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首例人眼 CorNeat 角膜假体植入术。

The first-in-human implantation of the CorNeat keratoprosthesis.

机构信息

Department of Ophthalmology, Rabin Medical Center, Petach Tikva, Israel.

Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

出版信息

Eye (Lond). 2023 May;37(7):1331-1335. doi: 10.1038/s41433-022-02105-3. Epub 2022 Jun 1.

Abstract

OBJECTIVES

To describe the first clinical implantation of the CorNeat™ keratoprosthesis, which utilizes a polymeric scaffold for biointegration within ocular tissue.

METHODS

The CorNeat keratoprosthesis was implanted in the right eye of a patient with bilateral corneal opacification and neovascularization secondary to multiple failed grafts. The following surgical technique was used: 360 degree peritomy; epithelial scraping and corneal marking; pre-placement of three corneo-scleral sutures through the implant; central trephination using a 7 mm trephine and host cornea removal; keratoprosthesis placement and sutures tightening while fitting the corneal edge into the posterior groove of the CorNeat keratoprosthesis; and repositioning of the conjunctiva over the implant skirt and fixation with sutures and Fibrin sealant.

RESULTS

Twelve months postoperatively visual acuity improved to 1/16 from hand movement. The keratoprosthesis was properly positioned. Tactile intraocular pressure was assessed as normal. Regional, mostly nasal, conjunctival retraction of 4-5 mm over the nano-fibre skirt was seen throughout follow-up. The anterior chamber was quiet and well-formed. No other postoperative complications were observed.

CONCLUSION

This initial case may imply a potential breakthrough in the treatment of corneal disease not amenable to standard corneal transplant. Long follow-up and additional implantations are desired to prove the long-term safety and efficacy of this device.

摘要

目的

描述首例 CorNeat™ 角膜假体的临床植入,该假体利用聚合物支架在眼组织内实现生物整合。

方法

将 CorNeat 角膜假体植入一名双侧角膜混浊伴新生血管化患者的右眼,该患者因多次移植失败导致角膜混浊伴新生血管化。采用以下手术技术:360 度环周切开;上皮刮除和角膜标记;通过植入物预先放置三根角巩膜缝线;使用 7mm 环钻进行中央环钻切开并切除宿主角膜;角膜假体放置和缝线收紧,同时将角膜边缘拟合到 CorNeat 角膜假体的后槽中;将结膜重新定位在植入物裙边上方并用缝线和纤维蛋白胶固定。

结果

术后 12 个月,视力从手动提高到 1/16。角膜假体位置正确。触觉眼压被评估为正常。在整个随访过程中,纳米纤维裙边上方出现 4-5mm 的区域性(主要为鼻侧)结膜退缩。前房安静,形态良好。未观察到其他术后并发症。

结论

首例病例可能意味着在治疗无法进行标准角膜移植的角膜疾病方面取得了潜在突破。需要长期随访和更多的植入物来证明该设备的长期安全性和有效性。

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