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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondation Ophtalmologique Adolphe de Rothschild

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Pregnant or breastfeeding woman

Sleep apnea

Renal insufficiency

Parkinson's disease

Trial 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).

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Glycocheck

    Procedure/Surgery

    Assessment of the sublingual microvascularization

  • Ophthalmological examinations

    Procedure/Surgery

    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)

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Case group: primary open angle glaucoma2 interventions
Group B: Control group: No Absence of optic nerve pathology2 interventions

Trial outcomes

Primary outcomes

1

Thickness of the Perfused boundary region (PBR)

Evaluated with the Glycocheck, in µm

Time frame
Baseline day

Secondary outcomes

Other outcomes

Sponsors and contacts

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