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Recruiting NCT07567040

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

Phase III Interventional Myopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Atropine Sulfate 0.05% Oph Soln, Placebo.
Who it may be relevant to
Registry conditions: Myopia. Basic parameters: 6 years — 11 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

The "Delaying the Onset of Nearsightedness (DONUT) Study - Data Coordinating Center" is a randomized clinical trial designed to compare the effectiveness 0.05% atropine and a placebo in delaying the onset of nearsightedness. It is a multicenter (14 clinic centers) randomized clinical trial of 606 children (recruited over two years) ages 6 to 11 years who are determine to be at high risk of myopia onset, as measured by cycloplegic autorefraction and age. The primary outcome is the two-year cumulative incidence of myopia. The second aim of this project will determine whether atropine is associated with slower axial elongation in children receiving nightly drops of atropine versus placebo.

Participants will be seen every six months for at least two years to determine the onset of myopia.

Interventions

  • Drug Atropine Sulfate 0.05% Oph Soln
    Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy
  • Drug Placebo
    Placebo drop with same formulation as treatment minus the atropine

Primary outcome measures

  • Cumulative incidence of myopia (spherical equivalent by Myopia Master) [Time frame: Two years]
  • Axial elongation (by Myopia Master) [Time frame: Two years]
Secondary outcome measures (2)
  • Time to event in incident myopes (measured by spherical equivalent by Myopia Master) [Time frame: 2 years]
  • Progression of spherical equivalent (by Myopia Master) [Time frame: 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 14 centers
  • University of Alabama School of Optometry — Birmingham
  • University of California, Berkeley, School of Optometry — Berkeley
  • Southern California College of Optometry at Marshall B. Ketchum University — Fullerton
  • Stanford University — Palo Alto
  • Illinois College of Optometry — Chicago
  • Indiana University — Bloomington
  • New England College of Optometry — Boston
  • State University of New York College of Optometry — New York
  • … and 6 more centers

Identifiers

NCT: NCT07567040 · DONUTCT · UG1EY037202 · UG1EY037201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