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Идёт набор NCT05832723

A Real-world Study of 650nm Low-intensity Single-wavelength Red Light for Children and Adolescents

— Наблюдательное Myopia

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: 650 nm low-level red-light.
Кому может быть актуально
Состояния в реестре: Myopia. Базовые параметры: 7 лет — 18 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
Китай
Следующий шаг
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Официальное название

A Real-world Study to Evaluate the Efficacy of 650nm Low-intensity Single-wavelength Red Light in the Prevention and Control of Myopia in Children and Adolescents

Обзор

To evaluate the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children under less restrictive conditions than randomized controlled trials. Participants included children(aged 7 to 18 years, spherical equivalent error of 0.5D or below) who are already myopic at recruitment, and those who are of Emmetropia or low hyperopia.

Подробное описание

This multicenter real world study will be conducted in at least 100 hospitals: Beijing Tongren Hospital will be the initiator of the study, other hospitals such as the Capital Institute of Pediatrics will serve as sub-centers. The whole study will last for three years.The investigators will perform data analysis at 6 months follow-up, one-year follow-up, and two-year follow-up. Participants who used 650 nm low-level red-light would be recruited. This kind of intervention will be integrated into a headworn device. This device could be used for treatment of myopia or amblyopia, and is safe for the eyes and has been verified by the Chinese market supervision and administration department.

Вмешательства

  • Устройство 650 nm low-level red-light
    Typically, children who uses the 650 nm low-level red-light will be recruited into this study. The use of any other myopia intervention is not restricted except for low concentrations of atropine. Because atropine will cause pupils dilated, the amount of light entering the eye can not be controlled, and red-light is a laser, to be safe, we need to take certain consideration of the amount of light-entering. Participants receive the 650 nm low-level red-light intervention not because they are enro

Первичные конечные точки

  • Change in axial length [Срок оценки: Baseline, six-month follow-up, one-year follow-up, two-year follow-up]
  • Change in spherical equivalent error [Срок оценки: Baseline, six-month follow-up, one-year follow-up, two-year follow-up]
Вторичные конечные точки (6)
  • Change in Choroid thickness to measure [Срок оценки: Baseline, six-month follow-up, one-year follow-up, two-year follow-up]
  • Change in steep keratometry [Срок оценки: Baseline, six-month follow-up, one-year follow-up, two-year follow-up]
  • Change in flat keratometry [Срок оценки: Baseline, six-month follow-up, one-year follow-up, two-year follow-up]
  • Change in length thickness [Срок оценки: Baseline, six-month follow-up, one-year follow-up, two-year follow-up]
  • Change in anterior chamber depth [Срок оценки: Baseline, six-month follow-up, one-year follow-up, two-year follow-up]
  • Change in central corneal thickness [Срок оценки: Baseline, six-month follow-up, one-year follow-up, two-year follow-up]

Критерии участия

Критерии включения

  • Children aged 7 to 18 years
  • The cycloplegic spherical equivalent error (SER) is +0.5D or less in both eyes
  • Astigmatism of 2.5 D or less (≤2.5D)
  • Willing to participate in the study and sign the informed consent form

Критерии исключения

  • Including but not limited to the following eye diseases: strabismus, amblyopia, ocular tumors, glaucoma/macular disease and other fundus diseases (including heredity), keratitis, eye trauma, uveitis
  • Including but not limited to the following systemic diseases: epilepsy, tumor, heart disease, asthma, systemic immune diseases, infectious diseases
  • Mental diseases
  • Similar interventions have been used in the past year
  • Allergic to cycloplegic agents or to red light
  • The 650nm red light intervention was not suitable for the condition evaluated by the researchers
  • are currently using atropine or similar drugs, or have stopped using them for less than 1 month

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Red light — Пекин

Идентификаторы

NCT: NCT05832723 · TongrenJY2023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