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development of a correlation model linking retinal vascular quantification and cerebral small vessel disease

development of a correlation model linking retinal vascular quantification and cerebral small vessel disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114643
Enrollment
Unknown
Registered
2025-12-16
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral small vessel disease

Interventions

Gold Standard:The gold standard for diagnosing CSVD is the CSVD total burden score (with a total score of 0-4 points), which is assessed based on MRI findings and includes 4 imaging markers: 1. Recent
2. White matter hyperintensities (Fazekas score)
3. Cerebral microbleeds
4. Perivascular spaces enlargement.
Index test:The CSVD risk prediction model constructed by quantitatively analyzing non-mydriatic fundus photographs based on artificial intelligence technology to extract retinal vascular morphological

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old; 2. Patients suspected of cerebral small vessel disease who visited the Department of Neurology, Beijing Hospital; 3. Underwent MRI examination and non-mydriatic fundus color photography of both eyes within one week.

Exclusion criteria

Exclusion criteria: 1. History of aneurysm or presence of an untreated aneurysm (diameter >3mm); 2. Confirmed degenerative central nervous system disorders, such as Parkinson's disease, Alzheimer's disease, or dementia caused by brain injury from other causes; 3. Exclusion of all TOAST subtypes except small artery disease; 4. Neuroinfectious or immune-mediated leukoencephalopathies; 5. Confirmed psychiatric disorders; 6. Concurrent ophthalmic conditions affecting retinal vascular or optic disc structures, such as retinal vascular dysplasia, glaucoma, or congenital optic disc abnormalities; 7. Severe opacity of the refractive media compromising the quality of fundus colour photography; 8. Presence of severe organic diseases, such as malignant tumours, with an expected survival time of <2 years; 9. Pregnant women or women of childbearing age not using effective contraception and lacking pregnancy test records.

Design outcomes

Primary

MeasureTime frame
AUC;Accuracy;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactXiaoya Gu

Beijing Hospital

guxiaoya4435@bjhmoh.cn+86 135 8196 7487

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026