Dataset Information

Sustained and rebound effect of repeated low-level red-light therapy on myopia control: A 2-year post-trial follow-up study.

ABSTRACT:

Background

To evaluate the long-term efficacy and safety of continued repeated low-level red-light (RLRL) therapy on myopia control over 2 years, and the potential rebound effect after treatment cessation.

Methods

The Chinese myopic children who originally completed the one-year randomised controlled trial were enrolled. Children continued RLRL-therapy were defined as RLRL-RLRL group, while those who stopped and switched to single-vision spectacle (SVS) in the second year were RLRL-SVS group. Likewise, those who continued to merely wear SVS or received additional RLRL-therapy were SVS-SVS and SVS-RLRL groups, respectively. RLRL-therapy was provided by an at-home desktop light device emitting red-light of 650 nm and was administered for 3 min at a time, twice a day and 5 days per week. Changes in axial length (AL) and cycloplegic spherical equivalence refraction (SER) were measured.

Results

Among the 199 children who were eligible, 138 (69.3%) children attended the examination and 114 (57.3%) were analysed (SVS-SVS: n = 41; SVS-RLRL: n = 10; RLRL-SVS: n = 52; RLRL-RLRL: n = 11). The baseline characteristics were balanced among four groups. In the second year, the mean changes in AL were 0.28 ± 0.14 mm, 0.05 ± 0.24 mm, 0.42 ± 0.20 mm and 0.12 ± 0.16 mm in SVS-SVS, SVS-RLRL, RLRL-SVS and RLRL-RLRL group, respectively (p < 0.001). The respective mean SER changes were -0.54 ± 0.39D, -0.09 ± 0.55D, -0.91 ± 0.48D, and -0.20 ± 0.56D (p < 0.001). Over the 2-year period, axial elongation and SER progression were smallest in RLRL-RLRL group (AL: 0.16 ± 0.37 mm; SER: -0.31 ± 0.79D), followed by SVS-RLRL (AL: 0.44 ± 0.37 mm; SER: -0.96 ± 0.70D), RLRL-SVS (AL: 0.50 ± 0.28 mm; SER: -1.07 ± 0.69D) and SVS-SVS group (AL: 0.64 ± 0.29 mm; SER: -1.24 ± 0.63D). No self-reported adverse events, functional or structural damages were noted.

Conclusions

Continued RLRL therapy sustained promising efficacy and safety in slowing myopia progression over 2 years. A modest rebound effect was noted after treatment cessation.

SUBMITTER: Xiong R

PROVIDER: S-EPMC10086781 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Sustained and rebound effect of repeated low-level red-light therapy on myopia control: A 2-year post-trial follow-up study.

Xiong Ruilin R Zhu Zhuoting Z Jiang Yu Y Kong Xiangbin X Zhang Jian J Wang Wei W Kiburg Katerina K Yuan Yixiong Y Chen Yanping Y Zhang Shiran S Xuan Meng M Zeng Junwen J Morgan Ian G IG He Mingguang M

Clinical & experimental ophthalmology 20220907 9

<h4>Background</h4>To evaluate the long-term efficacy and safety of continued repeated low-level red-light (RLRL) therapy on myopia control over 2 years, and the potential rebound effect after treatment cessation.<h4>Methods</h4>The Chinese myopic children who originally completed the one-year randomised controlled trial were enrolled. Children continued RLRL-therapy were defined as RLRL-RLRL group, while those who stopped and switched to single-vision spectacle (SVS) in the second year were RLR ...[more]

PMID: 36054314

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Project description:PurposeTo investigate the long-term effects of repeated low-level red light (RLRL) therapy on the axial length (AL), spherical equivalent (SE), and choroidal parameters.MethodsTwo hundred eight myopic eyes were recruited. The RLRL group included 100 eyes, whereas the control group included 108 eyes. Throughout the one-year follow-up period, changes in AL and SE were recorded for both groups. The RLRL group underwent additional choroidal imaging, and changes in choroidal thickness (CT), choroidal vascularity (CV), and choriocapillaris luminal area (CLA) were assessed before and after RLRL therapy.ResultsDuring the follow-up period, the changing trends in AL and SE differed significantly between the RLRL and control groups. In the RLRL group, AL decreased at three and six months (both P < 0.05) and returned to pretreatment values at 12 months (P = 0.453). In contrast, AL increased significantly throughout the follow-up period (three, six, and 12 months) in the control group (all P < 0.001). The SE increased significantly during the entire follow-up period in the RLRL group (all P < 0.001), whereas it decreased significantly in the control group (all P < 0.05). Regarding choroidal parameters, significant improvements were observed in CT, CV and CLA throughout the follow-up period (all P < 0.05), and changes in most choroidal parameters were significantly correlated with changes in AL and SE during the follow-up period (all P < 0.05). Furthermore, AL, SE, and most choroidal parameters showed significant correlations between changes at three and 12 months (all P < 0.05).ConclusionsRLRL therapy significantly improved choroidal blood perfusion and circulation, which may explain the observed slowing or reversal of myopia progression in the RLRL group. Thus RLRL therapy may be a novel and effective method for controlling myopia. Furthermore, the short-term effect of photobiomodulation therapy (i.e., changes at three months) can be used to predict the long-term effects (i.e., changes at 12 months).Translational relevanceIn this study, RLRL therapy showed a significant control effect on the development of axial length and spherical equivalent. RLRL therapy also promoted the choroidal blood perfusion and circulation. RLRL therapy could be a novel and effective method for myopia control.

