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Recruiting NCT06613555

Retinal Microvascularization in OCT-angiography and Systemic Diseases

Observational Systemic Vascular Damage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Retinal imaging, Biological check-up.
Who it may be relevant to
Registry conditions: Systemic Vascular Damage. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Comparison of the evolution of retinal microvascular densities in OCT-A [Time frame: Up to 10 years]
  • Comparison of the clinical course of patients with systemic pathologies [Time frame: Up to 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Chu Dijon Bourogne — Dijon

Identifiers

NCT: NCT06613555 · ARNOULD 2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