Purpose and scope:This position statement was developed by The Royal Australian and New ZealandCollege of Ophthalmologists (RANZCO). The purpose of this position statement is toprovide guidance to RANZCO Fellows and other health professionals regarding bestpractices for the diagnosis and treatment of progressive myopia in children. Weacknowledge that there is still much to be determined regarding factors that bring aboutprogressive myopia and the optimal interventions to minimise progression.
Abstract To find and assess the effectiveness and safety of short-term Photobiomodulation (PBM) treatment in children with low-to-moderate myopia. Children with low-to-moderate myopia were recruited and divided into PBM or control groups based on whether they received PBM treatment. The PBM group underwent a three-month treatment with a 650 nm low-energy semiconductor laser, while the control group did not receive any therapeutic intervention. At the end of the trial, the changes in spherical equivalent refractive (SER) and axial length (AL) before and after treatment were compared between the PBM group and the control group to evaluate the effectiveness of PBM in preventing myopia. The best corrected visual acuity (BCVA), nerve fiber layer thickness (RNFLT), ganglion cell layer thickness (GCLT), central point retinal thickness (CPRT), 3-mm subfield central retinal thickness (3 mm-CRT), superficial retinal vascular density (SCP), and central choroid thickness (CCT) were self-compared to assess the safety of PBM. A total of 57 subjects were prospectively followed from October 2020 to September 2021, comprising 28 participants (56 eyes) in the PBM group and 29 participants (58 eyes) in the control group. After three months of treatment, the AL decreased by 0.07 ± 0.11 mm, and the SER decreased by -0.12 ± 0.39 D in the PBM group. However, both SER and AL increased in the control group. Furthermore, there were statistically significant differences between the PBM and control groups (p < 0.01). The BCVA, RNFLT, GCLT, CPRT, and 3 mm-CRT remained almost unchanged in the PBM group; The SCP decreased from 0.37 ± 0.03 to 0.35 ± 0.02 in the PBM group with a statistically significant difference before and after treatment (p = 0.045). The CCT increased from 255 ± 41 µm to 274 ± 29 µm in the PBM group without any significant difference before and after treatment. The administration of PBM significantly suppresses the elevation of AL and SER following a three-month duration. No significant adverse effects were observed on visual function and retinal morphology.Trial Registration: This study is registered at https://clinicaltrials.gov/ (registration number: NCT04604405).
Purpose: To evaluate the impact of repeated low-level red-light (RLRL) therapy on choroidal thickness and blood flow in pediatric myopia. Methods: A three-month trial (April 1, 2023 - September 30, 2023) was conducted involving 44 children (ages 6-16) with myopia. Participants underwent RLRL therapy at home twice daily for five days per week, with each session lasting three minutes. Assessments at baseline, one month, and three months included cycloplegic refraction, best-corrected visual acuity (BCVA), intraocular pressure (IOP), ocular biometrics, swept-source optical coherence tomography angiography (SS-OCTA), slit-lamp, and fundus examinations. Results: The study included 44 children (average age: 9.79 years; 56.82 % male). RLRL therapy significantly increased subfoveal choroidal thickness (Baseline: 272.82 ± 64.01 μm; 1-month: 297.77 ± 72.94 μm; 3-month: 298.77 ± 77.17 μm, p = 0.001), reduced axial length (Baseline: 24.97 ± 1.47 mm; 3-month: 24.88 ± 1.38 mm, p = 0.002), and showed a marginal regression in spherical equivalent (p = 0.055). Significant elevations in choroidal vessel volume and thickness were noted, with positive correlations intensifying with distance from the fovea. Conclusion: RLRL therapy shows promise in managing pediatric myopia by increasing choroidal vessel volume and thickness, potentially mitigating myopia progression.
Background/aims: To compare the effects of repeated low-level red light (RLRL) treatment on axial length growth and refractive error changes in myopic and premyopic children. Methods: Subjects were assigned randomly to four subgroups: myopia-RLRL group (M-RL), myopia-control group (M-C), premyopia-RLRL group (PM-RL) and premyopia-control group (PM-C). Subjects in the RLRL group completed a 12-month treatment composed of a 3 min RLRL treatment session twice daily, with an interval of at least 4 hours, for 7 days per week. Visits were scheduled before and at 1-month, 3-month, 6-month, 9-month and 12-month follow-up after the treatment. Repeated-measures analysis of variance was used to compare the spherical equivalent refractive errors (SE) and axial length (AL) changes between the groups across the treatment period. Results: After 12 months of treatment, in the myopia group, SE and AL changes were -0.078±0.375 D and 0.033±0.123 mm for M-RL and -0.861±0.556 D and 0.415±0.171 mm for M-C; in the premyopia group, the progression of SE and AL was -0.181±0.417 D and 0.145±0.175 mm for PM-RL and -0.521±0.436 D and 0.292±0.128 mm for PM-C. PM-RL indicated a lower myopia incidence than PM-C (2.5% vs 19.4%). Additionally, the percentage of AL shortening in the M-RL was higher than that in the PM-RL before the 9-month follow-up. Conclusion: RLRL effectively delayed myopia progression in children with myopia and reduced the incidence of myopia in premyopic children. Moreover, RLRL exhibited a stronger impact on myopic children compared with premyopic individuals.
