Mizuno Yu, Komatsu Kaori, Tokumo Kana, Okada Naoki, Onoe Hiromitsu, Okumichi Hideaki, Hirooka Kazuyuki, Aoki Gaku, Miura Yukiko, Kiuchi Yoshiaki
Department of Ophthalmology and Visual Science, Hiroshima University, 1-2-3 Kasumi Minamiku, Hiroshima 734-8551, Japan.
Department of Biostatistics, Clinical Research Center, Hiroshima University Hospital, 1-2-3 Kasumi Minamiku, Hiroshima 734-8551, Japan.
J Clin Med. 2023 Dec 22;13(1):75. doi: 10.3390/jcm13010075.
Ripasudil, a rho-associated protein kinase inhibitor ophthalmic solution, shows a protective effect in preventing excessive scarring in vitro. This study aims to evaluate the safety and efficacy of ripasudil for glaucoma patients submitted to the needling procedure. In this prospective, multicenter, single-arm study, we included 20 eyes of 20 patients with glaucoma who underwent the needling procedure without antimetabolites. All patients administered ripasudil after needling for three months. The primary endpoint of this study was the safety of ripasudil in patients, and the secondary endpoint was the change in IOP at 12 weeks after the needling procedure. No serious complications were found in the patients. One eye experienced pruritus and conjunctival follicle, while another eye had conjunctival follicle. These complications were transient and resolved quickly after discontinuation of ripasudil. The mean preoperative IOP was 14.6 ± 4.6 mmHg, which decreased to 11.0 ± 4.7 mmHg ( = 0.0062) at 1 week postoperatively. The IOP reduction effect continued to 12 weeks (11.8 ± 3.1 mmHg; = 0.0448). The administration of the ROCK inhibitor, ripasudil, after the needling procedure is safe and effective in maintaining IOP for 12 weeks.
玻璃体内注射用Rho相关蛋白激酶抑制剂（Ripasudil）滴眼液在体外对预防过度瘢痕形成具有保护作用。本研究旨在评估Ripasudil用于接受针刺术的青光眼患者的安全性和有效性。在这项前瞻性、多中心、单臂研究中，我们纳入了20例接受针刺术且未使用抗代谢药物的青光眼患者的20只眼。所有患者在针刺术后使用Ripasudil三个月。本研究的主要终点是Ripasudil在患者中的安全性，次要终点是针刺术后12周时眼压的变化。患者未发现严重并发症。一只眼出现瘙痒和结膜滤泡，另一只眼出现结膜滤泡。这些并发症是短暂的，在停用Ripasudil后迅速缓解。术前平均眼压为14.6±4.6 mmHg，术后1周降至11.0±4.7 mmHg（P = 0.0062）。眼压降低效果持续至12周（11.8±3.1 mmHg；P = 0.0448）。针刺术后给予ROCK抑制剂Ripasudil在维持眼压12周方面安全有效。
