Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial
ConditionMyopia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-11
SponsorOhio State University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.)
Trial design
Treatments tested in this trial
- Atropine Sulfate 0.05% Oph Soln
- Placebo
Treatment groups
664 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ohio State University
Lead sponsor
National Eye Institute (NEI)
Collaborator
Source ClinicalTrials.gov