Introduction: Myopia is recognized as a progressive eye disease. The aim of this study was to evaluate the frequency and associated factors of clinically significant axial length (AL) shortening among myopic children following repeated low-level red light (RLRL) therapy. Methods: The clinical data that were collected for the myopic children aged 3-17 years who received an RLRL therapy delivered by home-use desktop light device that emitted light at 650 nm for at least 1 year, were reviewed. The clinical data included AL, spherical equivalent refraction (SER), and visual acuity measured at baseline and follow-up. The primary outcomes were frequency of AL shortening of > 0.05 mm, > 0.10 mm, and > 0.20 mm per year, and associated factors of AL shortening per year. Results: A total of 434 myopic children with at least 12 months of follow-up data were included. The mean age of participants was 9.7 (2.6) years with SER of -3.74 (2.60) diopters. There were 115 (26.50%), 76 (17.51%), and 20 (4.61%) children with AL shortening based on cutoffs of 0.05 mm/year, 0.10 mm/year, and 0.20 mm/year, respectively. In the multivariable model, AL shortening was significantly associated with older baseline age, female gender, and longer baseline AL or greater spherical equivalent refraction (all P < 0.05). Among AL shortened eyes, the mean AL difference (standard deviation, SD) was -0.142 (0.094) mm/year. Greater AL shortening was observed among children who were younger and had longer baseline AL (all P < 0.05). Conclusions: More than a quarter of children had AL shortening > 0.05 mm following RLRL therapy, and the overall mean AL change was -0.142 mm/year. Further studies should explore the mechanisms underlying AL shortening.
近视是目前全球范围内引发视觉损害的重要原因之一。北大国家发展研究院数据统计显示:2012年我国5岁以上罹患近视总人数在4.5亿左右，到2020年近视患病人数约为7亿。寻求有效的近视防控措施一直是眼科领域研究热点，也是“健康中国战略”中重要内容。近来，苏州宣嘉光电科技有限公司创新性研发并应用“艾尔兴哺光仪”防控青少年近视进展取得了可喜的临床效果。临床研究数据显示，应用重复低能量半导体红色激光(波长，650nm:功率，2mW)照射可以有效控制青少年近视的发展，压低近视度数增长的曲线。然而，长期应用半导体红色激光进行眼部照射，其对视网膜安全性也一直是萦绕眼科医生与使用者心中的重要问题。 吉林大学白求恩第二医院眼科医院李光宇教授课题组围绕“艾尔兴哺光仪”所使用的“650nm 红色半导体激光”对视网膜、视细胞的影响展开了系列实验研究。课题研究主要以体外培养视细胞(661W)，以及 4-6 周龄 C57/BL 小鼠为研究对象，并利用 450nm 蓝色半导体激光作为对比性研究，深入探究了长、短波长激光照 射，以及不同照射方式、照射功率对视网膜的影响。课题研究发现：①辐照度为2.55mW/cm2（发射功率约为 2mW）450nm 蓝色激光照射可以显著诱导视细胞光氧化性损伤，导致视细胞死亡率显著上升；而相同功率 650nm 红色激光照射却未诱导出显著视细胞损伤。②间断性重复性低功率（2mW）650nm 红色激光与 450nm蓝色激光照射均未诱导出小鼠视网膜显著损伤。③连续性低功率（2mW）650nm红色激光照射未诱导出小鼠视网膜显著损伤，而连续性低功率 450nm 蓝光照射却可以造成小鼠视网膜显著损伤。④间断性重复性高功率（10mW） 650nm 红色激光照射未诱导出小鼠视网膜显著损伤，而间断性重复性高功率 450nm 蓝色激光照射却可以显著造成小鼠视网膜损伤。⑤连续性高功率（10mW）照射，650nm红色激光与 450nm 蓝色激光均可诱导出小鼠视网膜损伤，但 450nm 蓝色激光连续照射造成视网膜损伤更显著。据此，通过对课题实验结果分析，现可以得出如下研究结论：1.不同波长光照对视网膜影响具有差异性，相同照射方式与照射剂量下短波长蓝光较长波长红光对视网膜损伤严重。2.单次光照对视网膜损伤具有能量依赖性，随着光照功率的增加对视网膜所造成的损伤逐渐加重。3.单次光照对视网膜损伤具有时间依赖性，随着单次光照时长的增加对视网膜所造成的损伤逐渐显著;在总照射时长相同情况下，间断重复性照射较连续性照射安全。 基于以上研究结果，结合“艾尔兴哺光仪”现有临床应用方式，我们提出进一步优化策略:1.在技术条件允许情况下，可以进行个体化照射功率设置;在确保治疗有效性的前题下可以个体化设定较低的照射功率和剂量;2.在确保治疗有效性的前题下，可以进一步缩短照射时长或尝试增加照射频次而缩短照射时长。
