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Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial
Sponsor: Ohio State University
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.
Key Details
Gender
All
Age Range
6 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
664
Start Date
2026-04-15
Completion Date
2028-05-15
Last Updated
2026-05-05
Healthy Volunteers
Yes
Conditions
Interventions
Atropine Sulfate 0.05% Oph Soln
Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy
Placebo
Placebo drop with same formulation as treatment minus the atropine
Locations (14)
University of Alabama School of Optometry
Birmingham, Alabama, United States
University of California, Berkeley, School of Optometry
Berkeley, California, United States
Southern California College of Optometry at Marshall B. Ketchum University
Fullerton, California, United States
Stanford University
Palo Alto, California, United States
Illinois College of Optometry
Chicago, Illinois, United States
Indiana University
Bloomington, Indiana, United States
New England College of Optometry
Boston, Massachusetts, United States
State University of New York College of Optometry
New York, New York, United States
Case Western Reserve Department of Ophthalmology
Cleveland, Ohio, United States
The Ohio State University College of Optometry
Columbus, Ohio, United States
Pennsylvania College of Optometry at Drexel University
Elkins Park, Pennsylvania, United States
Southern College of Optometry
Memphis, Tennessee, United States
University of Houston College of Optometry
Houston, Texas, United States
Rosenberg College of Optometry at the University of Incarnate Word
San Antonio, Texas, United States