Examining retinal blood vessels to understand systemic diseases

Retinal Microvascularization in OCT-angiography and Systemic Diseases

This study looks at the tiny blood vessels in the eye to see if they can help us understand and predict chronic inflammatory diseases in people with and without systemic vascular conditions.

Quick facts

• Study type: Observational
• Enrollment: 5000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire Dijon (Academic / other)
• Locations: 1 site (Dijon)
• Trial ID: NCT06613555 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between retinal microvascularization and systemic vascular damage. It aims to identify predictive indicators of chronic inflammatory diseases by analyzing the health of small blood vessels in the retina using non-invasive imaging techniques. Patients with systemic vascular conditions and healthy controls will be monitored over time to assess the progression of these diseases. The study utilizes retinal imaging and biological check-ups to gather data.

Who should consider this trial

Good fit: Ideal candidates include patients with systemic vascular pathology, high cardiovascular risk, inflammatory vascular pathology, or preeclampsia, as well as healthy individuals without systemic or vascular issues.

Not a fit: Patients with existing ocular diseases or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection and better management of systemic vascular diseases.

How similar studies have performed: While the approach of using retinal microcirculation as a predictive indicator is promising, it is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

For the \"patients with systemic vascular disease\" group

* Patients who have given oral, free and informed consent
* Patients with either :

  * systemic vascular pathology
  * high cardiovascular risk
  * inflammatory vascular pathology
  * preeclampsia during pregnancy

The study will also be offered to patients who have already had an OCT-A examination as part of their routine care, in order to follow them over time.

For the \"healthy control\" group

* Patients who have given free, oral and informed consent
* Patients with no prior systemic or vascular inflammatory pathology, and no high cardiovascular risk
* Non-diabetic patients
* Pregnant patients with risk-free pregnancies recruited from the gynecology department of CHU Dijon Bourgogne OR
* Adult patients without maculopathy recruited from the Ophthalmology Department of CHU Dijon Bourgogne

Exclusion Criteria:

* For the \"patients with systemic vascular disease\" group
* Ophthalmological history in both eyes (vascular and degenerative macular pathologies)
* Protected patient :

  * Minor patient
  * Patient under legal protection (guardianship, curatorship, court order)
  * Patient unable to give consent Person not affiliated to a social security scheme
  * Breast-feeding women
* Person with a contraindication to Tropicamide
* OCT-A signal strength \< 7

For the \"healthy control\" group

* Any pathology studied in the case group
* Ophthalmological history in both eyes (vascular and degenerative macular pathologies)
* Type 1 or type 2 diabetes
* Person with a contraindication to Tropicamide
* Protected person :

  * Minor
  * Person under legal protection (guardianship, curatorship, court order)
  * Person unable to give consent
  * Person not affiliated to a social security scheme
  * Breast-feeding women
* OCT-A signal strength \< 7

Where this trial is running

Dijon

• Chu Dijon Bourogne — Dijon, France (Recruiting)

Study contacts

• Study coordinator: Louis ARNOULD

Conditions Systemic Vascular Damage