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

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

Treatments tested in this trial

  • MCL1
  • MCL2

Treatment groups

76 Participants
are divided into 2 treatment groups

Sponsors and collaborators