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NCT07567040PHASE3RecruitingAccepts Healthy Volunteers

Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial

Ohio State University

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

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 (# of unit-dose vials used divided by # nights since baseline visit must equal 0.90 or greater) Exclusion Criteria: * If Visit 2 (randomization visit) is not completed within 4 weeks of the baseline, eligibility visit. * Presence of strabismus (intermittent or constant) based on unilateral cover test at distance and near * Known allergy to atropine * Systemic issues that may affect accommodation or convergence (e.g., multiple sclerosis, myasthenia gravis, Graves ophthalmopathy, diabetes mellitus, Parkinson's disease, Down syndrome, etc.) * Ocular disease (e.g., congenital glaucoma, retinal disease, nystagmus, amblyopia, etc.) * Ocular surgery (e.g., cataracts, strabismus) * Any previous myopia prevention/control therapy (e.g., atropine, soft contact lenses, orthokeratology, myopia control spectacles, etc.) for more than one month * Pregnancy by self-report

Interventions

DRUG

Atropine Sulfate 0.05% Oph Soln

DRUG

Placebo

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Conditions

Myopia

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