接英教授团队：低水平红光（LLRL）近视儿童等效球镜误差和眼轴长度的作用

650 nm的LLRL已被相关研究证明有助于减缓近视进展。然而，LLRL是否对没有近视的儿童有类似的影响目前还不清楚，并且出于伦理考虑，通常不会为他们提供干预措施。但是一些患有正视或远视的儿童可能会迅速发展近视，与同龄人相比，他们的远视储备会迅速耗尽。此外，之前的一项研究报告了LLRL治疗依从性与近视控制疗效之间的剂量反应关系。值得探讨的是，如之前的研究所采用的，每周7天使用LLRL是否比每周5天使用LLLR更有效。

本研究为一项单中心、单盲、随机对照试验，共纳入336名 6 至 12 岁的儿童，这些参与者被按照1:1的比例随机分配到红光组和对照组。其中红光组给予650nm低强度单波长红光干预，每天照射两次，每次3分钟，中间间隔4小时以上，每周照射7天，不设休息间隔；而对照组则不提供其他干预措施。另外，在这两组中，近视儿童均可配戴单光框架镜，尚未近视的儿童不戴镜。本试验基线测量于 2021 年 8 月至 9 月完成，数据分析时间为 2023 年 3 月至 7 月。

图1 研究设计流程图

2021 年 8 月至 9 月，对 451 名已登记的儿童进行了资格评估；104 名儿童不符合纳入标准，11 名拒绝签署知情同意书。剩下的336 名参与者被纳入本研究，两组受试者随机化分配。6 个月时 LLRL 组和对照组的失访率分别为 4.2%（168 人中的 7 人）和 5.4%（168 人中的 9 人），12 个月时 LLRL 组和对照组的失访率分别为 6.5%（168 人中的 11 人）和 9.5%（168 人中的 16 人）。

表1 参与者的人口统计学和基线特征：受试者基线检查结果提示两组在人口统计学、初始眼轴长度、眼压等方面没有显著差异

1）6 个月时 LLRL 组和对照组的 SER 平均 (SD) 变化分别为 0.15 (0.16) D 和 -0.26 (0.21) D（差异，-0.41 D；95% CI，-0.48 至 -0.34 D；P  < .001）；

2）12 个月时 LLRL 组和对照组的 SER 平均 (SD) 变化分别为 0.24 (0.27) D 和 -0.65 (0.33) D（差异，-0.89 D；95% CI，-0.95 至 -0.83 D；P  < .001）6 个月时，LLRL 组和对照组的 AL 平均 (SD) 变化分别为 -0.06 (0.08) 毫米和 0.13 (0.12) 毫米（差异，0.19 毫米；95% CI，0.16 至 0.22 毫米；P  < .001）；

3）12 个月时，LLRL 组和对照组的 AL 平均 (SD) 变化分别为 -0.11 (0.10) 毫米和 0.26 (0.16) 毫米（差异，0.37 毫米；95% CI，0.34 至 0.40 毫米；P  < .001）；

图2 不同时间点测量的结果线图：显示了从基线到 6 个月和 12 个月随访的 AL 和 SER 的变化趋势

表2 各项结果一年内的变化

LLRL组和对照组的1年近视发生率分别为7.14%（4/56 患者）和23.21%（13/56患者）。对照组近视发生率高于LLRL组（16.07%；95%CI，2.66%至29.35%；P= .02）。对照组和LLRL组UDVA的平均（SD）变化分别为-0.09（0.32）和0.02（0.36），平均差为-0.11（95%CI，-0.18至-0.04；P < .001）。

本研究采用随机单盲对照试验研究了每天使用650 nm LLRL在中国大陆地区儿童中治疗近视的有效性和安全性。研究表明通过持续一年每天使用 650 nm LLRL ，SER 和 AL 的平均变化分别为 -0.11 mm 和 0.24 D，中心凹下 ChT 的平均变化为 16.46 μm。并且眼底和 OCT 图像分析的解释显示没有不良事件或视网膜损伤。这为今后低强度红光照射用于我国儿童近视的防控提供重要依据。

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