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Microneedle Intra-Arterial Injection for Retinal Artery Occlusion
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
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 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.
Official title: Microneedle Intra-Arterial Injection With Pars Plana Vitrectomy for Acute Retinal Artery Occlusion: A Prospective Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-09-01
Completion Date
2027-07-31
Last Updated
2025-09-03
Healthy Volunteers
No
Conditions
Interventions
Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care
The patients will receive standard pars plana vitrectomy (PPV) combined with direct intra-arterial microneedle thrombolysis under microscopic visualization, in addition to standard clinical treatment for RAO. A 47G microneedle will be used to deliver thrombolytic agent intra-arterially per protocol.
Standard Clinical Care Only
The patients will receive standard clinical treatment for RAO without vitrectomy or intra-arterial microneedle thrombolysis.
Locations (1)
Eye Center of the Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China