Feltgen N, Neubauer A, Jurklies B, Schmoor C, Schmidt D, Wanke J, Maier-Lenz H, Schumacher M
Department of Ophthalmology, University of Freiburg, Killlianstrasse 5, 79106, Freiburg, Germany.
Graefes Arch Clin Exp Ophthalmol. 2006 Aug;244(8):950-6. doi: 10.1007/s00417-005-0140-2. Epub 2005 Dec 22.
The natural course of central retinal artery occlusion (CRAO) often leads to legal blindness in the affected eye. To date, none of the conservative therapies had proven effective in retrospective studies. In 1991, a new minimally invasive therapy was started in patients with an acute CRAO. This therapy, namely, local intra-arterial fibrinolysis, is comparable to the minimally invasive therapy in patients with an acute ischemic stroke. In pilot studies, it showed promising results in comparison with conservative treatments. The efficacy of this method is now being investigated in a randomized multicenter study.
The European Assessment Group for Lysis in the Eye (EAGLE) started a prospective and randomized multicenter study in 2002 to evaluate therapeutic efficacy. Inclusion criteria are age between 18 and 75 years and a CRAO not older than 20 h with a visual acuity less than 0.32. The most important exclusion criteria are branch retinal artery occlusion (BRAO), cilioretinal arteries supplying the macula, and serious general disease. After randomization the patient is treated by conservative or local intra-arterial lysis therapy. The conservative regime included bulbus massage, lowering intraocular pressure with topical beta-blocker and acetazolamide, acetylsalicylic acid, heparin, and-depending on the hematocrit-isovolemic hemodilution. In case of local intra-arterial fibrinolysis, a maximum of 50 mg rtPA is injected into the ophthalmic artery by the neuroradiologist. During the following 5 days, all patients are treated with heparin. Primary study end point is visual acuity 1 month after therapy in comparison with visual acuity before therapy. The calculated sample size is 100 patients per subtrial (a total of 200 patients). The study was started in June 2002. To April 2005, 47 patients were included.
The EAGLE Study is the first randomized prospective clinical trial to compare conservative medical treatment and local intra-arterial fibrinolysis in patients with CRAO. The results of this study should enable ophthalmologists and neuroradiologists to improve the therapy of patients with acute CRAO. To April 2005, treatment is only justified in randomized multicenter studies because of the limited therapeutical visual outcome. We welcome new study centers to join.
视网膜中央动脉阻塞（CRAO）的自然病程常常导致患眼法定失明。迄今为止，回顾性研究中尚无任何保守治疗方法被证明有效。1991年，针对急性CRAO患者开始了一种新的微创治疗方法。这种治疗方法，即局部动脉内纤溶治疗，类似于急性缺血性脑卒中患者的微创治疗。在初步研究中，与保守治疗相比，它显示出了有前景的结果。目前正在一项随机多中心研究中对该方法的疗效进行调查。
欧洲眼部纤溶评估组（EAGLE）于2002年启动了一项前瞻性随机多中心研究以评估治疗效果。纳入标准为年龄在18至75岁之间且CRAO发病不超过20小时，视力低于0.32。最重要的排除标准为视网膜分支动脉阻塞（BRAO）、供应黄斑的睫状视网膜动脉以及严重的全身性疾病。随机分组后，患者接受保守治疗或局部动脉内纤溶治疗。保守治疗方案包括眼球按摩、使用局部β受体阻滞剂和乙酰唑胺降低眼压、阿司匹林、肝素，以及根据血细胞比容进行等容血液稀释。在进行局部动脉内纤溶治疗时，神经放射科医生向眼动脉内注射最多50毫克的重组组织型纤溶酶原激活剂（rtPA）。在接下来的5天里，所有患者均接受肝素治疗。主要研究终点是治疗1个月后的视力与治疗前视力的比较。计算得出的样本量为每个亚组100名患者（总共200名患者）。该研究于2002年6月开始。至2005年4月，已纳入47名患者。
EAGLE研究是第一项比较CRAO患者保守药物治疗和局部动脉内纤溶治疗的随机前瞻性临床试验。该研究结果应能使眼科医生和神经放射科医生改进急性CRAO患者的治疗方法。至2005年4月，由于治疗性视力结果有限，仅在随机多中心研究中治疗才是合理的。我们欢迎新的研究中心加入。
