Reduction of intraocular pressure and glaucoma progression - Results from the early manifest glaucoma trial
Reduction of intraocular pressure and glaucoma progression - Results from the early manifest glaucoma trial
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DOI：
10.1001/archopht.120.10.1268
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发表时间：
2002-10-01
影响因子：
--
通讯作者：
Hussein, M
中科院分区：
文献类型：
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作者：
Heijl, A;Leske, MC;Hussein, M
目的：提供早期显性青光眼试验的结果，该试验比较了立即降低眼内压（IOP）与不治疗或后期治疗对新发现的开角型青光眼进展的影响。设计：随机临床试验。255例年龄在50至80岁之间的患者（中位数，68岁），患有早期青光眼、视野缺损（中位数平均偏差，-4 dB）和中位数IOP为20 mm Hg，主要通过人群筛查确定。眼压大于30毫米汞柱或先进的视野损失的患者是uneligible.Interventions：患者随机激光小梁成形术加局部盐酸倍他洛尔（n = 129）或没有初始治疗（n = 126）。研究访视包括Humphrey全阈值30-2视野测试和眼压测量，每3个月一次，以及每6个月一次视盘摄影。关于治疗的决定与患者共同进展时发生，aftershore.Main结果测量：青光眼进展的定义是特定的视野和视盘的结果。视野进展标准基于计算机，定义为相同的3个或更多测试点位置，显示3次连续测试的青光眼变化概率图较基线显著恶化。视神经盘的进展是由蒙面分级机使用闪烁计时加上并排photo-gradings.Results：经过中位随访期为6年（范围，51-102个月），保留是极好的，只有6例患者失去了后续的原因以外的死亡。平均而言，治疗使IOP降低了5.1 mm Hg或25%，在整个随访期间保持降低，治疗组（58/129; 45%）的进展频率低于对照组（78/126; 62%）（P = 0.007），治疗患者的进展时间明显较晚。当按中位IOP、平均偏差、年龄以及剥脱状态对患者进行分层时，治疗效果也很明显。尽管患者报告的全身或眼部状况很少，但临床核透镜混浊分级的增加与治疗相关（P = 0.002）。结论：早期显性青光眼试验是第一个有充分把握的随机试验，未治疗对照组评价开角型青光眼患者眼压升高和正常眼压降低的效果。其意向治疗分析显示，治疗具有相当大的有益效果，可显著延迟疾病进展。尽管不同患者类别的进展不同，但治疗效果在老年和年轻患者、高眼压和正常眼压青光眼以及视野损失较少和较大的眼睛中均存在。
Objective: To provide the results of the Early Manifest Glaucoma Trial, which compared the effect of immediately lowering the intraocular pressure (IOP), vs no treatment or later treatment, on the progression of newly detected open-angle glaucoma.Design: Randomized clinical trial.Participants: Two hundred fifty-five patients aged 50 to 80 years (median, 68 years) with early glaucoma, visual field defects (median mean deviation, -4 dB), and a median IOP of 20 mm Hg, mainly identified through a population screening. Patients with an IOP greater than 30 mm Hg or advanced visual field loss were ineligible.Interventions: Patients were randomized to either laser trabeculoplasty plus topical betaxolol hydrochloride (n = 129) or no initial treatment (n = 126). Study visits included Humphrey Full Threshold 30-2 visual field tests and tonometry every 3 months, and optic disc photography every 6 months. Decisions regarding treatment were made jointly with the patient when progression occurred and thereafter.Main Outcome Measures: Glaucoma progression was defined by specific visual field and optic disc outcomes. Criteria for perimetric progression were computer based and defined as the same 3 or more test point locations showing significant deterioration from baseline in glaucoma change probability maps from 3 consecutive tests. Optic disc progression was determined by masked graders using flicker chronoscopy plus side-by-side photo-gradings.Results: After a median follow-up period of 6 years (range, 51-102 months), retention was excellent, with only 6 patients lost to follow-up for reasons other than death. On average, treatment reduced the IOP by 5.1 mm Hg or 25%, a reduction maintained throughout follow-up Progression was less frequent in the treatment group (58/129; 45%) than in controls (78/126; 62%) (P = .007) and occurred significantly later in treated patients. Treatment effects were also evident when stratifying patients by median IOP, mean deviation, and age as well as exfoliation status. Although patients reported few systemic or ocular conditions, increases in clinical nuclear lens opacity gradings were associated with treatment (P = .002).Conclusions: The Early Manifest Glaucoma Trial is the first adequately powered randomized trial with an untreated control arm to evaluate the effects of IOP reduction in patients with open-angle glaucoma who have elevated and normal IOP. Its intent-to-treat analysis showed considerable beneficial effects of treatment that significantly delayed progression. Whereas progression varied across patient categories, treatment effects were present in both older and younger patients, high- and normal-tension glaucoma, and eyes with less and greater visual field loss.