Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Département d'Ophtalmologie, Hôpital Fondation Adolphe de Rothschild
Paris, France, 75019
Actively Recruiting
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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