Clinical trial NCT05243849: Characterization of Retinal Microvascular and FAZ Changes in Ischemic Stroke and Its Different Types
Official title: Characterization of Retinal Microvascular and FAZ Changes in Ischemic Stroke and Its Different Types
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke
Optical Coherence Tomography Angiography
Retina
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with ischemic stroke by MRI and healthy controls were scheduled for an OCTA examination.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vascular Area Density(VAD)
timeFrame: immediately after meeting the inclusion and exclusion criteria
measure: Vascular Fractal Dimension(VFD)
timeFrame: immediately after meeting the inclusion and exclusion criteria
measure: Vascular Orientation Distribution(VOD)
timeFrame: immediately after meeting the inclusion and exclusion criteria
measure: FAZ Area(FA)
timeFrame: immediately after meeting the inclusion and exclusion criteria
measure: FAZ Axis Ratio(FAR)
timeFrame: immediately after meeting the inclusion and exclusion criteria
measure: FAZ Circularity(FC)
timeFrame: After meeting the inclusion and exclusion criteria
measure: FAZ Roundness(FR)
timeFrame: immediately after meeting the inclusion and exclusion criteria
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Hongyu Duan, MD
role: STUDY_DIRECTOR
References: