Retinal Microvascularization in OCT-angiography and Systemic Diseases (OCTAVA)

Systemic diseases are inflammatory, chronic illnesses affecting different organs and altering their function. At present, there are few non-invasive methods for predicting their onset and progression.

Some chronic diseases can be anticipated earlier thanks to predictive indicators. These indicators could help doctors decide which treatment is best suited to each patient. In particular, the state of microcirculation in the eyes, specifically in the retina, is linked to the progression of certain diseases in the body. Unfortunately, assessing the health of the small blood vessels in the retina is complicated. Most current methods are imprecise, difficult to reproduce and require qualified specialists. However, the use of retinal microcirculation appears to be a promising approach to solving these problems.

In fact, the structure of retinal blood vessels can be observed easily, painlessly and without invasive procedures, thanks to fundus photographs or scans providing imaging slices known as optical coherence tomography-angiography (OCT-A).

The vascularization of the retina is very often presented as a window giving access to the peripheral vascularization (the vascularization of other organs distant from the eyes).

For example, we recently demonstrated a link between retinal vascularization and the risk of heart problems in patients with coronary artery disease.

The aim of this study is to gather original information on the evolution of retinal vascularization, using specific markers that may be associated with damage to distant organs.

By regularly monitoring these changes over time, the researchers hope to identify early changes that could indicate the development or evolution of these diseases.

The main aim of this study is to create a database of images obtained by OCT-Angiography in patients with systemic diseases and in healthy individuals. This will enable us to identify early changes in retinal vascularization that may be associated with these systemic pathologies.

With this information, we hope to improve early diagnosis and monitoring of diseases, which could have a positive impact on patients' health.

Study Overview

• Status: Recruiting
• Conditions: Systemic Vascular Damage
• Intervention / Treatment: Other: Retinal imaging; Biological: Biological check-up

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Louis ARNOULD; Phone Number: 0380293453; Email: Louis.arnould@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • Chu Dijon Bourogne
    • Contact: Laure-Anne Steinberg; Phone Number: 0380281324; Email: laure-anne.steinberg@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with systemic vascular disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with systemic vascular disease; patients with either:; systemic vascular pathology; high cardiovascular risk; inflammatory vascular pathology; preeclampsia during pregnancy	Other: Retinal imaging; the retinal imaging work-up includes: OCT-angiography; Retinophotography; Adaptive optics performed at inclusion, at 6 months and then once a year for 10 years for patients Only performed at inclusion for controls; Biological: Biological check-up; it is performed at inclusion and then once a year for 10 years for patients Only performed at inclusion for controls
healthy controls; patients with no systemic or vascular inflammatory pathology and no high cardiovascular risk	Other: Retinal imaging; the retinal imaging work-up includes: OCT-angiography; Retinophotography; Adaptive optics performed at inclusion, at 6 months and then once a year for 10 years for patients Only performed at inclusion for controls; Biological: Biological check-up; it is performed at inclusion and then once a year for 10 years for patients Only performed at inclusion for controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of the evolution of retinal microvascular densities in OCT-A	Up to 10 years
Comparison of the clinical course of patients with systemic pathologies	Up to 10 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2024
• Primary Completion (Estimated): June 1, 2044
• Study Completion (Estimated): June 1, 2044

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ARNOULD 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No