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 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2022-08-29 · Ophthalmology · vol. 130 · número 2 · págs. 198–204
- Editorial
- Elsevier BV
- Citado
- 168 citas · más que el 100% de estudios similares · 19.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 13 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC-ND
- Áreas de investigación
- Ophthalmology and Visual Impairment Studies · Laser Applications in Dentistry and Medicine · Retinopathy of Prematurity Studies
- Palabras clave
- 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 autores
- Jing Dong🇨🇳Baotou Medical College
- Zhuoting Zhu🇦🇺The University of Melbourne; Centre for Eye Research Australia
- Haifeng Xu🇨🇳Baotou Central Hospital
- Mingguang He🇨🇳🇦🇺 · autor de correspondenciaSun Yat-sen University; The University of Melbourne; Centre for Eye Research Australia
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC-ND).
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