DyslexiaNCT04586621
Evaluation of the Performance and Safety of the Atoldys/ Lexilens Glasses Developed to Improve the Reading of Dyslexic Subjects
A study of Dyslexia, run by ABEYE at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslexia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 3 sitesFrance
- Study dates
- 19 Jan 2021to 29 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Dr Laurence Derieux
Caen, 14000
Dr Luc-Marie Virlet
Faumont, 59310
CHU Rennes
Rennes, 35000
About this study
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.
Read the 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
- Conditions
- Dyslexia
- Being tested
- Atoldys/ Lexilens - SHAM, SHAM- Atoldys/ Lexilens
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atoldys/ Lexilens - SHAMDevice
Atoldys/ Lexilens: glasses with specific light frequency SHAM: glasses with no frequency
SHAM- Atoldys/ LexilensDevice
SHAM: glasses with no frequency Atoldys/ Lexilens: glasses with specific light frequency
| Study group | Role | What they receive |
|---|---|---|
| Atoldys/ Lexilens - SHAM | Experimental | Not described Receives: Device: Atoldys/ Lexilens - SHAM |
| SHAM- Atoldys/ Lexilens | Experimental | Not described Receives: Device: SHAM- Atoldys/ Lexilens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (5)
Reading performance aloud of isolated words with french BALE Test
BALE test (=Batterie Analytique de Langage Ecrit): percentile
Measured: 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,...).
Measured: 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,...).
Measured: 1 day
Child's satisfaction regarding reading fluency and comprehension
Child interview with numeric scale (0-10) and yes/ no answer
Measured: 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)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start19 Jan 2021
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- ABEYE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586621
- Sponsor's protocol ID
- Atoldys/ Lexilens
- Status last verified
- Feb 2022
- First submitted
- 7 Oct 2020
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance and Safety of the Atoldys/ Lexilens Glasses Developed to Improve the Reading of Dyslexic Subjects
- ClinicalTrials.gov ID
- NCT04586621
- Acronym / sponsor ID
- Atoldys/ Lexilens
- Conditions
- Dyslexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- ABEYEIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atoldys/ Lexilens - SHAM | Experimental | Device: Atoldys/ Lexilens - SHAM |
| SHAM- Atoldys/ Lexilens | Experimental | Device: SHAM- Atoldys/ Lexilens |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atoldys/ Lexilens - SHAMAtoldys/ Lexilens: glasses with specific light frequency SHAM: glasses with no frequency | Device | Atoldys/ Lexilens - SHAM |
| SHAM- Atoldys/ LexilensSHAM: glasses with no frequency Atoldys/ Lexilens: glasses with specific light frequency | Device | SHAM- Atoldys/ Lexilens |
Primary outcome
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
5 secondary outcomes
Reading performance aloud of isolated words with french BALE Test
Time frame: 1 day
Security: incidence of Adverse Events
Time frame: 1 day
Security: device deficiencies
Time frame: 1 day
Child's satisfaction regarding reading fluency and comprehension
Time frame: 1 day
Speech therapist's satisfaction regarding Securirty, Performance and Usability of glasses
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Dyslexia, run by ABEYE at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading performance aloud of a text with french E.L.FE Test (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.