PURPOSE To evaluate the effectiveness and safety of RLRL in delaying the progression of high myopes -6.00 D or worse. DESIGN Multicenter, randomized, parallel-group, single-blind clinical trial. PARTICIPANTS Two hundred and two high myopic children aged 7 to 12 years with cycloplegia spherical equivalent refraction (SE) ≤ -6.00 D, astigmatism less than 2.50 D, anisometropia of 1.50 D or less were enrolled from March 2022 to December 2022. Follow-up was completed in December 2023. METHODS Eligible participants were randomly allocated to either the intervention (RLRL + single vision spectacle [SVS]) or the control group (SVS). The RLRL treatment was administered every day for 3 minutes, twice a day, with an interval of at least 4 hours. MAIN OUTCOMES MEASURES The primary outcome was the change in axial length (AL) at 12 months compared to baseline. Secondary outcomes included changes in SE, changes of choroidal thickness (ChT) and retinal thickness (RT) in different circle sectors. Outcomes were analyzed by means of intention-to-treat and per-protocol methods. RESULTS After 12-month treatment, AL and SE changes were -0.11 ± 0.25 mm and 0.18 ± 0.63 D for RLRL group and 0.32 ± 0.09 mm and -0.80 ± 0.42 D for control group. Axial shortening > 0.05 mm was observed to 59% in the RLRL and 0% in the control group at 12 months. ChT and RT from a single center were analyzed. In the RLRL group, ChT were thickened in all sectors at 12 months. RT was increased in parafoveal and perifoveal circles. In the control group, all sectors of ChT and only perifoveal RT were significantly thinner at 12 months. The multivariate linear regression model revealed significant correlations between changes in ChT central foveal circle and RT perifoveal circle at 1 month and AL changes at 12 months. No fundus structure changes, afterimage exceeding 6 minutes nor best corrected visual acuity decreased reported. CONCLUSIONS RLRL could effectively shorten the AL and inhibit the progression of myopia in high myopic patients -6.00 D or worse. AL shortening is sustained over 12 months of treatment. These observed changes appeared to be associated with increases in ChT and RT.

中文翻译：

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重复低强度红光治疗对高度近视儿童的轴向缩短效果：一项多中心随机对照试验。


目的 评价 RLRL 在延缓高度近视 -6.00 D 或更差进展方面的有效性和安全性。设计 多中心、随机、平行组、单盲临床试验。参与者 2022 年 3 月至 2022 年 12 月入组了 2022 名 7 至 12 岁的高度近视儿童，眼睑肌麻痹球面等效屈光度 （SE） ≤ -6.00 D，散光小于 2.50 D，屈光参差 1.50 D 或更低。随访于 2023 年 12 月完成。方法 符合条件的参与者被随机分配到干预组 （RLRL + 单视眼镜 [SVS]） 或对照组 （SVS）。RLRL 治疗每天给药 3 分钟，每天两次，间隔至少 4 小时。主要结局指标 主要结局是与基线相比 12 个月时眼轴长度 （AL） 的变化。次要结局包括 SE 的变化、不同圆圈扇区脉络膜厚度 （ChT） 和视网膜厚度 （RT） 的变化。通过意向性治疗和按方案方法分析结局。结果 治疗 12 个月后，RLRL 组 AL 和 SE 变化分别为 -0.11 ± 0.25 mm 和 0.18 ± 0.63 D，对照组分别为 0.32 ± 0.09 mm 和 -0.80 ± 0.42 D。在 12 个月时，在 RLRL 中观察到轴向缩短 > 0.05 mm，达到 59%，在对照组中达到 0%。分析来自单个中心的 ChT 和 RT。在 RLRL 组中，ChT 在 12 个月时所有部门都增厚。RT 在旁中心凹和中心凹周围圆圈中增加。在对照组中，ChT 的所有扇区和仅中心凹周围 RT 在 12 个月时均显著变薄。多变量线性回归模型显示 1 个月时 ChT 中央凹圈和 RT 中心凹周围圈的变化与 12 个月时的 AL 变化之间存在显着相关性。 没有眼底结构改变，残影超过 6 分钟，最佳矫正视力也没有下降报告。结论 RLRL 可有效缩短 -6.00 D 或更差高度近视患者的 AL 并抑制近视进展。AL 缩短持续 12 个月的治疗。这些观察到的变化似乎与 ChT 和 RT 的增加有关。