Clinical trial NCT05562284: Safety and Efficacy After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion
Official title: Safety and Efficacy of the Visual Field Improvement After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Retinal Artery Occlusion
Keywords: central retinal artery occlusion
intra-arterial thrombolysis
visual field
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. Thus, IAT 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. Sequential evaluation by Humphrey perimetry will evaluate the temporal changes before and after IAT or conservative therapies. Our study will enroll patients within 7 days of symptom onset and aims at evaluating the safety of IAT and comparing the improvement of the VFDs between conservative treatments and IAT combined with conservative treatments.

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,
4. Meet the inclusion of HBOT

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

Primary outcomes:
measure: Change of the visual field index as mean deviation (MD) examed by Humphrey visual field analyzer at 3 months
timeFrame: 90 days
measure: Change of the visual field index as visual field index (VFI) examed by Humphrey visual field analyzer at 3 months
timeFrame: 90 days
Secondary outcomes:
measure: Change of Best corrected visual acuity (BCVA) at 3 months
timeFrame: 90 days
measure: Adverse reactions at 1 month
timeFrame: 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Ping Fei, MD#PhD
role: PRINCIPAL_INVESTIGATOR
References: