EndoArt® Implantation in Subjects With Chronic Corneal Edema - US Study (NCT07344168) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
EndoArt® Implantation in Subjects With Chronic Corneal Edema - US Study
123 participantsStarted 2026-05-01
Plain-language summary
The EndoArt® device is intended to treat patients with chronic corneal edema due to endothelial dysfunction, in whom prior multiple keratoplasty (EK/PK) have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty.
The EndoArt® (Corneal Artificial Endothelial layer) is a permanent synthetic implant. It is made of a clear, transparent, foldable, biologically compatible hydrophilic copolymer. The device serves as an inert physical barrier, blocking the ingress of fluid from the Anterior Chamber (AC) into the cornea.
Who can participate
Age range
35 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female subjects 30-85 years of age.
. Have chronic corneal edema (lasting at least 3 months) and have experienced at least 3 prior keratoplasty (EK/PK) failures.
. Is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.
. CCT of 650-1200 μm, not including DSAEK thickness.
. Pseudophakia
. Cornea WTW between 10-13 mm
. IOP \<20 mmHg and IOP≥8 mmHg
. BCVA of the study eye equal or worse than 0.50 LogMAR and up to 2.40 LogMAR (Hand motion is between 2.20-2.40 LogMAR).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.