About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.)
Trial design
Crossover
Treatments tested in this trial
MCL1
DeviceMyopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children.
MCL2
DeviceMyopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in axial length
Secondary outcomes
Change from baseline in cycloplegic spherical equivalent
Effect of optical parameters, assessed at baseline, on myopia control efficacy of MCL1 and MCL2 at 6-month.
Correlation between amount of ocular aberrations (Root Mean Square of global High Order Aberrations) at baseline and the change of eye length induced by wearing MCL1 vs MCL2 at 6-month.
Effect of self-reported exposure time to natural light on myopia control efficacy of MCL1 and MCL2 at 6-month
Correlation between self-reported weekly hours of exposure to natural outdoor light, assessed with questionnaires each week and averaged at 6-month, and the change of axial length induced by wearing MCL1 vs MCL2 at 6-month.
Sponsors and contacts
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