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

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Recruiting
CT.gov ID
NCT05264818
Collaborator
(none)
100
1
15.9
6.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Glycocheck
  • Procedure: Ophthalmological examinations

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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Assessment of Endothelial Glycocalyx in Patients With Primary Open-angle Glaucoma: a Prospective Single-center Cross-sectional Case-control Study
Actual Study Start Date :
May 6, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Case group: primary open angle glaucoma

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)

Control group: No Absence of optic nerve pathology

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)

Outcome Measures

Primary Outcome Measures

  1. Thickness of the Perfused boundary region (PBR) [Baseline day]

    Evaluated with the Glycocheck, in µm

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Fondation A. de Rothschild Paris France 75019

Sponsors and Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Cédric LAMIREL, MD, Hôpital Fondation A. de Rothschild
  • Study Chair: Georges AZAR, MD, Hôpital Fondation A. de Rothschild

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT05264818
Other Study ID Numbers:
  • CLL_2021_27
First Posted:
Mar 3, 2022
Last Update Posted:
Jun 8, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2022