Kass Michael A, Heuer Dale K, Higginbotham Eve J, Johnson Chris A, Keltner John L, Miller J Philip, Parrish Richard K, Wilson M Roy, Gordon Mae O
Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St Louis, MO 63110, USA.
Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.
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.
To determine the safety and efficacy of topical ocular hypotensive medication in delaying or preventing the onset of POAG.
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.
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.
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.
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.
原发性开角型青光眼（POAG）是美国及全球致盲的主要原因之一。在美国，有300万至600万人因眼压（IOP）升高或高眼压症而患POAG的风险增加。对于药物治疗在延迟或预防眼压升高个体发生POAG方面的疗效尚无共识。因此，我们设计了一项随机临床试验，即高眼压治疗研究。
确定局部降眼压药物在延迟或预防POAG发病方面的安全性和有效性。
共有1636名年龄在40至80岁之间、无青光眼损害证据、一只眼眼压在24 mmHg至32 mmHg之间且另一只眼眼压在21 mmHg至32 mmHg之间的参与者被随机分为观察组或使用市售局部降眼压药物治疗组。药物治疗组的目标是使眼压降低20%或更多，并使眼压达到24 mmHg或更低。
主要结局是出现可重复的视野异常或归因于POAG的可重复的视盘恶化。异常由阅读中心的蒙面认证阅片者确定，而归因于POAG则由蒙面终点委员会决定。
在研究过程中，药物治疗组眼压的平均降低幅度±标准差为22.5%±9.9%。观察组眼压下降了4.0%±11.6%。在60个月时，药物治疗组发生POAG的累积概率为4.4%，观察组为9.5%（风险比，0.40；95%置信区间，0.27 - 0.59；P<0.0001）。几乎没有证据表明降眼压药物会增加全身或眼部风险。
局部降眼压药物在延迟或预防眼压升高个体发生POAG方面有效。虽然这并不意味着所有眼压临界或升高的患者都应接受药物治疗，但临床医生应考虑对患POAG中度或高风险的高眼压个体开始治疗。
