An interventional study of Schirmer test paper in Ocular Rosacea and Pachychoroid Disease, sponsored by Clinact. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by Clinact · Not applicable, Interventional, and Diagnostic
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.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's planned enrollment of 400 is above the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →Clinact is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Diagnostic Test: Schirmer test paper
Diagnostic Test: Schirmer test paper
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, 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.
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
Time frame: Screening visit, visits A1, A2, and end-of-study visit
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
Time frame: From inclusion to end of study (Inclusion, year 1, year 2, year 3)
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 ;
Time frame: From inclusion to end of study (Inclusion, year 1, year 2, year 3)
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
Time frame: At inclusion and end of study (Inclusion, year 3)
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