A Novel Artificial Endothelial Replacement Membrane for the Treatment of Chronic Corneal Edema.

IF 1.9 3区 医学 Q2 OPHTHALMOLOGY Cornea Pub Date : 2024-11-05 DOI:10.1097/ICO.0000000000003734
Ofer Daphna, Gerd U Auffarth, Ruth Lapid-Gortzak, Sunita Chaurasia, Efrat Gilboa, Anat Lemze, Michael Dover, Arie L Marcovich
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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.

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用于治疗慢性角膜水肿的新型人工内皮替代膜。
目的:本研究旨在报告人工板层植入治疗慢性角膜水肿的安全性和有效性结果:方法:在 24 位低度至正常视力患者的 24 只眼睛中植入 EndoArt(EyeYon Medical,以色列 Ness Ziona),这是一种用于治疗角膜水肿的人工内皮替代膜。我们介绍了一项为期 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:结果:共有 24 名患者入组,未报告与设备相关的严重不良事件。17 名患者完成了为期 12 个月的随访,结果显示角膜中央平均厚度从 759 ± 116 μm 降至 613 ± 135 μm。最佳矫正距离视力从 1.88 ± 0.79 对数最小分辨角(logMAR)提高到 1.34 ± 0.57 对数最小分辨角。60%的患者获得了至少3条早期治疗糖尿病视网膜病变研究(ETDRS)线。有5例患者因EndoArt不完全附着而被移除,改为角膜移植;1例患者失去随访机会,1例患者手术失败。没有出现与设备相关的长期并发症、感染或炎症。在整个研究过程中,植入体始终保持透明:EndoArt的首次人体植入结果表明,该设备具有治疗角膜水肿患者的潜力,其安全性良好,大多数受试者的水肿都得到了有效缓解,而且没有发生与设备相关的严重不良事件。EndoArt 可为缺少供体角膜的地区以及使用人体组织预后不佳的患者提供可行的解决方案。
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来源期刊
Cornea
Cornea 医学-眼科学
CiteScore
5.20
自引率
10.70%
发文量
354
审稿时长
3-6 weeks
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. Sponsored by The Cornea Society which was founded as the Castroviejo Cornea Society in 1975.
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