EndoArt® Implantation in Subjects With Chronic Corneal Edema - US Study

Starting soon · Not applicable

Conditions studied: Corneal Edema

In brief

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.

Key facts

Study ID

NCT07344168

Run by

Eye-yon Medical

People needed

123

Starts

2026-05-01

Expected to finish

2030-04-30

Last updated by the study team

2026-03-13

Who can join

Age: 35 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• In cases where the treated eye has undergone PKP, or if the corneal thickness of the contralateral eye cannot be measured (e.g., monocular patient, or if the contralateral eye has corneal edema or a history of PKP), the CCT of the study eye must be between 700-1200 μm.
• 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).
• Must have better visual acuity in the contralateral eye, which must be at least 0.20 LogMAR better than the treated eye and have a visual acuity of at least 1.00 LogMAR.
• Central general clarity grade ≥2 (See Table 14. Central general clarity grading)
• Willing and able to understand and sign informed consent prior to any study-related procedure.
• Willing and able to follow study instructions (e.g., to lay on one's back for at least 4 hours post op.), able to self-administer or have caregiver available to administer eyedrops as required by the protocol for the duration of the study, and able to attend study visits/assessments for the duration of the study.

You may not qualify if…

• 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.
• Diagnosis of: Sjogren's Syndrome, GVHD.
• PUK (peripheral ulcerative keratitis)
• Phthisis bulbi or subject is at high risk of developing phthisis (Hypothony).
• History of corneal refractive surgery: LASIK, PRK, SMILE, Epi-keratoplasty (or any anterior lamellar keratoplasty, inlays) and Radial Keratotomy (RK).
• Severe corneal distortion e.g.: keratoconus, pellucid marginal degeneration or keratoglobus (not relevant post PKP).
• Subject with medically uncontrolled intra ocular pressure, which requires surgical intervention.
• Aphakia.
• Active inflammation, or active, recurrent, or Chronic Uveitis
• Dislocation or partial dislocation of the IOL.
• Have large iris defect (more than 90 degrees) which could compromise intraoperative air bubble formation, excluding inferior defect.
• Severe ptosis (middle of pupil or covering the pupil entirely).
• Subject receiving regular intravitreal injection.
• History of persistent/ recurrent corneal erosion or persistent epithelial defect with difficulties in epithelial re-growth (erosion more than 2 months).
• History of ocular herpetic keratitis
• Current retinal detachments
• Advanced optic nerve cupping (defined as a cup-disc ratio of 0.9 or greater).
• Posterior segment masses or other acute significant posterior segment pathology (e.g., active age-related macular degeneration or chronic cystoid macular edema).
• Afferent Pupillary Defect (APD)
• Fellow eye CCT < 500 µm
• Any other acute ocular condition

Full record on ClinicalTrials.gov

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