Идёт набор NCT07539012

Effect of Descemet Membrane Polishing in Fuchs Endothelial Corneal Dystrophy

Без фазы С лечением Fuchs Endothelial Corneal Dystrophy

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: Fuchs Polishing.
Кому может быть актуально: Состояния в реестре: Fuchs Endothelial Corneal Dystrophy. 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 →

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Обзор

Fuchs endothelial corneal dystrophy (FECD) is the leading indication for corneal transplantation worldwide. It is characterized by the accumulation of guttae and progressive loss of corneal endothelial cells, leading to corneal edema and visual impairment. Endothelial keratoplasty remains the standard treatment; however, graft shortages have driven the development of cell-based therapies involving the injection of cultured endothelial cells. A key unresolved issue is whether removal of the pathological endothelium prior to injection improves cell adhesion. Clinical data are limited and sometimes contradictory, particularly regarding endothelial polishing. The actual effectiveness of this procedure in removing guttae and enhancing the survival of injected cells remains uncertain. Therefore, an in vivo clinical evaluation is required to assess its impact on guttae removal.

Вмешательства

Процедура Fuchs Polishing
he study will be offered to all patients for whom corneal transplantation for FECD is indicated at participating centers. After verification of the eligibility criteria, the study will be explained and informed consent will be obtained during the inclusion visit. Only one follow-up visit is planned, on the day of surgery. During the procedure, polishing of one half of the pathological endothelium will be performed prior to its removal and replacement with healthy donor endothelium (Fuchs polishi

Первичные конечные точки

Compare the progression of the number of guttata with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy [Срок оценки: After surgery : Months 1]

Вторичные конечные точки (2)

Compare the progression of guttae height with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy (FECD). [Срок оценки: After surgery : Months 1]
Compare the removal of corneal endothelial cells with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy (FECD) [Срок оценки: After surgery : Months 1]

Критерии участия

Критерии включения

Patient affiliated with or entitled to a social security scheme
Patient scheduled for endothelial keratoplasty for Fuchs endothelial corneal dystrophy
Patient having received full information and having provided written informed consent