Your session is about to expire
← Back to Search
Other
Donor Diabetes Impact on Corneal Transplant Success (DEKS Trial)
Phase 3
Recruiting
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of pseudophakic corneal edema with specific criteria
Failed Descemet stripping automated endothelial keratoplasty (DSAEK) or DMEK originally performed for specific indications without current exclusionary criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
DEKS Trial Summary
This trial will test whether corneas from donors with diabetes are associated with successful transplants and loss of endothelial cells.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the information provided does not specify side effects related to receiving a DMEK procedure from donors with/without diabetes, typical risks may include rejection of the donor tissue, infection risk post-surgery, vision changes or complications that could arise from any surgical intervention on the eye.
DEKS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have swelling in my eye after cataract surgery.
Select...
My previous cornea transplant surgery was unsuccessful.
Select...
I have a specific eye condition (like FECD) that requires a special cornea surgery.
Select...
I am between 30 and 90 years old and expected to live at least another year.
DEKS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Graft failure
Secondary outcome measures
Endothelial cell density
DEKS Trial Design
2Treatment groups
Active Control
Group I: Cornea from donor with diabetesActive Control1 Intervention
Participant will be assigned a cornea recovered from a donor with diabetes.
Group II: Cornea from donor without diabetesActive Control1 Intervention
Participant will be assigned a cornea recovered from a donor without diabetes.
Find a Location
Who is running the clinical trial?
Jaeb Center for Health ResearchOTHER
152 Previous Clinical Trials
33,249 Total Patients Enrolled
National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,400,508 Total Patients Enrolled
3 Trials studying Fuchs' Dystrophy
1,172 Patients Enrolled for Fuchs' Dystrophy
Case Western Reserve UniversityLead Sponsor
299 Previous Clinical Trials
258,677 Total Patients Enrolled
1 Trials studying Fuchs' Dystrophy
60 Patients Enrolled for Fuchs' Dystrophy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have swelling in my cornea due to missing lens, with or without a specific corneal disease.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.I have a rare eye condition affecting the cornea.I can visit the study site for follow-ups after 1 month and 1 year.My eye has adhesions affecting more than three clock hours.I have or will get a specific lens implant in my eye before a cornea transplant.I am unable to understand and give consent for medical procedures.I have scarring in my eye that could affect surgery outcomes.I need eye surgery that cannot be done with DMEK.I have scar tissue in the front part of my eye.I am fluent in either English or Spanish.My other eye's vision is worse than 20/200 not because of a cornea issue.I have a specific eye condition (like FECD) that requires a special cornea surgery.My eye's inner layer has blood vessels that could affect clarity assessment.I am between 30 and 90 years old and expected to live at least another year.I am scheduled to have my front eye lens replaced with a back chamber lens during the study.I have glaucoma that is managed and I've had a tube shunt surgery for it.My glaucoma is not under control, regardless of past surgeries.I have used a Rho kinase inhibitor like netarsudil in the last month and plan to continue.
Research Study Groups:
This trial has the following groups:- Group 1: Cornea from donor with diabetes
- Group 2: Cornea from donor without diabetes
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots available for participation in this trial?
"According to the clinicaltrials.gov database, participants are currently being sought out for this trial which was initially posted on January 21st 2022 and most recently updated on October 3rd of that same year."
Answered by AI
Does this trial have an age cut-off, and if so, what is it?
"This research study is open to adults aged 30 and above but below 90 years old."
Answered by AI
Are there certain criteria for individuals who should enroll in this medical experiment?
"Eligibility conditions for this trial include having fuchs' endothelial dystrophy, and being between 30 to 90 years old. In total, 1420 individuals may be accepted into the study."
Answered by AI
How many participants are being surveyed in this exploration?
"Correct. According to clinicaltrials.gov, this current medical study is actively attempting to recruit participants. This trial was first posted on January 21st 2022 and received its last update October 3rd 2022; it requires 1420 individuals at 2 different sites for enrollment."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger