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Набор скоро начнётся NCT06652594

"Eye" Education for Parents and Myopia Control in Children

Без фазы С лечением Children Health Education Anxiety

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: Eye Education Intervention, Control.
Кому может быть актуально
Состояния в реестре: Children, Health Education, Anxiety. Базовые параметры: 5 лет — 17 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

Effect of "eye" Education for Parents on Myopia Prevention and Control in Children

Обзор

This is a randomized controlled trial aimed to explore the effect of behavioral interventions based on doctors' and nurses' health education on the onset and development of myopia in children's. Participants were randomly assigned to one of two groups: eye health intervention, or the control group. Intervention group's parents would reveive eye health education in response to their children's myopia progression at baseline, 1 month, 3 months, and 6 months, while the control group did not receive any. Visual acuity, cycloplegic refraction, axial length, Strengths and Difficulties Questionnaire, and Generalized Anxiety Disorder 7-item Scale were the main outcomes and measures.

Подробное описание

After doctors' and nurses' education, parents would keep a diary to regulate the children's "Sedentary", "Sunshine", "Sleep", "Screen", and "Stress" that is, the "5S" eye education. To urging parents pay attention to the children's eye behavior every day, and targeted to children "eye" education to delay the occurrence and development of myopia and reduce the incidence of high myopia.

Вмешательства

  • Поведенческое Eye Education Intervention
    Doctors and nurses will educate parents about eye health in response to theirchild's myopia progression at baseline, 1 month, 3 months, 6 months.
  • Поведенческое Control
    Parents in the control group will not receive eye health education informationfrom doctors and nurses.

Первичные конечные точки

  • Axial Length [Срок оценки: Baseline, 1 month, 3 months, 6 months.]
  • Cycloplegic Refraction [Срок оценки: Baseline, 1 month, 3 months, 6 months.]
Вторичные конечные точки (3)
  • Visual acuity [Срок оценки: Baseline, 1 month, 3 months, 6 months.]
  • Anxiety Disorder Screening 7-item Scale [Срок оценки: Baseline, 6 month]
  • Strengths and Difficulties Questionnaire [Срок оценки: Baseline, 6 month.]

Критерии участия

Критерии включения

  • Children aged 5-17;
  • Removing flexible lenses for at least 1 week, flexible astigmatism and hard lenses for at least 3 weeks, orthokeratology lenses for at least 3 months;
  • Best corrected visual acuity of either eye were all ≥ 1.0;
  • The range of myopia in either eye was -15 D ≤ SE ≤ +2.0 D;
  • Astigmatism of either eye less than -5.0 D;
  • Anisometropia ≤ -1.5 D;
  • There was no active ocular inflammatory diseases; no obvious corneal cloud or macula, anormal corneal topography, and no tendency of keratoconus.
  • Intraocular pressure of either eye is of 10 to 21 mmHg;
  • On the basis of full understanding, children and their guardians sign the informed consent;

Критерии исключения

  • Amblyopia: best corrected visual acuity (BCVA) of either eye less than 1.0 for children over 6 years old;
  • Active ocular inflammatory diseases, such as uveitis and other inflammatory diseases;
  • Secondary myopia, genetic disease or connective tissue- related myopia;
  • Moderate or severe ptosis;
  • Congenital cataract, glaucoma;
  • Other fundus diseases other than myopic related fundus lesions;
  • Intraocular or refractive surgery history;
  • The refractive medium is turbid, and it is impossible to take a clear fundus image; (9)Unable to cooperate with fundus image shooting and other examination;

(10)Do not receive cycloplegia or have contraindications; (11)Poor overall condition, unable to follow up for a long time; (12)The subject refuses to participate in the research; (13)Other cases in which the researcher judges that it is not suitable for participation in the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Beijing Tongren Hospital, Beijing — Пекин

Идентификаторы

NCT: NCT06652594 · 2024-2G-1081

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