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Ensayo controlado aleatorizado2025

Axial Shortening Effects of Repeated Low-level Red-light Therapy in Children With High Myopia: A Multicenter Randomized Controlled Trial

Liu G, Liu L, Rong H, Li L, Liu X, Jia Z, Zhang H, Wang B, Song D, Hu J, Shi X, Du B, Wei R

American journal of ophthalmology · 28 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
Gobierno
National Key Clinical Specialty Discipline Construction Program of China

Según 2 financiadores declarados.

Publicación

Publicado
2024-10-16 · Am J Ophthalmol · vol. 270 · págs. 203–215
Editorial
Elsevier BV
Citado
47 citas · más que el 99% de estudios similares · 12.3× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
54 trabajos
Acceso
Acceso abierto (revista híbrida) · CC-BY-NC-ND
Áreas de investigación
Ophthalmology and Visual Impairment Studies · Retinopathy of Prematurity Studies · Corneal surgery and disorders
Palabras clave
Medicine, Randomized controlled trial, Ophthalmology, Internal medicine
MeSH
humans, myopia, degenerative, disease progression, tomography, optical coherence, refraction, ocular, treatment outcome, phototherapy, follow-up studies, single-blind method, visual acuity, child, female, male, axial length, eye

13 autores

  • Guihua Liu🇨🇳Tianjin Medical University Eye Hospital; Tianjin Medical University
  • Lin Liu🇨🇳Tianjin Medical University Eye Hospital; Tianjin Medical University
  • Hua Rong🇨🇳Tianjin Medical University Eye Hospital; Tianjin Medical University
  • Li Li🇨🇳Beijing Children’s Hospital
  • Xuan Liu🇨🇳Beijing Tsinghua Chang Gung Hospital
  • Zhiyang Jia🇨🇳Hospital of Hebei Province; Hebei General Hospital
  • Hua Zhang🇨🇳First Hospital of Shijiazhuang
  • Biying Wang🇨🇳Tianjin Medical University Eye Hospital; Tianjin Medical University
  • Desheng Song🇨🇳Tianjin Medical University Eye Hospital; Tianjin Medical University
  • Jiamei Hu🇨🇳Tianjin Medical University Eye Hospital; Tianjin Medical University
  • Xinrui Shi🇨🇳Tianjin Medical University Eye Hospital; Tianjin Medical University
  • Bei Du🇨🇳 · autor de correspondenciaTianjin Medical University Eye Hospital; Tianjin Medical University
  • Ruihua Wei🇨🇳 · autor de correspondenciaTianjin Medical University Eye Hospital; Tianjin Medical University

Resumen

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

Purpose

To evaluate the effectiveness and safety of repeated low-level red-light (RLRL) in delaying the progression of high myopes with -6.00 diopters (D) or worse.

Design

Multicenter, randomized, parallel-group, single-blind clinical trial. A total of 202 high myopic children aged 7 to 12 years with cycloplegia spherical equivalent (SE) refraction ≤-6.00 D, astigmatism less than 2.50 D, and anisometropia of 1.50 D or less were enrolled from March 2022 to December 2022. Follow-up was completed in December 2023.

Methods

Eligible participants were randomly allocated to the intervention (RLRL + single vision spectacle) or the control group (single vision spectacle). The RLRL treatment was administered every day for 3 minutes, twice a day, with an interval of at least 4 hours. The primary outcome was the change in axial length (AL) at 12 months compared with baseline. Secondary outcomes included changes in SE, changes in choroidal thickness (ChT), and changes in retinal thickness (RT) in different circle sectors. Outcomes were analyzed by means of intention-to-treat and per-protocol methods.

Results

After 12 months of treatment, AL and SE changes were -0.11 ± 0.25 mm and 0.18 ± 0.63 D for the RLRL group and 0.32 ± 0.09 mm and -0.80 ± 0.42 D for the control group, respectively. Axial shortening >0.05 mm was 59% in the RLRL and 0% in the control group at 12 months. ChT and RT from a single center were analyzed. In the RLRL group, ChT was thickened in all sectors at 12 months. RT was increased in parafoveal and perifoveal circles. In the control group, all sectors of ChT and only perifoveal RT were significantly thinner at 12 months. The multivariate linear regression model revealed significant correlations between changes in the ChT central foveal circle and RT perifoveal circle at 1 month and AL changes at 12 months. No fundus structure changes, afterimage exceeding 6 minutes, or best-corrected visual acuity decrease were reported.

Conclusions

RLRL could effectively shorten the AL and inhibit the progression of myopia in high myopic patients with -6.00 D or worse. AL shortening is sustained over 12 months of treatment. These observed changes appeared to be associated with increases in ChT and RT.

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

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