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