Changes of Visual Field Defects After IAT for CRAO

NCT ID: NCT05739487

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-03-31

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.

Conditions

Central Retinal Artery Occlusion; Visual Field; Intra-arterial Thrombolysis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

IAT therapy

patients with central retinal artery occlusion received selective intra-arterial thrombolysis

selective intra-arterial thrombolysis

Intervention Type: PROCEDURE

IAT introduces rt-PA (50mg) directly into the ophthalmic circulation by super-selective microcatheterization

Interventions

selective intra-arterial thrombolysis

IAT introduces rt-PA (50mg) directly into the ophthalmic circulation by super-selective microcatheterization

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ping Fei

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ping Fei, MD#PhD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

XHEC-C-2022-057-1

Identifier Type: -

Identifier Source: org_study_id