State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangdong Provincial Key Laboratory of Ophthalmology Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Sun Yat-sen University, Guangzhou, China.
Foshan Women and Children's Hospital, Foshan, Guangdong, China.
JAMA Pediatr. 2024 Jun 1;178(6):533-539. doi: 10.1001/jamapediatrics.2024.0578.
Early onset of myopia increases the risk of high myopia, which can lead to irreversible retinal damage and even loss of central vision.
To investigate the efficacy and safety of naked-eye 3-dimensional vision training (NVT) in preventing the progression of myopia in children.
DESIGN, SETTING, AND PARTICIPANTS: This 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).
Children in the intervention group received 20 minutes of NVT treatment every day, whereas children in the control group lived as usual without vision training.
The primary outcome was the change in axial length at 6 months. Spherical equivalent refraction (SER) was included as a secondary outcome.
Among 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.
NVT is a safe and promising means to control myopia progression in children with good adherence.
ClinicalTrials.gov Identifier: NCT05468775.
近视的早期发病会增加高度近视的风险，而高度近视可能导致不可逆转的视网膜损伤，甚至丧失中心视力。
研究裸眼 3D 视觉训练（NVT）在预防儿童近视进展中的疗效和安全性。
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。参与者为患有近视（等效球镜度为-0.75 至-6.00 屈光度（D））的 6-18 岁儿童。
干预组的儿童每天接受 20 分钟的 NVT 治疗，而对照组的儿童照常生活，不进行视力训练。
主要结局为 6 个月时眼轴长度的变化。球镜等效屈光度（SER）作为次要结局纳入研究。
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 名患者（86.3%）完成了 6 个月的随访，其中干预组 102 名，对照组 125 名。在干预组中，6 个月时眼轴长度和 SER 的变化分别为 0.18 毫米（95%置信区间，0.16 至 0.20 毫米）和-0.25 D（95%置信区间，-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 毫米（95%置信区间，0.21 至 0.25 毫米）和-0.35 D（95%置信区间，-0.41 至-0.30 D）。两组间 AL 和 SER 的差异均有统计学意义（AL 差异：-0.06 毫米；95%置信区间，-0.09 至-0.03；P < 0.001；SER 差异：0.10 D；95%置信区间，0.02 至 0.19；P = 0.02）。随访期间未报告与研究相关的不良反应。
NVT 是一种安全且有前途的方法，可以控制依从性良好的儿童近视进展。
ClinicalTrials.gov 标识符：NCT05468775。
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