Background and Purpose:Central retinal artery occlusion results in sudden, painless, usually permanent loss of vision in the affected eye. There is no proven, effective treatment to salvage visual acuity and a clear, unmet need for an effective therapy. In this work, we evaluated the efficacy of intravenous tissue-type plasminogen activator (IV alteplase) in a prospective cohort study and an updated systematic review and meta-analysis.Methods:We enrolled consecutive patients with acute central retinal artery occlusion within 48 hours of symptoms onset and with a visual acuity of <20/200 from January 2009 until May 2019. The primary outcomes were safety and functional visual acuity recovery. We compared rates of visual recovery between those treated with alteplase within 4.5 hours of symptom onset to those who did not receive alteplase (including an analysis restricted to untreated patients presenting within the window for treatment). We incorporated these results into an updated systematic review and patient-level meta-analysis.Results:We enrolled 112 patients, of whom 25 (22.3% of the cohort) were treated with IV alteplase. One patient had an asymptomatic intracerebral hemorrhage after IV alteplase treatment. Forty-four percent of alteplase-treated patients had recovery of visual acuity when treated within 4.5 hours versus 13.1% of those not treated with alteplase (P=0.003) and 11.6% of those presenting within 4 hours who did not receive alteplase (P=0.03). Our updated patient-level meta-analysis of 238 patients included 67 patients treated with alteplase within 4.5 hours since time last known well with a recovery rate of 37.3%. This favorably compares with a 17.7% recovery rate in those without treatment. In linear regression, earlier treatment correlated with a higher rate of visual recovery (P=0.01).Conclusions:This study showed that the administration of intravenous alteplase within 4.5 hours of symptom onset is associated with a higher likelihood of a favorable visual outcome for acute central retinal artery occlusion. Our results strongly support proceeding to a randomized, placebo-controlled clinical trial.

中文翻译：

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静脉纤维蛋白溶解治疗中央视网膜动脉阻塞：一项队列研究和最新的患者水平荟萃分析。

背景与目的：视网膜中央动脉阻塞导致患眼突然，无痛，通常永久性失明。没有可以挽救视力的行之有效的治疗方法，并且对有效治疗方法的明确未满足的需求。在这项工作中，我们在一项前瞻性队列研究以及更新的系统评价和荟萃分析中评估了静脉内组织型纤溶酶原激活剂（IV阿替普酶）的疗效。从2009年1月至2019年5月，症状发作且视力<20/200。主要结果是安全性和功能性视力恢复。我们比较了在4岁以下接受阿替普酶治疗的患者的视觉恢复率。那些没有接受阿替普酶治疗的患者有5个小时的症状发作（包括仅限于未接受治疗的患者的分析）。我们将这些结果纳入了更新的系统评价和患者水平的荟萃分析中。结果：我们招募了112例患者，其中25例（占队列的22.3％）接受了静脉使用阿替普酶治疗。一名患者接受静脉注射阿替普酶治疗后无症状性脑出血。在接受阿替普酶治疗的患者中，有4.5％在4.5小时内恢复视力，而未接受阿替普酶治疗的患者为13.1％（队列中有3％的患者接受了静脉注射阿替普酶治疗。一名患者接受静脉注射阿替普酶治疗后无症状性脑出血。在接受阿替普酶治疗的患者中，有4.5％在4.5小时内恢复视力，而未接受阿替普酶治疗的患者为13.1％（队列中有3％的患者接受了静脉注射阿替普酶治疗。一名患者接受静脉注射阿替普酶治疗后无症状性脑出血。在接受阿替普酶治疗的患者中，有4.5％在4.5小时内恢复视力，而未接受阿替普酶治疗的患者为13.1％（P = 0.003）和在4小时内未接受阿替普酶治疗的患者中有11.6％（P = 0.03）。我们对238例患者进行了最新的患者水平荟萃分析，其中67例患者自上次了解时间以来在4.5小时内接受了阿替普酶治疗，恢复率为37.3％。相比之下，未经治疗的患者的恢复率为17.7％。在线性回归中，早期治疗与较高的视力恢复率相关（P = 0.01）。结论：这项研究表明，在症状发作的4.5小时内静脉注射阿替普酶与急性期视力改善的可能性较高相关。视网膜中央动脉闭塞。我们的结果强烈支持进行随机，安慰剂对照的临床试验。