Improving Function In Age-Related Macular Degeneration

描述（由申请人提供）：我们提出了一项随机对照临床试验，即改善AMD功能试验（IFAMD），以测试问题解决治疗（PST）改善老年人年龄相关性黄斑变性（AMD）视觉功能的疗效。AMD是一种高度流行的致残性老年疾病，可导致严重的视力丧失和功能下降。它是美国老年人失明的主要原因，可能影响超过1000万人。 目前，还没有有效的治疗方法来恢复视力。因此，改善视觉功能是治疗的主要目标。视觉功能是指进行日常生活活动的视觉相关能力（例如阅读食谱以准备膳食）。随着人口老龄化和AMD患病率的增加，视觉功能下降将成为一个主要的公共卫生问题。 PST是一种简短、标准化的认知行为治疗，教授解决问题的技能。 我们相信PST将使AMD患者找到解决视力相关问题的实用方法，从而改善视力功能。我们将从Wills Eye Hospital，Philadelphia，PA的视网膜诊所招募240名患有双侧AMD且较好眼的视力差于20/70且对侧眼的视力不差于20/400的AMD患者。接受过PST培训的护士将为随机分配至PST的120例受试者提供6次1小时的家庭治疗。对照治疗是支持性治疗（ST），一种类似结构的标准化心理治疗，控制治疗的非特异性效应（n = 120）。ST不含非特异性成分以外的活性成分;因此，它是一种安慰剂治疗。对治疗分配设盲的独立评估者将在3个月时评估目标视觉功能（主要结局）和视觉相关生活质量（次要结局），以评估PST的疗效，并在6个月时评估其长期效果。随着人口老龄化，AMD的残疾将变得更加普遍，昂贵，并给患者，家庭和眼科医生带来负担。这使得设计和测试实用和负担得起的干预措施，以改善视力功能成为国家的优先事项。

DESCRIPTION (provided by applicant): We propose a randomized, controlled clinical trial, the Improving Function in AMD Trial {IFAMD), to test the efficacy of Problem-Solving Treatment (PST) to improve vision function in older persons with age-related macular degeneration (AMD). AMD is a highly prevalent, disabling disease of aging that causes severe vision loss and functional decline. It is the leading cause of blindness in older persons in the United States and may affect more than 10 million people. Currently, there are no effective treatments to restore vision. Thus, improving Vision Function is a major goal of treatment. Vision function refers to vision-related abilities to perform daily living activities (e.g. reading recipes to prepare meals). Decrements in vision function will become a major public health problem as the population ages and the prevalence of AMD increases. PST is a brief, standardized, cognitive-behavioral treatment that teaches problem-solving skills. We believe PST will enable patients with AMD find practical solutions to vision-related problems and thereby improve vision function. We will recruit 240 AMD patients from the retina clinics of Wills Eye Hospital, Philadelphia, PA, with bilateral AMD and visual acuity worse than 20/70 in the better eye and no worse than 20/400 in the fellow eye. PST-trained nurses will deliver 6 1-hour, in-home sessions to the 120 subjects randomized to PST. The control treatment is Supportive Therapy (ST), a similarly structured, standardized psychological treatment that controls for the non-specific effects of treatment (n = 120). ST contains no active elements beyond its non-specific components; in this way it is a placebo treatment. Independent raters, masked to treatment assignment, will assess Targeted Vision Function (primary outcome) and vision-related quality of life (secondary outcome) at 3 months to assess PST's efficacy, and at 6 months to evaluate its long-term effects. As the population ages, the disability of AMD will become more prevalent, costly, and burdensome to patients, families, and ophthalmologists. This makes devising and testing practical and affordable interventions to improve vision function a national priority.