Delaying the onset of nearsightedness study – coordinating center
openNEI - National Eye Institute
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.
Up to $4.5M
health research