Evaluation of the Performance and Safety of the Atoldys/ Lexilens Glasses Developed to Improve the Reading of Dyslexic Subjects

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.

Study Overview

• Status: Completed
• Conditions: Dyslexia
• Intervention / Treatment: Device: Atoldys/ Lexilens - SHAM; Device: SHAM- Atoldys/ Lexilens

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Dr Laurence Derieux
  • Faumont, France, 59310
    • Dr Luc-Marie Virlet
  • Rennes, France, 35000
    • CHU Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atoldys/ Lexilens - SHAM	Device: Atoldys/ Lexilens - SHAM; Atoldys/ Lexilens: glasses with specific light frequency SHAM: glasses with no frequency
Experimental: SHAM- Atoldys/ Lexilens	Device: SHAM- Atoldys/ Lexilens; SHAM: glasses with no frequency Atoldys/ Lexilens: glasses with specific light frequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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,...).	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

Collaborators and Investigators

• Sponsor: ABEYE
• Collaborators: Slb Pharma

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2021
• Primary Completion (Actual): June 29, 2021
• Study Completion (Actual): June 29, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Dyslexia
• Other Study ID Numbers: Atoldys/ Lexilens

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No