Targeted Lens Intervention for Myopic Anisometropia in Children

Официальное название

Clinical Investigation of Targeted Lens Intervention in the Management of Myopic Anisometropia in Children

Обзор

The goal of this clinical trial is to learn if our research spectacles will lower the difference in prescription (spectacles degree) between the eyes in children between 6 to 13 years old with anisometropic myopia. Anisometropic myopia is when the difference in myopia prescription between the two eyes are more than 1 diopter. The main question it aims to answer is: * How the eye responds to the research spectacles over time by measuring: 1. Change in axial length: the physical length of the eye from front to back. 2. Change in cycloplegic spherical equivalent refraction: an accurate measurement of the eye's prescription taken while the focusing muscles are temporarily relaxed with eye drops. Participants will: * Wear the study spectacles * Visit Essilor R\&D Centre and an eye clinic for follow-up sessions

Вмешательства

• Устройство More myopic eye: MCL1; Less myopic eye: MCL2
  Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL1) and Myopia Control Lens 2 (MCL2) design, with one type of lens in each eye throughout the study period. MCL1 will be worn in the more myopic eye, and MCL2 in the less myopic eye for a period of 12 months.

Первичные конечные точки

• Change in axial length difference between the eyes [Срок оценки: Base line, 12 months]
• Change in cycloplegic spherical equivalent refraction between the eyes [Срок оценки: Baseline, 12 months]

Вторичные конечные точки (1)

• Change in axial length difference between the eyes [Срок оценки: Baseline, 6 months]

Критерии участия

Критерии включения

• Voluntary
• Informed consent of parent/guardian and assent of participant
• Age equal to or greater than 6 years old and less than 13 years at the time of signing informed consent and assent
• SER equal or less than -0.50 D and equal or greater than .5.00 D with astigmatism not more than 2.50 D
• Difference in SER (anisometropia) between two eyes .1.00 D
• Best corrected visual acuity (BCVA) better than or equal to +0.20 LogMAR in each eye
• Agree to wear study spectacles for .12 hours/day and 7 days/week
• Willingness and ability to participate in investigation for 12 months and attend scheduled visits punctually
• Agree for no concurrent involvement in other myopia control treatment

Критерии исключения

• History or presence of an ocular disease affecting refractive status
• History or presence of strabismus
• Presence of amblyopia
• Current or previous use of atropine and/or orthokeratology
• Known allergy to cycloplegic agents
• Contraindication to cycloplegic agents
• Cognitive or psychological vulnerability

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• Essilor R&D Centre Singapore — Singapore

Публикации

• Li X, Huang Y, Liu C, Chang X, Cui Z, Yang Q, Drobe B, Bullimore MA, Chen H, Bao J. Myopia control efficacy of spectacle lenses with highly aspherical lenslets: results of a 5-year follow-up study. Eye Vis (Lond). 2025 Mar 5;12(1):10. doi: 10.1186/s40662-025-00427-3. PMID 40038807
• Lu J, Long W, Zheng B, Liang Z, Hou F, Cui D. Effects of weekly unilateral application of 1% atropine on reducing anisometropia in Chinese children with low myopia. J Optom. 2025 Oct-Dec;18(4):100578. doi: 10.1016/j.optom.2025.100578. Epub 2025 Aug 26. PMID 40865156

Идентификаторы

NCT: NCT07533149 · WS10460

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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