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

NCT07344168 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CLI-E053
• Study Type: interventional
• Target: 123
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Corneal Edema

Keywords

Corneal edema; Chronic corneal edema; Artificial Endothelial layer; EndoArt; Failed keratoplasty; Human tissue corneal transplantation failure; Failed DSEK; Failed DMEK

Outcome Measures

Primary Outcomes (2)

• The rate of any device related SAE

  SAEs may include, but are not limited to, e.g., secondary surgical intervention, severe infectious keratitis requiring hospitalization, and corneal perforation

  12 months

• Improvement in visual acuity as measured by BCVA

  The proportion of subjects achieving a change in visual acuity of at least 0.20 LogMAR for subjects with baseline BCVA better than 1.30 LogMAR, or a visual acuity of 1.30 LogMAR or better at 12 months postoperatively for subjects with baseline BCVA of 1.30 LogMAR or worse

  12 months

Secondary Outcomes (8)

• All AE rate

  12 months

• BCVA Success rate

  12 months

• CCT

  12 months

• Change in manifest refraction

  12 months

• Corneal clarity

  12 months

Study Arms (1)

EndoArt® Artificial Endothelial Layer

EXPERIMENTAL

Implantation of the EndoArt (Artificial Endothelial Layer)

Device: The EndoArt® (Corneal Artificial Endothelial layer)

Interventions

The EndoArt® (Corneal Artificial Endothelial layer) DEVICE

Implantation of EndoArt® is similar to other anterior segment surgical procedures such as DSEK/DMEK

EndoArt® Artificial Endothelial Layer

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Eye-yon Medical: lead

MeSH Terms

Conditions

Corneal Edema

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Central Study Contacts

Limor Kuznits

CONTACT

+972-73-7803607; limor@eye-yon.com

Tamar Shaked

CONTACT

+972-73-7803607; Tamar@eye-yon.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2030
• Last Updated: March 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share