Project description:BackgroundMyopia 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).MethodsThis 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.ResultsFive 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]).ConclusionThis 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.

Project description:ImportanceMyopia is a global concern, but effective prevention measures remain limited. Premyopia is a refractive state in which children are at higher risk of myopia, meriting preventive interventions.ObjectiveTo assess the efficacy and safety of a repeated low-level red-light (RLRL) intervention in preventing incident myopia among children with premyopia.Design, setting, and participantsThis was a 12-month, parallel-group, school-based randomized clinical trial conducted in 10 primary schools in Shanghai, China. A total of 139 children with premyopia (defined as cycloplegic spherical equivalence refraction [SER] of -0.50 to 0.50 diopter [D] in the more myopic eye and having at least 1 parent with SER ≤-3.00 D) in grades 1 to 4 were enrolled between April 1, 2021, and June 30, 2021; the trial was completed August 31, 2022.InterventionsChildren were randomly assigned to 2 groups after grade stratification. Children in the intervention group received RLRL therapy twice per day, 5 days per week, with each session lasting 3 minutes. The intervention was conducted at school during semesters and at home during winter and summer vacations. Children in the control group continued usual activities.Main outcomes and measuresThe primary outcome was the 12-month incidence rate of myopia (defined as SER ≤-0.50 D). Secondary outcomes included the changes in SER, axial length, vision function, and optical coherence tomography scan results over 12 months. Data from the more myopic eyes were analyzed. Outcomes were analyzed by means of an intention-to-treat method and per-protocol method. The intention-to-treat analysis included participants in both groups at baseline, while the per-protocol analysis included participants in the control group and those in the intervention group who were able to continue the intervention without interruption by the COVID-19 pandemic.ResultsThere were 139 children (mean [SD] age, 8.3 [1.1] years; 71 boys [51.1%]) in the intervention group and 139 children (mean [SD] age, 8.3 [1.1] years; 68 boys [48.9%]) in the control group. The 12-month incidence of myopia was 40.8% (49 of 120) in the intervention group and 61.3% (68 of 111) in the control group, a relative 33.4% reduction in incidence. For children in the intervention group who did not have treatment interruption secondary to the COVID-19 pandemic, the incidence was 28.1% (9 of 32), a relative 54.1% reduction in incidence. The RLRL intervention significantly reduced the myopic shifts in terms of axial length and SER compared with the control group (mean [SD] axial length, 0.30 [0.27] mm vs 0.47 [0.25] mm; difference, 0.17 mm [95% CI, 0.11-0.23 mm]; mean [SD] SER, -0.35 [0.54] D vs -0.76 [0.60] D; difference, -0.41 D [95% CI, -0.56 to -0.26 D]). No visual acuity or structural damage was noted on optical coherence tomography scans in the intervention group.Conclusions and relevanceIn this randomized clinical trial, RLRL therapy was a novel and effective intervention for myopia prevention, with good user acceptability and up to 54.1% reduction in incident myopia within 12 months among children with premyopia.Trial registrationClinicalTrials.gov Identifier: NCT04825769.