摘要 引言:近视的眼轴(AL)伸长被认为是不可逆的。我们的目的是系统地报告随机临床试验(RCT)中重复低强度红光(RLRL)治疗后意外观察到的AL缩短。 方法:这是一项多中心，单盲RCT(随机临床试验)的事后分析。264名8-13岁的近视儿童被分配到RLRL治疗(干预组)或单光框架眼镜(SVS,对照组)。在基线，1,3,6和12个月的随访中使用IOL-master 500测量AL.眼轴(AL)缩短定义为从基线到任一随访，AL缩短达到以下3个临界点:>0.05mm,>0.10mm 和>0.20mm。然后，计算了不同截止点定义下的发生AL缩短的频率。本研究的分析根据意向治疗(ITT)进行。 结果 在12个月的随访中，RLRL组和对照组发生AL缩短>0.05mm的频率分别为26/119(21.85%)和2/145(1.38%).AL缩短>0.10mm的频率分别为18/119(15.13%)和0/145(0%).眼轴(AL)缩短>0.20mm的频率分别为7/119(5.88%)和0/145(0%)(p<0.001)。12个月后RLRL组AL平均缩短-0.156(SD:0.086)mm,对照组中为-0.06mm。在多因素分析中，年龄与AL缩短明显相关。在发生了AL缩短(n=56)的RLRL组中，脉络膜厚度(ChT)增厚(0.056mm)只能解释28.3%的AL缩短(-0.20mm)。 结论:接近四分之一的孩子在接受12个月的重复低强度红光(RLRL)治疗后,AL缩短超过0.05mm，而在对照组中几乎没有出现眼轴缩短。
简介:本研究分析了650nm红光哺光仪在近视防控中的作用。 方法:在本研究中，深圳市164 名诊断患有近视的学龄参与者被纳入一项红光哺光仪研究。其中，41人加入了轻中度近视接受红光治疗组(RLMM)，65人加入了轻中度近视接受单纯佩戴框架眼镜治疗组(SVSMM),58人被纳入接受红光治疗的的严重近视组(RLS组)。结果:三个小组的基准值比对后，右眼数据被用于统计分析。每个小组的平均回访时间为60.42天，治疗前后观察指标变化进行了比较。作为主要结果,SVSMM组(0.08±0.40mm)、RLMM组(-0.03±0.11mm)和RLS组(-0.07士0.11mm)，右眼眼轴长度变化进行比较，显示统计结果p<0.001。 结论:研究结果证实红光对近视控制效果显著，并且低强度红光在高度近视治疗中发挥着重要作用。
目的 评估低强度红光(LIRL)在低龄高度近视儿童中的疗效。方法 招募年龄≤10岁的高度近视儿童50例，最终40例(右眼)纳入研究。根据ILLRL、足矫单光眼镜(SVS)干预及弱视情况分为LLRL弱视组(15例)、LLRL非弱视组(11例)、SVS弱视组(9例)、SVS非弱视组(5例)。干预前(基线)以及干预后(1个月、3个月、6个月)，分别对入组儿童进行最佳矫正视力(BCVA)、等效球镜(SER)、眼轴长度(AL)、SER增长量、AL增长量检测。分别比较两弱视组间、两非弱视组间各时间点检测指标的差异。结果 两弱视组间和两非弱视组间患者的性别、年龄、基线BCVA、基线SER、基线AL差异均无统计学意义(均为P>0.05)。LLRL弱视组患者BCVA在干预后1个月、3个月、6个月均大于SVS弱视组,SER增长量在干预后3个月、6个月均高于SVS弱视组，AL增长量在干预后1个月、3个月、6个月均低于SVS弱视组(均为P<0.05),而两弱视组患者间干预后1个月、3个月、6个月SER、AL以及干预后1个月SER增长量差异均无统计学意义(均为P>0.05)。LILRL非弱视组患者SER增长量在干预后1个月、3个月、6个月均大于SVS非弱视组(均为P<0.05),AL增长量在干预后1个月、3个月、6个月均低于SVS非弱视组(均为P<0.05)，而干预后1个月、3个月、6个月两弱视组患者间BCVA、SER、AL差异均无统计学意义(均为P>0.05)。结论 LLRL在低龄高度近视儿童中有一定短期疗效，既能治疗弱视的同时也能很好防控近视，可作为低龄高度近视儿童治疗的一个优质选择。
Purpose: 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. Design: Randomized, double-blind, controlled clinical trial. Participants: 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. Methods: 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. Main outcome measures: Changes in cycloplegic spherical equivalence refraction (SER) and AL between 2 groups were compared using a generalized estimating equation (GEE). Results: 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. Conclusions: 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. Keywords: Myopia; Randomized clinical trial; Repeated low-level red-light (RLRL) therapy.
