Chen Hongyan, Wang Wei, Liao Ya, Zhou Wen, Li Qin, Wang Jingjing, Tang Jie, Pei Yifei, Wang Xiaojuan
Department of Ophthalmology, The First People's Hospital of Xuzhou, The Affiliated Xuzhou Municipal Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.
Xuzhou Medical University, Xuzhou, Jiangsu, China.
Graefes Arch Clin Exp Ophthalmol. 2023 Feb;261(2):575-584. doi: 10.1007/s00417-022-05794-4. Epub 2022 Aug 17.
To investigate the effect of low-intensity red-light (LRL) therapy on myopic control and the response after its cessation.
A prospective clinical trial. One hundred two children aged 6 to 13 with myopia were included in the LRL group (n = 51) and the single-focus spectacles (SFS) group (n = 51). In LRL group, subjects wore SFS and received LRL therapy provided by a laser device that emitted red-light of 635 nm and power of 0.35 ± 0.02 mW. One year after the control trial, LRL therapy was stopped for 3 months. The outcomes mainly included axial length (AL), spherical equivalent refraction (SER), subfoveal choroidal thickness (SFCT), and accommodative function.
After 12 months of therapy, 46 children in the LRL group and 40 children in the SFS group completed the trial. AL elongation and myopic progression were 0.01 mm (95%CI: - 0.05 to 0.07 mm) and 0.05 D (95%CI: - 0 .08 to 0.19 D) in the LRL group, which were less than 0.39 mm (95%CI: 0.33 to 0.45 mm) and - 0.64 D (95%CI: - 0.78 to - 0.51 D) in the SFS group (p < 0.05). The change of SFCT in the LRL group was greater than that in the SFS group (p < 0.05). Accommodative response and positive relative accommodation in the LRL group were more negative than those in the SFS group (p < 0.05). Forty-two subjects completed the observation of LRL cessation, AL and SER increased by 0.16 mm (95%CI: 0.11 to 0.22 mm) and - 0.20 D (95%CI: - 0.26 to - 0.14 D) during the cessation (p < 0.05), and SFCT returned to baseline (p > 0.05).
LRL is an effective measure for preventing and controlling myopia, and it may also have the ability to improve the accommodative function. There may be a slight myopic rebound after its cessation. The effect of long-term LRL therapy needs to be further explored.
Chinese Clinical Trial Registry: Chinese Clinical Trails registry: ChiCTR2100045250. Registered 9 April 2021; retrospectively registered. http://www.chictr.org.cn/showproj.aspx?proj=124250.
探讨低强度红光（LRL）治疗对近视控制的效果及其停止治疗后的反应。
一项前瞻性临床试验。102名6至13岁的近视儿童被纳入LRL组（n = 51）和单焦点眼镜（SFS）组（n = 51）。在LRL组中，受试者佩戴SFS并接受由发射635nm红光、功率为0.35±0.02mW的激光设备提供的LRL治疗。对照试验1年后，LRL治疗停止3个月。主要观察指标包括眼轴长度（AL）、等效球镜度（SER）、黄斑中心凹下脉络膜厚度（SFCT）和调节功能。
治疗12个月后，LRL组46名儿童和SFS组40名儿童完成试验。LRL组的AL伸长和近视进展分别为0.01mm（95%CI：-0.05至0.07mm）和0.05D（95%CI：-0.08至0.19D），均小于SFS组的0.39mm（95%CI：0.33至0.45mm）和-0.64D（95%CI：-0.78至-0.51D）（p<0.05）。LRL组的SFCT变化大于SFS组（p<0.05）。LRL组的调节反应和正相对调节比SFS组更负（p<0.05）。42名受试者完成了LRL停止治疗后的观察，停止治疗期间AL和SER分别增加了0.16mm（95%CI：0.11至0.22mm）和-0.20D（95%CI：-0.26至-0.14D）（p<0.05），SFCT恢复到基线水平（p>0.05）。
LRL是预防和控制近视的有效措施，还可能具有改善调节功能的能力。停止治疗后可能会有轻微的近视反弹。LRL长期治疗的效果有待进一步探索。
中国临床试验注册中心：中国临床试验注册中心：ChiCTR2100045250。2021年4月9日注册；回顾性注册。http://www.chictr.org.cn/showproj.aspx?proj=124250。
