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，AMD试验中的改善功能(IFAMD)，以测试问题解决治疗(PST)改善老年老年性黄斑变性(AMD)患者视觉功能的有效性。AMD是一种非常普遍的致残性衰老疾病，会导致严重的视力丧失和功能衰退。它是美国老年人失明的主要原因，可能会影响1000多万人。目前，还没有有效的治疗方法来恢复视力。因此，改善视功能是治疗的主要目标。视觉功能是指与视觉相关的日常生活活动能力(例如，阅读食谱准备食物)。随着人口老龄化和AMD患病率的增加，视力功能减退将成为一个主要的公共卫生问题。 PST是一种简短、标准化的认知行为疗法，教授解决问题的技能。我们相信，PST将使AMD患者找到与视觉相关的问题的实用解决方案，从而改善视觉功能。我们将从宾夕法尼亚州费城Wills眼科医院的视网膜诊所招募240名AMD患者，双眼AMD患者的双眼视力低于20/70，对侧眼的视力不低于20/400。接受过PST培训的护士将向随机参加PST的120名受试者提供6个1小时的家庭会议。对照治疗是支持性治疗(ST)，这是一种类似结构的标准化心理治疗，控制治疗的非特定效果(n=120)。除了其非特定成分外，ST不含任何活性成分；在这种情况下，它是一种安慰剂治疗方法。独立评分者戴着面具接受治疗分配，将在3个月时评估目标视觉功能(主要结果)和与视力相关的生活质量(次要结果)，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，费用更高，对患者、家庭和眼科医生来说也是负担。这使得设计和测试实用且负担得起的干预措施以改善视力功能成为国家优先事项。

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.