Retinal Microvascularization in OCT-angiography and Systemic Diseases

NCT ID: NCT06613555

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-19
• Study Completion Date: 2044-06-30

Brief Summary

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.

Conditions

Systemic Vascular Damage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with systemic vascular disease

• patients with either:
• systemic vascular pathology
• high cardiovascular risk
• inflammatory vascular pathology
• preeclampsia during pregnancy

Retinal imaging

Intervention Type: 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

Intervention Type: BIOLOGICAL

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

Retinal imaging

Intervention Type: 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

Intervention Type: BIOLOGICAL

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

Only performed at inclusion for controls

Interventions

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

Intervention Type: OTHER

Biological check-up

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

Only performed at inclusion for controls

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourogne

Dijon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Louis ARNOULD

Role: CONTACT

Louis.arnould@chu-dijon.fr

0380293453

Facility Contacts

Laure-Anne Steinberg

Role: primary

laure-anne.steinberg@chu-dijon.fr

0380281324

Other Identifiers

ARNOULD 2022

Identifier Type: -

Identifier Source: org_study_id