Randomized controlled trial2023

Myopia Control Effect of Repeated Low-Level Red-Light Therapy in Chinese Children: A Randomized, Double-Blind, Controlled Clinical Trial

Dong J, Zhu Z, Xu H, He M

Ophthalmology · 122 citations

Review labels

Funding not disclosed

Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.

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
Funding not disclosed

Publication

Published
2022-08-29 · Ophthalmology · vol. 130 · issue 2 · pp. 198–204
Publisher
Elsevier BV
Cited
168 citations · more than 100% of similar papers · 19.2× the field average
Impact
Top 10% most cited in its field
References
13 works
Access
Open access (hybrid journal) · CC-BY-NC-ND
Research areas
Ophthalmology and Visual Impairment Studies · Laser Applications in Dentistry and Medicine · Retinopathy of Prematurity Studies
Keywords
Medicine, Dioptre, Anisometropia, Randomized controlled trial, Repeated measures design, Confidence interval, Gee, Astigmatism, Generalized estimating equation, Randomization, Visual acuity, Ophthalmology, Refractive error, Surgery, Internal medicine
MeSH
humans, myopia, disease progression, mydriatics, refraction, ocular, phototherapy, child, east asian people

4 authors

From CN, AU

  • Jing DongBaotou Medical College
  • Zhuoting ZhuThe University of Melbourne; Centre for Eye Research Australia
  • Haifeng XuBaotou Central Hospital
  • Mingguang He · correspondingSun Yat-sen University; The University of Melbourne; Centre for Eye Research Australia

Abstract

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.

Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-ND).

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