Repeated low-level red-light therapy combined with orthokeratology for myopia control in Spain: a randomised controlled study
Fernández Fidalgo MJ, Ferigo Ferrel VD, Wu Y, Qi Z, Yin-Moe Aung Y, Chen Y, Zhu Z, Fernández-Velázquez FJ
The British journal of ophthalmology · 2 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
- 2025-11-20 · Br J Ophthalmol · vol. 110 · número 7 · págs. 771–777
- Editorial
- BMJ
- Citado
- 2 citas · más que el 82% de estudios similares · 1.2× el promedio de su campo
- Referencias
- 34 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, Randomized controlled trial, Eye disease, Ethnic group, Blindness, Refractive error
- MeSH
- humans, myopia, tomography, optical coherence, refraction, ocular, treatment outcome, combined modality therapy, follow-up studies, visual acuity, adolescent, child, spain, female, male, orthokeratologic procedures, axial length, eye, red light
8 autores
- María José Fernández Fidalgo
- Victoria Ferigo Ferrel
- Yue Wu🇭🇰Hong Kong Polytechnic University
- Ziyi Qi🇨🇳Shanghai Jiao Tong University; Shanghai First People's Hospital
- 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 correspondencia
Resumen
El texto original del estudio, en el idioma en que se publicó.
Aim
To evaluate the 12-month efficacy and safety of repeated low-level red-light (RLRL) therapy combined with orthokeratology (ortho-k) (RCO) for controlling myopia in Spanish children.
Methods
In this single-site, randomised, parallel-group, non-blinded clinical trial (NCT06899139), eligible myopic children aged 10-13 years were recruited and assigned randomly either to the RCO group or the ortho-k group. Follow-up assessments were conducted at 6, 9 and 12 months after baseline. The primary outcome and secondary outcome were the axial length (AL) and macular thickness (MT) changes at 12 months estimated by longitudinal mixed model.
Results
All participants (n=26; 11 in the RCO group and 15 in the ortho-k group) were included in the analysis. After 12 months, the adjusted mean AL change was -0.124 mm (95% CI -0.164 to -0.084) in the RCO group, whereas the ortho-k group continued to exhibit a modest axial elongation of 0.102 mm (95% CI 0.068 to 0.136). The adjusted mean difference in AL change was -0.226 mm (95% CI -0.279 to -0.174) between the groups (p-0.05 mm, whereas no children in the ortho-k group showed AL shortening. No severe adverse events were reported during the study.
Conclusions
Combining RLRL therapy with ortho-k is an effective and safe myopia control strategy in Caucasian Spanish children, supporting the potential generalisability of the synergistic effect across diverse ethnic groups.
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