Assessing the Glycocalyx in Patients with Primary Open-angle Glaucoma
Assessment of Endothelial Glycocalyx in Patients With Primary Open-angle Glaucoma: a Prospective Single-center Cross-sectional Case-control Study
Fondation Ophtalmologique Adolphe de Rothschild · NCT05264818
This study is testing a special imaging technique to see if the tiny blood vessels in people with primary open-angle glaucoma are working properly compared to those without eye problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild (network) |
| Locations | 1 site (Paris) |
| Trial ID | NCT05264818 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the integrity of the microvascular system in patients with primary open-angle glaucoma using a specialized imaging technique called GlycoCheck. By measuring parameters such as capillary density, red blood cell filling percentage, and perfused boundary region, the study will generate a MicroVascular Health score (MVHS) to explore the ischemic theory of glaucoma. The study includes a case group of patients with glaucoma and a control group without optic nerve pathology. Participants will undergo ophthalmological examinations alongside the GlycoCheck assessment.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with primary open-angle glaucoma who exhibit visual field damage attributed to glaucomatous optic neuropathy.
Not a fit: Patients with conditions such as sleep apnea, renal insufficiency, or recent history of stroke or myocardial infarction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of glaucoma's underlying mechanisms and lead to improved diagnostic and therapeutic strategies.
How similar studies have performed: While the approach of assessing glycocalyx integrity in glaucoma is innovative, similar studies in other vascular conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hôpital Fondation A. de Rothschild — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Cédric LAMIREL, MD — Hôpital Fondation A. de Rothschild
- Study coordinator: Amélie YAVCHITZ, MD
- Email: ayavchitz@for.paris
- Phone: 01 48 03 64 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Open-angle Glaucoma, Glaucoma, Glycocheck, Sublingual microvascularization, Glycocalyx