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Ensayo controlado aleatorizado2024

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 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
Shanghai Municipal Health and Family Planning Commission

Según 1 financiador declarado.

Publicación

Publicado
2024-06-06 · Ophthalmology · vol. 131 · número 11 · págs. 1314–1323
Editorial
Elsevier BV
Citado
77 citas · más que el 100% de estudios similares · 20.2× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
27 trabajos
Acceso
Acceso abierto (revista híbrida) · CC-BY-NC-ND
Áreas de investigación
Ophthalmology and Visual Impairment Studies · Corneal surgery and disorders · Retinopathy of Prematurity Studies
Palabras clave
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 autores

  • Yan Xu🇨🇳Tongji University; Shanghai Eye Disease Prevention & Treatment Center
  • Lipu Cui🇨🇳Shanghai Jiao Tong University; Shanghai First People's Hospital
  • Miao Kong🇨🇳Shanxi Eye Hospital
  • Qian Li🇨🇳Shanghai East Hospital
  • Xueliang Feng🇨🇳Shanxi Eye Hospital
  • K D Feng🇨🇳Soochow University
  • Huang Zhu🇨🇳Shanghai Jiao Tong University; XinHua Hospital
  • Hongping Cui🇨🇳Shanghai East Hospital
  • Caiping Shi🇨🇳Children's Hospital of Zhejiang University
  • Jian Zhang🇨🇳 · autor de correspondenciaSun Yat-sen University; Key Laboratory of Guangdong Province; Guangdong Provincial Center for Disease Control and Prevention
  • Haidong Zou🇨🇳 · autor de correspondenciaTongji University; Shanghai Jiao Tong University; Shanghai Eye Disease Prevention & Treatment Center; Shanghai First People's Hospital

Resumen

El texto original del estudio, en el idioma en que se publicó.

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.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC-ND).

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