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Mid-term Clinical Results of CO2 Laser-assisted Sclerectomy Surgery (CLASS) for Open-Angle Glaucoma Treatment

机译:CO2激光辅助巩膜切除术(CLASS)治疗开角型青光眼的中期临床结果

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Purpose:To evaluate the efficacy and safety of CO2 Laser-assisted Sclerectomy Surgery (CLASS) in primary and pseudoexfoliative open-angle glaucoma.Materials and Methods:Single-arm, open-label study included data from 9 medical centers located in 7 countries. Subjects underwent nonpenetrating CLASS procedure with a CO2 laser system (IOPtiMate). Intraocular pressure (IOP) and number of medications were measured at baseline, 1, 2, 4, and 6 weeks, and 3, 6, 12, 24, and 36 months. Complete success was defined as 5IOP18 mm Hg and at least 20% IOP reduction with no medications, and qualified success as the same with or without medications at 12, 24, and 36 months.Results:A total of 111 consecutive eyes were enrolled in the study, 14 were excluded from the study due to protocol deviation or operator error. The mean age was 69.312.8 and 73.9% were whites. Percent change in IOP from baseline at 1, 2, and 3 years was, respectively, 45.1%, 46.8%, and 42.5% (P<0.001). Complete success rates after 12, 24, and 36 months were 60.2%, 57.9%, and 47.8%, respectively. Qualified success rates after 12, 24, and 36 months were 79.6%, 91.2%, and 84.8%, respectively. Number of medications dropped from 2.39 +/- 1.24 to 0.47 +/- 0.84, 0.53 +/- 0.75, and 0.71 +/- 0.89 at 12, 24, and 36 months, respectively (P<0.001).Conclusions:The CLASS procedure may be a simple and effective treatment for open-angle glaucoma providing extended relief of elevated IOP.
机译:目的:评价CO2激光辅助巩膜切除术(CLASS)在原发性和假性剥脱性开角型青光眼中的有效性和安全性。材料与方法:单臂,开放标签研究包括来自7个国家的9个医疗中心的数据。使用CO2激光系统(IOPtiMate)对受试者进行非穿透性CLASS手术。在基线,1、2、4和6周以及3、6、12、24和36个月时测量眼内压(IOP)和用药次数。完全成功的定义为5IOP18 mm Hg,无药物至少降低20%的IOP,并在12、24和36个月获得与有或无药物相同的成功结果。研究中,由于方案偏差或操作员错误,有14位患者被排除在研究之外。平均年龄为69.312.8,白人为73.9%。在第1、2和3年时,眼压与基线相比的变化百分比分别为45.1%,46.8%和42.5%(P <0.001)。 12、24和36个月后的完全成功率分别为60.2%,57.9%和47.8%。 12、24和36个月后的合格成功率分别为79.6%,91.2%和84.8%。在12、24和36个月时,药物数量分别从2.39 +/- 1.24降至0.47 +/- 0.84、0.53 +/- 0.75和0.71 +/- 0.89(P <0.001)。对于开角型青光眼可能是一种简单有效的治疗方法,可延长IOP的缓解时间。

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