Characterization of Retinal Microvascular and FAZ Changes in Ischemic Stroke and Its Different Types

Ischemic Stroke Clinical Trial

Official title:

Characterization of Retinal Microvascular and FAZ Changes in Ischemic Stroke and Its Different Types

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243849
• Other study ID #: OCTA
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: June 2022

Study information

• Verified date: December 2021
• Source: Peking University Third Hospital
• Contact: Hong Qi, PhD
• Phone: 13901066889
• Email: doctorqihong[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aimed to access the microvascular changes in the superficial capillary plexus (SCP) and deep capillary plexus (DCP) in patients with ischemic stroke and its different types using optical coherence tomography angiography.

Description:

Investigators used OCTA to quantitatively access the retinal microvasculature of SCP and DCP, aiming to detect the geometry changes of retinal microvasculature and FAZ in ischemic stroke patients and its different types.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

Patients who were diagnosed with ischemic stroke by MRI were scheduled for an OCTA examination. The diagnosis of ischemic stroke was obtained from previous diagnostic reports or electronic medical records, according to the diagnostic criteria from the Trial of Org 10172 in Acute Stroke Treatment (TOAST).

Exclusion Criteria:

1) Retinal diseases or diseases affecting vessel structure in fundus photography, including age-related maculopathy; diabetic retinopathy, central serous chorioretinopathy, retinal pigment epithelial detachment and glaucoma); poor cooperation in ophthalmic examinations; high refractive error (>+6.00 D or <-6.00 D Spherical Equivalent); low-quality OCTA images (signal strength index < 6/10). Inclusion criteria for healthy controls were no history of ischemic stroke or other neurological and ocular diseases.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Optical Coherence Tomography Angiography
Optical coherence tomography angiography (OCTA) is a novel non-invasive, non-dye and high-resolution imaging technique, allowing real-time quantitative evaluation of retinal vasculature and the structure of foveal avascular zone (FAZ).

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular Area Density(VAD)	The total length in millimeters of perfused retinal microvasculature per unit area in square millimeters in the annular region of analyzed area	immediately after meeting the inclusion and exclusion criteria
Primary	Vascular Fractal Dimension(VFD)	A well-known parameter which indicates the degree of geometric complexity of vasculature	immediately after meeting the inclusion and exclusion criteria
Primary	Vascular Orientation Distribution(VOD)	The direction of each vascular pixel to indicate the trend of the blood flow	immediately after meeting the inclusion and exclusion criteria
Primary	FAZ Area(FA)	The total numbers of pixels in the FAZ region	immediately after meeting the inclusion and exclusion criteria
Primary	FAZ Axis Ratio(FAR)	The ratio between the major and minor axes of the fitted ellipse from the FAZ boundary. The axis ratio of a perfect circular FAZ is equal to 1	immediately after meeting the inclusion and exclusion criteria
Primary	FAZ Circularity(FC)	The ratio of the perimeter of the FAZ to the parameter of a circle with equal area, reflecting the degree of roundness of the FAZ	After meeting the inclusion and exclusion criteria
Primary	FAZ Roundness(FR)	Similar to FC, but is less sensitive to irregular borders along the parameter of FAZ	immediately after meeting the inclusion and exclusion criteria