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

Study acronym: DONUT
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Eligibility criteria expanded, about 13 words
    • Site details revised at 2 of 13 sites
  2. Study sites: 14 to 13v6
  3. Site details revised at 2 of 14 sitesv5
  4. Site details revised at 1 of 14 sitesv4
  5. Start date changed from estimate of May 6, 2026 to May 27, 2026
    • Site details revised at 4 of 14 sites
    v3
  6. Primary endpoint(s) modifiedv2 Show 5 more changesShow less
    • Phase changed: Phase 4 → Phase 3
    • Recruitment opened
    • Start date: Apr 15, 2026 to May 6, 2026
    • Secondary endpoints revised (2)
    • Site details revised at 14 of 14 sites
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07567040
Lead Sponsor Ohio State University
Collaborators: National Eye Institute (NEI)
Conditions
(from sponsor)		 Myopia
Related terms Myopia
Enrollment 664 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov