Effect of Repeated Low-Level Red-Light Therapy for Myopia Control in Children: A Multicenter Randomized Controlled Trial
Jiang Y, Zhu Z, Tan X, Kong X, Zhong H, Zhang J, Xiong R, Yuan Y, Zeng J, Morgan IG, He M
Ophthalmology · 249 citas
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 independiente
- Gobierno
- National Natural Science Foundation of China
- Universidad u hospital
- State Key Laboratory of Ophthalmology
- Universidad u hospital
- Sun Yat-Sen University Zhongshan Ophthalmic Center State Key Laboratory of Ophthalmology
Según 3 financiadores declarados.
Publicación
- Publicado
- 2021-12-01 · Ophthalmology · vol. 129 · número 5 · págs. 509–519
- Editorial
- Elsevier BV
- Citado
- 345 citas · más que el 100% de estudios similares · 24.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 32 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC-ND
- Áreas de investigación
- Ophthalmology and Visual Impairment Studies · Corneal surgery and disorders · Laser Applications in Dentistry and Medicine
- Palabras clave
- Medicine, Light therapy, Ophthalmology, Optometry, Internal medicine, Circadian rhythm
- MeSH
- humans, myopia, disease progression, refraction, ocular, phototherapy, single-blind method, eyeglasses, child
11 autores
- Yu Jiang🇨🇳Sun Yat-sen University
- Zhuoting Zhu🇨🇳Sun Yat-sen University
- Xingping Tan🇨🇳Central South University; Xiangya Hospital Central South University
- Xiangbin Kong🇨🇳Southern Medical University
- Hui Zhong🇨🇳Shenzhen Children's Hospital
- Jian Zhang🇨🇳Sun Yat-sen University
- Ruilin Xiong🇨🇳Sun Yat-sen University
- Yixiong Yuan🇨🇳Sun Yat-sen University
- Junwen Zeng🇨🇳 · autor de correspondenciaSun Yat-sen University
- Ian George Morgan🇦🇺Australian National University
- 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
To assess the efficacy and safety of repeated low-level red-light (RLRL) therapy in myopia control in children.
Design
Multicenter, randomized, parallel-group, single-blind clinical trial.
Participants
Two hundred sixty-four eligible children 8 to 13 years of age with myopia of cycloplegic spherical equivalent refraction (SER) of -1.00 to -5.00 diopters (D), astigmatism of 2.50 D or less, anisometropia of 1.50 D or less, and best-corrected visual acuity (BCVA) of 0.0 logarithm of the minimum angle of resolution or more were enrolled in July and August 2019. Follow-up was completed in September 2020.
Methods
Children were assigned randomly to the intervention group (RLRL treatment plus single-vision spectacle [SVS]) and the control group (SVS). The RLRL treatment was provided by a desktop light therapy device that emits red light of 650-nm wavelength at an illuminance level of approximately 1600 lux and a power of 0.29 mW for a 4-mm pupil (class I classification) and was administered at home under supervision of parents for 3 minutes per session, twice daily with a minimum interval of 4 hours, 5 days per week.
Main outcome measures
The primary outcome and a key secondary outcome were changes in axial length and SER measured at baseline and the 1-, 3-, 6-, and 12-month follow-up visits. Participants who had at least 1 postrandomization follow-up visit were analyzed for treatment efficacy based on a longitudinal mixed model.
Results
Among 264 randomized participants, 246 children (93.2%) were included in the analysis (117 in the RLRL group and 129 in the SVS group). Adjusted 12-month axial elongation and SER progression were 0.13 mm (95% confidence interval [CI], 0.09-0.17mm) and -0.20 D (95% CI, -0.29 to -0.11D) for RLRL treatment and 0.38 mm (95% CI, 0.34-0.42 mm) and -0.79 D (95% CI, -0.88 to -0.69 D) for SVS treatment. The differences in axial elongation and SER progression were 0.26 mm (95% CI, 0.20-0.31 mm) and -0.59D (95% CI, -0.72 to -0.46 D) between the RLRL and SVS groups. No severe adverse events (sudden vision loss ≥2 lines or scotoma), functional visual loss indicated by BCVA, or structural damage seen on OCT scans were observed.
Conclusions
Repeated low-level red-light therapy is a promising alternative treatment for myopia control in children with good user acceptability and no documented functional or structural damage.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC-ND).
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