Microneedle Intra-Arterial Injection for Retinal Artery Occlusion
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
| Condition(s) | Central Retinal Artery Occlusion |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | 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 medicati |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2025-09-01 |
| NCT ID | NCT07151755 |
| Official listing | https://clinicaltrials.gov/study/NCT07151755 |