Myopia Adjustment Using Dual-intervention: Red-Light Therapy & Innovative Design in Orthokeratology

Launched by CENTRO DE MIOPÍA FERNÁNDEZ-VELÁZQUEZ · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial, called the MADRID study, is looking at how effective a combination of special contact lenses, known as orthokeratology (OK) lenses, and low-level red-light therapy can be in slowing down the worsening of nearsightedness, or myopia, in children who haven’t responded well to OK lenses alone. The study is taking place in Madrid, Spain, and is focused on children aged 8 to 15 years who have certain levels of myopia and have been struggling with rapid progression of their vision problems.

To participate, children need to have a specific range of nearsightedness and a clear vision of 20/20 or better in both eyes. They should also be willing to attend follow-up appointments and have permission from a parent or guardian. Participants will be divided into two groups: one will wear only the OK lenses, while the other will wear the lenses and receive the red-light therapy. Throughout the study, the children will have regular eye exams to monitor their eye growth. This research is fully funded by the institution and follows strict safety and ethical guidelines.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children aged 8 to 15 years. Intention to undergo orthokeratology (OK) lens treatment. Spherical equivalent refractive error between -1.00 and -4.00 diopters in either eye.
• • Astigmatism no greater than 1.50 D in either eye. Best corrected visual acuity (BCVA) of 25/25 or better in both eyes. Birth weight of at least 1500 g. Classified as ortho-k non-responders: continued OK use with persistent rapid myopia progression.
• • Willingness of child and legal guardian to participate and attend follow-up visits.
• • Signed informed consent by parent or guardian.
• Exclusion Criteria:
• • cular conditions such as strabismus, amblyopia, cataract, or ptosis. Previous use of OK lenses or atropine for myopia control. Contraindications to atropine (e.g., known allergy, cardiovascular disease, epilepsy).
• • Ocular contraindications to OK lens wear (e.g., inflammation, infection). Systemic diseases that may affect ocular growth (e.g., Down syndrome, Marfan syndrome).
• • Any other ocular disease that could interfere with study outcomes.