Long-Term Corneal Rejuvenation after Transplantation of Cultured Human Corneal Endothelial Cells.

IF 13.1 1区医学 Q1 OPHTHALMOLOGY

Ophthalmology Pub Date : 2025-05-28 DOI:10.1016/j.ophtha.2025.05.020

Shigeru Kinoshita, Morio Ueno, Munetoyo Toda, Kojiro Imai, Yasufumi Tomioka, Kohsaku Numa, Hiroshi Tanaka, Tsutomu Inatomi, Takanori Kameda, Akitaka Tsujikawa, Michio Hagiya, John Bush, Satomi Sakabayashi, Satoshi Teramukai, Junji Hamuro, Chie Sotozono

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引用次数: 0

Abstract

Purpose: To investigate the long-term efficacy of cultured human corneal endothelial cell (CEC) transplantation with rho-associated protein kinase (ROCK) inhibitor for the treatment of corneal endothelial failure (CEF).

Design: Prospective observational study.

Participants: This study involved 65 patients with corneal endothelial failure treated via cell therapy using cultured allogeneic human CECs (0.2-1.0 x10⁶ cells) supplemented with a ROCK inhibitor injected into the anterior chamber of the eye who were followed up to 10-years postoperative.

Methods: At 24-weeks and 1 to 10-years postoperative, corneal transparency, corneal endothelial cell density (CECD), central corneal thickness (CCT), and best-corrected visual acuity (BCVA) on a Landolt C eye chart were recorded. The Kaplan-Meier method was used to estimate the postoperative probability for restoration and persistence of corneal transparency.

Main outcome measures: The primary outcome was the corneal restoration and transparency post-surgery. Secondary outcomes were a CEC density exceeding 500 cells/mm² and 1000 cells/mm², corneal thickness of below 630 μm, and an improvement in BCVA equivalent to a decrease of at least 0.2 in logMAR BCVA at 24-weeks and 5-years postoperative.

Results: For the primary outcome, the overall success in maintaining corneal transparency at 24-weeks, 5-years, and 10-years postoperative was 98.5% (95% confidence interval [CI], 89.6-99.8%), 93.0% (95% CI, 82.4-97.3%), and 83.7% (95% CI, 54.4-95.0%), respectively. A CEC density of greater than 1000 cells/mm² was achieved in 79.6% (95% CI, 65.7-89.8%), a corneal thickness of below 630 μm was achieved in 85.4% (95% CI, 72.2-93.9%), and a BCVA improvement was achieved in 85.7% (95% CI, 72.8-94.1%) at 5-years postoperative. There were no severe adverse reactions.

Conclusions: Cultured human CEC-transplantation therapy was found to be safe and effective over a long-term period for the treatment of CEF.

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培养的人角膜内皮细胞移植后的长期角膜年轻化。

目的：探讨人工角膜内皮细胞（CEC）移植联合rho相关蛋白激酶（ROCK）抑制剂治疗角膜内皮功能衰竭（CEF）的远期疗效。设计：前瞻性观察研究。参与者：本研究涉及65例角膜内皮衰竭患者，通过细胞疗法治疗，使用培养的异体人CECs （0.2-1.0 x106细胞）补充ROCK抑制剂注射到眼睛前房，随访至术后10年。方法：术后24周和1 ~ 10年，分别记录Landolt C视频表上角膜透明度、角膜内皮细胞密度（ced）、角膜中央厚度（CCT）和最佳矫正视力（BCVA）。Kaplan-Meier法用于估计术后角膜透明恢复和持续的概率。主要观察指标：主要观察指标为术后角膜恢复及透明度。次要结果是CEC密度超过500个细胞/mm2和1000个细胞/mm2，角膜厚度低于630 μm， BCVA的改善相当于术后24周和5年logMAR BCVA降低至少0.2。结果：对于主要结局，术后24周、5年和10年维持角膜透明度的总体成功率分别为98.5%（95%可信区间[CI]， 89.6-99.8%）、93.0% （95% CI, 82.4-97.3%）和83.7% （95% CI, 54.4-95.0%）。术后5年CEC密度大于1000个细胞/mm2的患者占79.6% (95% CI, 65.7-89.8%)，角膜厚度低于630 μm的患者占85.4% (95% CI, 72.2-93.9%)， BCVA改善的患者占85.7% （95% CI, 72.8-94.1%）。未见严重不良反应。结论：培养人cec移植治疗CEF是安全有效的长期治疗方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Ophthalmology 医学-眼科学

CiteScore

22.30

自引率

3.60%

发文量

412

审稿时长

18 days

期刊介绍： The journal Ophthalmology, from the American Academy of Ophthalmology, contributes to society by publishing research in clinical and basic science related to vision.It upholds excellence through unbiased peer-review, fostering innovation, promoting discovery, and encouraging lifelong learning.