Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Atropine Sulfate 0.05% Oph Soln

    Drug

    Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy

  • Placebo

    Drug

    Placebo drop with same formulation as treatment minus the atropine

Treatment groups

664 Participants
are divided into 2 treatment groups
Group A: 0.05% AtropineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative incidence of myopia (spherical equivalent by Myopia Master)

Cumulative incidence of myopia as measured by cycloplegic autorefraction comparison between treatment and placebo

Time frame
Two years
2

Axial elongation (by Myopia Master)

Axial elongation comparison between treatment and placebo

Time frame
Two years

Secondary outcomes

1

Time to event in incident myopes (measured by spherical equivalent by Myopia Master)

A comparison of the time to myopia onset between the treatment and placebo groups

Time frame
2 years
2

Progression of spherical equivalent (by Myopia Master)

Spherical equivalent progression (change) comparison between treatment and placebo

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

National Eye Institute (NEI)

Collaborator

Source ClinicalTrials.gov
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