Ocular Rosacea Clinical Trial
— BIOCOROfficial title:
Recherche de Biomarqueurs moléculaires et d'Imagerie Diagnostiques et Pronostiques Des Atteintes Oculaires associées à Des dérégulations Neurovasculaires : Cohorte Biocor
Verified date | June 2024 |
Source | Clinact |
Contact | CRA |
Phone | + 3315 841 28 98 |
contact[@]multihealthgroup.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | October 1, 2026 |
Est. primary completion date | October 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Departement of Ophthalmology, COCHIN Hospital | Paris Cedex 14 |
Lead Sponsor | Collaborator |
---|---|
Clinact | Association CRO - Tous unis pour la vision |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical phenotype of ocular rosacea | 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 |
Screening visit, visits A1, A2, and end-of-study visit | |
Primary | Pachychoroid clinical phenotype | 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 |
From inclusion to end of study (Inclusion, year 1, year 2, year 3) | |
Secondary | Evolvolution of clinical profile of each phenotype in the cohort | Progression of limbic insufficiency (Deng grades) of ocular rosacea;
Ocular dryness (Oxford score, OSDI questionnaire); Quantification of corneal nerves (density), tear film (OSI score, Schirmer score, BUT score, OXFORD score), meibomian glands (meibographic score); variation in the thickness of the subfoveal choroid, a vascular index of the choroid quantified on analysis of the foveolar section in EDI; Quantification of the surface area of epithelial atrophy on blue autofluorescence blue ; |
From inclusion to end of study (Inclusion, year 1, year 2, year 3) | |
Secondary | Heart rate | Measurement of static and dynamic heart rate variability (HRV) in patients and control group
Correlation of HRV with phenotypic stages and biological markers of interest |
At inclusion and end of study (Inclusion, year 3) |
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