Effect of ripasudil after trabeculectomy with mitomycin C: a multicentre, randomised, prospective clinical study

Background To investigate if there are improvements in trabeculectomy outcomes supporting filtration bleb formation caused by Rho-associated protein kinase (ROCK) inhibitors.Methods This prospective, multicentre, randomised, open-label clinical study examined open-angle glaucoma patients who underwe...

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Main Authors: Kazuyuki Hirooka, Eri Nitta, Yoshiaki Kiuchi, Masaki Tanito, Shunsuke Nakakura, Tetsuya Baba, Hideaki Okumichi, Aisyah Muhlisah, Ariyanie Nurtania, Hiromitsu Onoe, Yotaro Matsuoka
Format: Article
Language:English
Published: BMJ Publishing Group 2024-05-01
Series:BMJ Open Ophthalmology
Online Access:https://bmjophth.bmj.com/content/9/1/e001449.full
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author Kazuyuki Hirooka
Eri Nitta
Yoshiaki Kiuchi
Masaki Tanito
Shunsuke Nakakura
Tetsuya Baba
Hideaki Okumichi
Aisyah Muhlisah
Ariyanie Nurtania
Hiromitsu Onoe
Yotaro Matsuoka
author_facet Kazuyuki Hirooka
Eri Nitta
Yoshiaki Kiuchi
Masaki Tanito
Shunsuke Nakakura
Tetsuya Baba
Hideaki Okumichi
Aisyah Muhlisah
Ariyanie Nurtania
Hiromitsu Onoe
Yotaro Matsuoka
author_sort Kazuyuki Hirooka
collection DOAJ
description Background To investigate if there are improvements in trabeculectomy outcomes supporting filtration bleb formation caused by Rho-associated protein kinase (ROCK) inhibitors.Methods This prospective, multicentre, randomised, open-label clinical study examined open-angle glaucoma patients who underwent trabeculectomy or trabeculectomy combined with cataract surgery followed by 3-month postoperative ripasudil treatments. After randomly allocating patients to ripasudil—ROCK inhibitor (ripasudil) or without ripasudil (non-ripasudil) groups. Mean intraocular pressure (IOP) changes, success rate, and number of eyedrops were compared for both groups.Results A total of 17 and 15 subjects dropped out in the ripasudil group and non-ripasudil group, respectively. At baseline, the mean IOP was 16.8±5.0 mm Hg in the ripasudil group (38 patients) and 16.2±4.4 in the non-ripasudil group (52 patients). The IOP decreased to 11.4±3.2 mm Hg, 10.9±3.9 mm Hg and 10.6±3.5 mm Hg at 12, 24 and 36 months in the ripasudil group, while it decreased to 11.2±4.1 mm Hg, 10.5±3.1 mm Hg and 10.9±3.2 mm Hg at 12, 24 and 36 months in the non-ripasudil group, respectively. There was a significant decrease in the number of IOP-lowering medications after trabeculectomy in the ripasudil group versus the non-ripasudil group at 24 (p=0.010) and 36 months (p=0.016). There was no statistically significant difference between the groups for the 3-year cumulative probability of success.Conclusion Although ripasudil application did not increase the primary trabeculectomy success rate, it did reduce IOP-lowering medications after trabeculectomy with mitomycin C.
