Six-month repeated irradiation of 650 nm low-level red light reduces the risk of myopia in children: a randomized controlled trial

Tian, Lei; Cao, Kai; Ma, Dongli; Lü, Ling; Zhao, Shi-Qiang; Li, Ao; Chen, Changxi; Ma, Zhang-Fang; Ma, Chun-Rong; Jin, Ying

doi:10.1007/s10792-023-02762-7

Cited by 8 publications

(5 citation statements)

References 48 publications

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“…A noteworthy approach involves the repeated application of low-level red light, utilizing a device emitting 650 nm visible red light. When administered twice daily in sessions of 3 min, this novel therapy has demonstrated efficacy in children with myopia [ 45 , 46 ], and recent studies have corroborated its effectiveness in children with premyopia [ 47 , 48 ]. The 12-month incidence of myopia was 40.8% in the intervention group and 61.3% in the control group, whereas SE and AL progression was also reduced in the intervention group [ 48 ].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Low-Dose Atropine on Myopia Prevention in Premyopic Children: Systematic Review and Meta-Analysis

Lee,

Tseng,

Wang

et al. 2024

JCM

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Background: Early-onset myopia increases the risk of irreversible high myopia. Methods: This study systematically evaluated the efficacy and safety of low-dose atropine for myopia control in children with premyopia through meta-analysis using random-effects models. Effect sizes were calculated using risk ratios (RRs) with 95% confidence intervals (CIs). Comprehensive searches of PubMed, EMBASE, Cochrane CENTRAL, and ClinicalTrials.gov were conducted until 20 December 2023, without language restrictions. Results: Four studies involving 644 children with premyopia aged 4–12 years were identified, with atropine concentrations ranging from 0.01% to 0.05%. The analysis focused on myopia incidence and atropine-related adverse events. Lower myopia incidence (RR, 0.62; 95% CI, 0.40–0.97 D/y; p = 0.03) and reduction in rapid myopia shift (≥0.5 D/1y) (RR, 0.50; 95% CI, 0.26–0.96 D/y; p < 0.01) were observed in the 12–24-month period. Spherical equivalent and axial length exhibited attenuated progression in the atropine group. No major adverse events were detected in either group, whereas the incidence of photophobia and allergic conjunctivitis did not vary in the 12–24-month period. Conclusions: Our meta-analysis supports atropine’s efficacy and safety for delaying myopia incidence and controlling progression in children with premyopia. However, further investigation is warranted due to limited studies.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Low-Dose Atropine on Myopia Prevention in Premyopic Children: Systematic Review and Meta-Analysis

Lee,

Tseng,

Wang

et al. 2024

JCM

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Section: Methodsmentioning

confidence: 99%

“…Children in the LLRL group were given a head-worn device 11 with a 650-nm single-wavelength light source incorporated. This device was confirmed to be safe and was certified by the State Administration for Market Regulation of China.…”

Section: Intervention and Study Proceduresmentioning

confidence: 99%

“…The ChT was measured via the enhanced-depth imaging technique (Spectralis HRA+OCT; Heidelberg Engineering) at 9 locations in the fundus as follows: subfoveal, 1 mm, and 3 mm around the fovea (temporal, nasal, superior, and inferior). ChT referred to the distance between outer choroid sclera margin and retinal pigment epithelium-Bruch complex, and was measured automatically using the built-in software of OCT. 11 Fundus photography was performed with a Canon retinal fundus camera (CR-DGI; Canon, Inc) after pupils were dilated. The interpretation of the fundus images was performed independently by 2 ophthalmologists from Beijing Tongren Hospital, and the final interpretation was given by another senior ophthalmologist (L.T.).…”

Section: Intervention and Study Proceduresmentioning

confidence: 99%

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Daily Low-Level Red Light for Spherical Equivalent Error and Axial Length in Children With Myopia

