Evaluation of the Performance and Safety of the Atoldys/ Lexilens Glasses Developed to Improve the Reading of Dyslexic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Reading performance aloud of a text with french E.L.FE Test
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of a new medical device (Atoldys/ Lexilens glasses) on the improvement of reading skills of young dyslexic subjects.
详细描述
Dyslexia is defined as a specific learning disability that is characterized by reading difficulties, in the absence of intellectual disability, neurological or psychiatric disorder, uncorrected sensory disturbance (sight, hearing) or an educational deficiency.
Dyslexia appears in the child from the earliest stages of learning in the form of a difficulty in mastering the learning of reading. This disorder is manifested by a generally hesitant reading, slowed down, full of errors, requiring a lot of effort for the child and may impact his reading comprehension. The dyslexia-related deficiency is of variable intensity depending on the individual; it may be accompanied by calculus disorders (dyscalculia), oral language (dysphasia), motor coordination (dyspraxia) or attention disorders with or without hyperactivity. In nearly 40% of cases, a child affected by Dys disorders presents several learning disorders.
To date, the causes of dyslexia are not yet clearly established. The wide variety of symptoms and disorders associated with dyslexia does not facilitate the identification of precise neurobiological / psycho cognitive mechanisms. There are therefore several theories: phonological, visual, temporal, cerebellar or proprioceptive auditory processing.
Recently, following work published in 2017, an anatomical cause based on Maxwell's spots could also be a cause of dyslexia.
The aim of this study is to evaluate a new medical device (class I CE marked) to compensate this probable anatomical cause: the Atoldys/ Lexilens glasses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schooled in CM1, CM2 or 6ème,
- •French mother tongue,
- •For whom developmental dyslexia has been diagnosed by a health professional who specializes in this learning disorder,
- •With near vision, without optical correction, equivalent to P5 or better according to the Parinaud scale (distance: 30-40 cm),
- •Presenting an IQ ≥ 80 and ≤130 according to the WISC-V test performed by a psychologist,
- •For whom a written consent was obtained regarding his study participation.
排除标准
- •With medical history or presenting a neurological pathology,
- •Presenting a developmental disorder (autism, ADHD, ...),
- •Presenting hearing disorders,
- •Presenting an astigmatism of more than one uncorrected diopter,
- •Presenting other visual disorders,
- •Any other condition that, in the opinion of health professionals, could impair its ability to complete the study or could pose a significant risk.
结局指标
主要结局
Reading performance aloud of a text with french E.L.FE Test
时间窗: 1 day
E.L.FE Test (=Evaluation de la Lecture en FluencE) - "Monsieur Petit" and "Le Géant égoïste" texts : percentile
次要结局
- Speech therapist's satisfaction regarding Securirty, Performance and Usability of glasses(1 day)
- Reading performance aloud of isolated words with french BALE Test(1 day)
- Security: incidence of Adverse Events(1 day)
- Child's satisfaction regarding reading fluency and comprehension(1 day)
- Security: device deficiencies(1 day)