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spelling doaj-art-ec770b42a59d4e588c84029e3f7df3352025-02-06T13:45:14ZengBMJ Publishing GroupBMJ Open Ophthalmology2397-32692024-05-019110.1136/bmjophth-2023-001449Effect of ripasudil after trabeculectomy with mitomycin C: a multicentre, randomised, prospective clinical studyKazuyuki Hirooka0Eri Nitta1Yoshiaki Kiuchi2Masaki Tanito3Shunsuke Nakakura4Tetsuya Baba5Hideaki Okumichi6Aisyah Muhlisah7Ariyanie Nurtania8Hiromitsu Onoe9Yotaro Matsuoka10Department of Ophthalmology and Visual Science, Hiroshima University Faculty of Medicine Graduate School of Biomedical and Health Sciences, Hiroshima, Hiroshima, JapanDepartment of Ophthalmology, Kagawa University Faculty of Medicine Graduate School of Medicine, Kita-gun, Kagawa, JapanDepartment of Ophthalmology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Hiroshima, JapanOphthalmology, Shimane University Faculty of Medicine, Izumo, JapanOphthalmology, Saneiekai Tsukazaki Hospital, Himeji, JapanDepartment of Ophthalmology, Shirai Eye Hospital, Mitoyo, JapanOphthalmology, Hiroshima University Faculty of Medicine Graduate School of Biomedical and Health Sciences, Hiroshima, Hiroshima, JapanDepartment of Ophthalmology and Visual Science, Hiroshima University Faculty of Medicine Graduate School of Biomedical and Health Sciences, Hiroshima, Hiroshima, JapanDepartment of Ophthalmology and Visual Science, Hiroshima University Faculty of Medicine Graduate School of Biomedical and Health Sciences, Hiroshima, Hiroshima, JapanHiroshima University Faculty of Medicine Graduate School of Biomedical and Health Sciences, Hiroshima, Hiroshima, JapanDepartment of Ophthalmology, Matsue Red Cross Hospital, Matsue, JapanBackground To investigate if there are improvements in trabeculectomy outcomes supporting filtration bleb formation caused by Rho-associated protein kinase (ROCK) inhibitors.Methods This prospective, multicentre, randomised, open-label clinical study examined open-angle glaucoma patients who underwent trabeculectomy or trabeculectomy combined with cataract surgery followed by 3-month postoperative ripasudil treatments. After randomly allocating patients to ripasudil—ROCK inhibitor (ripasudil) or without ripasudil (non-ripasudil) groups. Mean intraocular pressure (IOP) changes, success rate, and number of eyedrops were compared for both groups.Results A total of 17 and 15 subjects dropped out in the ripasudil group and non-ripasudil group, respectively. At baseline, the mean IOP was 16.8±5.0 mm Hg in the ripasudil group (38 patients) and 16.2±4.4 in the non-ripasudil group (52 patients). The IOP decreased to 11.4±3.2 mm Hg, 10.9±3.9 mm Hg and 10.6±3.5 mm Hg at 12, 24 and 36 months in the ripasudil group, while it decreased to 11.2±4.1 mm Hg, 10.5±3.1 mm Hg and 10.9±3.2 mm Hg at 12, 24 and 36 months in the non-ripasudil group, respectively. There was a significant decrease in the number of IOP-lowering medications after trabeculectomy in the ripasudil group versus the non-ripasudil group at 24 (p=0.010) and 36 months (p=0.016). There was no statistically significant difference between the groups for the 3-year cumulative probability of success.Conclusion Although ripasudil application did not increase the primary trabeculectomy success rate, it did reduce IOP-lowering medications after trabeculectomy with mitomycin C.https://bmjophth.bmj.com/content/9/1/e001449.full
spellingShingle Kazuyuki Hirooka
Eri Nitta
Yoshiaki Kiuchi
Masaki Tanito
Shunsuke Nakakura
Tetsuya Baba
Hideaki Okumichi
Aisyah Muhlisah
Ariyanie Nurtania
Hiromitsu Onoe
Yotaro Matsuoka
Effect of ripasudil after trabeculectomy with mitomycin C: a multicentre, randomised, prospective clinical study
BMJ Open Ophthalmology
title Effect of ripasudil after trabeculectomy with mitomycin C: a multicentre, randomised, prospective clinical study
title_full Effect of ripasudil after trabeculectomy with mitomycin C: a multicentre, randomised, prospective clinical study
title_fullStr Effect of ripasudil after trabeculectomy with mitomycin C: a multicentre, randomised, prospective clinical study
title_full_unstemmed Effect of ripasudil after trabeculectomy with mitomycin C: a multicentre, randomised, prospective clinical study
title_short Effect of ripasudil after trabeculectomy with mitomycin C: a multicentre, randomised, prospective clinical study
title_sort effect of ripasudil after trabeculectomy with mitomycin c a multicentre randomised prospective clinical study
url https://bmjophth.bmj.com/content/9/1/e001449.full
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