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全黄斑转位术(FMT)与维替泊芬光动力疗法(PDT)治疗新生血管性年龄相关性黄斑变性的前瞻性、对照、随机试验(FMT-PDT)的2年结果

Full macular translocation (FMT) versus photodynamic therapy (PDT) with verteporfin in the treatment of neovascular age-related macular degeneration: 2-year results of a prospective, controlled, randomised pilot trial (FMT-PDT).

作者信息

Lüke Matthias, Ziemssen Focke, Völker Michael, Altpeter Elke, Beutel Julia, Besch Dorothea, Bartz-Schmidt Karl Ulrich, Gelisken Faik

机构信息

University Eye Hospital, University of Lübeck, Lübeck, Germany.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2009 Jun;247(6):745-54. doi: 10.1007/s00417-009-1050-5. Epub 2009 Feb 12.

DOI:10.1007/s00417-009-1050-5
PMID:19214552
Abstract

BACKGROUND

To report the outcome of best-corrected visual acuity (BCVA), near visual acuity (NVA), contrast sensitivity (CS) and vision-related quality of life (VRQOL) in patients 2 years after undergoing photodynamic therapy (PDT) or full macular translocation (FMT) for the treatment of neovascular age-related macular degeneration (AMD).

METHODS

Fifty patients with predominantly classic subfoveal choroidal neovascularisation (CNV) secondary to AMD were randomized to PDT or FMT. BCVA was determined according a standardized protocol with ETDRS charts. NVA were calculated after testing with SNAB (Swiss National Association of and for the Blind) visual acuity cards. CS was measured with Pelli-Robson charts. The 39-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25 plus supplement) was performed. Primary end points were the changes of BCVA, NVA, CS and VRQOL at 24-month examination.

RESULTS

A stabilisation of BCVA (+0.3 letters) was found in the FMT group, whereas a decrease of more than 12 letters (-12.6 letters) was found in the PDT group (p = 0.052). Mean NVA improved by 7.0 letters in the FMT group and was superior to the PDT group (-9.6 letters, p = 0.036), while mean CS showed a time-dependent decrease in both treatment groups (FMT: -3.3 letters, PDT: -3.8 letters, p = 0.726). Considering the results of the VRQOL scores, the improvement of the subscales scores for general vision (p = 0.015), mental health (p = 0.028) and near activity (p = 0.020) were significantly higher in the FMT group.

CONCLUSIONS

FMT can stabilise BCVA and improve NVA over a period of 2 years in patients with subfoveal classic CNV secondary to neovascular AMD, whereas a decrease of BCVA and NVA was found in the PDT group. CS did not differ between FMT and PDT. A significant increase of VRQOL scores was only found in the FMT group and not in the PDT group. FMT seems to be a therapeutic approach that can increase visual function resulting in an improvement of patient's VRQOL, but exhibits a higher number of severe complications compared to PDT.

摘要

背景

报告接受光动力疗法(PDT)或全黄斑转位术(FMT)治疗新生血管性年龄相关性黄斑变性(AMD)的患者在2年后的最佳矫正视力(BCVA)、近视力(NVA)、对比敏感度(CS)及视力相关生活质量(VRQOL)的结果。

方法

50例主要为继发于AMD的典型中心凹下脉络膜新生血管(CNV)患者被随机分为PDT组或FMT组。BCVA根据采用ETDRS视力表的标准化方案测定。NVA在使用瑞士国家盲人协会(SNAB)视力卡片测试后计算得出。CS用贝利-罗伯逊视力表测量。采用39项的美国国立眼科研究所视觉功能问卷(NEI-VFQ-25加补充问卷)。主要终点是24个月检查时BCVA﹑NVA﹑CS及VRQOL的变化。

结果

FMT组BCVA稳定(提高0.3字母),而PDT组下降超过12字母(-12.6字母)(p = 0.052)。FMT组平均NVA提高7.0字母,优于PDT组(-9.6字母,p = 0.036),而两组平均CS均呈时间依赖性下降(FMT组:-3.3字母,PDT组:-3.8字母,p = 0.726)。考虑VRQOL评分结果,FMT组在总体视力(p = 0.015)、心理健康(p = 0.028)及近视力活动(p = 0.020)子量表评分方面的改善显著更高。

结论

对于继发于新生血管性AMD的中心凹下典型CNV患者,FMT在2年期间可稳定BCVA并改善NVA,而PDT组BCVA和NVA下降。FMT组与PDT组CS无差异。仅在FMT组发现VRQOL评分显著增加,而PDT组未发现。FMT似乎是一种可提高视觉功能从而改善患者VRQOL的治疗方法,但与PDT相比,严重并发症数量更多。

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