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

Condition(s) studied

Investigational drug(s) / intervention(s)

Orthokeratology Lens Wear: Orthokeratology Lens Wear Intervention Type: Device Description: Participants will wear gas-permeable orthokeratology (OK) lenses overnight for a minimum of 8 hours per night. Lenses are designed to reshape the cornea temporarily to reduce refractive error and slow axial elongation. This intervention is administered to both the experimental and control groups.

Repeated Low-Level Red-Light Therapy Intervention Type: Device Description: Participants in the experimental group will receive repeated low-level red-light (R.L.R.L.) therapy twice daily using a no: Description: Participants in the experimental group will receive repeated low-level red-light (R.L.R.L.) therapy twice daily using a non-invasive light-emitting device. Each session will last no more than 3 minutes, with a minimum interval of 4 hours between sessions. The therapy is administered under parental supervision and aims to enhance myopia control in conjunction with orthokeratology.

Study summary

This clinical trial investigates the efficacy of combining orthokeratology (OK) lenses with repeated low-level red-light (R.L.R.L.) therapy in slowing the progression of myopia in children classified as ortho-k non-responders. The MADRID study is a single-centre, prospective, randomized controlled trial conducted at the Centro Fernández-Velázquez in Madrid, Spain. Participants aged 8 to 15 years will be randomly assigned to either a control group (OK lenses only) or an experimental group (OK lenses + R.L.R.L. therapy). The primary objective is to assess the potential additive effect of R.L.R.L. therapy on axial length control over a 6 to 12-month follow-up period. All participants will undergo ocular biometry and posterior segment OCT at regular intervals. The study is fully self-funded by the institution and adheres to rigorous ethical and safety standards.

Eligibility

Primary outcome measure(s)

• Change in Axial Length — 12 months
  Axial length (in millimetres) will be measured using the Myopia Master (Oculus) at baseline and at 6 and 12 months to evaluate the progression of myopia. Measurements will be conducted between 9:00-11:00 a.m. to reduce diurnal variation.

Trial sites (1)

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