Actively Recruiting
Microneedle Intra-Arterial Injection for Retinal Artery Occlusion
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-09-03
24
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective interventional study evaluates the efficacy and safety of direct intra-arterial microneedle injection combined with pars plana vitrectomy for acute retinal artery occlusion (including central retinal artery occlusion \[CRAO\] and branch retinal artery occlusion \[BRAO\] involving the macula or causing severe visual loss). The primary endpoint is best-corrected visual acuity (BCVA, LogMAR) at 1 month. Secondary objectives include assessing the effect of treatment timing and monitoring longitudinal changes in visual function and retinal structure over 12 months.
CONDITIONS
Official Title
Microneedle Intra-Arterial Injection for Retinal Artery Occlusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Acute non-arteritic retinal artery occlusion (CRAO or BRAO involving the macula or causing severe vision loss) with symptom onset within 7 days confirmed by exam or imaging
- Best-corrected visual acuity less than 0.5 decimal
You will not qualify if you...
- Active bleeding disorder, significant bleeding within past 3 months, or bleeding diathesis
- Severe hypertension: systolic blood pressure over 185 mmHg or diastolic blood pressure over 110 mmHg
- Severe coagulopathy or ongoing therapeutic anticoagulation
- Ischemic stroke within past 3 months
- Severe, unstable systemic disease causing unacceptable surgery or anesthesia risk
- Known hypersensitivity to thrombolytic agents or study medications/materials
- Active eye infection
- Vitreous hemorrhage
- Retinal arteritis
- Pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Eye Center of the Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310058
Actively Recruiting
Research Team
J
Jian Ma, MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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