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养Ava Kiser， O.D.成为一名成功的，独立的临床医生和科学家，能够在低视力方面进行高质量的临床研究。这一目标将通过指导的研究项目和教学课程来完成，最终获得临床研究博士学位。培训计划将涉及两种类型的导师，涉及1)针对慢性病患者的心理评估和基于正念的减压干预；2)临床试验，包括数据分析统计、研究设计和方法学。众多的机构资源也将在这个培训项目中发挥支持作用。候选人的研究目标包括进行低视力的临床试验，可能涉及补充和替代医学（CAM）或其他视力受损患者的干预措施。负面的心理状态，如痛苦，焦虑和抑郁是常见的视网膜色素变性（RP）由于慢性，缓慢进行性致残的性质。与正常视力的人相比，法定失明的RP受试者的心理物理视力测量变化更大，RP患者表明视力的变化通常与压力或疲劳有关。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之内和一天之间的波动是否与感知到的压力、嗜睡或消极情绪状态有关。这将通过基于家庭电脑的问卷调查和视力测试来完成，由受试者在一天和一周的不同时间自行进行。我们还将评估光照、睡眠和实验室诱发的社会心理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临床试验，试图通过身心，认知行为减压干预与对照眼保健操项目来减轻RP患者的这些因素。在正确评估结果之前，需要确定和解决未来治疗临床试验中视力测量变异性的来源。这项研究可能表明cam相关干预措施的价值，从而有可能提高视力测试作为未来临床试验结果测量的可靠性，并提高RP患者的生活质量。

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.