Department of Ophthalmology, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University, School of Medicine, Tongji University, Shanghai, 200072, China.
The Third the People's Hospital of Bengbu, Central Hospital of Bengbu, Anhui, 233099, China.
BMC Ophthalmol. 2024 Sep 16;24(1):358. doi: 10.1186/s12886-024-03580-w.
To assess the efficacy and safety of virtual reality-based visual training (VRVT) in myopia control among children.
The randomized, parallel-group, single-blind clinical trial conducted at the Department of Ophthalmology of Shanghai Tenth People's Hospital enrolled 65 low-myopic children (aged 8 to 13 years) with cycloplegic spherical equivalent (SE) between - 0.50 and - 3.00 diopters (D), astigmatism less than - 1.00 D, anisometropia less than 1.50D, and best corrected visual acuity (BCVA) more than 0.0 logarithm (LogMAR) of the minimum angle of resolution. The participants were enrolled in December 2020, and the follow-up of this study concluded on August 2021. Children were assigned randomly to the intervention group (VRVT plus single-vision spectacle [SVS]) and the control group (only SVS without receiving VRVT). The intervention group was administered for 20 min per day with VRVT under parental supervision at home. The primary outcome was changes in axial length (AL) at 3 months. Macular choroidal thickness (mCT) was regarded as a key secondary outcome.
Among 65 participants (mean age: 10.8 years, 52.3% male), 60 children (92.3%) who completed the 3-month intervention and 6-month follow-up were included in the analysis (30 in the intervention group and 30 in the control group). The changes of AL were 0.063 ± 0.060 mm (95% confidence interval [CI], 0.074 to 0.119 mm) in the intervention group and 0.129 ± 0.060 mm (95% CI, 0.107 to 0.152 mm) and in the control group at 3 months (t = - 2.135, P = 0.037), and the mean difference between the two groups was 0.066 mm. The change of mCT were 22.633 ± 36.171 μm (95% CI, 9.127 to 36.140 μm) in the intervention group and - 3.000 ± 31.056 μm (95% CI, - 14.597 to 8.597 μm) in the control group at 3 months (t = 2.945, P = 0.005). VR vertigo was the most common adverse event which was occurred in two children (2/30, 6.67%) in the intervention group.
VRVT is a promising method for myopia control in children with good user acceptability. Among children aged 8 to 13 years with low-myopia, nightly use of VRVT resulted in slowing myopia progression.
This protocol was registered with ClinicalTrials.gov (NCT06250920), retrospectively registered on 01 February 2024.
评估虚拟现实视觉训练（VRVT）在儿童近视控制中的疗效和安全性。
这项在上海第十人民医院眼科进行的随机、平行分组、单盲临床试验纳入了 65 名低近视儿童（年龄 8 至 13 岁），他们的睫状肌麻痹球镜等效值（SE）在-0.50 至-3.00 屈光度（D）之间，散光小于-1.00 D，屈光参差小于 1.50 D，最佳矫正视力（BCVA）大于 0.0 最小角分辨率对数（LogMAR）。参与者于 2020 年 12 月入组，本研究的随访于 2021 年 8 月结束。儿童被随机分配到干预组（VRVT 加单焦眼镜[SVS]）和对照组（仅接受 SVS 而不接受 VRVT）。干预组在家庭中由家长监督下每天接受 20 分钟 VRVT。主要结局是 3 个月时眼轴长度（AL）的变化。脉络膜视网膜厚度（mCT）被视为关键次要结局。
在 65 名参与者（平均年龄：10.8 岁，52.3%为男性）中，60 名（92.3%）完成 3 个月干预和 6 个月随访的儿童纳入分析（干预组 30 名，对照组 30 名）。干预组 AL 的变化为 0.063±0.060mm（95%置信区间[CI]：0.074 至 0.119mm），对照组为 0.129±0.060mm（95%CI：0.107 至 0.152mm），差异有统计学意义（t=-2.135，P=0.037），两组之间的平均差异为 0.066mm。mCT 的变化在干预组为 22.633±36.171μm（95%CI：9.127 至 36.140μm），对照组为-3.000±31.056μm（95%CI：-14.597 至 8.597μm），差异有统计学意义（t=2.945，P=0.005）。VR 眩晕是最常见的不良反应，发生在干预组的 2 名儿童（2/30，6.67%）中。
VRVT 是一种有前途的儿童近视控制方法，具有良好的用户可接受性。在 8 至 13 岁的低近视儿童中，夜间使用 VRVT 可减缓近视进展。
本方案在 ClinicalTrials.gov（NCT06250920）注册，于 2024 年 2 月 1 日进行了回顾性注册。
