Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia in Chinese Children
试验速览
- 阶段
- 不适用
- 入组人数
- 176
- 主要终点
- best corrected visual acuity
研究概览
简要总结
To evaluate the efficacy and safety of Eyetronix Flicker Glassess therapy in treating anisometropic amblyopia.
详细描述
A total of 176 children with anisometropic amblyopia, aged 4 to 13 years, will randomize to receive patching or Eyetronix Flicker Glasses treatment in a 1:1 ratio.Eyetronix Flicker Glasses, a lightweight spectacle frame with liquid crystal lenses that provide direct square-wave alternating occlusion, will be used at a pre-programmed temporal frequency. Patching is a traditional treatment of amblyopia. The best corrected visual acuity, contrast sensitivity, binocular function,visual evoked potential and functional MRI will be measured at baseline and follow-up visits to assess the improvement of amblyopia.Feedback information from the questionnaires will be used to evaluate the compliance and adverse effects.
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 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged from 4 to 13 years old
- •the best corrected visual acuity in the amblyopic eye is no more than 0.1logMAR, with two lines or more of difference between the two eyes
- •anisometropia is defined as an inter-ocular spherical refractive error difference of 1.00 D or more or a cylindrical difference of 1.50 D or more.
- •no amblyopia treatment one month prior to the study except refractive correction.
- •myopia is less than -6.00D or hyperopia is less than +9.00D, strabismus was less than 20 prism diopters
- •willing to participate in this study and be able to follow up on time
排除标准
- •ocular disease and other disease that have an influence on the visual acuity
- •history of ocular surgery that have an influence on the visual acuity
- •the patient is receiving other amblyopia treatment except refractive correction
- •a family or personal history of seizures
- •the patient is using some medicine that may have an influence on visual acuity
结局指标
主要结局
best corrected visual acuity
时间窗: 6 months
have an improvement of best corrected visual acuity in the amblyopic eyes
次要结局
- contrast sensitivity function(6 months)
- visual evoked potential(6 months)
- functional MRI(6 months)
- stereocuity(6 months)
- best corrected visual acuity(a year and a half)