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

• Conditions: Ocular Ischemia Syndrome
• Interventions: Diagnostic Test: Arterial spin labeling (ASL) magnetic resonance imaging; Diagnostic Test: Fundus fluorescein angiography

• Registration Number: NCT03863171
• Lead Sponsor: Beijing Friendship Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-28
• Status Verified: 2019-03
• Study Start: 2019-03-01
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-05
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-14
• Primary Completion: 2020-03-01
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 190

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Arterial spin labeling (ASL) magnetic resonance imaging	Patients with age-related macular degeneration
Control	Fundus fluorescein angiography	Patients with age-related macular degeneration
Ocular ischemia syndrome	Fundus fluorescein angiography	Patients with ocular ischemia syndrome
Ocular ischemia syndrome	Arterial spin labeling (ASL) magnetic resonance imaging	Patients with ocular ischemia syndrome

Primary Outcome Measures

Name	Time	Method
Blood Flow (BF)	through study completion, an average of 2 years	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)

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China