a year. The trial suits individuals with corneal issues related to endothelial dysfunction, such as Fuchs endothelial corneal dystrophy, who require this specific surgery. As an unphased trial, it provides participants the chance to contribute to valuable research that could enhance future transplant outcomes.
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 prior data suggests that this protocol is safe for corneal transplant recipients?
Research has shown that Descemet membrane endothelial keratoplasty (DMEK) is generally safe and well-tolerated. This procedure replaces a damaged part of the cornea with a healthy one from a donor. Studies have found that using corneas from donors with diabetes can sometimes cause more tissue damage during surgery. However, the transplant's success after one year remains similar, regardless of the donor's diabetes status.
DMEK is a common and approved treatment for certain eye conditions, indicating its general safety. While the donor's health may introduce some differences, the procedure itself remains safe for patients.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover how the diabetes status of a cornea donor impacts the success of corneal transplants. Most corneal transplants focus on matching donors and recipients based on factors like tissue compatibility, but this study dives into the unique question of whether a donor's diabetes affects transplant outcomes. If successful, this could refine donor selection criteria, potentially improving transplant success rates and helping more patients regain their vision.
What evidence suggests that this trial's treatments could be effective for corneal transplant success?
Research has shown that Descemet membrane endothelial keratoplasty (DMEK) usually yields excellent results. In this trial, participants will receive corneas from either donors with diabetes or those without. Studies have found that corneas from diabetic donors may not perform as well. One study discovered that grafts from diabetic donors had a lower success rate and lost more of the essential cells needed for cornea health over three years. Another study observed that by the fourth week after surgery, grafts from diabetic donors had significantly fewer of these cells. In contrast, grafts from non-diabetic donors were slightly more successful in preparation. Overall, DMEK is effective, but donor diabetes might affect the graft's success.16789
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 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a cornea transplant from either a donor with or without diabetes
Follow-up
Participants are monitored for graft success and endothelial cell density
What Are the Treatments Tested in This Trial?
Interventions
- Descemet membrane endothelial keratoplasty
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Western Reserve University
Lead Sponsor
Jaeb Center for Health Research
Collaborator
National Eye Institute (NEI)
Collaborator