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

RecruitingPhase 3Ages 6 Years - 11 YearsAllOhio State University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Atropine Sulfate 0.05% Oph Soln
  • Placebo
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Where

13 sites
University of Alabama School of Optometry
Birmingham, United States
University of California, Berkeley, School of Optometry
Berkeley, United States
Southern California College of Optometry at Marshall B. Ketchum University
Fullerton, United States
Stanford University
Palo Alto, United States
Illinois College of Optometry
Chicago, United States
Indiana University
Bloomington, United States
New England College of Optometry
Boston, United States
State University of New York College of Optometry
New York, United States

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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