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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05264818
Acronym
GLAUCALYX
Enrollment
100
Registered
2022-03-03
Start date
2022-05-06
Completion date
2026-05-31
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Primary Open-angle Glaucoma

Keywords

Glycocheck, Sublingual microvascularization, Glycocalyx, Primary Open-angle Glaucoma, Glaucoma

Brief 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).

Interventions

PROCEDUREGlycocheck

Assessment of the sublingual microvascularization

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)

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Express consent to participate in the study * Only for case group: primary open angle glaucoma (defined as the presence of visual field damage attributed to glaucomatous optic neuropathy) in both eyes * Only for control group: Absence optic nerve pathology (including primary open angle glaucoma)

Exclusion criteria

* Pregnant or breastfeeding woman * Sleep apnea * Renal insufficiency * Parkinson's disease * Alzheimer's disease * Antiphospholipid syndrome * Cancer for which treatment ended less than 2 years ago * Stroke less than 1 year ago * Myocardial infarction less than 1 year ago

Design outcomes

Primary

MeasureTime frameDescription
Thickness of the Perfused boundary region (PBR)Baseline dayEvaluated with the Glycocheck, in µm

Countries

France

Contacts

Primary ContactAmélie YAVCHITZ, MD
ayavchitz@for.paris01 48 03 64 33

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026