Improving Visual Functions in Young Children With Amblyopia Through Perceptual Learning
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Crowding Ratio (CR)
研究概览
简要总结
Amblyopia, affects 4% of the population. In the presence of a normal retina and optic nerve, the visual cortex does not develop normally secondary to the amblyopic eye being at a disadvantage in the sensitive period such as in strabismus. Amblyopia is associated with visuospatial disorders, and poor to absent stereopsis. Amblyopia is treated by occlusion of the non- amblyopic eye in childhood. The present study aims to evaluate the effectiveness of perceptual learning (PL), that is a training of visual drawing tasks (12 sessions of 30 Minutes duration) with crowding (c) for children with amblyopia compared to an amblyopic control group with a placebo drawing task.
Arm 1: Crowded (PLc)- Training with small spacing Arm 2: Uncrowded (PLu)- Training with large spacing Prior to this, a small group will help optimize parameters such as contrast and distance of visual objects presented
详细描述
Outcome(s):
Primary endpoints: improvement of amblyopia,crowding ratio (CR) and visual acuity before and after training, at 7 weeks, at 6 months Secondary outcome: hand-eye coordination, evaluated with the Beery VMI test before and after training, at 7 weeks, at 6 months Tertiary outcome over 6 years of age: macular structure measured with the OCT before and after training, at 7 weeks, at 6 months
Study design:
Cohort study, randomised controlled trial, single blind, active control, parallel groups
Inclusion / Exclusion criteria:
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 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged 4-8 years with
- •strabismic amblyopia
- •cycloplegic refraction corrected at least 3 months prior to enrolment
- •Reliable test results for two previous examinations
- •absence of ocular conditions other than strabismus, amblyopia and corrected refractive error
排除标准
- •inability to perform reliably when examined
- •inability to draw
- •unstable visual results on 2 previous examinations
结局指标
主要结局
Crowding Ratio (CR)
时间窗: 7 weeks
CR= Ratio of crowded versus uncrowded visual acuity. This is compared pre to post treatment
次要结局
- hand-eye coordination(7 weeks)
研究者
Anja Palmowski-Wolfe
Prof. Dr.med.
University of Basel