NCT06553404进行中（未招募）4 期
A Prospective, Randomized, Controlled Double Masked Trial to Assess the Performance of Myoslow Lens in Slowing Myopia Progression in Children
Crystal Optic1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2022年11月24日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- spherical equivalent error
研究概览
简要总结
A Prospective, randomized, controlled double masked trial to assess the performance of Myoslow lens in slowing myopia progression in children.
The following study measures will be assessed:
- Demographics and medical history
- Current spectacles
- Best Corrected Visual Acuity (BCVA) assessed by Measurement and Summation (M&S) system
- Biometry
- Cover test
- Stereopsis
- Ocular Motility
- Pupil responses
- Cycloplegic refraction
- Fundus Examination
- Vision related quality of life using the questionnaire Pediatric Refractive Error Profile (PREP)2
- Adverse Events
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants and site staff will be masked to the assigned arm
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
- •Children, 6-12 years old
- •Spherical Equivalence Refraction (SER): -1.00 to -5.00 Diopter (D).
- •Astigmatism and anisometropia of 1.50 D or less.
- •Best Corrected Visual Acuity (BCVA) (6 / 7.5) or higher.
排除标准
- •Eye and systemic disorders.
- •Previously treated for myopia
结局指标
主要结局
spherical equivalent error
时间窗: 24 months
Change in spherical equivalent refractive error from baseline to 24-month visit
次要结局
- Axial length(24 months)
研究者
研究点 (1)
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