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临床试验/NCT06613555
NCT06613555招募中不适用

Retinal Microvascularization in OCT-angiography and Systemic Diseases

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2024年6月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
Comparison of the evolution of retinal microvascular densities in OCT-A

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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 :
  • 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

研究组 & 干预措施

healthy controls

patients with no systemic or vascular inflammatory pathology and no high cardiovascular risk

干预措施: Biological check-up (Biological)

patients with systemic vascular disease

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

干预措施: Retinal imaging (Other)

patients with systemic vascular disease

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

干预措施: Biological check-up (Biological)

healthy controls

patients with no systemic or vascular inflammatory pathology and no high cardiovascular risk

干预措施: Retinal imaging (Other)

结局指标

主要结局

Comparison of the evolution of retinal microvascular densities in OCT-A

时间窗: Up to 10 years

Comparison of the clinical course of patients with systemic pathologies

时间窗: Up to 10 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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