RecruitingNot Applicable

Microneedle Intra-Arterial Injection for Retinal Artery Occlusion

China24 participantsStarted 2025-09-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Best-Corrected Visual Acuity

Timeframe: 1 month postoperatively

Trial details

NCT IDNCT07151755

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

Jian Ma, MD.

+8618858299889 jian_ma@zju.edu.cn