College of Optometry, The Ohio State University, Columbus, Ohio.
Mayo Clinic, Rochester, Minnesota.
Ophthalmology. 2019 Jun;126(6):876-887. doi: 10.1016/j.ophtha.2018.12.049. Epub 2019 Jan 4.
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.
Prospective randomized clinical trial.
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.
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.
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.
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).
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).
在 1 至 2 岁患有中高度远视且无显性斜视的儿童中，比较了两种管理策略：（1）立即配镜与（2）不戴眼镜观察，除非视力（VA）、立体视锐度降低或出现显性斜视。
前瞻性随机临床试验。
共有 130 名年龄在 1 至 2 岁之间的儿童，他们的远视在至少一只眼中为+3.00 屈光度（D）至+6.00 D 球镜等效（SE），双眼屈光参差≤1.50 D SE，散光≤1.50 D，基于睫状肌麻痹验光，且无显性斜视。
参与者被随机分配至眼镜（比完全睫状肌麻痹远视低 1.00 D）组或观察组，并在 3 年内每 6 个月随访一次。如果观察组的儿童符合以下特定的恶化标准，包括视力或近立体视锐度低于年龄正常值，或出现显性斜视，则会配眼镜：（1）在试验镜架下，无需矫正，经过遮盖后复测证实，无论之前是否有过恶化；（2）进行斜视手术。
在 3 年的主要结果检查中，如果视力或立体视锐度低于年龄正常值，或观察到显性斜视（无论是否在试验镜架下矫正，经遮盖后复测证实，且不论是否之前已经恶化），或者已经进行了斜视手术，则判定儿童不符合随机管理方案，即治疗失败。
在完成 3 年主要结果检查的 106 名参与者（82%）中，53 名佩戴眼镜的儿童中有 11 名（21%）失败，53 名观察组儿童中有 18 名（34%）失败（差异为-13%；95%置信区间[CI]，-31 至 4；P=0.14）。观察组中 62%（95% CI，49-74）的儿童和眼镜组中 34%（95% CI，23-48）的儿童符合恶化标准（如果不戴眼镜则需要戴眼镜）。
对于未经矫正的中高度远视（+3.00 D 至+6.00 D SE）的 1 至 2 岁儿童，我们估计 3 年 6 个月的随访后，治疗失败的情况不确定，与立即配镜相比，谨慎观察（如果恶化则配镜）可能有小到中度的益处或无益处。
