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

A Prospective, Open-label, Single Arm Study to Evaluate the Safety and Effectiveness of the EndoArt® in Subjects With Chronic Corneal Edema in Whom Multiple Prior Keratoplasty (EK/PK) Have Failed, and Who Are Not Reasonable Candidates for Any Form of Corneal Transplant, Including Penetrating Keratoplasty

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Corneal Edema
• Intervention / Treatment: Device: The EndoArt® (Corneal Artificial Endothelial layer)

Detailed Description

The study is a prospective, multi-center, open-label, single arm pivotal clinical investigation. The objective is to evaluate the safety and effectiveness of EndoArt® implantation in subjects with chronic corneal edema, in whom multiple prior keratoplasty (EK/PK) procedures have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty.

Safety will be assessed by evaluating the rate of any device related SAE occurred through the 12-month follow-up period.

The primary effectiveness endpoint is the proportion of subjects achieving an improvement in visual acuity of at least 0.20 LogMAR for subjects with baseline BCVA better than 1.30 LogMAR, or an improvement to at least 1.30 LogMAR for subjects with baseline BCVA equal or worse than 1.30 LogMAR, at 12 months postoperatively.

Subjects with chronic corneal edema, in whom multiple prior keratoplasty (EK/PK) have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty will be the study target population.

Only subjects who have signed the informed consent form and meet all the eligibility criteria listed below will be qualified for enrollment. The study will include a total of 123 surgically treated subjects. This clinical investigation will be conducted in a maximum of fifteen (20) clinical sites in the USA.

• Study Type: Interventional
• Enrollment (Estimated): 123
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Limor Kuznits; Phone Number: +972-73-7803607; Email: limor@eye-yon.com
• Study Contact Backup: Name: Tamar Shaked; Phone Number: +972-73-7803607; Email: Tamar@eye-yon.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects 30-85 years of age.
2. Have chronic corneal edema (lasting at least 3 months) and have experienced at least 3 prior keratoplasty (EK/PK) failures.
3. Is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.

4. 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.

5. Pseudophakia
6. Cornea WTW between 10-13 mm
7. IOP <20 mmHg and IOP≥8 mmHg
8. 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).
9. 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.
10. Central general clarity grade ≥2 (See Table 14. Central general clarity grading)
11. Willing and able to understand and sign informed consent prior to any study-related procedure.
12. 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.

Exclusion Criteria:

1. No light perception or light perception.
2. Opaque scar in the visual axis that is indicated for PKP.
3. Irregular posterior cornea (e.g. post trauma) in the 6.5 mm central part of the cornea (EndoArt® diameter).
4. Current infection of the cornea.
5. Central Band keratopathy and/or limbal stem cell deficiency.
6. Diagnosis of: Sjogren's Syndrome, GVHD.
7. PUK (peripheral ulcerative keratitis)
8. Phthisis bulbi or subject is at high risk of developing phthisis (Hypothony).
9. History of corneal refractive surgery: LASIK, PRK, SMILE, Epi-keratoplasty (or any anterior lamellar keratoplasty, inlays) and Radial Keratotomy (RK).
10. Severe corneal distortion e.g.: keratoconus, pellucid marginal degeneration or keratoglobus (not relevant post PKP).
11. Subject with medically uncontrolled intra ocular pressure, which requires surgical intervention.
12. Aphakia.
13. Active inflammation, or active, recurrent, or Chronic Uveitis
14. Dislocation or partial dislocation of the IOL.
15. Have large iris defect (more than 90 degrees) which could compromise intraoperative air bubble formation, excluding inferior defect.
16. Severe ptosis (middle of pupil or covering the pupil entirely).
17. Subject receiving regular intravitreal injection.
18. History of persistent/ recurrent corneal erosion or persistent epithelial defect with difficulties in epithelial re-growth (erosion more than 2 months).
19. History of ocular herpetic keratitis
20. Current retinal detachments
21. Advanced optic nerve cupping (defined as a cup-disc ratio of 0.9 or greater).
22. Posterior segment masses or other acute significant posterior segment pathology (e.g., active age-related macular degeneration or chronic cystoid macular edema).
23. Afferent Pupillary Defect (APD)
24. Fellow eye CCT < 500 µm
25. Any other acute ocular condition
26. Bilateral implantation of the EndoArt®
27. Posterior vitrectomy (anterior vitrectomy is allowed)
28. Subjects with mental impairment
29. Subject with history of spontaneous corneal perforations.
30. Pregnant or lactating women, or with childbirth plans during the clinical trial
31. Currently participating or have participated in an investigational study, other than this study, within the past 60 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EndoArt® Artificial Endothelial Layer; Implantation of the EndoArt (Artificial Endothelial Layer)	Device: The EndoArt® (Corneal Artificial Endothelial layer); Implantation of EndoArt® is similar to other anterior segment surgical procedures such as DSEK/DMEK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All AE rate	Rate of each AE	12 months
BCVA Success rate	BCVA Success rate of bad Vision Population (Baseline BCVA ≥ 1.30 LogMAR)	12 months
CCT	Change in central corneal thickness as measured by OCT from baseline to 12 months	12 months
Change in manifest refraction	The change in manifest refraction	12 months
Corneal clarity	Change in central general clarity grading score (using a scale of 0-normal to 4-severe)	12 months
Distribution of BCVA change	BCVA change	12 months
Distribution of BCVA outcomes (using FrACT10)	BCVA outcomes	12 months
BCVA Success rate	BCVA Success rate of good Vision Population (Baseline BCVA < 1.30 LogMAR)	12 months

Collaborators and Investigators

• Sponsor: Eye-yon Medical

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Corneal edema; Chronic corneal edema; Artificial Endothelial layer; EndoArt; Failed keratoplasty; Human tissue corneal transplantation failure; Failed DSEK; Failed DMEK
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Corneal Edema
• Other Study ID Numbers: CLI-E053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes