Changes of Visual Field Defects After IAT for CRAO

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

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.

Study Overview

• Status: Completed
• Conditions: Visual Field; Central Retinal Artery Occlusion; Intra-arterial Thrombolysis
• Intervention / Treatment: Procedure: selective intra-arterial thrombolysis

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 Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with non-arteritic CRAO and treated by IAT between July 2020 and March 2022 were analyzed retrospectively.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IAT therapy; patients with central retinal artery occlusion received selective intra-arterial thrombolysis	Procedure: selective intra-arterial thrombolysis; IAT introduces rt-PA (50mg) directly into the ophthalmic circulation by super-selective microcatheterization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Ping Fei, MD#PhD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Estimate): February 22, 2023

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Eye Diseases; Retinal Diseases; Retinal Artery Occlusion
• Other Study ID Numbers: XHEC-C-2022-057-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No