An Investigation of Vitamin A Palmitate Supplementation in Patients withAMD and/or Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation

AMD 和/或网状假性玻璃膜疣 (RPD) 和暗适应延迟患者补充维生素 A 棕榈酸酯的研究

• 批准号: 10020044
• 负责人: Catherine Cukras
• 金额: $ 5.51万
• 依托单位: NATIONAL EYE INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10020044
• 关键词: Adverse reactions; Dark Adaptation; Eligibility Determination; Enrollment; Event; Investigation; Kinetics; Measurement; Measures; Outcome Measure; Participant; Patient Outcomes Assessments; Patients; Questionnaires; Supplementation; Time; Visual Acuity; design; improved; luminance; primary outcome; prospective; retinyl palmitate; secondary outcome; study population

Objective: The objective of this study is to investigate the potential efficacy of vitamin A palmitate in improving dark adaptation in participants with reticular pseudodrusen (RPD) and abnormal dark adaptation. Study Population: Ten participants will be initially accrued, however, up to twenty participants with RPD who meet the eligibility criteria may be enrolled. In the event that a participant withdraws from the study prior to receiving two months of study supplementation for a reason unrelated to an adverse reaction, an additional participant will be accrued. A maximum of ten additional participants may be accrued in order to obtain ten participants for the primary outcome analysis. Design: This is a pilot, uncontrolled, prospective, single center study to investigate the potential efficacy of vitamin A palmitate in improving dark adaptation in participants with AMD and abnormal dark adaptation. Outcome Measures: The primary outcome is the measurement of dark adaptation parameters (thresholds and kinetics) by the following: dark adaptation times as measured by the AdaptDx comparing before and after vitamin A palmitate and dark adaptation parameters as measured by the Medmont comparing before and after vitamin A palmitate supplementation. The secondary outcomes are changes in low luminance visual acuity (LLVA) and changes in patient reported outcomes as measured by the low luminance questionnaire (LLQ).

目的：这项研究的目的是研究棕榈酸维生素A的潜在功效 在改善网状假曲霉（RPD）和异常黑暗参与者的黑暗适应性方面 适应。 研究人群：最初将累积10名参与者 与符合资格标准的RPD可能会被录取。如果参与者 在接受两个月的研究补充之前退出研究，原因是 与不良反应无关，将产生其他参与者。最多十个 为了获得十个参与者的主要结果，可能会累积其他参与者 分析。 设计：这是一名飞行员，不受控制的，前瞻性的单中心研究，以调查潜力 维生素A棕榈酸酯在改善AMD和AMD参与者的黑暗适应性方面的功效 异常的黑暗适应。 结果指标：主要结果是测量黑暗适应参数 （阈值和动力学）通过以下：ADAPTDX测量的深色适应时间 比较维生素A之前和之后的棕榈酸酯和深色适应参数 Medmont在补充维生素A之前和之后进行了比较。次要 结果是低亮度视力（LLVA）的变化和患者报告的变化 结果由低亮度问卷（LLQ）衡量。