Clinically Study the Ocular Axial Length and Sphere Equivalence Changes of Children With Distance-image Screen Usage for One Year
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes of refractive error (D)
研究概览
简要总结
This study is for testing the efficacy and safety of distance-image screens for preventing myopia in children for 12 month. Each subjects would be asked to paired test the ocular parameters between before and after 12-month distance-image screens.
详细描述
This study is for testing the efficacy and safety of distance-image screens intended usage for preventing myopia in children with reading after a 6-meter-distant-image device. It was a prospective study. The investigators would like to recruit 100 volunteers, aged 6 years 16 in Beijing.
All the volunteers will be complete examined their ocular parameters before using the distant-image screen in a random order for at least 2 hours daily for 12 month. The changes of ocular axial length and refractive error were both calculated before and after 12-month usage for paired t-test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) Must be 6~12 years old;
- •(2) Must be best corrected visual acuity < logMAR: 0.1;
- •(3) Spherical Equivalence (SE) must be -1.00~ + 6.00 Diopter (D),
- •(4) Spherical Equivalence (SE) must have changed > 1.25 Diopter (D) in the recent 2 years;
- •(5) Must be astigmatism <1.75 Diopter (D);
- •(6) Must be anisometropia <1.75 Diopter(D).
排除标准
- •(1) Strabismus disease;
- •(2) Amblyopia disease;
- •(3) Cataract disease;
- •(4) Glaucoma disease;
- •(5) Severe dry eye disease;
- •(6) Cannot use distance-image screen for 12 month;
- •(7) Other severe diseases that would effect the use of distance-image screen.
结局指标
主要结局
Changes of refractive error (D)
时间窗: 12-month
Cycloplegic refraction with autorefractor will test each eye before the testing and after the testing with distance-image screen
Changes of ocular axial length (mm)
时间窗: 12-month
IntraOcularLens (IOL) master biometry will exam each eye before the testing and after the testing with distance-image screen
次要结局
- Changes of subretina choroidal thickness (um)(at 12-month)
- Changes of center macular thickness (um)(12-month)
- Changes of other regions choroidal thickness (um)(12-month)