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 range35 Years – 85 Years
SexALL
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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).
Exclusion criteria
✕. No light perception or light perception.
✕. Opaque scar in the visual axis that is indicated for PKP.
✕. Irregular posterior cornea (e.g. post trauma) in the 6.5 mm central part of the cornea (EndoArt® diameter).
✕. Current infection of the cornea.
✕. Central Band keratopathy and/or limbal stem cell deficiency.