Research Into Diagnostic and Prognostic Molecular and Imaging Biomarkers of Ocular Disorders Associated With Neurovascular Deregulation: Biocor Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Schirmer test paper.
- Who it may be relevant to
- Registry conditions: Ocular Rosacea, Pachychoroid Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Recherche de Biomarqueurs moléculaires et d'Imagerie Diagnostiques et Pronostiques Des Atteintes Oculaires associées à Des dérégulations Neurovasculaires : Cohorte Biocor
Overview
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.
Interventions
- Diagnostic test Schirmer test paper
This paper is centrifuged and your tears are collected then frozen before analysis. We collect the fat from your tears by scraping the edge of your lower eyelid with small sterile tweezers. All surgical waste will be collected during eye surgeries only if you must have them. During each ocular surgical procedure, the vitreous, subretinal fluids and/or aqueous humor will eventually be recovered when required by the procedure. The rest of the blood samples, not used during diagnostic analyses, wi
Primary outcome measures
- Clinical phenotype of ocular rosacea [Time frame: Screening visit, visits A1, A2, and end-of-study visit]
- Pachychoroid clinical phenotype [Time frame: From inclusion to end of study (Inclusion, year 1, year 2, year 3)]
Secondary outcome measures (2)
- Evolvolution of clinical profile of each phenotype in the cohort [Time frame: From inclusion to end of study (Inclusion, year 1, year 2, year 3)]
- Heart rate [Time frame: At inclusion and end of study (Inclusion, year 3)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Departement of Ophthalmology, COCHIN Hospital — Paris
Identifiers
NCT: NCT06466018 · 2022-A02713-40