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选择性内皮细胞清除:一项具有长期随访的I/II期外科试验的病例系列研究。

Selective endothelial removal: A case series of a phase I/II surgical trial with long-term follow up.

作者信息

Liu Yu-Chi, Soh Yu Qiang, Kocaba Viridiana, Mehta Jodhbir S

机构信息

Cornea and Refractive Surgery Group, Singapore Eye Research Institute, Singapore, Singapore.

Tissue Engineering and Cell Therapy Group, Singapore Eye Research Institute, Singapore, Singapore.

出版信息

Front Med (Lausanne). 2022 Jul 29;9:901187. doi: 10.3389/fmed.2022.901187. eCollection 2022.

Abstract

Peters anomaly is a congenital condition which results in a central corneal opacity from birth. Selective Endothelial Removal (SER) is a novel surgical technique and a form of regenerative therapy, which encourages clearance of the central corneal opacity by the patient's own corneal endothelial cells, and it may potentially be beneficial for the treatment of Peters anomaly. We have performed a phase I/II surgical trial, evaluating the safety of SER in four eyes (three patients) with Peters Anomaly. These patients underwent SER at between 9 and 39 months of age, each demonstrating clearance of central corneal opacities and improvements in vision post-operatively. No complications occurred in any of these eyes, at a minimal post-operative follow-up duration of 48 months. We conclude that SER for Peters anomaly is a safe surgical procedure. While encouraging efficacy outcomes have been observed, these findings should be further evaluated in a larger scale Phase II/III surgical trial.

摘要

彼得斯异常是一种先天性疾病,出生时即导致中央角膜混浊。选择性内皮细胞去除术(SER)是一种新型手术技术和再生治疗形式,它促使患者自身的角膜内皮细胞清除中央角膜混浊,可能对彼得斯异常的治疗有益。我们进行了一项I/II期手术试验,评估SER在4只眼(3例患者)患有彼得斯异常中的安全性。这些患者在9至39个月大时接受了SER,术后每只眼均显示中央角膜混浊清除且视力改善。在至少48个月的术后随访期内,这些眼中均未发生并发症。我们得出结论,用于彼得斯异常的SER是一种安全的手术程序。虽然已观察到令人鼓舞的疗效结果,但这些发现应在更大规模的II/III期手术试验中进一步评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4175/9372295/74816a66643b/fmed-09-901187-g001.jpg

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