Project description:ImportanceEarly-onset myopia is well known to progress to high myopia in adulthood. However, no accurate estimation of how a specific age at myopia onset is associated with the probability of developing high myopia in adulthood is available, and a very-long-term follow-up study with data from annual visits is needed.ObjectiveTo estimate the risk of developing high myopia in adulthood associated with a specific age at myopia onset from a data set with a 12-year annual follow-up.Design, setting, and participantsThis ongoing, population-based prospective cohort study of twins was conducted in Guangzhou, China, on July 11, 2006. Data from baseline to August 31, 2018, were analyzed. The first-born twins completed follow-up until 17 years or older, and the 443 participants (after exclusions) who developed myopia were included in the analysis. Data were analyzed from September 1, 2018, to January 20, 2020.Main outcomes and measuresAge at myopia onset was determined by prospective annual cycloplegic refractions (365 participants [82.4%]) or with a questionnaire. Refraction in adulthood was defined as the cycloplegic refraction measured at the last follow-up visit.ResultsAmong the 443 eligible participants (247 [55.8%] female; mean [SD] age at myopia onset, 11.7 [2.0] years), 54 (12.2%) developed high myopia (spherical equivalent, -6.00 diopters or worse determined by cycloplegic refractions) in adulthood. Among participants with age at myopia onset of 7 or 8 years, 14 of 26 (53.9%; 95% CI, 33.4%-73.4%) developed high myopia in adulthood; among those with onset at 9 years of age, 12 of 37 (32.4%; 95% CI, 18.0%-49.8%); among those with onset at 10 years of age, 14 of 72 (19.4%; 95% CI, 11.1%-30.5%); among those with onset at 11 years of age, 11 of 78 (14.1%; 95% CI, 7.3%-23.8%); and among those with onset at 12 years or older, 3 of 230 (1.3%; 95% CI, 0.2%-3.8%). Results of multivariate logistic regression analysis suggested that the risk of developing high myopia in adulthood decreased significantly with delay in the age at myopia onset (odds ratio, 0.44; 95% CI, 0.36-0.55; P < .001), from greater than 50% for 7 or 8 years of age to approximately 30% for 9 years of age and 20% for 10 years of age.Conclusions and relevanceThese findings suggest that the risk of high myopia is relatively high in children with myopia onset during the early school ages. Each year of delay in the age at onset substantially reduces the chance of developing high myopia in adulthood, highlighting the importance of identifying effective prevention strategies under investigation, such as increasing outdoor time.

Project description:PurposeTo evaluate myopia control efficacy in myopic children wearing spectacle lenses with highly aspherical lenslets (HAL) for 5 years.MethodsThis is a randomized, double-masked extended trial. Myopic children aged 8 to 13 years who were originally allocated to the HAL group in the 2-year clinical trial. The HAL group underwent a 5-year assessment for myopia progression using cycloplegic spherical equivalent refraction (SER) and axial length (AL). An extrapolated single-vision spectacle lenses (ESVL) group was used as a control group. The 5-year myopia progression and axial elongation of the ESVL group was calculated based on the 2-year data from the single-vision spectacle lenses group in the same clinical trial, and the data for the following 3 years was estimated by assuming an annual reduction in SER by 9.7% and in AL by 15%. A generalized linear model approach was used to evaluate the treatment efficacy. The validity of the ESVL group was evaluated by comparing myopia progression in the first year of the 3-year estimates with a single-vision spectacle lenses (SVL2) group from a 1-year extended study of the same clinical trial.ResultsForty-three participants from the original HAL group completed the 5-year visit (74%). Five-year myopia progression [mean ± standard error (SE)] in the HAL group was - 1.27 ± 0.14 D. Compared with the ESVL (- 3.03 ± 0.18 D), myopia progression was - 1.75 ± 0.24 D less for the HAL group (P < 0.001). The mean AL elongation over 5 years was 0.67 ± 0.06 mm for the HAL group compared with 1.40 mm in the ESVL group (P < 0.001), AL elongation was slower by 0.72 ± 0.10 mm for the HAL group (P < 0.001). No significant differences were found for myopia (- 0.58 ± 0.04 D vs. - 0.56 ± 0.05 D) or AL elongation (0.28 ± 0.02 mm vs. 0.28 ± 0.02 mm) between the ESVL group and SVL2 group (PSER = 0.83; PAL = 0.93) in year 3.ConclusionsIn this 5-year study, HAL spectacles reduced the rate of myopia progression and axial elongation, preventing the equivalent of 3 years of myopia progression and axial elongation. Long-term use of HAL spectacles also decreased the incidence of high myopia. Extrapolated control groups are valid for evaluating myopia progression in long-term studies. Trial registration The study was registered at the Chinese Clinical Trial Registry (ChiCTR2100047262), https://www.chictr.org.cn/showproj.html?proj=127182 .

Dataset Information

Sustained and rebound effect of repeated low-level red-light therapy on myopia control: A 2-year post-trial follow-up study.

Background

Methods

Results

Conclusions

Publications

Sustained and rebound effect of repeated low-level red-light therapy on myopia control: A 2-year post-trial follow-up study.

Similar Datasets

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