Delaying the onset of nearsightedness study - coordinating center

The National Eye Institute awarded The Ohio State University a cooperative agreement valued at $9.078 million on September 15, 2025, under the Vision Research program (CFDA 93.867) to serve as the data coordinating center for the Delaying the Onset of Nearsightedness (DONUT) Study, a multicenter randomized clinical trial testing whether nightly 0.05% atropine eye drops delay myopia onset in children ages 6 to 11 at high risk of myopia compared to placebo. The study will recruit 606 children over two years across 14 clinical centers, measure whether atropine delays myopia onset via cycloplegic autorefraction, and determine whether atropine slows axial elongation. The Ohio State University's coordinating center responsibilities include managing clinical center operations, conducting data management and statistical analysis, and providing sample size justification and clinical trial coordination. Performance occurs in Ohio with a period extending through July 31, 2030.

The award passes funding to clinical site partners including Case Western Reserve University (Ohio), Southern College of Optometry (Tennessee), University of Houston (Texas), Indiana University (Indiana), Marshall B. Ketchum University (California), Drexel University (Pennsylvania), Illinois College of Optometry (Illinois), University of Alabama at Birmingham (Alabama), Stanford University (California), University of California Berkeley (California), The Leland Stanford Junior University (California), The Research Foundation for the State University of New York, The New England College of Optometry (Massachusetts), and University of the Incarnate Word (Texas). Each clinical site sub-recipient is responsible for ordering the Myopia Master diagnostic equipment from Oculus and participating in training and certification at the Full Investigator Meeting. Southern College of Optometry and the University of Houston also provide principal investigator and clinical examiner roles with pediatric optometry expertise and myopia control research experience.

Abstract

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.