近视X-1 缓慢青少年近视进展的新方法的安全性和有效性:多中心,随机,受控试验
James Loughman1, Gareth Lingham2, Hakan Kaymak3,4
1Centre for Eye Research Ireland, Sustainability and Health Research Hub, Technological University Dublin, Dublin, Ireland.
Ophthalmology science
|December 24, 2025
概括
一个新的智能手机应用程序MyopiaX在为期12个月的试验中证明了安全性和耐受性,用于控制儿童近视的进展. 这种创新的蓝光疗法显示出作为渐进近视的补充治疗的潜力.
科学领域:
- 眼科医生 眼科 眼科
- 儿科眼科医生 儿科眼科医生
- 医疗技术 医疗技术 医学技术
背景情况:
- 近视 (近视) 是儿童和青少年日益严重的全球健康问题.
- 有效的近视控制策略对于预防视力障碍和相关风险至关重要.
研究的目的:
- 为了评估MyopiaX的安全性,耐受性和有效性,MyopiaX是一个智能手机应用程序,向视神经头部提供有针对性的蓝光.
- 调查MyopiaX在儿童群体中控制近视进展的潜力.
主要方法:
- 一个多中心的,随机的,主动控制的,检查员蒙面的临床试验,涉及6-12岁的近视儿童.
- 参与者被分配到MyopiaX或积极对照 (DIMS眼镜),使用协议超过12个月.
- 主要结局包括6个月轴长 (AL) 和球体等效折射 (SER) 的变化.
主要成果:
- 6个月后,AL的平均变化为MyopiaX的0.14 ± 0.11毫米,DIMS的0.08 ± 0.09毫米.
- 6个月后的平均SER变化为MyopiaX的 -0.18 ± 0.39 D和DIMS的 -0.16 ± 0.41 D.
- 22%的MyopiaX用户经历了轻微的,短暂的不良事件,如眼部不适和头痛.
结论:
- 在患近视的儿童中,MyopiaX被发现是安全的,在12个月内耐受良好.
- 这项研究提供了关于MyopiaX用于控制近视的蓝光刺激的第一个临床数据.
- MyopiaX代表了一种新的,潜在的补充治疗选择,用于管理渐进的近视.
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