Changes of Visual Field Defects After IAT for CRAO

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The respective responses of brain and retinal tissues to acute ischemia share many features is the rationale for therapeutic thrombolysis in CRAO. Intravenous thrombolysis (IVT) has been a therapeutic choice for CRAO since the 1960s, and in the United States, tPA is currently administered in 5.8% of patients admitted with CRAO. 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 which has the advantage of reducing the dose of rt-PA reaching the systemic circulation. It is clinically significant to study the changes in visual fields in eyes with CRAO. The short-term temporal changes (≤7-day) of VFDs and the adverse reactions in eyes with CRAO after IAT were investigated to assess the efficacy and safety of the procedure in this retrospective study.

Official Title
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Changes of Visual Field Defects After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion

Conditions
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Central Retinal Artery Occlusion, Visual Field, Intra-arterial Thrombolysis

Intervention / Treatment
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* Procedure: selective intra-arterial thrombolysis


Participation Criteria
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Eligibility Criteria
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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 Branch retinal artery occlusion Combined retinal vein occlusion Suspicious ocular ischemic syndrome, such as ophthalmic artery occlusion or carotid artery occlusion Existed retinal problems decreasing visual function, such as macular disease, severe nonproliferative or proliferative diabetic retinopathy, severe cataract or glaucoma Central retinal artery occlusion from iatrogenic cause History of thrombolysis for CRAO or CRVO Systemic factors restricting thrombolysis Uncontrolled hypertension (systolic blood pressure > 180mmHg ); Uncontrolled hyperglycemia (fasting blood glucose > 9mmol/L); Coagulation disorder History of intracranial hemorrhage, heart attack, cerebral infarction, or intracranial surgery within 3 mo Current antithrombotic treatment History of allergic reaction to contrast agent or rt-PA

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IAT therapy<br>patients with central retinal artery occlusion received selective intra-arterial thrombolysis | Procedure: selective intra-arterial thrombolysis<br>* IAT introduces rt-PA (50mg) directly into the ophthalmic circulation by super-selective microcatheterization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of best corrected visual acuity (BCVA) | best corrected visual acuity of logarithm of the minimum angle of resolution | 7 days | 
| Adverse reactions at 7 days | Death, symptomatic or asymptomatic intracranial hemorrhage, intraocular hemorrhage | 7 days |