Ofer Daphna, Gerd U Auffarth, Ruth Lapid-Gortzak, Sunita Chaurasia, Efrat Gilboa, Anat Lemze, Michael Dover, Arie L Marcovich
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引用次数: 0
Abstract
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.
期刊介绍:
For corneal specialists and for all general ophthalmologists with an interest in this exciting subspecialty, Cornea brings together the latest clinical and basic research on the cornea and the anterior segment of the eye. Each volume is peer-reviewed by Cornea''s board of world-renowned experts and fully indexed in archival format. Your subscription brings you the latest developments in your field and a growing library of valuable professional references.
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