PDF(Pubmed)
Abstract：
OBJECTIVE: To determine whether primary trabeculectomy or medical treatment produces better outcomes in terms of quality of life (QoL), clinical effectiveness, and safety in patients with advanced glaucoma.
METHODS: Multicenter randomized controlled trial.
METHODS: Between June 3, 2014, and May 31, 2017, 453 adults with newly diagnosed advanced open-angle glaucoma in at least 1 eye (Hodapp classification) were recruited from 27 secondary care glaucoma departments in the United Kingdom. Two hundred twenty-seven were allocated to trabeculectomy, and 226 were allocated medical management.
METHODS: Participants were randomized on a 1:1 basis to have either mitomycin C-augmented trabeculectomy or escalating medical management with intraocular pressure (IOP)-reducing drops as the primary intervention and were followed up for 5 years.
METHODS: The primary outcome was vision-specific QoL measured with the 25-item Visual Function Questionnaire (VFQ-25) at 5 years. Secondary outcomes were general health status, glaucoma-related QoL, clinical effectiveness (IOP, visual field, and visual acuity), and safety.
RESULTS: At 5 years, the mean ± standard deviation VFQ-25 scores in the trabeculectomy and medication arms were 83.3 ± 15.5 and 81.3 ± 17.5, respectively, and the mean difference was 1.01 (95% confidence interval [CI], -1.99 to 4.00; P = 0.51). The mean IOPs were 12.07 ± 5.18 mmHg and 14.76 ± 4.14 mmHg, respectively, and the mean difference was -2.56 (95% CI, -3.80 to -1.32; P < 0.001). Glaucoma severity measured with visual field mean deviation were -14.30 ± 7.14 dB and -16.74 ± 6.78 dB, respectively, with a mean difference of 1.87 (95% CI, 0.87-2.87 dB; P < 0.001). Safety events occurred in 115 (52.2%) of patients in the trabeculectomy arm and 124 (57.9%) of patients in the medication arm (relative risk, 0.92; 95% CI, 0.72-1.19; P = 0.54). Serious adverse events were rare.
CONCLUSIONS: At 5 years, the Treatment of Advanced Glaucoma Study demonstrated that primary trabeculectomy surgery is more effective in lowering IOP and preventing disease progression than primary medical treatment in patients with advanced disease and has a similar safety profile.
BACKGROUND: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
METHODS: Multicenter randomized controlled trial.
METHODS: Between June 3, 2014, and May 31, 2017, 453 adults with newly diagnosed advanced open-angle glaucoma in at least 1 eye (Hodapp classification) were recruited from 27 secondary care glaucoma departments in the United Kingdom. Two hundred twenty-seven were allocated to trabeculectomy, and 226 were allocated medical management.
METHODS: Participants were randomized on a 1:1 basis to have either mitomycin C-augmented trabeculectomy or escalating medical management with intraocular pressure (IOP)-reducing drops as the primary intervention and were followed up for 5 years.
METHODS: The primary outcome was vision-specific QoL measured with the 25-item Visual Function Questionnaire (VFQ-25) at 5 years. Secondary outcomes were general health status, glaucoma-related QoL, clinical effectiveness (IOP, visual field, and visual acuity), and safety.
RESULTS: At 5 years, the mean ± standard deviation VFQ-25 scores in the trabeculectomy and medication arms were 83.3 ± 15.5 and 81.3 ± 17.5, respectively, and the mean difference was 1.01 (95% confidence interval [CI], -1.99 to 4.00; P = 0.51). The mean IOPs were 12.07 ± 5.18 mmHg and 14.76 ± 4.14 mmHg, respectively, and the mean difference was -2.56 (95% CI, -3.80 to -1.32; P < 0.001). Glaucoma severity measured with visual field mean deviation were -14.30 ± 7.14 dB and -16.74 ± 6.78 dB, respectively, with a mean difference of 1.87 (95% CI, 0.87-2.87 dB; P < 0.001). Safety events occurred in 115 (52.2%) of patients in the trabeculectomy arm and 124 (57.9%) of patients in the medication arm (relative risk, 0.92; 95% CI, 0.72-1.19; P = 0.54). Serious adverse events were rare.
