Research Into Diagnostic and Prognostic Molecular and Imaging Biomarkers of Ocular Disorders Associated With Neurovascular Deregulation: Biocor Cohort (BIOCOR)

Clinact

Status: Enrolling

Conditions: Ocular Rosacea; Pachychoroid Disease

Treatments: Diagnostic Test: Schirmer test paper

Study type: Interventional

Funder types: Other

Identifiers

NCT06466018

2022-A02713-40

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 3 patient groups

Ocular rosacea group

Experimental group

Treatment:

Diagnostic Test: Schirmer test paper

Pachychoroid group

Experimental group

Treatment:

Diagnostic Test: Schirmer test paper

Control group

Other group

Treatment:

Diagnostic Test: Schirmer test paper