Cao,

Tian,

et al. 2024

JAMA Ophthalmol

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ImportanceTreatments are needed to slow progression of or reduce incidence of myopia.ObjectiveTo evaluate the efficacy and safety of daily 650-nm low-level red light (LLRL) for myopia treatment.Design, Setting, and ParticipantsSingle-masked, randomized clinical trial at 1 site in China. Baseline measurements were completed from August to September 2021. Participants were children aged 6 to 12 years with spherical equivalent error (SER) of −6 diopters (D) to 3 D. Data were analyzed from March to July 2023.InterventionsIrradiation daily with 650-nm LLRL for 3 minutes twice daily 4 or more hours apart or no intervention.Main Outcomes and MeasuresPrimary outcomes were changes in cycloplegia SER and axial length (AL) at 6- and 12-month follow-up visits. Safety was assessed on masked fundus photograph evaluations.ResultsA total of 336 children were randomly allocated into the LLRL group or control group in a 1:1 ratio. The control group contained 86 female patients (51.2%), and the treatment group contained 90 female patients (53.6%). The mean (SD) age, SER, and AL were 9.0 (1.9) years, −1.3 (1.5) D, and 23.8 (1.0) mm for all patients. A total of 161 (95.8%) in the LLRL group and 159 (94.6%) in the control group returned for the 6-month follow-up. A total of 157 (93.5%) in the LLRL group and 152 (90.5%) in the control group returned for the 12-month follow-up. Mean (SD) changes in SER were 0.15 (0.16) D and −0.26 (0.21) D for the LLRL group and the control group, respectively (difference, −0.41 D; 95% CI, −0.48 to −0.34 D; P &lt; .001), at 6 months and 0.24 (0.27) D and −0.65 (0.33) D for the LLRL group and the control group, respectively (difference, −0.89 D; 95% CI, −0.95 to −0.83 D; P &lt; .001), at 12 months. Mean (SD) changes in AL were −0.06 (0.08) mm and 0.13 (0.12) mm for the LLRL group and control group, respectively (difference, 0.19 mm; 95% CI, 0.16 to 0.22 mm; P &lt; .001), at 6 months and −0.11 (0.10) mm and 0.26 (0.16) mm for the LLRL group and control group, respectively (difference, 0.37 mm; 95% CI, 0.34 to 0.40 mm; P &lt; .001). Masked fundus photograph review did not identify retinal changes in either group.Conclusions and relevanceThese findings suggest daily use of 650-nm LLRL for 1 year can slow progression of SER and AL without safety concerns identified. Confirmation of these findings at independent sites seems warranted, as well as determining whether these effects can be sustained with or without continued treatment and whether LLRL has any effect on pathological myopia.Trial RegistrationChiCTR2200058963

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“…In animal studies, the duration of red light exposure was generally for the entire waking period (12–14 h per day), while protocols in children use 3 min of red light exposure twice a day. Since 2021, over 24 papers have been published on red light therapy for myopia, 2–5,12–26 including three review papers 27–29 . Eyerising International, manufacturer of the Eyerising Myopia Management Device, advertises the instrument for use in children as young as 3 years old, with online claims that over 100,000 children have been or are currently being treated.…”

Section: Introductionmentioning

confidence: 99%

Red light instruments for myopia exceed safety limits

Ostrin,

Schill

2024

Ophthalmic Physiologic Optic

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PurposeLow‐level red light (LLRL) therapy has recently emerged as a myopia treatment in children, with several studies reporting significant reduction in axial elongation and myopia progression. The goal of this study was to characterise the output and determine the thermal and photochemical maximum permissible exposure (MPE) of LLRL devices for myopia control.MethodsTwo LLRL devices, a Sky‐n1201a and a Future Vision, were examined. Optical power measurements were made using an integrating sphere radiometer through a 7‐mm diameter aperture, in accordance with ANSI Z136.1‐2014, sections 3.2.3–3.2.4. Retinal spot sizes of the devices were obtained using a model eye and high‐resolution beam profiler. Corneal irradiance, retinal irradiance and MPE were calculated for an eye positioned at the oculars of each device.ResultsBoth devices were confirmed to be Class 1 laser products. Findings showed that the Sky‐n1201a delivers laser light as a point source with a 654‐nm wavelength, 0.2 mW power (Ø 7 mm aperture, 10‐cm distance), 1.17 mW/cm2 corneal irradiance and 7.2 W/cm2 retinal irradiance (Ø 2 mm pupil). The MPE for photochemical damage is 0.55–7.0 s for 2–7 mm pupils and for thermal damage is 0.41–10 s for 4.25–7 mm pupils. Future Vision delivers the laser as an extended source subtending 0.75 × 0.325°. It has a 652‐nm wavelength, 0.06 mW power (Ø 7 mm aperture, 10 cm distance), 0.624 mW/cm2 corneal irradiance and 0.08 W/cm2 retinal irradiance (Ø 2 mm pupil). MPE for photochemical damage is 50–625 s for 2–7 mm pupils.DiscussionFor both of the LLRL devices evaluated here, 3 min of continuous viewing approached or surpassed the MPE, putting the retina at risk of photochemical and thermal damage. Clinicians should be cautious with the use of LLRL therapy for myopia in children until safety standards can be confirmed.

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Six-month repeated irradiation of 650 nm low-level red light reduces the risk of myopia in children: a randomized controlled trial

Cited by 8 publications

References 48 publications

Efficacy and Safety of Low-Dose Atropine on Myopia Prevention in Premyopic Children: Systematic Review and Meta-Analysis

Efficacy and Safety of Low-Dose Atropine on Myopia Prevention in Premyopic Children: Systematic Review and Meta-Analysis

Daily Low-Level Red Light for Spherical Equivalent Error and Axial Length in Children With Myopia

Red light instruments for myopia exceed safety limits

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