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

NCT05264818 | Recruiting

• 1 other identifier: CLL_2021_27
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open-angle Glaucoma; Glaucoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Thickness of the Perfused boundary region (PBR)

  Evaluated with the Glycocheck, in µm

  Baseline day

Study Arms (2)

Case group: primary open angle glaucoma

Procedure: Glycocheck; Procedure: Ophthalmological examinations

Control group: No Absence of optic nerve pathology

Procedure: Glycocheck; Procedure: Ophthalmological examinations

Interventions

Glycocheck PROCEDURE

Assessment of the sublingual microvascularization

Case group: primary open angle glaucoma; Control group: No Absence of optic nerve pathology

Ophthalmological examinations 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)

Case group: primary open angle glaucoma; Control group: No Absence of optic nerve pathology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Case group: patients with primary open angle glaucoma Control group : patient with no optic nerve pathology, matched with patients in case group on age (± 10 years), sex (male/female), and smoking status (active smoker/non-smoker or non-smoker or former smoker who had quit smoking for more than 6 months).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation A. de Rothschild

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Cédric LAMIREL, MD

  Hôpital Fondation A. de Rothschild

  PRINCIPAL INVESTIGATOR

• Georges AZAR, MD

  Hôpital Fondation A. de Rothschild

  STUDY CHAIR

Central Study Contacts

Amélie YAVCHITZ, MD

CONTACT

01 48 03 64 33; ayavchitz@for.paris

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 3, 2022
• Study Start: May 6, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

FR (1)