Research Into Diagnostic and Prognostic Molecular and Imaging Biomarkers of Ocular Disorders Associated With Neurovascular Deregulation: Biocor Cohort

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinact

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: Ocular rosacea groupExperimental treatment 1 intervention
Group B: Pachychoroid groupExperimental treatment 1 intervention
Group C: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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)

Secondary outcomes

1

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)
2

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinact

Lead sponsor

Association CRO - Tous unis pour la vision

Collaborator