近视与弱视是威胁儿童青少年眼健康的重要疾病，红光用于弱视治疗已有几十年历史，近年来逐渐应用于儿童青少年近视防控，成为新热点。通过从低能量红光治疗的干预方式、治疗效果、影响因素、可能机制及安全性方面阐述其在儿童青少年近视弱视中的应用，以期为下一步研究与实践提供参考。
重复低强度红光(RLRL)照射辅助儿童青少年近视治疗的研究应用已在国内多地开展，初步临床研究结果显示，RLRL眼部照射能够抑制儿童青少年近视的快速增长，但由于目前尚无相关的统一标准，导致不规范应用的现象时有发生，也增加了不良反应的潜在风险。因此有关专家基于当前的循证证据及结合实践经验，并广泛征求意见，从RLRL照射防控近视基本原理、适用对象、方法及剂量、检查项目及照射频次、设备选择及使用功率、不良反应、终止治疗、与其他方法联合应用问题的建议等8个方面制定《重复低强度红光照射辅助治疗儿童青少年近视专家共识(2022)》，为规范RLRL照射在儿童青少年近视防控中的应用提供指导意见。
我国近视呈现高发病率,低龄化的严峻形势,儿童和青少年近视防控问题已上升为国家战略.近年来相关研究已提供了多种儿童近视进展防控措施和方法,如低浓度阿托品滴眼液点眼,角膜塑形镜配戴等,但均存在操作不便和一定的不良反应.大量证据已经表明,增加户外活动时间可有效降低儿童近视的发病率,其效应与光照量有关.然而,在实际工作和实践中,切实有效增加或控制儿童每天的户外活动时间存在各种困难,因此难以有效指导相关人群实施近视防控措施.一项由中山大学中山眼科中心主持的多中心随机临床试验(RCT)采用低强度红光重复照射(RLRL)对学龄儿童进行重复,短时,直接的视网膜照射,评估RLRL控制近视进展的疗效和安全性,证实了该疗法对学龄儿童轻中度近视进展有较好的防控作用,为RLRL安全,有效防控近视进展提供了高等级循证证据.本文对这项RCT研究的主要结果和可推广性进行解读,并提出了进一步探讨RLRL在近视防控中的实践要点,建议眼科工作者关注RLRL对近视防控的研究进展。
Abstract Purpose: To evaluate longitudinal changes in macular choroidal thickness (mCT) in myopic children treated for 1 year with repeated low-level red-light (RLRL) therapy and their predictive value for treatment efficacy on myopia control. Design: A secondary analysis of data from a multicenter, randomized controlled trial (RCT; NCT04073238). Participants: Myopic children aged 8-13 years who participated in the RCT at 2 of 5 sites where mCT measurements were available. Methods: Repeated low-level red-light therapy was delivered using a home-use desktop light device that emitted red-light at 650 nm. Choroidal thickness was measured by SS-OCT at baseline and 1-, 3-, 6-, and 12-month follow-ups. Visual acuity, axial length (AL), cycloplegic spherical equivalent refraction (SER), and treatment compliance were measured. Main outcome measures: Changes in mCT at 1, 3, 6, and 12 months relative to baseline, and their associations with myopia control. Results: A total of 120 children were included in the analysis (RLRL group: n = 60; single-vision spectacle [SVS] group: n = 60). Baseline characteristics were well balanced between the 2 groups. In the RLRL group, changes in mCT from baseline remained positive over 1 year, with a maximal increase of 14.755 μm at 1 month and gradually decreasing from 5.286 μm at 3 months to 1.543 μm at 6 months, finally reaching 9.089 μm at 12 months. In the SVS group, mCT thinning was observed, with changes from baseline of -1.111, -8.212, -10.190, and -10.407 μm at 1, 3, 6, and 12 months, respectively. Satisfactory myopia control was defined as annual progression rates of less than 0, 0.05, or 0.10 mm for AL and less than 0, 0.25, or 0.50 diopters for SER. Models that included mCT changes at 3 months alone had acceptable predictive discrimination of satisfactory myopia control over 12 months, with areas under the curve of 0.710-0.786. The predictive performance of the models did not significantly improve after adding age, gender, and baseline AL or SER. Conclusions: This analysis from a multicenter RCT found RLRL induced sustained choroidal thickening over the full course of treatment. Macular choroidal thickness changes at 3 months alone can predict 12-month myopia control efficacy with reasonable accuracy. Financial disclosure(s): Proprietary or commercial disclosure may be found after the references. Keywords: Choroidal thickness; Myopia control; Repeated low-level red-light therapy.
