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

Inclusion Criteria3

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 Criteria10

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

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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.