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Completed

NCT Number: NCT05739487

Changes of Visual Field Defects After IAT for CRAO

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

selective intra-arterial thrombolysis

Procedure

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

Primary outcomes

  1. Change of the mean deviation

    Time frame: 7 days

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

  2. Change of the visual field index

    Time frame: 7 days

    Change of the visual field index as visual field index (VFI) examed by Humphrey visual field analyzer at 7 days

Secondary outcomes

  1. Change of best corrected visual acuity (BCVA)

    Time frame: 7 days

    best corrected visual acuity of logarithm of the minimum angle of resolution

  2. Adverse reactions at 7 days

    Time frame: 7 days

    Death, symptomatic or asymptomatic intracranial hemorrhage, intraocular hemorrhage

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 22, 2023
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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