Centre for Vision Research, Department of Ophthalmology, Westmead Hospital, the Westmead Millennium Institute for Medical Research, University of Sydney, Sydney, Australia.
Centre for Vision Research, Department of Ophthalmology, Westmead Hospital, the Westmead Millennium Institute for Medical Research, University of Sydney, Sydney, Australia.
Ophthalmology. 2016 Sep;123(9):1874-8. doi: 10.1016/j.ophtha.2016.05.043. Epub 2016 Jul 2.
Most classification systems for age-related macular degeneration (AMD) were developed from patients in clinical trials. We aimed to validate the Age-Related Eye Diseases Study (AREDS) simplified severity scale of AMD classification using 5- and 10-year incident late AMD data from the population-based Blue Mountains Eye Study (BMES) cohort.
Comparative study of population-based cohort and clinical trial.
Blue Mountains Eye Study participants 40 to 97 years of age at baseline (n = 2134) and AREDS participants 55 to 80 years of age (n = 3640).
In the BMES, AMD lesions were graded from stereoscopic color photographs and were classified according to the AREDS simplified severity scale. The AREDS simplified scale calculates a risk score based on the number of early AMD risk factors (large drusen and pigment abnormalities) in both eyes that can range from 0 to 4.
Five- and 10-year incident late AMD (presence of geographic atrophy or choroidal neovascularization).
The AREDS simplified scale performed similarly when applied to both the BMES population-based participants and the AREDS clinical trial-based participants in predicting 5- and 10-year incidence of late AMD. For scores 0 to 4, the 5-year incidence rates for the BMES compared with the AREDS were 0.2% versus 0.4%, 3.1% versus 3.1%, 12.1% versus 11.8%, 13.5% versus 25.9%, and 47.1% versus 47.3%, respectively. The corresponding 10-year incidence rates for the BMES compared with the AREDS were 0.7% versus 1.5%, 7.3% versus 8.4%, 36.6% versus 27.6%, 20.0% versus 52.7%, and 75.0% versus 71.4%, respectively.
The AREDS simplified severity scale classified late AMD risk levels similarly when applied to population-based and clinical trial samples. These results support the robustness of the AREDS simplified severity scale.
大多数与年龄相关的黄斑变性(AMD)分类系统都是从临床试验中的患者中开发出来的。我们旨在使用基于人群的蓝山眼研究(BMES)队列的 5 年和 10 年新发晚期 AMD 数据来验证年龄相关性眼病研究(AREDS)AMD 分类简化严重程度量表。
基于人群的队列和临床试验的比较研究。
基线时年龄为 40 至 97 岁的蓝山眼研究参与者(n=2134)和年龄为 55 至 80 岁的 AREDS 参与者(n=3640)。
在 BMES 中,AMD 病变从立体彩色照片中分级,并根据 AREDS 简化严重程度量表进行分类。AREDS 简化量表根据双眼早期 AMD 危险因素(大玻璃膜疣和色素异常)的数量计算风险评分,范围为 0 至 4。
5 年和 10 年新发晚期 AMD(存在地图样萎缩或脉络膜新生血管)。
当应用于 BMES 基于人群的参与者和 AREDS 基于临床试验的参与者时,AREDS 简化量表在预测 5 年和 10 年晚期 AMD 的发生率方面表现相似。对于 0 至 4 分,BMES 与 AREDS 的 5 年发生率分别为 0.2%比 0.4%、3.1%比 3.1%、12.1%比 11.8%、13.5%比 25.9%和 47.1%比 47.3%。相应的 BMES 与 AREDS 的 10 年发生率分别为 0.7%比 1.5%、7.3%比 8.4%、36.6%比 27.6%、20.0%比 52.7%和 75.0%比 71.4%。
当应用于基于人群和临床试验样本时,AREDS 简化严重程度量表对晚期 AMD 风险水平的分类相似。这些结果支持 AREDS 简化严重程度量表的稳健性。