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：本研究旨在探讨维生素A棕榈酸酯的潜在疗效。 改善网状假性红斑狼疮(RPD)和异常暗的参与者的暗适应 适应。 研究人群：最初将累积10名参与者，但最多20名参与者 符合资格标准的RPD可被录取。如果一名参与者 因某种原因在接受两个月的研究补充之前退出研究 与不良反应无关的，将额外增加一名参与者。最多十个 可能会累积更多的参与者，以便为主要结果获得10个参与者 分析。 设计：这是一项先导性、非对照、前瞻性、单中心研究，旨在调查潜在的 维生素A棕榈酸酯改善AMD患者暗适应的疗效 暗适应异常。 结果测量：主要结果是暗适应参数的测量 (阈值和动力学)：由AdaptDx测量的暗适应时间 维生素A棕榈酸酯和暗适应参数测定前后的比较 Medmont对补充维生素A棕榈酸酯前后的比较。第二个 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)测量。