Primary Open-angle GlaucomaGLAUCALYXNCT05264818
Assessment of Endothelial Glycocalyx in Patients With Primary Open-angle Glaucoma
An observational study of Primary Open-angle Glaucoma and Glaucoma, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Open-angle Glaucoma, Glaucoma
- What is being tested?
- Glycocheck and Ophthalmological examinations
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2022to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- Pregnant or breastfeeding woman
- Sleep apnea
- Renal insufficiency
- Parkinson's disease
- Alzheimer's disease
- Antiphospholipid syndrome
Show all 9Show fewer
- Cancer for which treatment ended less than 2 years ago
- Stroke less than 1 year ago
- Myocardial infarction less than 1 year ago
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Fondation A. de Rothschild
Paris, 75019
Cédric LAMIREL, clamirel@for.paris
Georges AZAR, gazar@for.paris
About this study
Official title: Assessment of Endothelial Glycocalyx in Patients With Primary Open-angle Glaucoma: a Prospective Single-center Cross-sectional Case-control Study
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:
Read more
- 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.
Read the 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
- Being tested
- Glycocheck, Ophthalmological examinations
- Keywords
- Glycocheck, Sublingual microvascularization, Glycocalyx, Primary Open-angle Glaucoma, Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycocheckProcedure or surgery
Assessment of the sublingual microvascularization
Ophthalmological examinationsProcedure or 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)
| Study group | Role | What they receive |
|---|---|---|
| Case group: primary open angle glaucoma | Not described Receives: Procedure: Glycocheck; Procedure: Ophthalmological examinations | |
| Control group: No Absence of optic nerve pathology | Not described Receives: Procedure: Glycocheck; Procedure: Ophthalmological examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of the Perfused boundary region (PBR)
Evaluated with the Glycocheck, in µm
Measured: Baseline day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start6 May 2022
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Cédric LAMIREL, MD, Principal investigator, Hôpital Fondation A. de RothschildGeorges AZAR, MD, Study chair, Hôpital Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264818
- Sponsor's protocol ID
- CLL_2021_27
- Acronym
- GLAUCALYX
- Status last verified
- Dec 2025
- First submitted
- 21 Feb 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Endothelial Glycocalyx in Patients With Primary Open-angle Glaucoma: a Prospective Single-center Cross-sectional Case-control Study
- ClinicalTrials.gov ID
- NCT05264818
- Acronym / sponsor ID
- GLAUCALYX / CLL_2021_27
- Conditions
- Primary Open-angle Glaucoma, Glaucoma
- Keywords
- Glycocheck, Sublingual microvascularization, Glycocalyx, Primary Open-angle Glaucoma, Glaucoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 6 May 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group: primary open angle glaucoma | – | Procedure: Glycocheck, Procedure: Ophthalmological examinations |
| Control group: No Absence of optic nerve pathology | – | Procedure: Glycocheck, Procedure: Ophthalmological examinations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding woman
- Sleep apnea
- Renal insufficiency
- Parkinson's disease
- Alzheimer's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlycocheckAssessment of the sublingual microvascularization | Procedure or surgery | Case group: primary open angle glaucoma, Control group: No Absence of optic nerve pathology |
| Ophthalmological examinationsDescription : 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) | Procedure or surgery | Case group: primary open angle glaucoma, Control group: No Absence of optic nerve pathology |
Primary outcome
Thickness of the Perfused boundary region (PBR)
Time frame: Baseline day
Evaluated with the Glycocheck, in µm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cédric LAMIREL, MD principal investigator
Hôpital Fondation A. de Rothschild
Georges AZAR, MD study chair
Hôpital Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open-angle Glaucoma and Glaucoma, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amélie YAVCHITZ, MD (01 48 03 64 33, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of the Perfused boundary region (PBR) (time frame: Baseline day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.