Microneedle Intra-Arterial Injection for Retinal Artery Occlusion

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care
  • Standard Clinical Care Only

Treatment groups

24 Participants
are divided into 2 treatment groups