Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
JAMA Ophthalmol. 2024 Jun 1;142(6):560-567. doi: 10.1001/jamaophthalmol.2024.0801.
Treatments are needed to slow progression of or reduce incidence of myopia.
To evaluate the efficacy and safety of daily 650-nm low-level red light (LLRL) for myopia treatment.
DESIGN, SETTING, AND PARTICIPANTS: Single-masked, randomized clinical trial at 1 site in China. Baseline measurements were completed from August to September 2021. Participants were children aged 6 to 12 years with spherical equivalent error (SER) of -6 diopters (D) to 3 D. Data were analyzed from March to July 2023.
Irradiation daily with 650-nm LLRL for 3 minutes twice daily 4 or more hours apart or no intervention.
Primary outcomes were changes in cycloplegia SER and axial length (AL) at 6- and 12-month follow-up visits. Safety was assessed on masked fundus photograph evaluations.
A total of 336 children were randomly allocated into the LLRL group or control group in a 1:1 ratio. The control group contained 86 female patients (51.2%), and the treatment group contained 90 female patients (53.6%). The mean (SD) age, SER, and AL were 9.0 (1.9) years, -1.3 (1.5) D, and 23.8 (1.0) mm for all patients. A total of 161 (95.8%) in the LLRL group and 159 (94.6%) in the control group returned for the 6-month follow-up. A total of 157 (93.5%) in the LLRL group and 152 (90.5%) in the control group returned for the 12-month follow-up. Mean (SD) changes in SER were 0.15 (0.16) D and -0.26 (0.21) D for the LLRL group and the control group, respectively (difference, -0.41 D; 95% CI, -0.48 to -0.34 D; P < .001), at 6 months and 0.24 (0.27) D and -0.65 (0.33) D for the LLRL group and the control group, respectively (difference, -0.89 D; 95% CI, -0.95 to -0.83 D; P < .001), at 12 months. Mean (SD) changes in AL were -0.06 (0.08) mm and 0.13 (0.12) mm for the LLRL group and control group, respectively (difference, 0.19 mm; 95% CI, 0.16 to 0.22 mm; P < .001), at 6 months and -0.11 (0.10) mm and 0.26 (0.16) mm for the LLRL group and control group, respectively (difference, 0.37 mm; 95% CI, 0.34 to 0.40 mm; P < .001). Masked fundus photograph review did not identify retinal changes in either group.
These findings suggest daily use of 650-nm LLRL for 1 year can slow progression of SER and AL without safety concerns identified. Confirmation of these findings at independent sites seems warranted, as well as determining whether these effects can be sustained with or without continued treatment and whether LLRL has any effect on pathological myopia.
ChiCTR2200058963.
重要性：需要治疗来减缓近视的进展或降低近视的发病率。
目的：评估每天使用 650nm 低水平红光（LLRL）治疗近视的疗效和安全性。
设计、地点和参与者：在中国的一个地点进行的单盲、随机临床试验。基线测量于 2021 年 8 月至 9 月完成。参与者为年龄在 6 至 12 岁之间、球镜等效误差（SER）为-6 屈光度（D）至 3 D 的儿童。数据于 2023 年 3 月至 7 月进行分析。
干预措施：每天用 650nm LLRL 照射两次，每次 3 分钟，两次照射间隔 4 小时以上或不进行干预。
主要结果和测量：主要结果是 6 个月和 12 个月随访时的睫状肌麻痹 SER 和眼轴（AL）变化。安全性通过眼底照片评估进行评估。
结果：共有 336 名儿童按 1:1 的比例随机分配到 LLRL 组或对照组。对照组有 86 名女性患者（51.2%），治疗组有 90 名女性患者（53.6%）。所有患者的平均（SD）年龄、SER 和 AL 分别为 9.0（1.9）岁、-1.3（1.5）D 和 23.8（1.0）mm。LLRL 组共有 161 名（95.8%）和对照组 159 名（94.6%）患者返回进行 6 个月随访。LLRL 组共有 157 名（93.5%）和对照组 152 名（90.5%）患者返回进行 12 个月随访。LLRL 组和对照组的 SER 变化的平均值（SD）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），在 6 个月和 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），在 12 个月。LLRL 组和对照组的 AL 变化的平均值（SD）分别为-0.06（0.08）mm 和 0.13（0.12）mm（差异，0.19 mm；95%CI，0.16 至 0.22 mm；P < .001），在 6 个月和-0.11（0.10）mm 和 0.26（0.16）mm（差异，0.37 mm；95%CI，0.34 至 0.40 mm；P < .001）。眼底照片复查未发现两组视网膜有任何变化。
结论和相关性：这些发现表明，每天使用 650nm LLRL 治疗 1 年可减缓 SER 和 AL 的进展，且未发现安全性问题。在独立地点进一步证实这些发现似乎是合理的，还需要确定这些效果是否可以在继续治疗或不继续治疗的情况下持续存在，以及 LLRL 是否对病理性近视有任何影响。
试验注册：ChiCTR2200058963。
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