Evaluation of the Effectiveness of a New Generation of Myopia Control Lens on the Progression of Myopia in Children Aged 6 to 14 Years
Recruiting now · Not applicable
Conditions studied: Myopia Progression
In brief
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.
Key facts
- Study ID
- NCT07462897
- Run by
- Essilor International
- People needed
- 76
- Starts
- 2026-03-18
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-04-23
Who can join
Age: 6 and older, up to 14. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- Written consent of the 2 holders of parental authority (or only one in the case of exclusive parental authority) and agreement of the participant
You may not qualify if…
- 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.)
- Presence of trauma in at least one eye - Presence of inflammatory pathologies in at least one eye
- History of intraocular surgery (cataracts, filtering surgery, intravitreal surgery) in at least one eye
- Past or current use of growth hormones
- Use of ocular or systemic drugs that, in the opinion of the investigator, may significantly affect 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
- Children with specific visual disorders requiring personalized treatments other than conventional corrective lenses.
- Intolerance to conventional optical corrections
- Lack of cooperation in wearing corrective lenses
Where it is running
- Département d'Ophtalmologie, Hôpital Fondation Adolphe de Rothschild — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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