A randomized clinical trial of progressive addition lenses versus single vision lenses on the progression of myopia in children
A randomized clinical trial of progressive addition lenses versus single vision lenses on the progression of myopia in children
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DOI：
10.1167/iovs.02-0816
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发表时间：
2003-04-01
影响因子：
4.4
通讯作者：
Scheiman, M
中科院分区：
文献类型：
--
作者：
Gwiazda, J;Hyman, L;Scheiman, M
目的.近视矫正评价试验（COMET）的目的是评价渐进多焦点镜片（帕尔斯）与单视镜片（SVLs）对青少年近视进展的影响。COMET招募了469名儿童（年龄6-11岁），近视眼在-1.25和-4.50 D等效球镜之间。这些儿童是在美国的四所验光学院招募的，种族多样。他们被随机分配接受帕尔斯+2.00增加（n = 235）或SVLs（n = 234），传统的近视眼镜治疗，并随访3年。主要结果指标是近视的进展，在每次年度访视时使用2滴1%托吡卡胺的睫状肌麻痹剂后通过自动验光确定。次要结局指标是眼轴长度的变化，通过A扫描超声检查进行评估。基于儿童的分析（即，两只眼睛的平均值）。通过使用多元线性回归对结果进行重要协变量调整。在469名儿童（基线时平均年龄为9.3 ± 1.3岁）中，462名（98.5%）完成了3年访视。PAL组和SVL组的3年平均（+/-SE）近视（等效球镜）增加分别为-1.28 +/- 0.06 D和-1.48 +/- 0.06 D。两组之间的3年进展差异为0.20 +/- 0.08 D，具有统计学显著性（P = 0.004）。治疗效果主要在第一年观察。仅在第一年，不同治疗组的处方变更数量存在显著差异。6个月时，PAL组17%与SVL组30%需要改变处方（P = 0.0007），1年时，PAL组43%与SVL组59%需要改变处方（P = 0.002）。相互作用分析发现，在近视时基线矫正反应较低与较高（P = 0.03）和基线近视较低与较高（P = 0.04）的儿童中，帕尔斯的治疗效果显著更大。PAL和SVL组儿童眼轴长度的平均（+/- SE）增加分别为：0.64 +/- 0.02 mm和0.75 +/- 0.02 mm，3年平均差异为0.11 +/- 0.03 mm（P = 0.0002），具有统计学意义。眼轴长度的平均变化与屈光不正相关（PAL的r = 0.86，SVL的r = 0.89）。与SVLs相比，使用帕尔斯仅在第一年内减缓了COMET儿童近视的进展。治疗效果的大小在接下来的2年中保持相似和显著。这些结果为COMET理论提供了一些支持，即离焦在近视发展中的作用。影响幅度较小，不需要改变临床实践。
PURPOSE. The purpose of the Correction of Myopia Evaluation Trial (COMET) was to evaluate the effect of progressive addition lenses (PALS) compared with single vision lenses (SVLs) on the progression of juvenile-onset myopia.METHODS. COMET enrolled 469 children (ages 6-11 years) with myopia between - 1.25 and - 4.50 D spherical equivalent. The children were recruited at four colleges of optometry in the United States and were ethnically diverse. They were randomly assigned to receive either PALS with a +2.00 addition (n = 235) or SVLs (n = 234), the conventional spectacle treatment for myopia, and were followed for 3 years. The primary outcome measure was progression of myopia, as determined by autorefraction after cycloplegia with 2 drops of 1% tropicamide at each annual visit. The secondary outcome measure was change in axial length of the eyes, as assessed by A-scan ultrasonography. Child-based analyses (i.e., the mean of the two eyes) were used. Results were adjusted for important covariates, by using multiple linear regression.RESULTS. Of the 469 children (mean age at baseline, 9.3+/- 1.3 years), 462 (98.5%) completed the 3-year visit. Mean (+/-SE) 3-year increases in myopia (spherical equivalent) were - 1.28 +/- 0.06 D in the PAL group and - 1.48 +/- 0.06 D in the SVL group. The 3-year difference in progression of 0.20 +/- 0.08 D between the two groups was statistically significant (P = 0.004). The treatment effect was observed primarily in the first year. The number of prescription changes differed significantly by treatment group only in the first-year. At 6 months, 17% of the PAL group versus 30% of the SVL group needed a prescription change (P = 0.0007), and, at 1 year, 43% of the PAL group versus 59% of the SVL group required a prescription change (P = 0.002). Interaction analyses identified a significantly larger treatment effect of PALS in children with lower versus higher baseline accommodative response at near (P = 0.03) and with lower versus higher baseline myopia (P = 0.04). Mean (+/- SE) increases in the axial length of eyes of children in the PAL and SVL groups, respectively, were: 0.64 +/- 0.02 mm and 0.75 +/- 0.02 mm, with a statistically significant 3-year mean difference of 0.11 +/- 0.03 mm (P = 0.0002). Mean changes in axial length correlated with those in refractive error (r = 0.86 for PAL and 0.89 for SVL).CONCLUSIONS. Use of PALS compared with SVLs slowed the progression of myopia in COMET children by a small, statistically significant amount only during the first year. The size of the treatment effect remained similar and significant for the next 2 years. The results provide some support for the COMET rationale-that is, a role for defocus in progression of myopia. The small magnitude of the effect does not warrant a change in clinical practice.