RecruitingNot ApplicableNCT07151755

Microneedle Intra-Arterial Injection for Retinal Artery Occlusion

Microneedle Intra-Arterial Injection With Pars Plana Vitrectomy for Acute Retinal Artery Occlusion: A Prospective Clinical Trial

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

24 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

central retinal artery occlusion

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Standard Clinical Care Only and a procedure called Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care for people with central retinal artery occlusion. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREVitrectomy + 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.

PROCEDUREStandard Clinical Care Only

The patients will receive standard clinical treatment for RAO without vitrectomy or intra-arterial microneedle thrombolysis.