Delay nearsightedness in high-risk children with nightly low-dose eye drops
Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial
This will test whether giving children ages 6–11 nightly 0.05% atropine eye drops delays the start of nearsightedness compared with nightly placebo drops.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 664 (estimated) |
| Ages | 6 Years to 11 Years |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 14 sites (Birmingham, Alabama and 13 other locations) |
| Trial ID | NCT07567040 on ClinicalTrials.gov |
What this trial studies
The DONUT trial is a multicenter, randomized, placebo-controlled Phase 3 trial enrolling 606 children aged 6–11 who are at high risk for developing myopia. Participants are randomized to nightly 0.05% atropine eye drops or matching placebo and are followed every six months for at least two years to measure refractive error and axial length. The primary outcome is the two-year cumulative incidence of myopia; a key secondary outcome is the rate of axial elongation. A short run-in period with unit-dose artificial tears confirms participants can reliably administer nightly drops before randomization.
Who should consider this trial
Good fit: Ideal candidates are children aged 6–11 judged to be at high risk for myopia onset who meet the study's refractive and ocular health criteria and can adhere to nightly drops and regular visits.
Not a fit: Children who already have at least −0.75 D myopia in either eye, who have strabismus, a known allergy to atropine, systemic issues affecting accommodation, or who cannot commit to nightly dosing and follow-up are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, nightly low‑dose atropine could reduce how many children develop myopia and slow the eye growth that leads to worsening vision.
How similar studies have performed: Previous trials have shown low‑dose atropine can slow myopia progression, but using 0.05% atropine specifically to delay the initial onset of myopia is less well tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 13 other locations
- University of Alabama School of Optometry — Birmingham, Alabama, United States (Not_yet_recruiting)
- University of California, Berkeley, School of Optometry — Berkeley, California, United States (Not_yet_recruiting)
- Southern California College of Optometry at Marshall B. Ketchum University — Fullerton, California, United States (Not_yet_recruiting)
- Stanford University — Palo Alto, California, United States (Not_yet_recruiting)
- Illinois College of Optometry — Chicago, Illinois, United States (Not_yet_recruiting)
- Indiana University — Bloomington, Indiana, United States (Not_yet_recruiting)
- New England College of Optometry — Boston, Massachusetts, United States (Not_yet_recruiting)
- State University of New York College of Optometry — New York, New York, United States (Not_yet_recruiting)
- Case Western Reserve Department of Ophthalmology — Cleveland, Ohio, United States (Not_yet_recruiting)
- The Ohio State University College of Optometry — Columbus, Ohio, United States (Recruiting)
- Pennsylvania College of Optometry at Drexel University — Elkins Park, Pennsylvania, United States (Not_yet_recruiting)
- Southern College of Optometry — Memphis, Tennessee, United States (Not_yet_recruiting)
- University of Houston College of Optometry — Houston, Texas, United States (Not_yet_recruiting)
- Rosenberg College of Optometry at the University of Incarnate Word — San Antonio, Texas, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Lisa A Jordan, PhD
- Email: jordan.646@osu.edu
- Phone: 614-247-7321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.