Actively Recruiting

Phase Not Applicable
Age: 6Years - 14Years
All Genders
NCT07462897

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

Led by Essilor International · Updated on 2026-04-23

76

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 14 years
  • Refractive error in spherical equivalent between -0.5 D and -4.5 D in each eye under cycloplegia
  • Astigmatism of 2.00 D or less in each eye
  • Difference in spherical equivalent between eyes (anisometropia) of 1.00 D or less
  • Corrected distance visual acuity of at least 8/10 (0.1 LogMAR) in each eye
  • Written consent from both parents or one if exclusive authority, plus agreement from the child
Not Eligible

You will not qualify if you...

  • Past or current use of any myopia control treatments (e.g., braking lenses, atropine, orthokeratology, multifocal contact lenses)
  • Presence of strabismus in near or far vision tests with best correction
  • Amblyopia
  • Any eye or systemic condition affecting refractive status (e.g., keratoconus, diabetes, Down syndrome)
  • Eye trauma or inflammatory eye diseases
  • History of intraocular surgery in either eye
  • Past or current use of growth hormones
  • Use of drugs affecting 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
  • Specific visual disorders needing treatments other than conventional corrective lenses
  • Intolerance to conventional optical corrections
  • Lack of cooperation in wearing corrective lenses

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Département d'Ophtalmologie, Hôpital Fondation Adolphe de Rothschild

Paris, France, 75019

Actively Recruiting

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Research Team

T

Thibaut Chapron, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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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 | DecenTrialz