ImportanceEarly onset of myopia increases the risk of high myopia, which can lead to irreversible retinal damage and even loss of central vision.ObjectiveTo investigate the efficacy and safety of naked-eye 3-dimensional vision training (NVT) in preventing the progression of myopia in children.Design, Setting, and ParticipantsThis randomized clinical trial was conducted in 3 hospitals from May 25, 2022, to February 24, 2023. Participants were children (aged 6-18 years) who had a diagnosis of myopia with a spherical equivalent refraction of −0.75 to −6.00 diopters (D).InterventionChildren in the intervention group received 20 minutes of NVT treatment every day, whereas children in the control group lived as usual without vision training.Main Outcome and MeasureThe primary outcome was the change in axial length at 6 months. Spherical equivalent refraction (SER) was included as a secondary outcome.ResultsAmong 263 participants, 125 (47.5%) were male and 138 (52.5%) were female; the mean (SD) age was 10.3 (1.9) years (range, 6.1-15.6 years). A total of 227 patients (86.3%) completed the 6-month follow-up, including 102 in the intervention group and 125 in the control group. In the intervention group, the changes in axial length and SER at 6 months were 0.18 mm (95% CI, 0.16 to 0.20 mm) and −0.25 D (95% CI, −0.31 to −0.19 D), respectively. In the control group, the changes in axial length and SER at 6 months were 0.23 mm (95% CI, 0.21 to 0.25 mm) and −0.35 D (95% CI, −0.41 to −0.30 D), respectively. The differences in AL and SER between the 2 groups were significant (AL difference: −0.06 mm; 95% CI, −0.09 to −0.03; P < .001; SER difference: 0.10 D; 95% CI, 0.02 to 0.19; P = .02). No study-related adverse reactions were reported during follow-up.Conclusions and RelevanceNVT is a safe and promising means to control myopia progression in children with good adherence.Trial RegistrationClinicalTrials.gov Identifier: NCT05468775

中文翻译：

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裸眼三维视觉训练控制近视

近视早期发病会增加高度近视的风险，从而导致不可逆的视网膜损伤，甚至中心视力丧失。目的探讨裸眼三维视觉训练（NVT）在预防近视加深方面的有效性和安全性。设计、设置和参与者这项随机临床试验于2022年5月25日至2023年2月24日在3家医院进行。参与者是被诊断为近视、等效球镜屈光度为−0.75至-6.00屈光度（D）。干预干预组儿童每天接受20分钟的NVT治疗，而对照组儿童照常生活，不进行视力训练。主要结果和测量主要结果是眼轴长度的变化6个月。等效球镜屈光 (SER) 被列为次要结果。 结果 在 263 名参与者中，125 名 (47.5%) 为男性，138 名 (52.5%) 为女性；平均 (SD) 年龄为 10.3 (1.9) 岁（范围：6.1-15.6 岁）。共有227例患者（86.3%）完成了6个月的随访，其中干预组102例，对照组125例。在干预组中，6个月时眼轴和SER的变化分别为0.18 mm（95% CI，0.16至0.20 mm）和-0.25 D（95% CI，-0.31至-0.19 D）。在对照组中，6个月时眼轴长度和SER的变化分别为0.23 mm（95% CI，0.21至0.25 mm）和-0.35 D（95% CI，-0.41至-0.30 D）。两组间 AL 和 SER 差异显着（AL 差异：-0.06 mm；95% CI，-0.09 至 -0.03；磷< .001; SER差值：0.10D； 95% CI，0.02 至 0.19；磷= .02)。随访期间未报告与研究相关的不良反应。结论和相关性NVT 是一种安全且有前景的控制儿童近视进展的方法，且依从性良好。试验注册ClinicalTrials.gov 标识符：NCT05468775