Myopia Adjustment Using Dual-intervention: Red-Light Therapy & Innovative Design in Orthokeratology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Axial Length
研究概览
简要总结
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.
详细描述
Background and Rationale Myopia is a growing public health concern worldwide, especially among children, due to its progressive nature and association with severe ocular complications later in life. Orthokeratology (OK) lenses are one of the most effective non-pharmacological interventions for myopia control, reducing axial elongation by up to 63%. However, a subset of children, referred to as "ortho-k non-responders", continue to exhibit rapid axial elongation despite consistent use of OK lenses.
Repeated low-level red-light (R.L.R.L.) therapy is a novel, non-invasive intervention that has shown promise in reducing myopia progression. Preliminary studies suggest its mechanism may involve choroidal thickening, potentially complementing the effects of OK lenses. This study seeks to evaluate whether the combination of OK and R.L.R.L. offers additive benefits in myopia control for this specific population.
Study Design and Objectives This is a prospective, single-centre, randomized controlled clinical trial. The trial is being conducted at the Centro Fernández-Velázquez (Madrid, Spain) and aims to recruit 10 participants aged 8-15 years who meet specific inclusion criteria, including documented poor response to orthokeratology alone.
Participants will be randomized into two groups:
Experimental Group: OK lens + R.L.R.L. therapy (2 sessions/day, 3 minutes/session, minimum 4-hour interval) Control Group: OK lens only The primary endpoint is the change in axial length over 6 months, with the possibility of extending the intervention and monitoring for up to 12 months. Secondary endpoints include changes in refractive error, choroidal thickness, and treatment tolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Axial Length
时间窗: 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.
次要结局
- Change in Refractive Error (Spherical Equivalent) at 6 and 12 Months(12 months)
- Change in Subfoveal Choroidal Thickness at 6 and 12 Months(12 months)
研究者
Fernando Fernandez Velazquez
Doctor of Optometry
Centro de Miopía Fernández-Velázquez