CONCLUSIONS: At 5 years, the Treatment of Advanced Glaucoma Study demonstrated that primary trabeculectomy surgery is more effective in lowering IOP and preventing disease progression than primary medical treatment in patients with advanced disease and has a similar safety profile.
BACKGROUND: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
摘要：
目的：确定原发性小梁切除术或药物治疗是否在生活质量（QoL）方面产生更好的结果，晚期青光眼患者的临床有效性和安全性。
方法：多中心随机对照试验参与者：在2014年6月3日至2017年5月31日之间，从英国27个二级治疗青光眼部门招募了453名至少有一只眼出现新诊断的晚期开角型青光眼（Hodapp分类）的成年人。227人被分配给小梁切除术，226人被分配给医疗管理。
方法：参与者以1:1的比例随机分组，以丝裂霉素C增强小梁切除术或逐步进行医疗管理并降低眼压作为主要干预措施，并随访5年。ISRCTN注册表：ISRCTN56878850。
方法：主要结果是在5年时使用视觉功能问卷-25（VFQ-25）测量特定于视觉的生活质量。
结果：一般健康状况，青光眼相关QoL,临床有效性[眼内压（IOP），视野(VF),视力（VA）]和安全性。
结果：在5年时，小梁切除术和药物治疗组的平均VFQ-25分别为83.3（SD15.5）和81.3（SD17.5），平均差1.01，（95%CI-1.99至4.00）；p=0.51。平均IOP分别为12.07(5.18)mmHg和14.76(4.14)mmHg,平均差-2.56（95%CI-3.80至-1.32）；p<0.001。用视野平均偏差测量的青光眼严重程度分别为-14.30（7.14）和-16.74（6.78）dB，平均差1.87(95%CI0.87至2.87)dB，p<0.001。小梁切除术组115例（52.2%）发生安全事件，用药组124例（57.9%）发生安全事件，相对风险0.92（95%CI0.72至1.19）；p=0.54。严重不良事件罕见。
结论：5年时，TAGS已经证明，原发性小梁切除术在降低IOP和预防疾病进展方面比原发性药物治疗更有效，并且具有相似的安全性TRIALREGISTRATION：健康技术评估（NIHR-HTA）计划（项目编号：12/35/38）。ISRCTN注册表：ISRCTN56878850。
方法：多中心随机对照试验参与者：在2014年6月3日至2017年5月31日之间，从英国27个二级治疗青光眼部门招募了453名至少有一只眼出现新诊断的晚期开角型青光眼（Hodapp分类）的成年人。227人被分配给小梁切除术，226人被分配给医疗管理。
方法：参与者以1:1的比例随机分组，以丝裂霉素C增强小梁切除术或逐步进行医疗管理并降低眼压作为主要干预措施，并随访5年。ISRCTN注册表：ISRCTN56878850。
方法：主要结果是在5年时使用视觉功能问卷-25（VFQ-25）测量特定于视觉的生活质量。
结果：一般健康状况，青光眼相关QoL,临床有效性[眼内压（IOP），视野(VF),视力（VA）]和安全性。
结果：在5年时，小梁切除术和药物治疗组的平均VFQ-25分别为83.3（SD15.5）和81.3（SD17.5），平均差1.01，（95%CI-1.99至4.00）；p=0.51。平均IOP分别为12.07(5.18)mmHg和14.76(4.14)mmHg,平均差-2.56（95%CI-3.80至-1.32）；p<0.001。用视野平均偏差测量的青光眼严重程度分别为-14.30（7.14）和-16.74（6.78）dB，平均差1.87(95%CI0.87至2.87)dB，p<0.001。小梁切除术组115例（52.2%）发生安全事件，用药组124例（57.9%）发生安全事件，相对风险0.92（95%CI0.72至1.19）；p=0.54。严重不良事件罕见。
结论：5年时，TAGS已经证明，原发性小梁切除术在降低IOP和预防疾病进展方面比原发性药物治疗更有效，并且具有相似的安全性TRIALREGISTRATION：健康技术评估（NIHR-HTA）计划（项目编号：12/35/38）。ISRCTN注册表：ISRCTN56878850。
