The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma.
The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma.
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DOI：
10.1001/archopht.120.6.701
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发表时间：
2002-06
影响因子：
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通讯作者：
R. Fechtner;Nicholas Karunaratne;Albert S. Khoury;T. Realini;Jianming Ren;Michelle Robison;George Shafra
中科院分区：
文献类型：
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作者：
R. Fechtner;Nicholas Karunaratne;Albert S. Khoury;T. Realini;Jianming Ren;Michelle Robison;George Shafra
原发性开角型青光眼（POAG）是美国和世界范围内致盲的主要原因之一。在美国，由于眼压升高（IOP）或高眼压，300万至600万人患POAG的风险增加。对于药物治疗在延迟或预防IOP升高患者POAG发病方面的有效性，目前尚无共识。因此，我们设计了一项随机临床试验，即高眼压治疗研究。目的探讨局部降压药物延缓或预防POAG发病的安全性和有效性。方法：1636名年龄在40 ~ 80岁之间，单眼IOP在24 ~ 32 mm Hg之间，另一只眼IOP在21 ~ 32 mm Hg之间，无青光眼损害证据的参与者被随机分为观察组或接受市售的局部降压药物治疗组。药物组的目标是将IOP降低20%或更多，并达到24毫米汞柱或更低的IOP。主要结局指标主要结局为POAG引起的可重复性视野异常或可重复性视盘恶化。异常由阅读中心的蒙面认证读者确定，POAG的归属由蒙面终点委员会决定。结果在研究过程中，药物组IOP平均+/- SD降低22.5% +/- 9.9%。观察组眼压下降4.0% +/- 11.6%。60个月时，用药组发生POAG的累积概率为4.4%，观察组为9.5%（风险比0.40,95%可信区间0.27-0.59，P< 0.0001）。几乎没有证据表明使用降压药物会增加全身或眼部风险。结论局部眼部降压药物可有效延缓或预防IOP升高患者POAG的发生。虽然这并不意味着所有的临界或高IOP患者都应该接受药物治疗，但临床医生应该考虑对有中度或高风险发生POAG的高眼压患者开始治疗。
BACKGROUND Primary open-angle glaucoma (POAG) is one of the leading causes of blindness in the United States and worldwide. Three to 6 million people in the United States are at increased risk for developing POAG because of elevated intraocular pressure (IOP), or ocular hypertension. There is no consensus on the efficacy of medical treatment in delaying or preventing the onset of POAG in individuals with elevated IOP. Therefore, we designed a randomized clinical trial, the Ocular Hypertension Treatment Study. OBJECTIVE To determine the safety and efficacy of topical ocular hypotensive medication in delaying or preventing the onset of POAG. METHODS A total of 1636 participants with no evidence of glaucomatous damage, aged 40 to 80 years, and with an IOP between 24 mm Hg and 32 mm Hg in one eye and between 21 mm Hg and 32 mm Hg in the other eye were randomized to either observation or treatment with commercially available topical ocular hypotensive medication. The goal in the medication group was to reduce the IOP by 20% or more and to reach an IOP of 24 mm Hg or less. MAIN OUTCOME MEASURES The primary outcome was the development of reproducible visual field abnormality or reproducible optic disc deterioration attributed to POAG. Abnormalities were determined by masked certified readers at the reading centers, and attribution to POAG was decided by the masked Endpoint Committee. RESULTS During the course of the study, the mean +/- SD reduction in IOP in the medication group was 22.5% +/- 9.9%. The IOP declined by 4.0% +/- 11.6% in the observation group. At 60 months, the cumulative probability of developing POAG was 4.4% in the medication group and 9.5% in the observation group (hazard ratio, 0.40; 95% confidence interval, 0.27-0.59; P<.0001). There was little evidence of increased systemic or ocular risk associated with ocular hypotensive medication. CONCLUSIONS Topical ocular hypotensive medication was effective in delaying or preventing the onset of POAG in individuals with elevated IOP. Although this does not imply that all patients with borderline or elevated IOP should receive medication, clinicians should consider initiating treatment for individuals with ocular hypertension who are at moderate or high risk for developing POAG.