Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease (FRESH-CSVD)

Zhejiang Provincial People's Hospital

Status: Enrolling

Conditions: Choroid; Injury; Cerebral Small Vessel Diseases; Retinal Ischemia

Study type: Observational

Funder types: Other

Identifiers

NCT06431711

KY2024050

Details and patient eligibility

About

Cerebral small-vessel disease (CSVD) is a significant contributor to stroke and dementia, primarily impacting individuals over the age of 60. Its prevalence exceeds 70% in the elderly population, imposing a substantial burden on brain health and the economy. Optical coherence tomography angiography (OCTA) is a new type of optical diagnostic imaging technology for non-invasive detection, which can perform multi-dimensional quantitative assessment of fundus retinopathy. Current studies have shown that fundus OCTA-derived parameters may have potential in characterizing imaging changes in CSVD. However, the correlation between retinal/choroidal parameters on OCTA and the CSVD imaging markers remains uncertain. FRESH-CSVD is a prospective, observational study that will use fundus OCTA-derived parameters to screen patients with CSVD, explore the relationship between relevant parameters based on OCTA measurements and CSVD, and evaluate the feasibility and clinical value of identification of CSVD through fundus OCTA.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Older than 35 years old;
2. Patients who underwent Multimodal MRI with any CSVD imaging marker;
3. Subjects who have signed informed consent.

Exclusion criteria

1. Patient who was unable to cooperate with examinations;
2. There are known diseases that may cause or worsen CSVD (brain injury, Down syndrome, Alzheimer's disease, Parkinson's disease, etc.);
3. There are known eye diseases or severe underlying fundus lesions that may impact fundus assessment;
4. Suffering from serious systemic diseases, such as heart, liver, kidney diseases or major mental illnesses;
5. Contraindications for imaging examinations

Exit Criteria:

1. Not meet the inclusion criteria.
2. For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator.
3. Any adverse or serious adverse events during the study period judged by investigator

Trial design

2,400 participants in 1 patient group

Individuals with CSVD

Description:

This does not entail the application of interventions.