Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study
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: Vivior.
- Кому может быть актуально
- Состояния в реестре: Myopia. Базовые параметры: 4 лет — 14 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
- США, Австралия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Multicenter Study of Near Vision Behavior and Outdoor Time in Children Undergoing Myopia Control
Обзор
Currently, optical and pharmacological interventions have been developed to prevent the progression of childhood myopia. However, no myopia control strategy has been shown to have complete efficacy in controlling myopia progression in children. One possible reason is that risk factors contributing to the development of myopia were not controlled in previous clinical studies including time outdoors and near vision behaviour. This study aims to quantify time spent outdoors and near vision behavior in myopic children and its impact on myopia control efficacy. The outcomes of this study will guide clinicians on risk management and improve responses to existing treatments for progressive myopia.
Вмешательства
- Устройство Vivior
The Vivior is a wearable clip-on sensor that objectively quantifies near viewing distance and duration, and ambient illumination. The Vivior will be attached to the spectacles frame of children undergoing myopia control treatment.
Первичные конечные точки
- Near viewing duration [Срок оценки: 12 months]
- Near viewing distance [Срок оценки: 12 months]
- Outdoor time [Срок оценки: 12 months]
Вторичные конечные точки (3)
- Objective cycloplegic central refraction [Срок оценки: 12 months]
- Axial length [Срок оценки: 12 months]
- Subjective cycloplegic central refraction [Срок оценки: 12 months]
Критерии участия
Критерии включения
- Aged 6 to below 14 years old
- Spherical equivalent myopic refractive error greater than -0.50 D
- Best corrected logMAR visual acuity of 0.1 or better in each eye for 6- to 14-year-old children, and 0.2 logMAR or better than in each eye for 4 and 5-year-old children (adjusted for age-related expectations)
- Good ocular and general health that would not preclude them from myopia control
- Competent enough in English to fully understand the participant information and consent form
- Willing to undergo treatment to slow myopia progression for one year
Критерии исключения
- Strabismus at distance or near, or amblyopia
- Systemic or ocular conditions that may affect contact lens use (e.g. severe allergy) or refractive development (e.g. ptosis)
- Previous history of ocular surgery, trauma or chronic ocular disease that may affect their vision
- Ocular or systemic medication use which may interfere or interact with myopia treatment or ocular development
- Child, parents or guardians not willing to comply with treatment and/or follow-up schedule and planning to migrate or move during the one-year study duration
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
США · 3 центра
- School of Optometry, University of California, Berkeley — Berkeley
- New England College of Optometry — Boston
- State University of New York (SUNY), College of Optometry — New York
Австралия · 2 центра
- School of Optometry and Vision Science, UNSW — Sydney
- Optometry and Vision Science, Queensland University of Technology — Kelvin Grove
Идентификаторы
NCT: NCT06119243 · MENOK