Long-Term Quality of Life in the Ocular Hypertension Treatment Study Cohort

项目摘要 该应用程序用于二次分析，以确定治疗的长期效果、临床 高眼压症患者视觉相关生活质量（VRQOL）的影响因素 治疗研究（OHTS）队列。这项申请是及时的，因为美国代表团 服务工作组最近得出结论，“没有足够的证据表明， 原发性开角型青光眼改善了健康结果例如减少了视力损害， 与视觉相关的功能和生活质量”（JAMA Ophthal，2022年5月）。 OHTS是唯一一项在1，636例队列中进行的20年临床和VRQOL结局的美国研究 高眼压患者。20年的随访是有意义的，因为它 接近基线时中位年龄为55岁的参与者的预期寿命。目标1将 报告来自国家眼科研究所视觉功能问卷的20年横截面数据 (NEI VFQ）和15项青光眼生活质量调查（GQL-15）。目标2将侧重于 参与者初始队列中临床和VRQOL的纵向变化， 在OHTS 1或2中发展POAG。在初始队列中收集的POAG前VRQOL数据将 允许对POAG后VRQOL的个体差异进行统计学调整， 提高POAG后对VRQOL影响的精确度。POAG诊断的准确日期 初始队列将能够严格测试持续时间和临床变化率的影响， VRQOL的参数。我们将分析治疗，临床和人口因素影响 20年随访时横断面样本（目标1）和纵向样本中的VRQOL 队列样本（目标2）。 按照方案，在13年内每6个月完成一次核心测试和测量，在1-3年内完成一次核心测试和测量。 随访20年后的随访。要分析的测试和措施包括以下指标： Humphrey 30-2 SITA标准视野，最佳矫正视力，Pelli-Robson对比度 敏感性和OCT（在20年时评估）。使用NEI-VFQ评估VRQOL 每2年施用一次，持续13年，并且在20年施用GQL-15。

Project Summary This application is for secondary analyses to determine the long-term effect of treatment, clinical and demographic factors on vision-related quality of life (VRQOL) in the Ocular Hypertension Treatment Study (OHTS) cohort. This application is timely because the US Preventative Services Task Force recently concluded there was “Inadequate evidence that treatment of primary open-angle glaucoma improves health outcomes such as reduced visual impairment, vision-related function, and quality of life” (JAMA Ophthal, May 2022). OHTS is the only US study with 20-year clinical and VRQOL outcomes in a cohort of 1,636 participants with ocular hypertension. The 20 year follow-up is meaningful because it approaches the life expectation of participants whose median age was 55 at baseline. Aim 1 will report cross-sectional 20 year data from the National Eye Institute Visual Function Questionnaire (NEI VFQ) and 15 item Glaucoma Quality Life survey (GQL-15). Aim 2 will focus on longitudinal changes in clinical and VRQOL in the inception cohort of participants who developed POAG in OHTS 1 or 2. Pre-POAG VRQOL data collected in the inception cohort will allow statistical adjustment for individual differences on post-POAG VRQOL which will increase precision of post-POAG impact on VRQOL. Accurate dates of POAG diagnosis in the inception cohort will enable a rigorous test of the effect of duration and rate of change in clinical parameters on VRQOL. We will analyze treatment, clinical and demographic factors affecting VRQOL in the cross-sectional sample at 20 years of follow-up (Aim 1) and in the longitudinal cohort sample (Aim 2). Core tests and measures were completed per protocol at 6 month intervals for 13 years and at 1-3 visits after 20 years of follow-up. Tests and measures to be analyzed include indices from Humphrey 30-2 SITA standard visual fields, best corrected acuity, Pelli-Robson contrast sensitivity, and OCT (assessed at 20 years). VRQOL was assessed using the NEI-VFQ administered every 2 years for 13 years and the GQL-15 administered at 20 years.