Jiang Yu, Zhu Zhuoting, Tan Xingping, Kong Xiangbin, Zhong Hui, Zhang Jian, Xiong Ruilin, Yuan Yixiong, Zeng Junwen, Morgan Ian G, He Mingguang
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.
Hunan Key Laboratory of Ophthalmology, Eye Center of Xiangya Hospital, Central South University, Changsha, Hunan, China.
Ophthalmology. 2022 May;129(5):509-519. doi: 10.1016/j.ophtha.2021.11.023. Epub 2021 Dec 1.
To assess the efficacy and safety of repeated low-level red-light (RLRL) therapy in myopia control in children.
Multicenter, randomized, parallel-group, single-blind clinical trial.
Two hundred sixty-four eligible children 8 to 13 years of age with myopia of cycloplegic spherical equivalent refraction (SER) of -1.00 to -5.00 diopters (D), astigmatism of 2.50 D or less, anisometropia of 1.50 D or less, and best-corrected visual acuity (BCVA) of 0.0 logarithm of the minimum angle of resolution or more were enrolled in July and August 2019. Follow-up was completed in September 2020.
Children were assigned randomly to the intervention group (RLRL treatment plus single-vision spectacle [SVS]) and the control group (SVS). The RLRL treatment was provided by a desktop light therapy device that emits red light of 650-nm wavelength at an illuminance level of approximately 1600 lux and a power of 0.29 mW for a 4-mm pupil (class I classification) and was administered at home under supervision of parents for 3 minutes per session, twice daily with a minimum interval of 4 hours, 5 days per week.
The primary outcome and a key secondary outcome were changes in axial length and SER measured at baseline and the 1-, 3-, 6-, and 12-month follow-up visits. Participants who had at least 1 postrandomization follow-up visit were analyzed for treatment efficacy based on a longitudinal mixed model.
Among 264 randomized participants, 246 children (93.2%) were included in the analysis (117 in the RLRL group and 129 in the SVS group). Adjusted 12-month axial elongation and SER progression were 0.13 mm (95% confidence interval [CI], 0.09-0.17mm) and -0.20 D (95% CI, -0.29 to -0.11D) for RLRL treatment and 0.38 mm (95% CI, 0.34-0.42 mm) and -0.79 D (95% CI, -0.88 to -0.69 D) for SVS treatment. The differences in axial elongation and SER progression were 0.26 mm (95% CI, 0.20-0.31 mm) and -0.59D (95% CI, -0.72 to -0.46 D) between the RLRL and SVS groups. No severe adverse events (sudden vision loss ≥2 lines or scotoma), functional visual loss indicated by BCVA, or structural damage seen on OCT scans were observed.
Repeated low-level red-light therapy is a promising alternative treatment for myopia control in children with good user acceptability and no documented functional or structural damage.
评估重复低强度红光（RLRL）疗法对儿童近视控制的疗效和安全性。
多中心、随机、平行组、单盲临床试验。
2019年7月和8月招募了264名符合条件的8至13岁儿童，其睫状肌麻痹等效球镜度（SER）为-1.00至-5.00屈光度（D），散光2.50 D或更低，屈光参差1.50 D或更低，最佳矫正视力（BCVA）为0.0最小分辨角对数或更高。随访于2020年9月完成。
将儿童随机分为干预组（RLRL治疗加单焦眼镜[SVS]）和对照组（SVS）。RLRL治疗由台式光疗设备提供，该设备发射波长为650 nm的红光，照度约为1600勒克斯，4 mm瞳孔时功率为0.29 mW（I类分类），在家长监督下在家中进行，每次治疗3分钟，每天两次，最小间隔4小时，每周5天。
主要观察指标和一项关键次要观察指标是在基线以及1、3、6和12个月随访时测量的眼轴长度和SER的变化。基于纵向混合模型对至少有1次随机分组后随访的参与者进行治疗效果分析。
在264名随机分组的参与者中，246名儿童（93.2%）纳入分析（RLRL组117名，SVS组129名）。RLRL治疗的调整后12个月眼轴伸长和SER进展分别为0.13 mm（95%置信区间[CI]，0.09 - 0.17 mm）和-0.20 D（95% CI，-0.29至-0.11 D），SVS治疗分别为0.38 mm（95% CI，0.34 - 0.42 mm）和-0.79 D（95% CI，-0.88至-0.69 D）。RLRL组和SVS组在眼轴伸长和SER进展方面的差异分别为0.26 mm（95% CI，0.20 - 0.31 mm）和-0.59 D（95% CI，-0.72至-0.46 D）。未观察到严重不良事件（视力突然下降≥2行或暗点）、BCVA提示的功能性视力丧失或OCT扫描显示的结构损伤。
重复低强度红光疗法是一种有前景的儿童近视控制替代治疗方法，用户接受度良好，且未记录到功能性或结构性损伤。
