A prospective, randomised, multicenter trial for surgical treatment of central retinal vein occlusion: results of the Radial Optic Neurotomy for Central Vein Occlusion (ROVO) study group

A prospective, randomised, multicenter trial for surgical treatment of central retinal vein occlusion: results of the Radial Optic Neurotomy for Central Vein Occlusion (ROVO) study group
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DOI:
10.1007/s00417-012-2134-1
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发表时间:
2013-04-01
影响因子:
2.7
通讯作者:
Binder, Susanne
Binder, Susanne
中科院分区:
医学3区
文献类型:
--
作者:
Aggermann, Tina;Brunner, Simon;Binder, Susanne

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比较两种治疗视网膜中央静脉闭塞(CRVO)、桡骨视神经切断术(RON)和玻璃体内曲安奈德(IVT)的手术效果和疗效,并与自然病史进行比较。一项前瞻性、安慰剂对照、随机和多中心研究。CRVO患者分为三组进行治疗——RON、单次玻璃体内注射4mg曲安奈德或安慰剂治疗。主要观察指标为从基线到第12个月的VA(视力)变化和VA显著改善的眼睛比例(定义为>.3线logMAR量表)。纳入90例患者。由于资料不足,7例被排除。47% (n = 18)接受RON治疗的患者显示VA增加,而安慰剂治疗的患者为10% (n = 2), IVT治疗的患者为20% (n = 5)。与安慰剂组相比,RON后VA改善的患者明显更多(p = 0.009)。与IVT组相比,RON术后VA改善的患者显著增加(p = 0.034)。直接比较IVT治疗与安慰剂治疗后VA的改善无显著性差异(p = 0.667)。安慰剂组出现VA恶化的患者(35%,n = 7)明显多于RON组(8%,n = 3)(定义为bbbb3线LogMAR量表)。我们的研究表明,在接受RON治疗后,CRVO患者的长期VA明显优于未治疗的患者和单剂量IVT治疗的患者。
To compare the surgical outcomes and evaluate the effectiveness of two treatments for central retinal vein occlusion (CRVO), radial optic neurotomy (RON) and intravitreal triamcinolone (IVT), in comparison to natural history.A prospective, placebo-controlled, randomised and multi-center study. Patients with CRVO were treated in three groups - with either RON, a single intravitreal injection of 4 mg triamcinolone acetonide, or a placebo treatment. The main outcome measures were change of VA (visual acuity) and proportion of eyes with a significant improvement (defined as > 3 lines logMAR scale) of VA from baseline to month 12.Ninety patients were included. Due to insufficient data, seven were excluded. Forty-seven percent (n = 18) of patients treated with RON showed an increase in VA, in comparison to 10 % (n = 2) of placebo-treated patients, and 20 % (n = 5) of patients treated with IVT. Significantly more patients showed an improvement in VA following RON than in the placebo group (p = 0.009). Significantly more patients showed an improvement in VA following RON than in the IVT group (p = 0.034). No significant difference was found when directly comparing improvement in VA following IVT and placebo (p = 0.667) treatment.Significantly (p = 0.007) more patients in the placebo group (35 %, n = 7) showed a deterioration (defined as > 3 lines LogMAR scale) in VA than patients in the RON group (8 %, n = 3).Our study showed that following treatment with RON, patients with CRVO display a significantly better long-term VA than untreated patients and patients treated with a single dose of IVT.