Daphna Ofer, Auffarth Gerd U, Lapid-Gortzak Ruth, Chaurasia Sunita, Gilboa Efrat, Lemze Anat, Dover Michael, Marcovich Arie L
EyeYon Medical, Ness Ziona, Israel.
Assuta Medical Center Hashalom, affiliated to Ben-Gurion University, Tel Aviv, Israel.
Cornea. 2024 Nov 5;44(10):1240-1247. doi: 10.1097/ICO.0000000000003734.
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.
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.
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.
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.
本研究旨在报告一种人工板层植入物治疗慢性角膜水肿的安全性和有效性结果。
EndoArt（EyeYon Medical，以色列内斯锡安）是一种用于治疗角膜水肿的人工内皮替代膜，被植入24例视力潜力低至正常的患者的24只眼中。我们展示了一项为期12个月的前瞻性、开放标签、单臂、多中心研究的安全性和有效性结果。
24例患者入组，未报告与器械相关的严重不良事件。17例患者完成了12个月的随访，平均中央角膜厚度从759±116μm降至613±135μm。最佳矫正远距离视力从1.88±0.79对数最小分辨角（logMAR）提高到1.34±0.57 logMAR。60%的患者至少提高了3行早期治疗糖尿病视网膜病变研究（ETDRS）视力表。5例因附着不完全而取出EndoArt，并用角膜移植替代；1例患者失访，1例手术失败。未报告与器械相关的长期并发症、感染或炎症。在整个研究过程中，植入物保持透明。
EndoArt植入的首例人体结果表明，该器械有潜力治疗角膜水肿患者，安全性良好，大多数受试者的水肿减轻有效，且未发生与器械相关的严重不良事件。EndoArt可能为面临供体角膜短缺的地区以及对人体组织预后不良的患者提供一种可行的解决方案。
