Microneedle Intra-Arterial Injection With Pars Plana Vitrectomy for Acute Retinal Artery Occlusion: A Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Best-Corrected Visual Acuity
研究概览
简要总结
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.
详细描述
Retinal artery occlusion lacks an established standard therapy. This prospective, non-randomized, parallel-group interventional trial compares pars plana vitrectomy with direct intra-arterial microneedle thrombolysis plus standard care (experimental arm) with standard clinical care alone (control arm). The trial is open-label, and outcome assessors for BCVA, automated perimetry, fluorescein angiography (FFA), and optical coherence tomography (OCT) will be masked. Scheduled visits occur at 1 week, 1 month, 3 months, 6 months, and 12 months. The symptom-to-treatment interval (≤3 days vs 3-7 days) is a prespecified subgroup for secondary analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Best-Corrected Visual Acuity
时间窗: 1 month postoperatively
次要结局
- Visual Field Improvement(Baseline to 1 week, 1, 3, 6, and 12 months postoperatively)
- Retinal Reperfusion Rate(Baseline to 1 week, 1, 3, 6, and 12 months postoperatively)
- OCT/OCTA Structural-Perfusion Changes(Baseline to 1 week, 1, 3, 6, and 12 months postoperatively)