NCT07344168

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (estimated)
• Sponsor: Eye-yon Medical · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Corneal Edema

Interventions

Type	Name	Description
DEVICE	The EndoArt® (Corneal Artificial Endothelial layer)	Implantation of EndoArt® is similar to other anterior segment surgical procedures such as DSEK/DMEK

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-04-30
• Completion: 2030-04-30
• First posted: 2026-01-15
• Last updated: 2026-03-13

Regulatory

• FDA-regulated device study