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

RecruitingPhase 3Healthy volunteers welcome

Who can join

Ages 6 to 11 · All sexes · Healthy volunteers welcome

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Ohio State University · Participants: 664 · Started: May 27, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07567040

Locations in the U.S.

AlabamaUniversity of Alabama School of Optometry, Birmingham
CaliforniaUniversity of California, Berkeley, School of Optometry, Berkeley
Southern California College of Optometry at Marshall B. Ketchum University, Fullerton
Stanford University, Palo Alto
IllinoisIllinois College of Optometry, Chicago
IndianaIndiana University, Bloomington
MassachusettsNew England College of Optometry, Boston
New YorkState University of New York College of Optometry, New York
OhioCase Western Reserve Department of Ophthalmology, Cleveland (Not yet recruiting)
The Ohio State University College of Optometry, Columbus
PennsylvaniaPennsylvania College of Optometry at Drexel University, Elkins Park
TennesseeSouthern College of Optometry, Memphis
TexasUniversity of Houston College of Optometry, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.