玻璃体内注射奥克纤溶酶治疗玻璃体黄斑牵拉和黄斑裂孔的视觉功能反应
Visual function response to ocriplasmin for the treatment of vitreomacular traction and macular hole.
作者信息
Jackson Timothy L, Verstraeten Thomas, Duchateau Luc, Lescrauwaet Benedicte
机构信息
School of Medicine, King's College London, London, UK.
P95 Pharmacovigilance and Epidemiology Services, Leuven, Belgium.
出版信息
Acta Ophthalmol. 2017 Dec;95(8):e740-e745. doi: 10.1111/aos.13369. Epub 2017 Jan 30.
PURPOSE
To assess the effect of an intravitreal ocriplasmin injection on visual function, measured using visual acuity (VA) and vision-related quality of life.
METHODS
Post hoc analysis of prespecified secondary end-points in two multicentre, randomized, double-masked, phase 3 clinical trials. A total of 652 participants with symptomatic vitreomacular adhesion were enrolled, of whom 464 received a single intravitreal injection of 125 μg ocriplasmin and 188 received a single intravitreal placebo injection. Based on principal components analysis results, visual function response (VFR) was defined as either a VA improvement of ≥2 lines; or an improvement in the composite score of the National Eye Institute Visual Function Questionnaire (VFQ-25) exceeding the minimal clinically important difference (MCID), estimated using the standard error of measurement approach; or an improvement in the VFQ-25 driving subscale score exceeding the MCID. The main outcome measure was VFR at 6 months.
RESULTS
A VFR occurred in 55.1% of the ocriplasmin group versus 34.2% of the placebo injection group (p < 0.0001). This comprised 23.7% versus 11.2% (p = 0.0003) with a ≥ 2-line VA improvement, 35.9% versus 22.7% (p = 0.0016) for the VFQ-25 composite score, and 10.2% versus 6.2% (p = 0.1697) for the driving subscale.
CONCLUSION
Ocriplasmin produces a clinically meaningful visual function benefit.
目的
评估玻璃体内注射奥克纤溶酶对视力（VA）和与视力相关的生活质量所测量的视觉功能的影响。
方法
对两项多中心、随机、双盲、3期临床试验中预先设定的次要终点进行事后分析。共纳入652例有症状性玻璃体黄斑粘连的参与者，其中464例接受单次玻璃体内注射125μg奥克纤溶酶，188例接受单次玻璃体内安慰剂注射。基于主成分分析结果，视觉功能反应（VFR）定义为以下情况之一：视力提高≥2行；或美国国立眼科研究所视觉功能问卷（VFQ-25）综合评分的改善超过使用测量标准误方法估计的最小临床重要差异（MCID）；或VFQ-25驾驶子量表评分的改善超过MCID。主要结局指标是6个月时的VFR。
结果
奥克纤溶酶组55.1%出现VFR，而安慰剂注射组为34.2%（p<0.0001）。这包括视力提高≥2行的情况分别为23.7%和11.2%（p=0.0003），VFQ-25综合评分为35.9%和22.7%（p=0.0016），驾驶子量表为10.2%和6.2%（p=0.1697）。
结论
奥克纤溶酶可产生具有临床意义的视觉功能益处。
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