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

IF 2 Q2 OPHTHALMOLOGY
Aisyah Muhlisah, Kazuyuki Hirooka, Ariyanie Nurtania, Hiromitsu Onoe, Hideaki Okumichi, Eri Nitta, Tetsuya Baba, Masaki Tanito, Yotaro Matsuoka, Shunsuke Nakakura, Yoshiaki Kiuchi
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引用次数: 0

Abstract

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.

使用丝裂霉素 C 进行小梁切除术后瑞帕舒地尔的效果:一项多中心、随机、前瞻性临床研究。
背景:研究Rho相关蛋白激酶(ROCK)抑制剂是否能改善小梁切除术的结果:研究Rho相关蛋白激酶(ROCK)抑制剂是否能改善小梁切除术的疗效,支持滤过性眼泡的形成:这项前瞻性、多中心、随机、开放标签临床研究对接受小梁切除术或小梁切除术联合白内障手术的开角型青光眼患者进行了检查,并在术后进行了为期3个月的利帕地尔治疗。将患者随机分配到利帕斯地尔-ROCK抑制剂组(利帕斯地尔组)或未使用利帕斯地尔组(非利帕斯地尔组)。比较两组患者的平均眼压(IOP)变化、成功率和滴眼次数:结果:瑞帕舒地尔组和非瑞帕舒地尔组分别有17名和15名受试者退出。基线时,雷帕地尔组(38名患者)的平均眼压为(16.8±5.0)毫米汞柱,非雷帕地尔组(52名患者)的平均眼压为(16.2±4.4)毫米汞柱。在12、24和36个月时,雷帕地尔组的眼压分别降至11.4±3.2毫米汞柱、10.9±3.9毫米汞柱和10.6±3.5毫米汞柱,而非雷帕地尔组在12、24和36个月时分别降至11.2±4.1毫米汞柱、10.5±3.1毫米汞柱和10.9±3.2毫米汞柱。在小梁切除术后24个月(P=0.010)和36个月(P=0.016),利帕苏地尔组与非利帕苏地尔组相比,降眼压药物的使用次数明显减少。在3年累计成功概率方面,两组间差异无统计学意义:结论:虽然应用利帕琥珀地尔并没有提高小梁切除术的初次成功率,但它确实减少了使用丝裂霉素C进行小梁切除术后的降眼压药物。
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来源期刊
BMJ Open Ophthalmology
BMJ Open Ophthalmology OPHTHALMOLOGY-
CiteScore
3.40
自引率
4.20%
发文量
104
审稿时长
20 weeks
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