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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Myopia

In brief

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 facts

Study ID

NCT07567040

Run by

Ohio State University

People needed

664

Starts

2026-05-27

Expected to finish

2028-05-15

Last updated by the study team

2026-07-13

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Illinois College of Optometry — Chicago, Illinois, United States (enrolling)
• The Ohio State University College of Optometry — Columbus, Ohio, United States (enrolling)
• Indiana University — Bloomington, Indiana, United States (enrolling)
• New England College of Optometry — Boston, Massachusetts, United States (enrolling)
• Southern California College of Optometry at Marshall B. Ketchum University — Fullerton, California, United States (enrolling)
• University of Alabama School of Optometry — Birmingham, Alabama, United States (enrolling)
• 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
• University of California, Berkeley, School of Optometry — Berkeley, California, United States
• Stanford University — Palo Alto, California, 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
• Pennsylvania College of Optometry at Drexel University — Elkins Park, Pennsylvania, United States

Full record on ClinicalTrials.gov

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