国际近视眼研究院在2019年提出了“近视眼前期”的概念,将其定义为儿童眼屈光度数≤+0.75D且>-0.50D,结合基线屈光度数、年龄和其他可量化危险因素,有较大可能在未来发展为近视眼,故值得采取预防性干预措施。本文从近视眼前期在儿童青少年中的流行病学特征、近视眼前期的判断标准和屈光变化特点、针对近视眼前期防控技术已有的和尚缺的研究证据、开展近视眼前期防控对促进近视眼防控关口前移的作用与收益4个方面,阐述儿童近视眼前期防控在近视眼综合防治中的重要价值和未来方向,以期和专业同道共同探讨有效防控近视眼发生发展的新策略。
Purpose: To investigate the efficacy and safety of orthokeratology (ortho-k) and repeated low-level red-light (RLRL) therapy in treating poor responders of ortho-k in myopic children. Methods: Study participants were 100 myopic children who completed two years of ortho-k treatment in a retrospective study. In the first year of ortho-k treatment (phase one), they experienced axial elongation of 0.30 mm or greater (defined as poor responders to ortho-k). Children were divided into two groups: the orthokeratology group (OK, n = 45) continued to receive ortho-k monotherapy and the combination group (OK-RLRL, n = 55) received RLRL in addition to ortho-k for the next year (phase two). Axial elongation over time between the groups was compared. Results: The mean age, male-to-female ratio, axial length (AL), and axial elongation in phase one were comparable between OK and OK-RLRL groups (all P > 0.05). During phase two, significant AL shortening was observed in the OK-RLRL group compared with children in the OK group (-0.10 ± 0.16 mm vs 0.30 ± 0.19 mm, P < 0.001). Among these 55 myopic children in the OK-RLRL group, 35 (63.6%), 25 (45.4%), 11 (20%), 6 (10.9%), and 3 (5.4%) of them had AL shortening over 0.05 mm/year, 0.10 mm/year, and 0.20 mm/year, 0.3 mm/year, and 0.4 mm/year, respectively. Older baseline age (β = -0.02), higher treatment compliance (β = -0.462), and AL change at 1 month (β = 1.263) were significantly associated with less AL elongation (all P < 0.05).
Purpose: To evaluate the effectiveness and safety of repeated low-level red-light (RLRL) in delaying the progression of high myopes with -6.00 diopters (D) or worse. Design: Multicenter, randomized, parallel-group, single-blind clinical trial. A total of 202 high myopic children aged 7 to 12 years with cycloplegia spherical equivalent (SE) refraction ≤-6.00 D, astigmatism less than 2.50 D, and anisometropia of 1.50 D or less were enrolled from March 2022 to December 2022. Follow-up was completed in December 2023. Methods: Eligible participants were randomly allocated to the intervention (RLRL + single vision spectacle) or the control group (single vision spectacle). The RLRL treatment was administered every day for 3 minutes, twice a day, with an interval of at least 4 hours. The primary outcome was the change in axial length (AL) at 12 months compared with baseline. Secondary outcomes included changes in SE, changes in choroidal thickness (ChT), and changes in retinal thickness (RT) in different circle sectors. Outcomes were analyzed by means of intention-to-treat and per-protocol methods. Results: After 12 months of treatment, AL and SE changes were -0.11 ± 0.25 mm and 0.18 ± 0.63 D for the RLRL group and 0.32 ± 0.09 mm and -0.80 ± 0.42 D for the control group, respectively. Axial shortening >0.05 mm was 59% in the RLRL and 0% in the control group at 12 months. ChT and RT from a single center were analyzed. In the RLRL group, ChT was thickened in all sectors at 12 months. RT was increased in parafoveal and perifoveal circles. In the control group, all sectors of ChT and only perifoveal RT were significantly thinner at 12 months. The multivariate linear regression model revealed significant correlations between changes in the ChT central foveal circle and RT perifoveal circle at 1 month and AL changes at 12 months. No fundus structure changes, afterimage exceeding 6 minutes, or best-corrected visual acuity decrease were reported. Conclusions: RLRL could effectively shorten the AL and inhibit the progression of myopia in high myopic patients with -6.00 D or worse. AL shortening is sustained over 12 months of treatment. These observed changes appeared to be associated with increases in ChT and RT.
