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Идёт набор NCT07628946

Establishment of a Multimodal Standard Database for Inflammation-related Ophthalmopathy

— Наблюдательное Ocular Surface Disease Inflammatory Disease Retinal Disease Choroid Diseases

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Ocular Surface Disease, Inflammatory Disease, Retinal Disease, Choroid Diseases. Базовые параметры: от 3 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 →

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Обзор

Through a systematic observational study, the intrinsic connections and patterns between the occurrence and development of common blinding retinal diseases such as diabetic retinopathy, pathological myopia, and age-related macular degeneration and the changes in fine parameters of the anterior structure of the eye are deeply explored. To achieve this goal, investigators will adopt cutting-edge multimodal imaging technology to simultaneously collect precise data from ocular surface and fundus of participants. By integrating and analyzing these multi-dimensional information from different parts of the same eye, investigators will build a high-quality and standardized ocular surface-fundus associated image database. This database not only aims to reveal potential ocular surface biomarkers that can be used for early warning or auxiliary diagnosis, but also lays a solid data foundation for the future development of artificial intelligence-assisted diagnostic tools and the establishment of a brand-new ocular surface-fundus integrated diagnosis and treatment assessment model.

Первичные конечные точки

  • Tear Break-Up Time [Срок оценки: Baseline and within 30 days post-procedure]
  • Dry Eye Questionnaire-5 [Срок оценки: Baseline and within 30 days post-procedure]
  • Meibomian Gland Dropout [Срок оценки: Baseline and within 30 days post-procedure]
  • Blink Rate [Срок оценки: Baseline and within 30 days post-procedure]
  • Lipid Layer Thickness [Срок оценки: Baseline and within 30 days post-procedure]
  • Tear Meniscus Height [Срок оценки: Baseline and within 30 days post-procedure]
Вторичные конечные точки (5)
  • Central Subfield Thickness [Срок оценки: Baseline and within 30 days post-procedure]
  • Subfoveal Choroidal Thickness [Срок оценки: Baseline and within 30 days post-procedure]
  • Subretinal Fluid [Срок оценки: Baseline and within 30 days post-procedure]
  • Intraretinal Fluid [Срок оценки: Baseline and within 30 days post-procedure]
  • Pigment Epithelial Detachment Height [Срок оценки: Baseline and within 30 days post-procedure]

Критерии участия

Критерии включения

  • Retinal vascular and metabolic-related diseases: Diabetic Retinopathy (DR, including NPDR and PDR), Retinal Vein Occlusion (RVO), Hypertensive Retinopathy.
  • Degenerative diseases: Age-related Macular Degeneration (including dry and wet forms), Pathologic Myopia (PM), Polypoidal Choroidal Vasculopathy (PCV).
  • Immune-mediated and inflammatory eye diseases: Uveitis (including primary and secondary), Optic Neuritis, Mooren's Ulcer, and corneal melting associated with systemic immune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).
  • Anterior segment and ocular surface syndromes: Various types of Dry Eye Disease (DED), Keratoconus, Glaucoma (especially cases with chronic inflammation or long-term medication use).
  • Developmental fundus diseases in children and adolescents: Coats' Disease, Familial Exudative Vitreoretinopathy (FEVR), Retinopathy of Prematurity (ROP).
  • Patients with a confirmed diagnosis of fundus diseases, including Diabetic Retinopathy, Pathologic Myopia, Age-related Macular Degeneration, Coats' Disease, Familial Exudative Vitreoretinopathy (FEVR), Retinopathy of Prematurity (ROP), and other adult or pediatric fundus diseases.
  • Ability to cooperate with study examinations, including acceptance of Ultra-Widefield (UWF) fundus photography, OCT/OCTA, AOSLO, corneal confocal microscopy, meibomian gland function assessment, corneal esthesiometry, and tear film function tests. Image quality must meet analytical standards.
  • Availability of complete or follow-up accessible ophthalmic medical records.
  • Blood pressure ≤ 160/100 mmHg (to avoid exacerbating ischemia due to uncontrolled hypertension).

Критерии исключения

  • Recent (within the past 3 months) corneal/conjunctival acute inflammation, ocular surgery, or ocular trauma; or presence of corneal alterations (e.g., contact lens wear).
  • Fundus images that are uninterpretable or severely obscured (e.g., vitreous hemorrhage).
  • Use of medications affecting tear secretion (e.g., antihistamines, antidepressants) within the past 30 days.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Beijing Tongren Hospital — Пекин

Идентификаторы

NCT: NCT07628946 · TREC2026-KY044

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