Repeated Low-Level Red Light Therapy for Myopia Control in High Myopia Children and Adolescents: A Randomized Clinical Trial
Xu Y, Cui L, Kong M, Li Q, Feng X, Feng K, Zhu H, Cui H, Shi C, Zhang J, Zou H
Ophthalmology · 66 citations
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- Government
- Shanghai Municipal Health and Family Planning Commission
Based on 1 listed funder(s).
Publication
- Published
- 2024-06-06 · Ophthalmology · vol. 131 · issue 11 · pp. 1314–1323
- Publisher
- Elsevier BV
- Cited
- 77 citations · more than 100% of similar papers · 20.2× the field average
- Impact
- Top 10% most cited in its field
- References
- 27 works
- Access
- Open access (hybrid journal) · CC-BY-NC-ND
- Research areas
- Ophthalmology and Visual Impairment Studies · Corneal surgery and disorders · Retinopathy of Prematurity Studies
- Keywords
- Medicine, Optometry
- MeSH
- humans, myopia, degenerative, refraction, ocular, treatment outcome, follow-up studies, single-blind method, eyeglasses, visual acuity, adolescent, child, female, male, low-level light therapy
11 authors
From CN
- Yan XuTongji University; Shanghai Eye Disease Prevention & Treatment Center
- Lipu CuiShanghai Jiao Tong University; Shanghai First People's Hospital
- Miao KongShanxi Eye Hospital
- Qian LiShanghai East Hospital
- Xueliang FengShanxi Eye Hospital
- K D FengSoochow University
Abstract
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.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-ND).
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