MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 12
- 主要终点
- Change in axial length and in spherical equivalent refractive error
研究概览
简要总结
The purpose of this trial is to investigate the safety and efficacy of MyopiaX - a digital treatment intended to slow the progression of myopia in children and adolescents.
详细描述
The present study is a multicentric, randomized, controlled, single masked trial to investigate the signals of effect, the safety and tolerability of MyopiaX in slowing the progression of myopia.
The trial consists of 12 months treatment period. The first 6 months participants will be treated either with MyopiaX or with myopia control spectacles. During the second half of the trial, participants treated with MyopiaX will receive the myopia control spectacles in addition. 81 children and adolescent aged 6 - 12 years will be included in the trial. Eligible subjects will be randomly assigned in a 2:1 ratio to either the MyopiaX or the myopia control spectacles group.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myopic children (-0.75 to -5.0 D SER, least myopic meridian -0.50 D in each eye)
- •At least VA 0.2 LogMAR in each eye
- •Age: 6 - 12 years old
- •Good tolerability of test session with VR system
- •Binocular adequacy as tested with VR
- •Ability to understand treatment and give valid assent
排除标准
- •Concomitant or previous therapies for myopia
- •Eye diseases/conditions:
- •Anisometropia ≥ 1.5 D
- •Astigmatism ≥ 3 D
- •Ophthalmological comorbidities
- •Optic nerve abnormalities
- •Suspicion of syndromic or monogenetic myopia
- •Systemic illnesses affecting eye health, eye growth, and/or refraction
- •Any illnesses affecting dopamine function (e.g., sleep disorder)
- •Medication affecting dopamine function, accommodation, pupil size, or having an impact on the ocular surface (such as allergy medications)
- •Participation in other clinical studies
- •Medical history (or family history) of photosensitive epilepsy
结局指标
主要结局
Change in axial length and in spherical equivalent refractive error
时间窗: 6 months
Change in axial length (mm) and in spherical equivalent refractive error )D)from baseline to month 6.
次要结局
未报告次要终点