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

NCT07567040

RecruitingPhase 3

Sponsor: Ohio State University

Conditions: Myopia

Interventions: Atropine Sulfate 0.05% Oph Soln, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 6 Years to 11 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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
Locations (13)
  • Birmingham, Alabama, United States
  • Berkeley, California, United States
  • Fullerton, California, United States
  • Palo Alto, California, United States
  • Chicago, Illinois, United States
  • Bloomington, Indiana, United States
  • Boston, Massachusetts, United States
  • New York, New York, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Elkins Park, Pennsylvania, United States
  • Memphis, Tennessee, United States
  • Houston, Texas, United States