地域における滲出型加齢黄斑変性の早期発見：DORADO無作為化比較試験の登録、継続性、受容性を評価する研究プロトコル

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.

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.

The DORADO study aims to assess the persistence and adherence to and acceptability of a community-based programme for the early detection of nAMD.

ISRCTN10005321. Registered on 08 November 2024.