PURPOSE Two strategies were compared for managing moderate hyperopia without manifest strabismus among 1- and 2-year-old children: (1) immediate prescription of glasses versus (2) observation without glasses unless reduced distance visual acuity (VA), reduced stereoacuity, or manifest strabismus. DESIGN Prospective randomized clinical trial. PARTICIPANTS A total of 130 children aged 1 to 2 years with hyperopia between +3.00 diopters (D) and +6.00 D spherical equivalent (SE) in at least 1 eye, anisometropia ≤1.50 D SE, and astigmatism ≤1.50 D based on cycloplegic refraction and no manifest strabismus. METHODS Participants were randomly assigned to glasses (1.00 D less than full cycloplegic hyperopia) versus observation and followed every 6 months for 3 years. Glasses were prescribed to those assigned to observation if they met prespecified deterioration criteria of distance VA or near stereoacuity below age norms, or development of manifest strabismus. MAIN OUTCOME MEASURES At the 3-year primary outcome examination, participants were classified as failing the randomized management regimen if distance VA or stereoacuity was below age norms or manifest strabismus was observed (each with and without correction in trial frames, confirmed by masked retest, irrespective of whether deterioration had occurred previously), or if strabismus surgery had been performed. RESULTS Of the 106 participants (82%) completing the 3-year primary outcome examination, failure occurred in 11 (21%) of 53 in the glasses group and 18 (34%) of 53 in the observation group (difference = -13%; 95% confidence interval [CI], -31 to 4; P = 0.14). Sixty-two percent (95% CI, 49-74) in the observation group and 34% (95% CI, 23-48) in the glasses group met deterioration criteria (requiring glasses if not wearing). CONCLUSIONS For 1- and 2-year-olds with uncorrected moderate hyperopia (+3.00 D to +6.00 D SE), our estimates of failure, after 3 years of 6-month follow-ups, are inconclusive and consistent with a small to moderate benefit or no benefit of immediate prescription of glasses compared with careful observation (with glasses only if deteriorated).

中文翻译：

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立即和延迟眼镜对1岁和2岁儿童中度远视的随机临床试验。

目的比较了两种在1岁和2岁儿童中治疗中度远视而无明显斜视的策略：（1）立即配镜与（2）不用眼镜进行观察，除非距离视力（VA）降低，立体视力降低或表现为斜视。设计前瞻性随机临床试验。参与者共有130名1至2岁的儿童，至少1只眼的屈光度在+3.00屈光度（D）和+6.00 D球形当量之间，远视眼屈光度≤1.50D SE，散光度≤1.50D并没有明显的斜视。方法参与者被随机分为眼镜组（比完全睫状肌麻痹远视少1.00 D）与观察组，每6个月随访3年。如果眼镜符合预定的变质标准，即距离VA或低于年龄标准的近立体视，或出现明显的斜视，则应开眼镜。主要观察指标在3年的主要结局检查中，如果距离VA或立体视力低于年龄标准或出现斜视，则将参与者分类为未通过随机治疗方案（每个人在试验框架中进行或不进行矫正，均通过掩盖复习进行确认，不论以前是否发生过恶化），还是已进行过斜视手术。结果在完成三年初次结局检查的106名参与者中（82％），眼镜组53名中的11名（21％）和观察组53名中的18名（34％）发生了失败（差异= -13％） ； 95％置信区间[CI]，-31至4; P = 0.14）。观察组中有62％（95％CI，49-74）和眼镜组中34％（95％CI，23-48）符合恶化标准（如果不戴眼镜，则需要眼镜）。结论对于未矫正的中度远视（+3.00 D至+6.00 D SE）的1岁和2岁儿童，我们经过3年的6个月随访后对失败的估计是不确定的，与小至中度一致与仔细观察相比，立即配镜有好处或没有好处（仅当眼镜变质时才使用）。