Purpose: To assess the effectiveness and safety of repeated low-level red light (RLRL), which is a newly available treatment for myopia control in children and adolescents with high myopia. Design: Multicenter, randomized, parallel-group, single-blind clinical trial (randomized controlled trial; NCT05184621). Participants: Between February 2021 and April 2022, 192 children aged 6 to 16 years were enrolled. Each child had at least 1 eye with myopia of cycloplegic spherical equivalent refraction (SER) at least -4.0 diopters (D), astigmatism of ≤2.0 D, anisometropia of ≤3.0 D, and best-corrected visual acuity (BCVA) of 0.2 logarithm of the minimum angle of resolution or better. Follow-up was completed by April 2023. Methods: Participants were randomly assigned at a 1:1 ratio to intervention (RLRL treatment plus single-vision spectacles) or control (single-vision spectacles) groups. The RLRL treatment was administered for 3 minutes per session, twice daily with a minimum interval of 4 hours, 7 days per week. Mean outcome measures: The primary outcome and key secondary outcome were changes in axial length (AL) and cycloplegic SER measured at baseline and the 12-month follow-up visit. Participants who had at least 1 postrandomization follow-up visit were analyzed for treatment efficacy. Results: Among 192 randomized participants, 188 (97.91%) were included in the analyses (96 in the RLRL group and 92 in the control group). After 12 months, the adjusted mean change in AL was -0.06 mm (95% confidence interval [CI], -0.10 to -0.02 mm) and 0.34 mm (95% CI, 0.30 to 0.39 mm) in the intervention and control groups, respectively. A total of 48 participants (53.3%) in the intervention group were still experiencing axial shortening >0.05 mm at the 12-month follow-up. The mean SER change after 12 months was 0.11 D (95% CI, 0.02to 0.19 D) and -0.75 D (95% CI, -0.88 to -0.62 D) in the intervention and control groups, respectively. Conclusions: Repeated low-level red light demonstrates stronger treatment efficacy among those with high myopia, with 53.3% experiencing substantial axial shortening. Repeated low-level red light provides an excellent solution for the management of high myopia progression, a significant challenge in ophthalmology practice. Financial disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Background: Myopia is the most prevalent form of refractive error that has a major negative impact on visual function and causes blurring of vision. We aimed to determine if Repeated Low-Level Red Light (RLRL) treatment is beneficial in treating childhood myopia in terms of axial length (AL), spherical equivalent refraction (SER), and sub foveal choroidal thickness (SFCT). Methods: This systematic review was performed on RLRL for treatment of myopia in children compared to single vision spectacles (SVS). We employed the search strategy with key terms myopia and low-level light therapy then we searched PubMed, Scopus, Cochrane, and Web of Science databases. The mean differences (MD) were used to evaluate the treatment effects. Heterogeneity was quantified using I2 statistics and explored by sensitivity analysis. Results: Five randomized controlled trials (RCTs) were included in our meta-analysis with a total of 833 patients, 407 in treatment group and 426 in control group. At a 3 month follow up period, pooled studies show a statistical difference in AL between RLRL and SVS group (MD = -0.16; 95% CI [-0.19, -0.12], SER (MD = 0.33; 95% CI [0.27, 0.38]), and SFCT (MD = 43.65; 95% CI [23.72, 45.58]). At a 6 month follow up period, pooled studies show a statistical difference in AL between RLRL and SVS group (MD = -0.21; 95% CI [-0.28, -0.15]), SER (MD = 0.46; 95% CI [0.26, 0.65]), and SFCT (MD = 25.07; 95% CI [18.18, 31.95]). At a 12 month follow up period, pooled studies show a statistical difference in AL between RLRL and SVS group (MD = -0.31; 95% CI [-0.42, -0.19]) and SER (MD = 0.63; 95% CI [0.52, 0.73]). Conclusion: This is the first systematic review and meta-analysis investigating only RCTs evidence supporting the efficacy of 650 nm RLRL for myopia control in the short term of 3, 6, and 12 months follow up. The present review revealed the clinical significance of RLRL as a new alternative treatment for myopia control with good user acceptability and no documented functional or structural damage. However, the effect of long-term RLRL treatment and the rebound effect after cessation require further investigations.