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

Ohio State University · with National Eye Institute (NEI) · NCT07567040

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–11 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 3
Target enrollment
664
US sites recruiting
12
Study start
May 27, 2026
Record last updated
September 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Atropine Sulfate 0.05% Oph Soln; Placebo

Conditions: Myopia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • University of Alabama School of Optometry

    Birmingham, AL 35233

    Site contact: Sindhu Gurrala · 205-975-3881 · OPT-donutstudy@uab.edu

  • University of California, Berkeley, School of Optometry

    Berkeley, CA 94720

    Site contact: Yoofi Mensah · 510-207-4758 · donut@berkeley.edu

  • Southern California College of Optometry at Marshall B. Ketchum University

    Fullerton, CA 92831

    Site contact: Susan Parker · 714-463-7580 · research@ketchum.edu

  • Stanford University

    Palo Alto, CA 94303

    Site contact: Joellen Leonard · 650-498-0842 · Robertsvisionlab@stanford.edu

  • Illinois College of Optometry

    Chicago, IL 60616

    Site contact: Jessica Martinez · 312-949-7340 · Research@ico.edu

  • Indiana University

    Bloomington, IN 47405

    Site contact: Amy Peterson, OD · 812-856-0242 · peteramy@iu.edu

  • New England College of Optometry

    Boston, MA 02115

    Site contact: Tamara Khanjyan · 617-587-5723 · donutstudy@neco.edu

  • State University of New York College of Optometry

    New York, NY 10036

    Site contact: Keyana Hunte · 212-938-4052 · clinicresearch@sunyopt.edu

  • The Ohio State University College of Optometry

    Columbus, OH 43210

    Site contact: Alexis Koston · 614-292-0200 · OPT-DonutStudy@osu.edu

  • Pennsylvania College of Optometry at Drexel University

    Elkins Park, PA 19027

    Site contact: Asami Kojima · 215-276-6053 · donutstudy@drexel.edu

  • Southern College of Optometry

    Memphis, TN 38104

    Site contact: Elaine Turcotte · 901-730-5004 · eturcotte@sco.edu

  • University of Houston College of Optometry

    Houston, TX 77004

    Site contact: Onose Okoeguale · 713-743-1994 · donut@uh.edu

Study contacts (from the official record)

  • Lisa A Jordan, PhD · 614-247-7321 · jordan.646@osu.edu
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Delaying the Onset of Nearsightedness Until Treatment (DONUT)… (NCT07567040) | Bored Studies