Changes of Visual Field Defects After IAT for CRAO

Completed

• Conditions: Visual Field; Central Retinal Artery Occlusion; Intra-arterial Thrombolysis
• Interventions: Procedure: selective intra-arterial thrombolysis

• Registration Number: NCT05739487
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2023-02
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-21
• Last Update Submitted: 2023-02-21
• Study First Posted: 2023-02-22
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IAT therapy	selective intra-arterial thrombolysis	patients with central retinal artery occlusion received selective intra-arterial thrombolysis

Primary Outcome Measures

Name	Time	Method
Change of the mean deviation	7 days	Change of the visual field index as mean deviation (MD) examed by Humphrey visual field analyzer at 7days
Change of the visual field index	7 days	Change of the visual field index as visual field index (VFI) examed by Humphrey visual field analyzer at 7 days

Secondary Outcome Measures

Name	Time	Method
Adverse reactions at 7 days	7 days	Death, symptomatic or asymptomatic intracranial hemorrhage, intraocular hemorrhage
Change of best corrected visual acuity (BCVA)	7 days	best corrected visual acuity of logarithm of the minimum angle of resolution

Trial Locations

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China