Status:
RECRUITING
Microneedle Intra-Arterial Injection for Retinal Artery Occlusion
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Central Retinal Artery Occlusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Retinal artery occlusion lacks an established standard therapy. This prospective, non-randomized, parallel-group interventional trial compares pars plana vitrectomy with direct intra-arterial micronee...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Acute non-arteritic retinal artery occlusion (RAO), including: Central retinal artery occlusion (CRAO), or Branch retinal artery occlusion (BRAO) involving the macula or causing severe visual loss; defined as symptom onset ≤7 days and confirmed by exam ± imaging (FFA/OCT)
- Best-corrected visual acuity (BCVA) \<0.5 (decimal)
Exclusion
- Active bleeding disorder, or significant bleeding within the past 3 months, or bleeding diathesis
- Severe hypertension: SBP \>185 mmHg or DBP \>110 mmHg
- Severe coagulopathy or ongoing therapeutic anticoagulation
- Ischemic stroke within the past 3 months
- Severe, unstable systemic disease rendering surgery or anesthesia risk unacceptable
- Known hypersensitivity to thrombolytic agents or any study medications/materials
- Active ocular infection
- Vitreous hemorrhage
- Retinal arteritis
- Pregnancy or lactation
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07151755
Start Date
September 1 2025
End Date
July 31 2027
Last Update
September 3 2025
Active Locations (1)
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1
Eye Center of the Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310058