Binocular Vision Alternations and Functional Magnetic Resonance Imaging Activation After Implantable Collamer Lens Implantation for High Myopia
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes of phoria at different time points
研究概览
简要总结
Implantable collamer lens (ICL) is one of the most effective operation for high myopia. Due to refractive correction changed, and prism effect of the spectacle removed, in the early stage after ICL implantation, binocular function might be dysfunction, leading to asthenopia, blurred vision, double vision and so on. This study will recruit the high myopia subjects that scheduled for ICL implantation, purpose to investigate the binocular vision alternations and brain activation that impacted by ICL implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-35
- •Spherical equivalent over -6.00DS, astigmatism within -2.00DC, anisometropia within -2.00DS
- •BCVA ≥ 0.8
- •Plan to accept implantable collamer lens surgery
- •Near point of convergence within 10cm
- •Positive fusion vergence over 20pd
排除标准
- •Stabismus
- •Previous ocular surgery or trauma
- •History of vision therapy
- •Monovision and nystagmus
- •Mental disease or craniocerebral trauma
结局指标
主要结局
Changes of phoria at different time points
时间窗: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Phoria was measured by phoropter.
Changes of fusion vergence at different time points
时间窗: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Fusion vergence was measured by phoropter.
Changes of accommodative response at different time points
时间窗: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Accommodative response was measured using monocular estimated method.
Changes of relative accommodation at different time points
时间窗: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Relative accommodation was measured by phoropter.
Changes of vergence facility at different time points
时间窗: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Vergence facility was measured by +2.00D/-2.00D flipper.
Changes of accommodative facility at different time points
时间窗: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Accommodative facility was measured by 3△BI/12△BO flipper.
Changes of AC/A at different time points
时间窗: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Gradient AC/A was measured by phoropter.
Changes of near point of convergence at different time points
时间窗: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Near point of convergence was measured using push-up method.
Changes of accommodation amplitude at different time points
时间窗: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Accommodative amplitude was measured using push-up method.
次要结局
- Changes of brain activation at different time points(The examination was performed before operation and 1 month, 6 monthes after ICL implantation.)