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Идёт набор NCT05264818

Assessment of Endothelial Glycocalyx in Patients With Primary Open-angle Glaucoma

Наблюдательное Primary Open-angle Glaucoma Glaucoma

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: Glycocheck, Ophthalmological examinations.
Кому может быть актуально
Состояния в реестре: Primary Open-angle Glaucoma, Glaucoma. Базовые параметры: от 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Assessment of Endothelial Glycocalyx in Patients With Primary Open-angle Glaucoma: a Prospective Single-center Cross-sectional Case-control Study

Обзор

The glycocalyx is a fibrillary lining structure that covers the inner surface of blood vessels. Composed of glycoproteins and polysaccharides, it is an essential determinant of vascular endothelial physiology: it limits coagulation activation and adapts capillary perfusion. Studies have shown glycocalyx alteration in various vascular and autoimmune pathologies such as diabetes, high blood pressure, chronic renal failure, ischemic heart disease, stroke, dementia, septic shock, and several other inflammatory pathologies with a common basis in vascular insufficiency. Glaucoma is a progressive, chronic and asymptomatic optic neuropathy characterized by visual field damage and abnormalities of the optic nerve head. Two hypotheses have been proposed as a basis for this progressive damage: * the mechanical theory, which explains the papillary excavation by a compression of the optic nerve head under the effect of high intraocular pressure; and * the ischemic theory, explained by a circulatory insufficiency at the level of the blood capillaries of the retina and especially of the optic nerve head. This latter theory is related to several pathologies that have circulatory insufficiency as common underlying pathophysiology, and in which damage to the glycocalyx has been well studied. Glycocalyx damage has rarely been studied in glaucoma. Yang et al. showed that the glycocalyx, present in Schlem's canal, plays a major role in the transduction of shear stress and regulation of outflow resistance to the aqueous humor, which may constitute an interesting biomarker for glaucomatous pathologies.

Подробное описание

This study propose to extend the exploration of the ischemic theory of glaucoma by a specific imaging technique (the GlycoCheck) which allows an assessment of the microvascular system integrity by giving a "vitality score" of this system. This score, known as the MicroVascular Health score (MVHS), depends on the following measured parameters: Capillary density (CD), Red blood cell filling Percent (RBF), and Perfused boundary region (PBR).

Вмешательства

  • Процедура Glycocheck
    Assessment of the sublingual microvascularization
  • Процедура Ophthalmological examinations
    Description : Measurement of best corrected distance visual acuity with ETDRS (Early Treatment Diabetic Retinopathy Study) Measurement of intraocular pressure by aplanation and forced air tonometer Central corneal thickness measurement with OCT (Optical Coherence Tomography) Non-mydriatic retinophotography Humphrey 24-2 visual field OCT-RNFL (Optical Coherence Tomography - retinal nerve fiber layer)

Первичные конечные точки

  • Thickness of the Perfused boundary region (PBR) [Срок оценки: Baseline day]

Критерии участия

Критерии включения

  • Express consent to participate in the study
  • Only for case group: primary open angle glaucoma (defined as the presence of visual field damage attributed to glaucomatous optic neuropathy) in both eyes
  • Only for control group: Absence optic nerve pathology (including primary open angle glaucoma)

Критерии исключения

  • Pregnant or breastfeeding woman
  • Sleep apnea
  • Renal insufficiency
  • Parkinson's disease
  • Alzheimer's disease
  • Antiphospholipid syndrome
  • Cancer for which treatment ended less than 2 years ago
  • Stroke less than 1 year ago
  • Myocardial infarction less than 1 year ago

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Франция · 1 центр
  • Hôpital Fondation A. de Rothschild — Paris

Идентификаторы

NCT: NCT05264818 · CLL_2021_27

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