Academic Journal
Repeated low-level red-light therapy combined with orthokeratology for myopia control in Spain: a randomised controlled study.
| Τίτλος: | Repeated low-level red-light therapy combined with orthokeratology for myopia control in Spain: a randomised controlled study. |
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| Συγγραφείς: | Fernández Fidalgo MJ; Centro Fernández-Velázquez, Madrid, Spain., Ferigo Ferrel VD; Centro Fernández-Velázquez, Madrid, Spain., Wu Y; The Hong Kong Polytechnic University, Hong Kong, China., Qi Z; Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China., Yin-Moe Aung Y; Eyerising International, Melbourne, Victoria, Australia., Chen Y; School of Optometry, The Hong Kong Polytechnic University, Hong Kong, China., Zhu Z; Centre for Eye Research Australia, Ophthalmology, University of Melbourne, Melbourne, Victoria, Australia., Fernández-Velázquez FJ; Centro Fernández-Velázquez, Madrid, Spain fernando@fernandez-velazquez.com. |
| Πηγή: | The British journal of ophthalmology [Br J Ophthalmol] 2026 Jun 22; Vol. 110 (7), pp. 771-777. Date of Electronic Publication: 2026 Jun 22. |
| Τύπος έκδοσης: | Journal Article; Randomized Controlled Trial |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: BMJ Pub. Group Country of Publication: England NLM ID: 0421041 Publication Model: Electronic Cited Medium: Internet ISSN: 1468-2079 (Electronic) Linking ISSN: 00071161 NLM ISO Abbreviation: Br J Ophthalmol Subsets: MEDLINE |
| Imprint Name(s): | Publication: Jan. 1992- : London : BMJ Pub. Group Original Publication: 1917-Dec. 1991: London : British Medical Association |
| Ιατρικοί όροι (MeSH): | Myopia*/therapy , Myopia*/physiopathology , Myopia*/diagnosis , Orthokeratologic Procedures*/methods , Refraction, Ocular*/physiology , Red Light*, Spain/epidemiology ; Visual Acuity/physiology ; Humans ; Child ; Female ; Male ; Adolescent ; Combined Modality Therapy ; Axial Length, Eye ; Treatment Outcome ; Follow-Up Studies ; Tomography, Optical Coherence |
| Περίληψη: | 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<0.001). Additionally, the adjusted mean change in MT showed no significant difference between groups at 12 months. In the RCO group, 80% of children achieved AL shortening >-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. (© Author(s) (or their employer(s)) 2026. No commercial re-use. See rights and permissions. Published by BMJ Group.) |
| Competing Interests: | Competing interests: Y-MA and ZZ are employees of Eyerising International. ZZ reported having a patent for CN110237432A. No other conflicting relationship exists. |
| Contributed Indexing: | Keywords: Child health (paediatrics); Clinical Trial; Optics and Refraction |
| Entry Date(s): | Date Created: 20251120 Date Completed: 20260623 Latest Revision: 20260629 |
| Update Code: | 20260629 |
| DOI: | 10.1136/bjo-2025-328347 |
| PMID: | 41266129 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1468-2079 |
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| DOI: | 10.1136/bjo-2025-328347 |