Central Retinal Artery Occlusion Clinical Trial
Official title:
Changes of Visual Field Defects After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion
Verified date | February 2023 |
Source | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Central retinal artery occlusion (CRAO) is an ophthalmic emergency which leads to devastating visual function defects and poor prognosis. Though traditional conservative treatments are widely used, none of them is proved to be effective. A number of meta-analyses and observational studies indicate intravenous thrombolysis to be beneficial in CRAO. Selective intra-arterial thrombolysis (IAT) introducing rt-PA directly into the ophthalmic circulation by super-selective microcatheterization may reduce the complications such as intracranial and systemic hemorrhage. The residual visual field is significant for patients with CRAO who have poor central visual acuity. Thus, it is clinically significant to study the changes in visual fields in eyes with CRAO.
Status | Completed |
Enrollment | 27 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 1. Non-arteritic CRAO with symptom duration =7d 2. Age from 18 years old between 80 years old 3. Qualified systemic conditions, well-controlled blood pressure, well-controlled blood glucose, qualified liver and kidney function, no allergic history to contrast agent or rt-PA. Exclusion Criteria: - Ocular factor or disease 1. Branch retinal artery occlusion 2. Combined retinal vein occlusion 3. Suspicious ocular ischemic syndrome, such as ophthalmic artery occlusion or carotid artery occlusion 4. Existed retinal problems decreasing visual function, such as macular disease, severe nonproliferative or proliferative diabetic retinopathy, severe cataract or glaucoma 5. Central retinal artery occlusion from iatrogenic cause 6. History of thrombolysis for CRAO or CRVO - Systemic factors restricting thrombolysis 1. Uncontrolled hypertension (systolic blood pressure > 180mmHg ); Uncontrolled hyperglycemia (fasting blood glucose > 9mmol/L); 2. Coagulation disorder 3. History of intracranial hemorrhage, heart attack, cerebral infarction, or intracranial surgery within 3 mo 4. Current antithrombotic treatment 5. History of allergic reaction to contrast agent or rt-PA |
Country | Name | City | State |
---|---|---|---|
China | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of the mean deviation | Change of the visual field index as mean deviation (MD) examed by Humphrey visual field analyzer at 7days | 7 days | |
Primary | Change of the visual field index | Change of the visual field index as visual field index (VFI) examed by Humphrey visual field analyzer at 7 days | 7 days | |
Secondary | Change of best corrected visual acuity (BCVA) | best corrected visual acuity of logarithm of the minimum angle of resolution | 7 days | |
Secondary | Adverse reactions at 7 days | Death, symptomatic or asymptomatic intracranial hemorrhage, intraocular hemorrhage | 7 days |
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