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| Name | Class |
|---|---|
| Slb Pharma | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atoldys/ Lexilens - SHAM | Experimental |
| |
| SHAM- Atoldys/ Lexilens | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atoldys/ Lexilens - SHAM | Device | Atoldys/ Lexilens: glasses with specific light frequency SHAM: glasses with no frequency |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reading performance aloud of a text with french E.L.FE Test | E.L.FE Test (=Evaluation de la Lecture en FluencE) - "Monsieur Petit" and "Le Géant égoïste" texts : percentile | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Reading performance aloud of isolated words with french BALE Test | BALE test (=Batterie Analytique de Langage Ecrit): percentile | 1 day |
| Security: incidence of Adverse Events | By questioning the child & the speech therapist - evaluation of adverse effects due to glasses (Yes/ No): headache, nausea, dizziness, fatigue and eye fatigue. According to patient questioning and clinical exam, the Adverse Event Table will be completed (description, dates, severity, imputability, action,...). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Laurence Derieux | Caen | 14000 | France | |||
| Dr Luc-Marie Virlet |
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| ID | Term |
|---|---|
| D004410 | Dyslexia |
| ID | Term |
|---|---|
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| SHAM- Atoldys/ Lexilens | Device | SHAM: glasses with no frequency Atoldys/ Lexilens: glasses with specific light frequency |
|
| 1 day |
| Security: device deficiencies | By questioning the speech therapist - evaluation of deficiencies due to glasses: the device deficienciesTable will be completed (description, relation with adverse effect, taken measures,...). | 1 day |
| Child's satisfaction regarding reading fluency and comprehension | Child interview with numeric scale (0-10) and yes/ no answer | 1 day |
| Speech therapist's satisfaction regarding Securirty, Performance and Usability of glasses | speech therapist interview with 4 points - Likert scale (Very good, Good, Moderate, Bad) | 1 day |
| Faumont |
| 59310 |
| France |
| CHU Rennes | Rennes | 35000 | France |
| D009422 | Nervous System Diseases |
| D000067559 | Specific Learning Disorder |
| D007859 | Learning Disabilities |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |