A novel artificial endothelial replacement membrane for the treatment of chronic corneal edema

Purpose: The purpose of this study was to report the safety and efficacy results of an artificial lamellar implant for the treatment of chronic corneal edema. Methods: The EndoArt (EyeYon Medical, Ness Ziona, Israel), an artificial endothelial replacement membrane designed to treat corneal edema, wa...

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Main Authors: Daphna, Ofer (Author) , Auffarth, Gerd U. (Author) , Lapid-Gortzak, Ruth (Author) , Chaurasia, Sunita (Author) , Gilboa, Efrat (Author) , Lemze, Anat (Author) , Dover, Michael (Author) , Marcovich, Arie L. (Author)
Format: Article (Journal)
Language:English
Published: October 2025
In: Cornea
Year: 2025, Volume: 44, Issue: 10, Pages: 1240-1247
ISSN:1536-4798
DOI:10.1097/ICO.0000000000003734
Online Access:Resolving-System, kostenfrei, Volltext: https://doi.org/10.1097/ICO.0000000000003734
Verlag, kostenfrei, Volltext: https://journals.lww.com/corneajrnl/fulltext/2025/10000/a_novel_artificial_endothelial_replacement.5.aspx
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Author Notes:Ofer Daphna, Gerd U. Auffarth, Ruth Lapid-Gortzak, Sunita Chaurasia, Efrat Gilboa, Anat Lemze, Michael Dover, and Arie L. Marcovich
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Summary:Purpose: The purpose of this study was to report the safety and efficacy results of an artificial lamellar implant for the treatment of chronic corneal edema. Methods: The EndoArt (EyeYon Medical, Ness Ziona, Israel), an artificial endothelial replacement membrane designed to treat corneal edema, was implanted in 24 eyes of 24 patients with low-to-normal visual potential. We present the safety and efficacy results from a prospective, open-label, single-arm, multicenter study conducted over a 12-month period. Results: Twenty-four patients were enrolled, with no device-related serious adverse events reported. Seventeen patients completed 12-month follow-up, showing a reduction in average central corneal thickness from 759 ± 116 μm to 613 ± 135 μm. Best-corrected distance visual acuity improved from 1.88 ± 0.79 logarithmic minimum angle of resolution (logMAR) to 1.34 ± 0.57 logMAR. Sixty percent gained at least 3 early treatment diabetic retinopathy study (ETDRS) lines. The EndoArt was removed in 5 cases due to incomplete attachment and replaced by corneal transplants; 1 patient was lost to follow-up, and 1 had a procedure failure. No device-related long-term complications, infections, or inflammations were reported. The implants remained transparent throughout the study. Conclusions: The first-in-human results of EndoArt implantation demonstrated the device's potential to treat patients suffering from corneal edema with a favorable safety profile and effective edema reduction in most subjects, with no device-related serious adverse event. The EndoArt may offer a viable solution in regions facing a shortage of donor corneas, as well as for patients who have poor prognosis with human tissue.
Item Description:Gesehen am 17.06.2026
Physical Description:Online Resource
ISSN:1536-4798
DOI:10.1097/ICO.0000000000003734