Eye Drops Study for Myopia Control in Schoolchildren
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Axial length change (mm) measured by non-contact biometry
研究概览
简要总结
The myopia prevalence in schoolchildren is high in Taiwan. The myopia progression is fast in children and often associated high myopia in later life. This prospective and randomized study to investigate the effect of myopia control in myopic children with ultra low concentrations of atropine eye drops and/or low concentrations of anti-allergic and inflammatory eye drops.
详细描述
Myopia onset earlier in children who would suffer a high degree of myopia in the future adulthood.and higher risk for retinal detachment, macular degeneration, and even blindness. In Taiwan, myopia macular degeneration is the first place of irreversible blind cause in the elderly. The evidence based medicine shows atropine is the most effective treatment for the progression of myopia so far, but the side effects including photophobia and near blurred vision often disturbing patients and resulting poor compliance and high drop-out rate.
Recently, the studies from Taiwan and Singapore showed that low concentrations of atropine (0.05% or 0.01%) can effectively inhibit the myopia progression, reduce the symptoms of photophobia, and to achieve favorable myopia control. Previous study found that myopia and allergic conjunctivitis and inflammation were related. The investigators designed a prospective and randomized study to investigate the effect of myopia control in myopic children with ultra low concentrations of atropine eye drops and/or low concentrations of anti-allergic and inflammatory eye drops. Due to environmental factors such as near work, after school class and outdoor activity are also great associated with myopia, the questionnaires also are collected in this study.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Myopia diagnosed with the spherical equivalent refraction at least -0.5 diopter (D)
- •Must be able to use eye drops
排除标准
- •astigmatism -1.50 D or greater
- •strabismus
- •amblyopia
- •any ocular diseases ocular surgery
- •history of systemic diseases (ex. asthma, heart disease...)
- •contact lenses user
- •orthokeratology user
研究组 & 干预措施
0.01% atropine
children who received 0.01% atropine for myopia
干预措施: eye drops (Drug)
0.005% atropine
children who received 0.005% atropine for myopia
干预措施: eye drops (Drug)
0.25% Ketorolac
children who received 0.25% Ketorolac for myopia
干预措施: eye drops (Drug)
0.01% atropine plus 0.25% Ketorolac
children who received 0.01% atropine plus 0.25% Ketorolac for myopia
干预措施: eye drops (Drug)
0.005% atropine plus 0.25% Ketorolac
children who received 0.005% atropine plus 0.25% Ketorolac for myopia
干预措施: eye drops (Drug)
结局指标
主要结局
Axial length change (mm) measured by non-contact biometry
时间窗: 1 year
Axial length change (mm) measured by non-contact biometry is another indicator of the myopia progression.
Cycloplegic spherical refraction change measured by auto-refractometer (Diopter)
时间窗: 1 year
Cycloplegic spherical refraction change measured by auto-refractometer (Diopter) is the main indicator of the myopia progression.
次要结局
- Pupil size (mm) by electronic rule(1 year)
- Intraocular pressure (mmHg) by non-contact tonometer(1 year)
- Anterior chamber depth (mm) measured by non-contact biometry(1 year)
- Posterior chamber depth (mm) measured by non-contact biometry(1 year)
- Accommodation (diopter) by accommodometer(1 year)