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Идёт набор NCT06162234

Wuhan High Myopia Study

Наблюдательное High 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: observational.
Кому может быть актуально
Состояния в реестре: High Myopia. Базовые параметры: 18 лет — 65 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Long Term Observation of Ocular Structure and Visual Function in Eyes With High Myopia:Wuhan High Myopia Study

Обзор

The study aims to observe the long-term changes of ocular(especially fundus) structure and visual function in patients with high myopia, so as to provide evidence for the prevention, diagnosis and prognosis of high myopia.

Подробное описание

High myopia is defined as a refractive error of ≤-6.00D or an axial length greater than 26mm. In recent years, the population of highly myopic individuals has been increasing rapidly. Scholars predict that if no effective interventions are taken, the global incidence rate of myopia is expected to increase from 22.9% in 2000 to 49.8% in 2050, and the visual impairment caused by high myopia will be seven times higher than in 2000 on a global scale. In China, a survey conducted by the National Health Commission in 2018 found that highly myopic students accounted for 21.9% of third-year high school students, indicating that high myopia has become a major public health issue due to its prevalence among younger populations.

In recent years, with the development of ocular imaging technologies such as optical coherence tomography (OCT) and corresponding image analysis techniques, high-resolution, non-invasive, fast and in vivo retinal imaging has become more accessible. This has led to the discovery and exploration of various imaging parameters related to optic disc and macula changes in highly myopic patients. We will conduct a 4 years prospective cohort study in the population of 1000 high myopia and controls which have established in mainly college student population, using the latest OCT-A and SS-OCT to observe the long-term changes of fundus structure combined with visual function in patients with high myopia , and explore biomarkers affecting visual function, so as to provide basis for prevention and control of high myopia and prognosis.

Вмешательства

  • Другое observational
    none (observational study)

Первичные конечные точки

  • Myopic optic nerve changes [Срок оценки: Baseline and 6 months and 1,2,3,4years]
  • Progression of axial length (AL) [Срок оценки: Baseline and 6 months and 1,2,3,4years]
  • Incidence and progression of visual field (VF) defects [Срок оценки: Baseline and 6 months and 1,2,3,4years]
  • Loss of best corrected visual acuity(BCVA) [Срок оценки: Baseline and 6 months and 1,2,3,4years]
  • Incidence and progression of myopic maculopathy [Срок оценки: Baseline and 6 months and 1,2,3,4years]
Вторичные конечные точки (4)
  • Relationship between the changes of visual function and pathological changes among patients with high myopia [Срок оценки: Baseline and 6 months and 1,2,3,4years]
  • Structural parameters of anterior segment [Срок оценки: Baseline and 6 months and 1,2,3,4years]
  • Intraocular pressure(IOP) [Срок оценки: Baseline and 6 months and 1,2,3,4years]
  • Mental state and quality of life [Срок оценки: Baseline and 6 months and 1,2,3,4years]

Критерии участия

Критерии включения

  • Voluntarily sign informed consent;
  • Commit to follow the research procedures and cooperate with the whole process of the study;
  • Age ≥18 years old;
  • Best corrected visual acuity ≥0.1;
  • Spherical Equivalent Refraction≤-6.00D or axial length ≥26mm in high myopia group;

Критерии исключения

  • Unable or unwilling to sign informed consent;
  • Unable to cooperate with the examination;
  • Astigmatism ≤-1.5D;
  • Patients with refractive interstitial opacity so that fundus images cannot be collected;
  • Patients with fundus diseases such as diabetic retinopathy, hypertensive retinopathy, age-related macular degeneration, retinal vein obstruction, retinal artery obstruction, etc

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
  • Renmin Hospital of Wuhan University — Ухань

Идентификаторы

NCT: NCT06162234 · WWDRY2023-K074

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