Early Detection Of neovascular age-Related mAcular Degeneration in the cOmmunity assessing persistence, adherence and acceptability: study protocol for the DORADO randomized controlled trial

在社区中早期检测新生血管性年龄相关性黄斑变性:评估持续性、依从性和可接受性:DORADO随机对照试验的研究方案

阅读:1

Abstract

BACKGROUND: Neovascular age-related macular degeneration (nAMD) is the leading cause of blindness in the Western world, with an estimated 40,000 newly diagnosed cases in the UK every year. Early detection and treatment of nAMD are important to achieve good visual acuity and quality-of-life (QoL) outcomes. Whilst early treatment of the second eye, following detection using optical coherence tomography (OCT) imaging, has shown maintenance of visual acuity and health-related QoL and reduced health and social care costs, there is a paucity of information about the benefits of early detection of nAMD in the first eye. In particular, although it is reasonable to consider a form of targeted screening of those most likely to develop nAMD, it is unclear if those invited would adhere to such a programme. METHODS: In this randomized controlled trial, 130 participants will be recruited from community-based eye healthcare practices within the UK whilst attending their routine appointment. Participants will be randomized to either a standard care arm to attend a further follow-up appointment at 12 months, or an intervention arm, attending every 3 months for assessment. The end of study is at 12 months. All participants will complete the NEI-VFQ-25, MacDQoL, PHQ9 and EQ-5D-3L questionnaires at baseline and 12 months. In addition, all participants and recruiting investigators will complete the Theoretical Framework of Acceptability questionnaire at 12 months. DISCUSSION: The DORADO study aims to assess the persistence and adherence to and acceptability of a community-based programme for the early detection of nAMD. TRIAL REGISTRATION: ISRCTN10005321. Registered on 08 November 2024.

特别声明

1、本页面内容包含部分的内容是基于公开信息的合理引用;引用内容仅为补充信息,不代表本站立场。

2、若认为本页面引用内容涉及侵权,请及时与本站联系,我们将第一时间处理。

3、其他媒体/个人如需使用本页面原创内容,需注明“来源:[生知库]”并获得授权;使用引用内容的,需自行联系原作者获得许可。

4、投稿及合作请联系:info@biocloudy.com。