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Evaluation of the Effectiveness of a New Generation of Myopia Control Lens on the Progression of Myopia in Children Aged 6 to 14 Years

RecruitingNAAges 6 Years - 14 YearsAllEssilor International
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical investigation is to learn how much a new generation of myopia control lens (MCL1 - Myopia Control Lens 1) is helpful in reducing myopia progression in children from 6 to 14 yo. The main questions it aims to answer is: How much this new generation of lens, called MCL1, slows down the growth of the eye? Researchers will compare MCL1 to a former generation of myopia control lens (i.e. MCL2) but with better vision quality. Participants will: * Wear MCL1 on right eye and MCL2 on left eye for 6 months and MCL2 on rigth eye and MCL1 on left eye for the next 6 months; * Visit the hospital at 6 and 12 months for tests; * Answer weekly questionnaires on compliance wearing glasses, quality of vision and out-of-school activities.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Refractive error in spherical equivalent (SE) ≤ -0.5 D and ≥ -4.5 D on each eye (autorefraction under cycloplegia) * Astigmatism ≤ 2.00 D for each eye * Anisometropia (difference in SE between the 2 eyes) ≤ 1.00 D * Corrected maximum distance visual acuity in each eye≥ 8/10 (equivalent to +0.1 LogMAR) * Written consent of the 2 holders of parental authority (or only one in the case of exclusive parental authority) and agreement of the participant Exclusion Criteria: * Past or current use of any type of myopic control solution (braking lenses, atropine, orthokeratology, multifocal contact lenses, etc * Strabismus (in the test of masking near or far with the best correction) * Amblyopia * Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down syndrome, etc.) * Presence of trauma in at least one eye - Presence of inflammatory pathologies in at least one eye * History of intraocular surgery (cataracts, filtering surgery, intravitreal surgery) in at least one eye * Past or current use of growth hormones * Use of ocular or systemic drugs that, in the opinion of the investigator, may significantly affect pupil size, accommodation, or refractive status. * Wearing contact lenses * Allergy or intolerance to cycloplegic eye drops (cyclopentolate 0.5%) * Known allergy or intolerance to eyeglass frame materials * Children with specific visual disorders requiring personalized treatments other than conventional corrective lenses. * Intolerance to conventional optical corrections * Lack of cooperation in wearing corrective lenses
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What it tests

  • MCL1
  • MCL2
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Where

1 site
Département d'Ophtalmologie, Hôpital Fondation Adolphe de Rothschild
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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