Clinical Trial

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

Study acronym: DONUT
Recruiting Phase 3
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Summary
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.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-05-09
critical Phase changed: Phase 4 -> Phase 3 2026-05-09
critical Primary endpoint(s) modified 2026-05-09
Trial Details
NCT Number NCT07567040
Lead Sponsor Ohio State University
Collaborators: National Eye Institute (NEI)
Conditions Myopia
Enrollment 664 participants
Start Date 2026-05-27
Primary Completion 2028-05-15 (estimated)
Study Completion 2028-05-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-12