Evaluation of the Performance and Safety of the Atoldys/ Lexilens Glasses Developed to Improve the Reading of Dyslexic Subjects
1 other identifier
interventional
41
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedStudy Start
First participant enrolled
January 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2021
CompletedFebruary 14, 2022
February 1, 2022
5 months
October 7, 2020
February 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Reading performance aloud of isolated words with french BALE Test
1 day
Security: incidence of Adverse Events
1 day
Security: device deficiencies
1 day
Child's satisfaction regarding reading fluency and comprehension
1 day
Speech therapist's satisfaction regarding Securirty, Performance and Usability of glasses
1 day
Study Arms (2)
Atoldys/ Lexilens - SHAM
EXPERIMENTALSHAM- Atoldys/ Lexilens
EXPERIMENTALInterventions
Atoldys/ Lexilens: glasses with specific light frequency SHAM: glasses with no frequency
SHAM: glasses with no frequency Atoldys/ Lexilens: glasses with specific light frequency
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ABEYElead
- Slb Pharmacollaborator
Study Sites (3)
Dr Laurence Derieux
Caen, 14000, France
Dr Luc-Marie Virlet
Faumont, 59310, France
CHU Rennes
Rennes, 35000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2020
First Posted
October 14, 2020
Study Start
January 19, 2021
Primary Completion
June 29, 2021
Study Completion
June 29, 2021
Last Updated
February 14, 2022
Record last verified: 2022-02