NCT00263471Unknown2 期
Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 主要终点
- Axial growth
研究概览
简要总结
7-methylxanthine has been shown to increase the concentration and thickness of collagen fibrils in rabbit sclera. Deficient collagen in the sclera may be the cause of progression of childhood myopia. The study hypothesis is that treatment with 7-methylxanthine will stabilize the sclera and prevent further progression of myopia.
详细描述
Participants are given tablets of 7-methylxanthine 400 mg per day or placebo tablets for 12 months. Axial length, cycloplegic refraction and corneal curvature is measured, as well as weight, height, blood pressure and heart rate. The participants are interviewed about possible CNS, gastrointestinal, or cardiopulmonal side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children in the age 8-13 years with myopia and an axial growth rate of 0.15 mm or more per year.
排除标准
- •Severe general ailment (for example diabetes, epilepsy, psychiatric disease) Eye diseases (for example cataract, keratoconus, chronic iritis, glaucoma)
结局指标
主要结局
Axial growth
次要结局
- Myopia progression
研究者
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