Early Diagnosis for Ocular Ischemia Syndrome Using Arterial Spin Labeling Magnetic Resonance Imaging Technique

Ocular Ischemia Syndrome Clinical Trial

Official title:

Early Diagnosis for Ocular Ischemia Syndrome Using Arterial Spin Labeling Magnetic Resonance Imaging Technique: a Prospective Multicenter Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03863171
• Other study ID #: 2018-P2-185-02
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2019
• Source: Beijing Friendship Hospital
• Contact: Yanling Wang, MD
• Phone: +86-13701277114
• Email: wangyanling999[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. To evaluate ocular blood perfusion status and the possibility of craniocerebral vascular lesions of patients with ocular ischemia syndrome (OIS) using arterial spin labeling (ASL) magnetic resonance imaging technique.

2. To evaluate the specificity, sensitivity and accuracy of arterial spin labeling (ASL) magnetic resonance imaging technique in OIS diagnosis, compared with the traditional routine examination method.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2020
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Ocular ischemia syndrome group: Patients diagnosed with ocular ischemia syndrome;

• Age-related macular degeneration group (Control group): Patients diagnosed with age-related macular degeneration;

• Age: 50-80 years;

• Sex: all;

• Patients signed written informed consent.

Exclusion Criteria:

• Fundus fluorescein angiography (FFA) clear images cannot be obtained due to refractive media problems(such as corneal leukoplakia, severe cataract, vitreous hemorrhage, etc.) ;

• Patients with contraindications for FFA;

• Patients was unable to perform magnetic resonance rmaging (MRI) test;

• Patients with history of bleeding and cerebral infarction;

• Patients with a history of surgery within 3 months;

• Patients who had participated in other clinical trials within 3 months;

• Patients who disagree and refuse to participate in the trial.

Related Conditions & MeSH terms

• Ischemia
• Ocular Ischemia Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Arterial spin labeling (ASL) magnetic resonance imaging
Arterial spin labeling (ASL) magnetic resonance imaging test
• Fundus fluorescein angiography
Fundus fluorescein angiography test

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Flow (BF)	Blood Flow (BF):a parameter measured by arterial spin labeling perfusion MRI to qualify the perfusion in tissue-specific units (ml blood/gram tissue/time)	through study completion, an average of 2 years