Einhorn Clinical Research Center, New York Eye and Ear Infirmary, New York, NY 10003, USA.
Invest Ophthalmol Vis Sci. 2012 Apr 2;53(4):1704-9. doi: 10.1167/iovs.11-8186.
The goal in this study was to compare rates of visual field (VF) change before and after the initiation of treatment in participants originally randomized to the observation arm of the Ocular Hypertension Treatment Study (OHTS).
We included OHTS participants originally randomized to observation and excluded those who reached non-POAG endpoints. VF progression was determined using trend analysis. Global and localized rates of VF change were calculated based on linear regression over time of mean deviation (MD) and threshold sensitivity values for each test location. MD rates (MDR) and pointwise linear regression (PLR) analysis were also assessed using six VF tests before and after the initiation of treatment. A PLR endpoint was defined as a VF test location progressing faster than -0.5 dB/year at P < 0.01.
We included 780 eyes from 432 OHTS participants. Following the initiation of treatment, the mean MDR decreased from -0.23 ± 0.6 to -0.06 ± 0.5 dB/year (P < 0.01) and the number of VF locations reaching a PLR endpoint decreased from 2.13 ± 6.0 to 1.00 ± 4.0 (P < 0.01). The benefit of treatment was significant both among participants who did not convert (-0.17 ± 0.6 vs. -0.01 ± 0.5 dB/year, P < 0.01) and among those who converted to glaucoma (-0.51 ± 0.8 vs. -0.27 ± 0.7 dB/year, P < 0.01) based on the OHTS event-based endpoint.
The initiation of ocular hypotensive medication among OHTS participants originally randomized to observation significantly reduced the velocity of VF progression.
本研究旨在比较初始随机分配至观察组的眼高血压治疗研究(OHTS)参与者在治疗开始前后视野(VF)变化率。
我们纳入了初始随机分配至观察组且未达到非 POAG 终点的 OHTS 参与者。VF 进展通过趋势分析确定。根据每个测试位置的平均偏差(MD)和阈值灵敏度值随时间的线性回归,计算全局和局部 VF 变化率。还使用治疗开始前后的六项 VF 测试评估 MD 率(MDR)和逐点线性回归(PLR)分析。将 PLR 终点定义为在 P < 0.01 处进展速度超过 -0.5 dB/年的 VF 测试位置。
我们纳入了 432 名 OHTS 参与者的 780 只眼。治疗开始后,平均 MDR 从 -0.23 ± 0.6 降至 -0.06 ± 0.5 dB/年(P < 0.01),达到 PLR 终点的 VF 位置数量从 2.13 ± 6.0 降至 1.00 ± 4.0(P < 0.01)。在未转换参与者(-0.17 ± 0.6 与 -0.01 ± 0.5 dB/年,P < 0.01)和转换为青光眼参与者(-0.51 ± 0.8 与 -0.27 ± 0.7 dB/年,P < 0.01)中,治疗的益处均有统计学意义,依据 OHTS 基于事件的终点。
初始随机分配至观察组的 OHTS 参与者开始使用眼部降眼压药物可显著降低 VF 进展速度。