Training in Clinical Trials for Subjects with Low Vision

描述（由申请人提供）：本职业培训计划的主要目的是培训艾娃凯泽，O.D.成为一个成功的，独立的临床科学家，能够在低视力进行高质量的临床研究。这一目标将通过指导研究项目和教学课程，导致在临床研究博士学位来实现。两种类型的导师将参与培训计划，涉及1）心理评估和慢性病患者基于正念的减压干预措施; 2）临床试验，包括数据分析统计，研究设计和方法。许多机构资源也将在这一培训方案中发挥支助作用。候选人的研究目标包括进行低视力临床试验，可能涉及补充和替代医学（CAM）或视力受损患者的其他干预措施。由于这种致残性疾病的慢性、缓慢进展的性质，视网膜色素变性（RP）中常见的负面心理状态，如痛苦、焦虑和抑郁。心理物理视力措施是更可变的法律盲RP科目比正常视力的个人，RP患者表示，视力的变化往往与压力或疲劳。短期研究的目的是确定RP患者的视敏度、对比敏感度和视野在一天内和一天之间的波动是否与感知压力、嗜睡或消极情绪状态相关。这将通过受试者在一天中的不同时间和一周中的不同天数自行进行的基于PC的问卷调查和视力测试来完成。我们还将评估光照、睡眠和实验室诱导的心理社会压力对视力测试的影响，以建立具有最可变视力的RP受试者的特征概况。候选人的培训将包括一个小型的临床试验，试图减轻这些因素在RP患者的身心，认知行为的压力减少干预与对照眼运动计划。在正确评估结果之前，需要确定和解决未来治疗临床试验期间视力测量结果变异性的来源。这项研究可能表明CAM相关干预措施的价值，从而可能提高视力测试的可靠性，作为未来临床试验和RP患者生活质量的结果。

DESCRIPTION (provided by applicant): The primary aim of this career training proposal is to train Ava Kiser, O.D. to become a successful, independent clinician-scientist, capable of performing high-quality clinical research in low vision. This goal will be accomplished through a mentored research project and didactic coursework leading to a PhD degree in clinical investigation. Two types of mentors will be involved in the training plan, related to 1) psychological evaluations and mindfulness-based stress reduction interventions for those with chronic disease; and 2) clinical trials, including data analysis statistics, study design and methodology. Numerous institutional resources will also play a supporting role during this training program. The candidate's research goals include the conduct of clinical trials in low vision, potentially involving Complementary and Alternative Medicine (CAM) or other interventions in visually impaired patients.. Negative psychological states such as distress, anxiety and depression are common in retinitis pigmentosa (RP) due to the chronic, slowly progressive nature of this disabling disease. Psychophysical vision measures are more variable in legally blind RP subjects than in normally sighted individuals, and RP patients indicate that variations in vision are often related to stress or fatigue. Short term research aims are to determine whether within and between day fluctuations in visual acuity, contrast sensitivity and visual field among RP patients are associated with perceived stress, sleepiness or negative mood states. This will be accomplished with at home PC-based questionnaires and vision tests, self-administered by the subjects at various times of the day and days of the week. We will also assess the impact of light exposure, sleep, and lab-induced pychosocial stress upon vision tests, to establish a profile of the characteristics of the RP subjects with the most variable vision. The candidate's training will include a small clinical trial to attempt to alleviate these factors in RP patients with a mind-body, cognitive-behavioral stress reduction intervention versus a control eye exercise program. Sources for the variability of vision measurements during future treatment clinical trials need to be identified and addressed before results can be properly assessed. This research may indicate the value of CAM-related interventions, and thus potentially improve the reliability of vision tests as outcome measures during future clinical trials and the quality of life for RP patients.