Recherche de Biomarqueurs moléculaires et d'Imagerie Diagnostiques et Pronostiques Des Atteintes Oculaires associées à Des dérégulations Neurovasculaires : Cohorte Biocor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ocular Rosacea
- Sponsor
- Clinact
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Clinical phenotype of ocular rosacea
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Clinical phenotype of ocular rosacea
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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))