Beck Roy W, Moke Pamela S, Turpin Andrew H, Ferris Frederick L, SanGiovanni John Paul, Johnson Chris A, Birch Eileen E, Chandler Danielle L, Cox Terry A, Blair R Clifford, Kraker Raymond T
Jaeb Center for Health Research, Tampa, Florida 33613, USA.
Am J Ophthalmol. 2003 Feb;135(2):194-205. doi: 10.1016/s0002-9394(02)01825-1.
To develop a computerized method of visual acuity testing for clinical research as an alternative to the standard Early Treatment for Diabetic Retinopathy Study (ETDRS) testing protocol, and to evaluate its test-retest reliability and concordance with standard ETDRS testing.
Test-retest reliability study.
Multicenter setting of a study population of 265 patients at three clinical sites. Visual acuity was measured with both the electronic visual acuity testing algorithm (E-ETDRS) and standard ETDRS protocol (S-ETDRS) twice on one eye of each patient. E-ETDRS testing was conducted using the electronic visual acuity tester (EVA), which utilizes a programmed Palm (Palm, Inc, Santa Clara, California, USA) hand-held device communicating with a personal computer and 17-inch monitor at a test distance of 3 meters.
For the E-ETDRS protocol, test-retest reliability was high (r = 0.99; with 89% and 98% of retests within 0.1 logMAR and 0.2 logMAR of initial tests, respectively) and comparable with that of S-ETDRS testing (r = 0.99; with 87% and 98% of retests within 0.1 logMAR and 0.2 logMAR of initial test, respectively). The E-ETDRS and S-ETDRS scores were highly correlated (r = 0.96 for initial tests and r = 0.97 for repeat tests). Based on estimates of 95% confidence intervals, a change in visual acuity of 0.2 logMAR (10 letters) from a baseline level is unlikely to be related to measurement variability using either the E-ETDRS or the S-ETDRS visual acuity testing protocol.
The E-ETDRS protocol has high test-retest reliability and good concordance with S-ETDRS testing. The computerized method has advantages over the S-ETDRS testing in electronically capturing the data for each tested letter, requiring only a single distance for testing from 20/12 to 20/800, potentially reducing testing time, and potentially decreasing technician-related bias.
开发一种用于临床研究的视力测试计算机化方法，以替代标准的糖尿病视网膜病变早期治疗研究（ETDRS）测试方案，并评估其重测信度以及与标准ETDRS测试的一致性。
重测信度研究。
在三个临床地点对265名患者的研究人群进行多中心研究。对每位患者的一只眼睛使用电子视力测试算法（E-ETDRS）和标准ETDRS方案（S-ETDRS）各测量两次视力。E-ETDRS测试使用电子视力测试仪（EVA）进行，该测试仪利用一台编程的Palm（美国加利福尼亚州圣克拉拉市的Palm公司）手持设备与一台个人计算机以及一台17英寸显示器相连，测试距离为3米。
对于E-ETDRS方案，重测信度很高（r = 0.99；分别有89%和98%的重测结果在初始测试结果的0.1 logMAR和0.2 logMAR范围内），与S-ETDRS测试相当（r = 0.99；分别有87%和98%的重测结果在初始测试结果的0.1 logMAR和0.2 logMAR范围内）。E-ETDRS和S-ETDRS得分高度相关（初始测试时r = 0.96，重复测试时r = 0.97）。根据95%置信区间的估计，使用E-ETDRS或S-ETDRS视力测试方案，视力从基线水平变化0.2 logMAR（10个字母）不太可能与测量变异性有关。
E-ETDRS方案具有较高的重测信度，且与S-ETDRS测试具有良好的一致性。这种计算机化方法相对于S-ETDRS测试具有优势，能够以电子方式捕获每个测试字母的数据，测试距离仅需20/12至20/800的单一距离，有可能减少测试时间，并可能减少与技术人员相关的偏差。
