Randomized controlled trial2026

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 citations

Review labels

Funding not disclosed

Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function

Who paid for it

Funding
Funding not disclosed

Publication

Published
2025-11-20 · Br J Ophthalmol · vol. 110 · issue 7 · pp. 771–777
Publisher
BMJ
Cited
2 citations · more than 82% of similar papers · 1.2× the field average
References
34 works
Access
Paywalled
Research areas
Ophthalmology and Visual Impairment Studies · Corneal surgery and disorders · Laser Applications in Dentistry and Medicine
Keywords
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 authors

From HK, CN, AU

  • María José Fernández Fidalgo
  • Victoria Ferigo Ferrel
  • Yue WuHong Kong Polytechnic University
  • Ziyi QiShanghai Jiao Tong University; Shanghai First People's Hospital
  • Yuri Yin-Moe AungCentre for Eye Research Australia
  • Yanxian ChenHong Kong Polytechnic University

Abstract

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.

Abstract via Europe PMC. Copyright remains with the authors or publisher.

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