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一项针对视网膜中央静脉阻塞手术治疗的前瞻性、随机、多中心试验:放射状视神经切开术治疗中央静脉阻塞(ROVO)研究组的结果。

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.

机构信息

Department of Ophthalmology, Rudolf Foundation Clinic, Juchgasse 25, 1030 Vienna, Austria.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2013 Apr;251(4):1065-72. doi: 10.1007/s00417-012-2134-1. Epub 2012 Sep 8.

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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).

CONCLUSION

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.

摘要

背景

比较两种治疗方法对视网膜中央静脉阻塞(CRVO)的手术效果,放射状视神经切开术(RON)和玻璃体内曲安奈德(IVT),并与自然病程进行比较。

方法

前瞻性、安慰剂对照、随机和多中心研究。CRVO 患者分为三组治疗 - RON 治疗组、单次玻璃体内注射 4mg 曲安奈德组和安慰剂治疗组。主要观察指标为治疗后 12 个月视力(VA)变化和 VA 显著改善(定义为>3 行 LogMAR 量表)的眼比例。

结果

90 例患者入选。由于数据不足,7 例被排除。RON 治疗组中有 47%(n=18)的患者 VA 增加,而安慰剂治疗组仅有 10%(n=2),IVT 治疗组仅有 20%(n=5)。RON 治疗组患者 VA 改善的比例显著高于安慰剂组(p=0.009)。RON 治疗组患者 VA 改善的比例显著高于 IVT 组(p=0.034)。IVT 和安慰剂治疗组间 VA 改善的直接比较无显著差异(p=0.667)。安慰剂组(35%,n=7)中有更多的患者 VA 恶化(定义为>3 行 LogMAR 量表),显著高于 RON 组(8%,n=3)(p=0.007)。

结论

我们的研究表明,与未经治疗的患者和单次 IVT 治疗的患者相比,CRVO 患者接受 RON 治疗后长期 VA 显著改善。

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