Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial
Start Date
5/27/2026
Completion Date
5/15/2028
Summary
The aims of this clinical trial will test whether or not the onset of nearsightedness 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 primary outcome is the two-year cumulative incidence of nearsightedness. The second aim of this project will determine whether atropine is associated with slower eye growth in children receiving nightly drops of atropine versus placebo.
Detailed Description
The "Delaying the Onset of Nearsightedness (DONUT) Study - Data Coordinating Center" is a randomized clinical trial designed to compare the effectiveness 0.05% atropine and a placebo in delaying the onset of nearsightedness. It is 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 primary outcome is the two-year cumulative incidence of myopia. 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. Participants will be seen every six months for at least two years to determine the onset of myopia.
Eligibility Criteria
Age Range: 6 years to 11 years
Interventions
Atropine Sulfate 0.05% Oph Soln
Placebo
Conditions
Locations
University of Alabama School of Optometry
Birmingham, Alabama 35233
United States
University of California, Berkeley, School of Optometry
Berkeley, California 94720
United States
Southern California College of Optometry at Marshall B. Ketchum University
Fullerton, California 92831
United States
Stanford University
Palo Alto, California 94303
United States
Illinois College of Optometry
Chicago, Illinois 60616
United States
Indiana University
Bloomington, Indiana 47405
United States
New England College of Optometry
Boston, Massachusetts 02115
United States
State University of New York College of Optometry
New York, New York 10036
United States
Case Western Reserve Department of Ophthalmology
Cleveland, Ohio 44106
United States
The Ohio State University College of Optometry
Columbus, Ohio 43210
United States
Pennsylvania College of Optometry at Drexel University
Elkins Park, Pennsylvania 19027
United States
Southern College of Optometry
Memphis, Tennessee 38104
United States
University of Houston College of Optometry
Houston, Texas 77004
United States
Rosenberg College of Optometry at the University of Incarnate Word
San Antonio, Texas 78229
United States