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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04586621
Recruitment Status : Completed
First Posted : October 14, 2020
Last Update Posted : February 14, 2022
Sponsor:
Collaborator:
Slb Pharma
Information provided by (Responsible Party):
ABEYE

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dyslexia Device: Atoldys/ Lexilens - SHAM Device: SHAM- Atoldys/ Lexilens Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Performance and Safety of the Atoldys/ Lexilens Glasses Developed to Improve the Reading of Dyslexic Subjects
Actual Study Start Date : January 19, 2021
Actual Primary Completion Date : June 29, 2021
Actual Study Completion Date : June 29, 2021

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




Primary Outcome Measures :
  1. Reading performance aloud of a text with french E.L.FE Test [ Time Frame: 1 day ]
    E.L.FE Test (=Evaluation de la Lecture en FluencE) - "Monsieur Petit" and "Le Géant égoïste" texts : percentile


Secondary Outcome Measures :
  1. Reading performance aloud of isolated words with french BALE Test [ Time Frame: 1 day ]
    BALE test (=Batterie Analytique de Langage Ecrit): percentile

  2. Security: incidence of Adverse Events [ Time Frame: 1 day ]
    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,...).

  3. Security: device deficiencies [ Time Frame: 1 day ]
    By questioning the speech therapist - evaluation of deficiencies due to glasses: the device deficienciesTable will be completed (description, relation with adverse effect, taken measures,...).

  4. Child's satisfaction regarding reading fluency and comprehension [ Time Frame: 1 day ]
    Child interview with numeric scale (0-10) and yes/ no answer

  5. Speech therapist's satisfaction regarding Securirty, Performance and Usability of glasses [ Time Frame: 1 day ]
    speech therapist interview with 4 points - Likert scale (Very good, Good, Moderate, Bad)



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586621


Locations
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France
Dr Laurence Derieux
Caen, France, 14000
Dr Luc-Marie Virlet
Faumont, France, 59310
CHU Rennes
Rennes, France, 35000
Sponsors and Collaborators
ABEYE
Slb Pharma
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Responsible Party: ABEYE
ClinicalTrials.gov Identifier: NCT04586621    
Other Study ID Numbers: Atoldys/ Lexilens
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslexia
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Learning Disabilities
Neurodevelopmental Disorders
Mental Disorders