Trials / Recruiting
RecruitingNCT05264818
Assessment of Endothelial Glycocalyx in Patients With Primary Open-angle Glaucoma
Assessment of Endothelial Glycocalyx in Patients With Primary Open-angle Glaucoma: a Prospective Single-center Cross-sectional Case-control Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The glycocalyx is a fibrillary lining structure that covers the inner surface of blood vessels. Composed of glycoproteins and polysaccharides, it is an essential determinant of vascular endothelial physiology: it limits coagulation activation and adapts capillary perfusion. Studies have shown glycocalyx alteration in various vascular and autoimmune pathologies such as diabetes, high blood pressure, chronic renal failure, ischemic heart disease, stroke, dementia, septic shock, and several other inflammatory pathologies with a common basis in vascular insufficiency. Glaucoma is a progressive, chronic and asymptomatic optic neuropathy characterized by visual field damage and abnormalities of the optic nerve head. Two hypotheses have been proposed as a basis for this progressive damage: * the mechanical theory, which explains the papillary excavation by a compression of the optic nerve head under the effect of high intraocular pressure; and * the ischemic theory, explained by a circulatory insufficiency at the level of the blood capillaries of the retina and especially of the optic nerve head. This latter theory is related to several pathologies that have circulatory insufficiency as common underlying pathophysiology, and in which damage to the glycocalyx has been well studied. Glycocalyx damage has rarely been studied in glaucoma. Yang et al. showed that the glycocalyx, present in Schlem's canal, plays a major role in the transduction of shear stress and regulation of outflow resistance to the aqueous humor, which may constitute an interesting biomarker for glaucomatous pathologies.
Detailed description
This study propose to extend the exploration of the ischemic theory of glaucoma by a specific imaging technique (the GlycoCheck) which allows an assessment of the microvascular system integrity by giving a "vitality score" of this system. This score, known as the MicroVascular Health score (MVHS), depends on the following measured parameters: Capillary density (CD), Red blood cell filling Percent (RBF), and Perfused boundary region (PBR).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Glycocheck | Assessment of the sublingual microvascularization |
| PROCEDURE | Ophthalmological examinations | Description : Measurement of best corrected distance visual acuity with ETDRS (Early Treatment Diabetic Retinopathy Study) Measurement of intraocular pressure by aplanation and forced air tonometer Central corneal thickness measurement with OCT (Optical Coherence Tomography) Non-mydriatic retinophotography Humphrey 24-2 visual field OCT-RNFL (Optical Coherence Tomography - retinal nerve fiber layer) |
Timeline
- Start date
- 2022-05-06
- Primary completion
- 2026-05-01
- Completion
- 2026-05-01
- First posted
- 2022-03-03
- Last updated
- 2025-12-08
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05264818. Inclusion in this directory is not an endorsement.