Ophthalmology Department, Gloucestershire Hospitals, Cheltenham, UK.
Eye (Lond). 2013 Jan;27(1):56-64. doi: 10.1038/eye.2012.225. Epub 2012 Nov 23.
The purpose of this study is to define which visual acuity (VA) measurements are the best indicators of high-quality care for patients receiving intravitreal ranibizumab for neovascular age-related macular degeneration (nAMD).
Analysis of prospectively collected data recorded within an electronic medical record system on treatment-naive, first-eligible eyes with nAMD, treated with ranibizumab using an as-needed treatment regimen with a minimum follow-up of 1 year. Data collection included the following: age, gender, laterality, type of nAMD, VA, central 1 mm OCT retinal thickness, number of intravitreal injections, and number of follow-up assessments.
Data were available on the first-treated eye from 406 patients with at least 1 year follow-up; of these, 198 had data at 2 years. The mean baseline VA of 54.4 Early Treatment Diabetic Retinopathy Study letters improved to 58.5 letters at 12 months and to 56.8 letters at 24 months. The mean VA changes from baseline to 1 year were +6.5, +7.5, +1.7, and -1.5 letters, respectively, for baseline VA categories of 23-35, 36-55, 56-70, and >70 letters. Change in mean VA from the end of the loading phase to year 1 ranged from -2.9 to +1.4 letters for the different baseline VA categories. The mean number of injections were similar across baseline VA categories ranging from 5.7 to 6.0 injections in year 1 and from 3.3 to 3.8 in year 2.
This large, real-world series demonstrates that mean change in VA is largely a function of selection criteria and baseline VA. The quality of a service is therefore better judged by actual VA outcomes and maintenance of vision after the loading phase.
本研究旨在确定哪些视力(VA)测量指标最能反映接受玻璃体腔内雷珠单抗治疗的新生血管性年龄相关性黄斑变性(nAMD)患者的高质量护理。
分析在电子病历系统中前瞻性收集的、未经治疗的、初次符合条件的 nAMD 患者的治疗数据,采用按需治疗方案,使用雷珠单抗治疗,随访时间至少 1 年。数据收集包括以下内容:年龄、性别、侧别、nAMD 类型、VA、中央 1 毫米 OCT 视网膜厚度、玻璃体腔内注射次数和随访次数。
在至少随访 1 年的 406 例患者中,有 406 例患者的第一只治疗眼有数据,其中 198 例患者有 2 年的数据。基线时平均 VA 为 54.4 个早期治疗糖尿病视网膜病变研究字母,在 12 个月时提高到 58.5 个字母,在 24 个月时提高到 56.8 个字母。从基线到 1 年,VA 变化分别为+6.5、+7.5、+1.7 和-1.5 个字母,基线 VA 分别为 23-35、36-55、56-70 和>70 个字母。从加载阶段结束到 1 年,不同基线 VA 类别之间的平均 VA 变化范围为-2.9 至+1.4 个字母。在不同的基线 VA 类别中,1 年的平均注射次数相似,为 5.7 至 6.0 次,2 年的平均注射次数为 3.3 至 3.8 次。
这项大型的真实世界研究表明,VA 的平均变化主要是由选择标准和基线 VA 决定的。因此,服务质量的判断标准应该是实际 VA 结果和加载阶段后的视力维持情况。