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

Официальное название

Evaluation of the Effectiveness of a New Generation of Myopia Control Lens, Producing a Higher Myopic Control Signal Than That Produced by a Previous Generation Lens, on the Progression of Myopia in Children Aged 6 to 14 Years

Обзор

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.

Подробное описание

Myopia is a global public health issue that could affect nearly 5 billion people by 2050. It progresses rapidly in children, increasing the risk of severe ocular diseases. Several solutions exist to slow its progression, including ophthalmic lenses, which are effective and free of side effects. Essilor® Stellest® lenses, incorporating H.A.L.T. technology with aspherical lenslets, slow axial eye elongation with an efficacy comparable to high-dose atropine.

A new version of this product provides an enhanced myopia-control signal thanks to increased optical parameters of the lenslets. A recent study has demonstrated its superior effectiveness in Asian children aged 6 to 10. The present study aims to assess its performance in European children, compared with another myopia control lens, which delivers the same myopia-control signal as the original Stellest® lens but with better visual quality.

The study will take into account interindividual variability in efficacy, particularly with respect to age-a key factor in myopia progression (which is high between ages 6 and 8). Three age groups will be analyzed (6-8, 9-11, and 12-14 years). A secondary objective is to explore the impact of individual ocular parameters on lens effectiveness.

Вмешательства

• Устройство MCL1
  Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children.
• Устройство MCL2
  Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children.

Первичные конечные точки

• Change from baseline in axial length [Срок оценки: 6-month]

Вторичные конечные точки (3)

• Change from baseline in cycloplegic spherical equivalent [Срок оценки: 6-month]
• Effect of optical parameters, assessed at baseline, on myopia control efficacy of MCL1 and MCL2 at 6-month. [Срок оценки: 6-month]
• Effect of self-reported exposure time to natural light on myopia control efficacy of MCL1 and MCL2 at 6-month [Срок оценки: 6-month]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Département d'Ophtalmologie, Hôpital Fondation Adolphe de Rothschild — Paris

Идентификаторы

NCT: NCT07462897 · WS10442 · 2025-A02213-46

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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