针对近视的4种红光疗法设备的安全性评估
Lisa A Ostrin1, Alexander W Schill1
1University of Houston College of Optometry, Houston, Texas.
JAMA ophthalmology
|February 5, 2026
概括
治疗近视的红色激光疗法设备可能会带来风险,因为有些设备很快就会超过安全限制. 在这些红光疗法设备在儿科广泛使用之前,严格的安全验证至关重要.
科学领域:
- 眼科医生 眼科 眼科
- 生物医学工程 生物医学工程
- 照相医疗 (photomedicine) 是一种医学.
背景情况:
- 红色激光疗法越来越多地用于近视治疗,特别是在亚洲.
- 有关商业上可用的红光疗法设备的眼睛安全存在担忧.
- 对这些设备的光输出和安全分类进行了有限的严格评估.
研究的目的:
- 评估四种商业红光治疗近视器件的光学输出和安全分类.
- 评估这些设备是否符合美国国家标准协会 (ANSI) 的安全指南.
主要方法:
- 在实验室中对四种近视管理设备 (Sky-n1201,Future Vision,EyeRising,AirDoc) 进行了评估.
- 在指定的距离和光圈大小测量辐射功率.
- 对各种瞳孔直径的视网膜辐射的计算.
- 根据ANSI Z80.36-2021和ANSI Z136.1-2022标准进行安全分类.
主要成果:
- 基于激光的设备 (Sky-n1201,EyeRising) 在1.4到2.8秒内达到ANSI1组安全限值,对于7毫米的瞳孔,分类为1和2M类.
- 未来视觉设备超过了延长的曝光时间,但仍然属于第1类.
- 基于LED的AirDoc设备达到极限的时间要长得多 (22,761秒),被归类为第一组.
结论:
- 激光红光疗法设备可能会在比推的治疗持续时间更短的暴露时间中产生辐射水平,达到安全极限.
- 视网膜损伤的临床报告和监管行动需要对儿科使用进行独立的安全验证.
- 在广泛采用之前,迫切需要对红光疗法设备进行严格的安全评估.
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