Department of Ophthalmology, The First Affiliated Hospital of Baotou Medical College, Baotou, China.
Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia; Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia.
Ophthalmology. 2023 Feb;130(2):198-204. doi: 10.1016/j.ophtha.2022.08.024. Epub 2022 Aug 29.
Repeated low-level red-light (RLRL) therapy is an emerging treatment for myopia control. Nevertheless, previous studies are limited by open-label design. Our study aimed to assess the efficacy and safety of RLRL therapy in controlling myopia progression compared to a sham device with only 10% of the original power.
Randomized, double-blind, controlled clinical trial.
A total of 112 Chinese children aged 7 to 12 years with myopia of at least -0.50 diopter (D), astigmatism of 1.50 D or less, and anisometropia of 1.50 D or less.
Participants were assigned randomly in a 1:1 ratio to the RLRL group or the sham device control group, following a schedule of 3 minutes per session, twice daily, with an interval between sessions of at least 4 hours. The RLRL therapy was provided by a desktop red-light therapy device and administered at home. The sham device was the same device but with only 10% of the original device's power. Cycloplegic refraction and axial length (AL) were measured at baseline and 6 months.
Changes in cycloplegic spherical equivalence refraction (SER) and AL between 2 groups were compared using a generalized estimating equation (GEE).
A total of 111 children were included in the analysis (n = 56 in the RLRL group and n = 55 in the sham device control group). The mean SER change over 6 months was 0.06 ± 0.30 D in the RLRL group and -0.11 ± 0.33 D in the sham device control group (P = 0.003), with respective mean increases in AL of 0.02 ± 0.11 mm and 0.13 ± 0.10 mm (P < 0.001). In the multivariate GEE models, children in the RLRL group showed less myopia progression and axial elongation than those in the sham device control group (SER: coefficient, 0.167 D; 95% confidence interval [CI], 0.050-0.283 D; P = 0.005; AL: coefficient, -0.101 mm; 95% CI, -0.139 to -0.062 mm; P < 0.001). No treatment-related adverse events were reported.
In myopic children, RLRL therapy with 100% power significantly reduced myopia progression over 6 months compared with those treated with a sham device of 10% original power. The RLRL treatment was well tolerated without treatment-related adverse effects.
重复低水平红光（RLRL）疗法是一种新兴的近视控制治疗方法。然而，之前的研究受到开放标签设计的限制。本研究旨在评估 RLRL 疗法与仅 10%原始功率的假设备相比，在控制近视进展方面的疗效和安全性。
随机、双盲、对照临床试验。
共有 112 名年龄在 7 至 12 岁的中国儿童，患有至少 -0.50 屈光度（D）的近视、1.50 D 或更低的散光和 1.50 D 或更低的屈光参差。
参与者按照 1:1 的比例随机分配到 RLRL 组或假设备对照组，每次治疗 3 分钟，每天两次，两次治疗之间的间隔至少 4 小时。RLRL 治疗由台式红光治疗设备在家中提供。假设备是同一种设备，但功率只有原始设备的 10%。在基线和 6 个月时测量睫状肌麻痹验光折射和眼轴（AL）。
使用广义估计方程（GEE）比较两组之间的睫状肌麻痹球镜等效折射（SER）和 AL 变化。
共有 111 名儿童纳入分析（RLRL 组 n=56，假设备对照组 n=55）。RLRL 组 6 个月时 SER 平均变化为 0.06±0.30 D，假设备对照组为 -0.11±0.33 D（P=0.003），相应的 AL 平均增加值分别为 0.02±0.11 mm 和 0.13±0.10 mm（P<0.001）。在多元 GEE 模型中，RLRL 组儿童的近视进展和轴向伸长速度均低于假设备对照组（SER：系数，0.167 D；95%置信区间[CI]，0.050-0.283 D；P=0.005；AL：系数，-0.101 mm；95%CI，-0.139 至 -0.062 mm；P<0.001）。未报告与治疗相关的不良事件。
在近视儿童中，与接受 10%原始功率假设备治疗的儿童相比，100%功率的 RLRL 治疗在 6 个月内显著减少了近视进展。RLRL 治疗耐受良好，无治疗相关不良事件。
