Recruiting

NCT Number: NCT06613555

Retinal Microvascularization in OCT-angiography and Systemic Diseases

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.

Recruiting

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Key information

Conditions

Systemic Vascular Damage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Location status: Recruiting

Location contact

Laure-Anne Steinberg

CONTACT

[email protected]

0380281324

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retinal imaging

Other

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 check-up

Biological

it is performed at inclusion and then once a year for 10 years for patients

Only performed at inclusion for controls

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Louis ARNOULD

CONTACT

[email protected]

0380293453

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon