Recherche de Biomarqueurs moléculaires et d'Imagerie Diagnostiques et Pronostiques Des Atteintes Oculaires associées à Des dérégulations Neurovasculaires : Cohorte Biocor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Clinact
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Clinical phenotype of ocular rosacea
研究概览
简要总结
BIOCOR is an interventional clinical trial whose main objectives are Objectif are identify molecular biomarker(s) of ocular rosacea and pachychoroid. Endpoints are : Correlation between pachychoroidosis (defined by choroidal phenotype parameters in OCT and autofluorescence) or the stage of ocular rosacea (ROSCO(29) definition) and biological markers selected on the basis of preclinical work (animal model) and by unbiased methods (proteomics, metabolomics, meibum lipidomics). The study of circulating, ocular and functional biomarkers would enable us to confirm our hypothesis and identify patients who could benefit from treatments that regulate the ANS and/or mineralocorticoid pathways.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female > 18 years of age, of European origin, with signed ± genetic consent
- •Clear ocular media for OCT and autofluorescence imaging
- •Signed consent form
- •Be affiliated to a health insurance scheme
- •Control patients are patients scheduled for cataract surgery or visual assessment.
排除标准
- •High myopia > 6D
- •Diabetic retinopathy, hereditary retinal dystrophy, untreated retinal detachment, choroidal ocular tumor, choroidal hemangioma
- •Epithelial or stromal keratopathy other than ocular rosacea
- •Corneal surgery less than 3 months old, keratoplasty
- •Deprived of liberty or under guardianship or curatorship
结局指标
主要结局
Clinical phenotype of ocular rosacea
时间窗: Screening visit, visits A1, A2, and end-of-study visit
* OSDI score * QoL score VF24 questionnaire * Stage and type of Rosacea * Blepharitis stage * Oxford score * Schirmer score * OSI Index * Meibomian meibography score * Quantification of corneal opacity and neovascularization by standardized score * Limbal insufficiency score * Clinical evolution under therapeutic effect
Pachychoroid clinical phenotype
时间窗: From inclusion to end of study (Inclusion, year 1, year 2, year 3)
* Measurement of total choroidal thickness * Measurement of choroidal vascular caliber * Measurement of foveolar avascular area * Calculation of fundus autofluorescence areas * Calculation of retinal non-perfusion areas * Cone counting
次要结局
- Heart rate(At inclusion and end of study (Inclusion, year 3))
- Evolvolution of clinical profile of each phenotype in the cohort(From inclusion to end of study (Inclusion, year 1, year 2, year 3))