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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorEssilor International

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • MCL1

    Device

    Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children.

  • MCL2

    Device

    Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: OD: MCL 1; OS: MCL 2Experimental treatment 2 interventions
Group B: OD: MCL 2; OS: MCL 1Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change from baseline in axial length

Time frame
6-month

Secondary outcomes

1

Change from baseline in cycloplegic spherical equivalent

Time frame
6-month
2

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.

Time frame
6-month
3

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.

Time frame
6-month

Other outcomes

Sponsors and contacts

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