Diagnostic Innovations in Glaucoma Study (DIGS): Functional Impairment

描述(申请人提供)：青光眼治疗的基本目标是防止患者发展到足以在日常生活中产生残疾的视力障碍，并损害他们与健康相关的生活质量(HRQOL)。青光眼诊断创新研究(DIGS)的总体目标是：功能障碍是为了提高对青光眼功能障碍及其与通常进行的临床测试的关系的了解。这项建议将在一组定义明确的青光眼患者中获得功能损害的测量，该队列已经通过非常广泛的临床功能和结构测试跟踪了15年以上。横向和纵向研究将涉及以下3个具体目标：1)使用基于性能的测试：驾驶模拟和视力相关残疾评估(AdRev)量表，客观评估青光眼患者的功能损害；2)使用患者报告的结果，提高对青光眼患者HRQOL恶化的了解；3)预测哪些患者存在青光眼功能损害和HRQOL下降的风险。在具体目标1中，我们将研究基于性能的功能损害测量与评估青光眼视盘和视网膜神经纤维层损害的标准临床测试之间的关系。对这些关系的调查将有助于将通过常规测试获得的结果与与疾病残疾相关的信息联系起来，因此，可能会对不同临床测试的结果如何用于决策和作为青光眼临床试验的替代终点产生重大影响。在具体目标2中，我们将通过研究主观(HRQOL问卷)和客观(基于表现的)功能损害测量之间的纵向关联，以及它们与临床测试结果、人口统计和社会经济因素的关系，来调查决定患者对青光眼损害的感知的因素。这将找出为什么某些方面的损害比其他方面对患者更容易察觉或更令人烦恼的原因，并可能有助于制定战略，以补偿或最大限度地减少残疾对青光眼患者日常生活的影响。在具体目标3中，我们将评估基线和纵向结构和功能测量在预测哪些患者发展为功能性残疾的最高风险方面的能力。其目标是开发可用于识别功能受损风险较高的患者的预测模型，从而更有效地管理青光眼，最终减少疾病造成的残疾。通过评估功能损害的措施和开发预测模型来识别有残疾风险的患者，该提案直接满足了当前国家眼科研究所国家眼科和视力研究计划的目标，即开发诊断方法以防止青光眼造成的视力损失。

DESCRIPTION (provided by applicant): The fundamental goal of glaucoma management is to prevent patients from developing visual impairment that is sufficient to produce disability in their daily lives and impair their health-related quality of life (HRQOL). The overall goal of the Diagnostic Innovations in Glaucoma Study (DIGS): Functional Impairment is to improve understanding of functional disability in glaucoma and how it relates to commonly performed clinical tests. This proposal will obtain measures of functional impairment in a well-defined cohort of glaucoma patients that has been followed for over 15 years with a very large variety of clinical functional and structural tests. Cross-sectional and longitudinal investigations will address the following 3 specific aims: 1) to objectively evaluate functional impairment in glaucoma using performance-based tests: driving simulation and the Assessment of Disability Related to Vision (ADREV) scale, 2) to improve understanding of HRQOL deterioration in glaucoma using patient-reported outcomes and 3) to predict which patients are at risk for functional impairment and decrease in HRQOL from glaucoma. In Specific Aim 1, we will study the relationships between performance-based measures of functional impairment and standard clinical tests for assessment of glaucomatous optic disc and retinal nerve fiber layer damage. The investigation of these relationships will help link the results obtained by conventional testing to information related to disability from the disease and, therefore, may have significant impact on how results from different clinical tests are used for decision making and as surrogate endpoints in clinical trials of glaucoma. In Specific Aim 2, we will investigate factors that determine patients' perceptions of impairment from glaucoma by studying the longitudinal associations between subjective (HRQOL questionnaires) and objective (performance-based) measures of functional impairment and how they are related to results of clinical tests, demographic and socio-economic factors. This will identify the reasons why some aspects of impairment are more perceptible or bothersome to patients than others and may assist in the development of strategies to compensate or minimize the impact of disability in the daily lives of glaucoma patients. In Specific Aim 3, we will evaluate the ability of baseline and longitudinal structural and functional measures in predicting which patients are at highest risk for development of functional disability. The goal is to develop predictive models that can be used for identification of patients at higher risk for functional impairment, leading to a more efficient management of glaucoma and ultimately to a reduction of disability from the disease. By evaluating measures of functional impairment and developing predictive models to identify patients at risk for disability, this proposal directly addresses the current National Eye Institute National Plan for Eye and Vision Research goal of developing diagnostic methodologies to prevent vision loss from glaucoma.