Delaying the onset of nearsightedness study – coordinating center

Project Summary This is the Data Coordinating Center’s grant proposal for the “Delaying the Onset of Nearsightedness (DONUT) Study – Data Coordinating Center”, a randomized clinical trial designed to compare the effectiveness 0.05% atropine and a placebo in delaying the onset of nearsightedness. We propose a multicenter (14 clinic centers) randomized clinical trial of 606 children (recruited over two years) ages 6 to 11 years who are determine to be at high risk of myopia onset, as measured by cycloplegic autorefraction and age. The aims of this clinical trial will test whether or not the onset of myopia is delayed in a group of children randomized to nightly drops in 0.05% atropine in both eyes, in comparison to children who receiving nightly placebo drops in both eyes. The second aim of this project will determine whether atropine is associated with slower axial elongation in children receiving nightly drops of atropine versus placebo. This Data Coordinating Center’s grant proposal provides the clinical centers, sample size and rationale, data management and analysis for this clinical trial. Accompanying documents include the Clinical Center Plan, Data Management and Handling, and the Statistical Analysis Plan attachments. There are also another application linked to the Data Coordinating Center Grant – the DONUT Study Chair’s grant application that provides the study rationale, design, and organization of this clinical trial.