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

Sponsor

Peking University Third Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05243849

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

20.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Device: Optical Coherence Tomography Angiography

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Ischemic Stroke 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).	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).
Control Inclusion criteria for healthy controls were no history of ischemic stroke or other neurological and ocular diseases.	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).

Arm

Intervention/Treatment

Ischemic Stroke

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).

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).

Control

Inclusion criteria for healthy controls were no history of ischemic stroke or other neurological and ocular diseases.

Device: Optical Coherence Tomography Angiography

Outcome Measures

Primary Outcome Measures

Vascular Area Density(VAD) [immediately after meeting the inclusion and exclusion criteria]
The total length in millimeters of perfused retinal microvasculature per unit area in square millimeters in the annular region of analyzed area
Vascular Fractal Dimension(VFD) [immediately after meeting the inclusion and exclusion criteria]
A well-known parameter which indicates the degree of geometric complexity of vasculature
Vascular Orientation Distribution(VOD) [immediately after meeting the inclusion and exclusion criteria]
The direction of each vascular pixel to indicate the trend of the blood flow
FAZ Area(FA) [immediately after meeting the inclusion and exclusion criteria]
The total numbers of pixels in the FAZ region
FAZ Axis Ratio(FAR) [immediately after meeting the inclusion and exclusion criteria]
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
FAZ Circularity(FC) [After meeting the inclusion and exclusion criteria]
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
FAZ Roundness(FR) [immediately after meeting the inclusion and exclusion criteria]
Similar to FC, but is less sensitive to irregular borders along the parameter of FAZ

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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.