Research Into Diagnostic and Prognostic Molecular and Imaging Biomarkers of Ocular Disorders Associated With Neurovascular Deregulation: Biocor Cohort
- Conditions
- Pachychoroid DiseaseOcular Rosacea
- Interventions
- Diagnostic Test: Schirmer test paper
- Registration Number
- NCT06466018
- Lead Sponsor
- Clinact
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ocular rosacea group Schirmer test paper - Pachychoroid group Schirmer test paper - Control group Schirmer test paper -
- Primary Outcome Measures
Name Time Method Clinical phenotype of ocular rosacea 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 effectPachychoroid clinical phenotype 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 Outcome Measures
Name Time Method Heart rate At inclusion and end of study (Inclusion, year 3) * Measurement of static and dynamic heart rate variability (HRV) in patients and control group
* Correlation of HRV with phenotypic stages and biological markers of interestEvolvolution of clinical profile of each phenotype in the cohort From inclusion to end of study (Inclusion, year 1, year 2, year 3) 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 ;
Trial Locations
- Locations (1)
Departement of Ophthalmology, COCHIN Hospital
🇫🇷Paris Cedex 14, France