Postmarketing Parallel Randomized Clinical Trial to Determine the Efficacy and Safety of Atropine and DIMS Lenses in the Control of Myopia in a Pediatric Population.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Cycloplegic spherical equivalent refraction (SER) change
研究概览
简要总结
Phase IV clinical trial to evaluate whether there is a significant difference in the control of myopia progression in myopic children treated with 0.025% atropine and DIMS spectacle lenses compared to 0.025% atropine and single vision (SV) lenses. Open-label, randomized, parallel clinical trial with 2 arms, involving 111 patients in total. The primary efficacy endpoint will be the change in cycloplegic spherical equivalent refraction (SER) and axial length (AL) compared to baseline values.
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
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DIMS Lenses
Atropine 0,025% + DIMS Lenses
干预措施: Atropine 0,025% (Drug)
DIMS Lenses
Atropine 0,025% + DIMS Lenses
干预措施: DIMS Lenses (Device)
Monofocal Lenses
Atropine 0,025% + monofocal (single vision) Lenses
干预措施: Atropine 0,025% (Drug)
Monofocal Lenses
Atropine 0,025% + monofocal (single vision) Lenses
干预措施: Monofocal lenses (Device)
结局指标
主要结局
Cycloplegic spherical equivalent refraction (SER) change
时间窗: 2 years (24 months)
Cycloplegic spherical equivalent refraction (SER) change
Axial length (AL) change
时间窗: 2 years (24 months)
Axial length (AL) change
次要结局
未报告次要终点
研究者
Noemi Guemes
Principal Investigator and sponsor
Hospital San Carlos, Madrid