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全黄斑转位术与维替泊芬光动力疗法治疗新生血管性年龄相关性黄斑变性:一项前瞻性、对照、随机试验(FMT-PDT)的1年结果

Full macular translocation versus photodynamic therapy with verteporfin in the treatment of neovascular age-related macular degeneration: 1-year results of a prospective, controlled, randomised pilot trial (FMT-PDT).

作者信息

Gelisken Faik, Voelker Michael, Schwabe Rainer, Besch Dorothea, Aisenbrey Sabine, Szurman Peter, Grisanti Salvatore, Herzau Volker, Bartz-Schmidt Karl U

机构信息

Centre for Ophthalmology, University of Tuebingen, Schleichstr. 12, 72076 Tuebingen, Germany.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2007 Aug;245(8):1085-95. doi: 10.1007/s00417-006-0524-y.

Abstract

BACKGROUND

The purpose of this study was to compare full macular translocation (FMT) with photodynamic therapy (PDT) in the treatment of neovascular age-related macular degeneration (AMD).

METHODS

In a prospective, randomised, non-masked, mono-center, pilot-trial, 50 eyes of 50 patients were assigned to either FMT or PDT. Baseline and control examinations in 3-monthly intervals over a 12-month period included standardized protocol refraction, visual acuity testing and fluorescein angiography. Primary outcome measurements were made to establish the change in distant visual acuity from the baseline to the 12-month examination. The statistical analyses were carried out on the intent-to-treat principle.

RESULTS

The improvement of one or more ETDRS lines was 56% (14/25) of the eyes in the FMT and 16% (4/25) of the eyes in the PDT arm (P = 0.007). Twenty eyes (80%) in the FMT and 16 eyes (64%) in the PDT group had less than three ETDRS lines of vision loss (P = 0.35). Retinal detachment (six eyes) and diplopia (five patients) were recorded in the FMT group. None of the eyes treated in the FMT group had phtysis.

CONCLUSION

This pilot study showed that no statistically significant difference existed between the FMT and PDT in terms of the vision loss of less than three ETDRS lines in eyes with neovascular AMD. The chance of vision improvement was significantly higher for the patients in the FMT group. However, in the era of promising therapy with anti-vascular endothelial growth factor for neovascular AMD, FMT should not be offered as a standard primary procedure for neovascular AMD.

摘要

背景

本研究旨在比较全黄斑转位术(FMT)与光动力疗法(PDT)治疗新生血管性年龄相关性黄斑变性(AMD)的效果。

方法

在一项前瞻性、随机、非盲、单中心的试点试验中,将50例患者的50只眼随机分为FMT组或PDT组。在12个月期间,每3个月进行一次基线和对照检查,包括标准化验光、视力测试和荧光素血管造影。主要结局指标是确定从基线到12个月检查时远距离视力的变化。统计分析按照意向性分析原则进行。

结果

FMT组中一只或多只眼的ETDRS视力表行数提高的比例为56%(14/25),PDT组为16%(4/25)(P = 0.007)。FMT组20只眼(80%)和PDT组16只眼(64%)的视力丧失少于3行ETDRS视力表行数(P = 0.35)。FMT组记录到视网膜脱离(6只眼)和复视(5例患者)。FMT组治疗的眼中没有一只发生眼球萎缩。

结论

这项试点研究表明,在新生血管性AMD患者中,FMT和PDT在视力丧失少于3行ETDRS视力表行数方面没有统计学上的显著差异。FMT组患者视力改善的机会显著更高。然而,在抗血管内皮生长因子治疗新生血管性AMD前景广阔的时代,FMT不应作为新生血管性AMD的标准主要治疗方法。

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