Assessment of Endothelial Glycocalyx in Patients With Primary Open-angle Glaucoma

NCT ID: NCT05264818

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-06
• Study Completion Date: 2026-05-31

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).

Conditions

Primary Open-angle Glaucoma; Glaucoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case group: primary open angle glaucoma

Glycocheck

Intervention Type: PROCEDURE

Assessment of the sublingual microvascularization

Ophthalmological examinations

Intervention Type: PROCEDURE

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)

Control group: No Absence of optic nerve pathology

Glycocheck

Intervention Type: PROCEDURE

Assessment of the sublingual microvascularization

Ophthalmological examinations

Intervention Type: PROCEDURE

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)

Interventions

Glycocheck

Assessment of the sublingual microvascularization

Intervention Type: 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)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cédric LAMIREL, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Fondation A. de Rothschild

Georges AZAR, MD

Role: STUDY_CHAIR

Hôpital Fondation A. de Rothschild

Locations

Hôpital Fondation A. de Rothschild

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Amélie YAVCHITZ, MD

Role: CONTACT

ayavchitz@for.paris

01 48 03 64 33

Facility Contacts

Cédric LAMIREL

Role: primary

clamirel@for.paris

Georges AZAR

Role: backup

gazar@for.paris

Other Identifiers

CLL_2021_27

Identifier Type: -

Identifier Source: org_study_id