Six-Month Interim Analyses of the Efficacy of Repeated Low-Level Red-Light Therapy Combined with Orthokeratology for Myopia Control in Spanish Children
Fernández Fidalgo MJ, Ferigo Ferrel VD, Qi Z, Aung YY, Chen Y, Zhu Z, Fernández-Velázquez FJ
Ophthalmic epidemiology · 2 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
- Sin clasificar
- Eyerising International
Según 1 financiador declarado.
Publicación
- Publicado
- 2025-10-30 · Ophthalmic Epidemiol · vol. 33 · número 3 · págs. 275–282
- Editorial
- Taylor & Francis
- Citado
- 2 citas · más que el 82% de estudios similares · 1.2× el promedio de su campo
- Referencias
- 42 trabajos
- Acceso
- De pago
- Áreas de investigación
- Ophthalmology and Visual Impairment Studies · Corneal surgery and disorders · Laser Applications in Dentistry and Medicine
- Palabras clave
- Orthokeratology, Interim, Interim analysis, Adverse effect, Clinical trial
- MeSH
- humans, myopia, refraction, ocular, treatment outcome, combined modality therapy, follow-up studies, single-blind method, visual acuity, adolescent, child, spain, female, male, orthokeratologic procedures, axial length, eye, low-level light therapy
7 autores
- María José Fernández Fidalgo🇮🇳🇦🇷🇪🇸Fernandez Hospital; Hospital Fernández; Casa de Velázquez
- Victoria Ferigo Ferrel🇮🇳🇦🇷🇪🇸Fernandez Hospital; Hospital Fernández; Casa de Velázquez
- Ziyi Qi🇨🇳Shanghai Jiao Tong University; Shanghai Eye Disease Prevention & Treatment Center
- Yuri Yin‐Moe Aung🇦🇺Centre for Eye Research Australia
- Yanxian Chen🇭🇰Hong Kong Polytechnic University
- Zhuoting Zhu🇦🇺Centre for Eye Research Australia
- Fernando J. Fernández-Velázquez🇮🇳🇦🇷🇪🇸 · autor de correspondenciaFernandez Hospital; Hospital Fernández; Casa de Velázquez
Resumen
El texto original del estudio, en el idioma en que se publicó.
Purpose
To evaluate the efficacy and safety of repeated low-level red-light (RLRL) therapy in combination with orthokeratology (OK) for controlling myopia in Spanish children.
Methods
A single-site, randomized, parallel-group, single-blinded clinical trial. Twenty-six children aged 8-15 years with myopia between -0.75 to -6.75 D were enrolled. Participants were randomly assigned to either the RLRL combined with OK (RCO) group (n = 11) or the OK-only group (n = 15). The OK group wore OK lenses for at least 8 hours per night, while the RCO group received additional daily RLRL therapy, administered twice daily for 3 minutes per session five days per week. Follow-up visits were conducted at 1, 3, 6, and 12 months, with compliance and safety monitoring. The primary outcome measure was axial length (AL) change.
Results
All 26 children completed the 6-month follow-up visit. After 6 months, the adjusted mean AL change was -0.057 mm (95% CI, -0.078 to -0.037 mm) in RCO group, and 0.041 mm (95% CI, 0.029 to 0.054 mm) in OK group. In RCO group, 5 children (45.5%) achieved clinically significant axial shortening (defined as AL change ≤ -0.05 mm). The adjusted mean macular thickness change was 0.664 µm (95% CI, 0.468 to 0.859 µm) in RCO group, and 0.077 µm (95% CI, -0.048 to 0.203 µm) in OK group. No severe adverse events or significant corneal findings were observed.
Conclusions
The six-month interim analysis indicates that combining RLRL therapy with OK effectively controls myopia progression in Spanish children, with no severe adverse effects. Long-term follow-up is ongoing.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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