Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: SVL, SVL with passive red-light emission, MCL, MCL with passive red-light emission.
- Кому может быть актуально
- Состояния в реестре: Myopia. Базовые параметры: 6 лет — 11 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Сингапур
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is: Does the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children? Researchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression. Participants will: * Wear the study spectacles * Visit Essilor R\&D Centre for follow-up sessions
Вмешательства
- Устройство SVL
Dispensed to one eye in Year 1 - Устройство SVL with passive red-light emission
Dispensed to the contralateral eye in Year 1. - Устройство MCL
Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1). - Устройство MCL with passive red-light emission
Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).
Первичные конечные точки
- Change in Axial Length [Срок оценки: From baseline to 12 months]
- Change in Axial Length [Срок оценки: From 12 months to 24 months]
Вторичные конечные точки (2)
- Change in Spherical Equivalent Refraction [Срок оценки: From baseline to 12 months]
- Change in Spherical Equivalent Refraction [Срок оценки: From 12 months to 24 months]
Критерии участия
Критерии включения
- Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent.
- Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D.
- Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D.
- Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen).
- Be in good general health, based on his/her and parent's/guardian's knowledge.
- Agree to wear spectacles for >12 hours/day and at least 6 days/week.
- Willingness and ability to participate in investigation for 2 years and attend scheduled visits.
Критерии исключения
- Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.)
- Any binocular vision anomalies
- Amblyopia
- Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month.
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
- Participation in any clinical investigation within 30 days of the baseline visit.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Сингапур · 1 центр
- Essilor R&D Centre Singapore — Singapore
Публикации
- Jiang Y, Zhu Z, Tan X, Kong X, Zhong H, Zhang J, Xiong R, Yuan Y, Zeng J, Morgan IG, He M. Effect of Repeated Low-Level Red-Light Therapy for Myopia Control in Children: A Multicenter Randomized Controlled Trial. Ophthalmology. 2022 May;129(5):509-519. doi: 10.1016/j.ophtha.2021.11.023. Epub 2021 Dec 1. PMID 34863776
- Dong J, Zhu Z, Xu H, He M. Myopia Control Effect of Repeated Low-Level Red-Light Therapy in Chinese Children: A Randomized, Double-Blind, Controlled Clinical Trial. Ophthalmology. 2023 Feb;130(2):198-204. doi: 10.1016/j.ophtha.2022.08.024. Epub 2022 Aug 29. PMID 36049646
Идентификаторы
NCT: NCT06850168 · WS10367