Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial
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.
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 associat…
Eligibility
- Age range
- 6–11 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Refractive Error (cycloplegic autorefraction, spherical equivalent, at least one eye, inclusive) 6 years: -0.74 D to +0.75 D 7 and 8 years: -0.74 D to +0.50 D 9 and 10 years: -0.74 D to +0.25 D 11 years: -0.74 D to plano * Neither eye has -0.75 D or more myopia, spherical component * Anisometropia: Less than 1.50 D difference between OD and OS, cycloplegic autorefraction, spherical equivalent * Astigmatism: Less than 1.50 DC in both eyes by cycloplegic autorefraction * Successfully complete run-in period: take at least 90% of unit dose artificial tears for 2 to 4 weeks (…
Interventions
- DrugAtropine Sulfate 0.05% Oph Soln
Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy
- DrugPlacebo
Placebo drop with same formulation as treatment minus the atropine
Locations (14)
- University of Alabama School of OptometryBirmingham, Alabama
- University of California, Berkeley, School of OptometryBerkeley, California
- Southern California College of Optometry at Marshall B. Ketchum UniversityFullerton, California
- Stanford UniversityPalo Alto, California
- Illinois College of OptometryChicago, Illinois
- Indiana UniversityBloomington, Indiana