Myopia Control Effect of Orthokeratology and 0.01% Atropine Sequential Treatment in Children and Adolescents: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Axial length change
研究概览
简要总结
The purpose of this multicenter randomized clinical trial is to evaluate the myopia control effect of orthokeratology and 0.01% atropine sequential treatment in children and adolescents, as compared to continuous treatment with orthokeratology.
详细描述
Myopia constitutes a major threat to vision health globally for its increasing prevalence and irriversible blinding complications. It is crucial to effectively intervene subjects with progressive myopia to reduce risks of myopic pathologies in later life.
Orthokeratology (ortho-k) is the first-line intervention for myopia control, with an efficacy of slowing axial elongation by 43-63%. However, the efficacy decreases over time. Sequential treatment strategy, which switches myopia control interventions at some intervals, has a potential to increase myopia control efficacy regarding the whole treatment period, compared to applying one intervention throughout. However, there lacks evidence supporting the benefit of this treatment strategy.
The purpose of this study is to evaluate the effectiveness of orthokeratology and 0.01% atropine sequential treatment on myopia control in children and adolescents, as compared to continuous treatment with orthokeratology, using a multicenter randomized controlled trial design. Subjects will be randomly assigned into either ortho-k and 0.01% atropine sequential treatment group or ortho-k continuous treatment group. Their axial length will be monitored over two years. Changes in axial length in the two groups will be compared.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 8-15 years old.
- •Spherical equivalent refractions (SERs) -0.50 to -6.00 Dioptres (D) and astigmatism less than -1.5 D in both eyes, anisometropia less than 1.5 D.
- •Best corrected visual acuity (BCVA) equal to or better than 20/25 in both eyes.
- •Bilateral intra-ocular pressure < 21mmHg.
- •Normal binocular and stereoscopic visual function.
- •Participants and their guardians' understanding and acceptance of random allocation of grouping.
排除标准
- •Manifest strabismus, except for intermittent tropia.
- •Ocular or systemic diseases which may affect vision or refractive error.
- •Previous use of myopia control without washout, including atropine, myopia control spectacles, myopia control contact lenses.
- •Other contraindications.
研究组 & 干预措施
Ortho-k and 0.01% atropine sequential treatment
Participants will be treated with ortho-k lenses during the first year, and swiched to recieve 0.01% atropine twice a day in the second year.
干预措施: Ortho-k lenses (Device)
Ortho-k continuous treatment
Participants will be treated with ortho-k lenses throughout, during the 2-year study period.
干预措施: Ortho-k lenses (Device)
Ortho-k and 0.01% atropine sequential treatment
Participants will be treated with ortho-k lenses during the first year, and swiched to recieve 0.01% atropine twice a day in the second year.
干预措施: 0.01% Atropine (Drug)
结局指标
主要结局
Axial length change
时间窗: From baseline to the end of treatment at 25 months
Axial length change (mm) is characterized as the difference between 25-month follow-up visit and baseline values. The IOLMaster or Lenstar are used to measure axial length (mm).
次要结局
- Axial length change(From baseline to 3, 6, 9, 12, and 19 months.)
- Proportion of rapid myopia progression(From baseline to the end of treatment at 25 months)
- Incidence of adverse events(From baseline to 25 months.)