Age-Related Eye Disease Follow-up Study (AREDS) Follow-up Study

年龄相关眼病随访研究（AREDS）随访研究

• 批准号: 10020007
• 负责人: EMILY Y CHEW
• 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/10020007
• 关键词: Adverse effects; Age; Age related macular degeneration; Antioxidants; Ascorbic Acid; Beta Carotene; Blindness; Blood specimen; Case Study; Cataract; Categories; Clinical; Clinical Trials; Copper; Data; Development; Disease; Disease Progression; Documentation; Dose; Elderly; Enrollment; Evaluation; Event; Eye diseases; Follow-Up Studies; Formulation; Fundus; Goals; Individual; Intake; Literature; Lutein; Multicenter Trials; Natural History; Nutritional; Omega-3 Fatty Acids; Ophthalmic examination and evaluation; Participant; Persons; Phase; Polyunsaturated Fatty Acids; Population; Protocols documentation; Publishing; Randomized Clinical Trials; Reporting; Risk; Risk Factors; Sampling; Telephone; Visit; Visual Acuity; Vitamins; Xanthophylls; Zinc; age related; cohort; design; follow-up; lens; logarithm; macula; oral supplementation; outcome forecast; population based; zeaxanthin

One-hundred and five participants previously enrolled at the Clinical Center for AREDS will be followed on an annual basis for five years. These annual visits will include a comprehensive eye exam, fundus and lens photographs and a blood sample. In addition, clinical coordinators will conduct semi-annual phone calls to the participants. These follow-up visits will provide data on a cohort of participants for whom we will have the very unusual ability to report on the 15-18 year natural history of two diseases, cataract and AMD. It will also provide additional data on possible adverse effects associated with the treatment with AREDS supplements (high doses of vitamins C, E, beta-carotene, zinc and copper). There are individual case reports in the literature on the progression of AMD over a 15-year period, and population data on follow-up of cohorts of participants for 10 years, but to our knowledge no systematic data have been collected over a 15-year period. The population based data demonstrate a clear increase in the risk of AMD progression after age 80. The ability to follow this progression of disease over a very long period with serial photos will allow us to better develop hypotheses as to why some persons progress while others do not. Study Objectives The objective of this study is to follow 105 former AREDS participants annually for 5 years with a semi-annual telephone contact to collect additional data on AMD and cataracts. These follow-up visits will allow the NEI to collect additional data on possible ocular events for both AMD and cataracts and for documentation of any adverse effects associated with the AREDS treatment. Most importantly, this very long follow-up with careful photographic documentation of the progress of both cataract and AMD will allow for the development of hypotheses as to why some persons progress while others do not.

之前在AREDS临床中心入组的105名受试者将每年接受一次随访，持续5年。 这些年度访问将包括全面的眼科检查，眼底和透镜照片和血液样本。此外，临床协调员将每半年给参与者打一次电话。这些随访访视将提供一组参与者的数据，我们将有非常不寻常的能力报告两种疾病（白内障和AMD）的15-18年自然史。 它还将提供与AREDS补充剂（高剂量维生素C，E，β-胡萝卜素，锌和铜）治疗相关的可能不良反应的额外数据。 文献中有关于AMD进展超过15年的个别病例报告，以及参与者队列随访10年的人群数据，但据我们所知，尚未收集到超过15年的系统性数据。基于人群的数据表明，80岁以后AMD进展的风险明显增加。 通过连续照片在很长一段时间内跟踪疾病进展的能力将使我们能够更好地提出假设，为什么有些人会进步，而另一些人则不会。 研究目的 本研究的目的是每年对105名前AREDS参与者进行为期5年的随访，每半年进行一次电话联系，以收集关于AMD和白内障的其他数据。这些随访访视将允许NEI收集关于AMD和白内障可能的眼部事件的额外数据，并记录与AREDS治疗相关的任何不良反应。 最重要的是，这种非常长的随访，仔细的摄影记录白内障和AMD的进展，将允许发展假设，为什么有些人进展，而其他人没有。