Evaluating retinal health in patients with cerebral small vessel disease
Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease
This study is testing if a special eye scan can help doctors understand how brain health is affected in older adults with cerebral small vessel disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2400 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Zhejiang Provincial People's Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06431711 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with cerebral small vessel disease (CSVD), a condition that significantly affects older adults and is linked to stroke and dementia. It utilizes optical coherence tomography angiography (OCTA), a non-invasive imaging technology, to assess retinal and choroidal health and its correlation with CSVD markers. The study aims to explore the relationship between OCTA-derived parameters and CSVD, providing insights into the potential clinical value of these measurements for screening and monitoring patients. By analyzing these parameters, the research seeks to enhance understanding of CSVD and its implications for brain health.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 35 years old who have undergone multimodal MRI and have any imaging markers indicative of cerebral small vessel disease.
Not a fit: Patients with known diseases that may worsen CSVD or those with significant eye diseases that could affect fundus assessment are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve early detection and management of cerebral small vessel disease, potentially reducing the risk of stroke and dementia in affected patients.
How similar studies have performed: While the use of OCTA in assessing retinal health is emerging, this specific approach to correlate OCTA parameters with CSVD markers is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Sheng Zhang
- Email: zhangsheng@hmc.edu.cn
- Phone: +8618758188313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.