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| Name | Class |
|---|---|
| Association CRO - Tous unis pour la vision | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocular rosacea group | Experimental |
| |
| Pachychoroid group | Experimental |
| |
| Control group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Schirmer test paper | Diagnostic Test | 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, will be kept for later analyses. Tears will be collected using a non-invasive and painless method that takes around ten minutes. The tissues (connectiva, cornea, retina, epi-retinal membrane) which must have been removed when required by the surgical procedure will also be preserved. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical phenotype of ocular rosacea |
| Screening visit, visits A1, A2, and end-of-study visit |
| Pachychoroid clinical phenotype |
| From inclusion to end of study (Inclusion, year 1, year 2, year 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Evolvolution of clinical profile of each phenotype in the cohort | Progression of limbic insufficiency (Deng grades) of ocular rosacea;
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CRA | Contact | + 3315 841 28 98 | contact@multihealthgroup.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement of Ophthalmology, COCHIN Hospital | Recruiting | Paris | 75679 | France |
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|
| From inclusion to end of study (Inclusion, year 1, year 2, year 3) |
| Heart rate |
| At inclusion and end of study (Inclusion, year 3) |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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