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

August 19, 2026 updated by: Ohio State University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

664

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama School of Optometry
        • Contact:
    • California
      • Berkeley, California, United States, 94720
        • Recruiting
        • University of California, Berkeley, School of Optometry
        • Contact:
      • Fullerton, California, United States, 92831
        • Recruiting
        • Southern California College of Optometry at Marshall B. Ketchum University
        • Contact:
      • Palo Alto, California, United States, 94303
        • Not yet recruiting
        • Stanford University
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Recruiting
        • Illinois College of Optometry
        • Contact:
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Recruiting
        • Indiana University
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • New England College of Optometry
        • Contact:
    • New York
      • New York, New York, United States, 10036
        • Recruiting
        • State University of New York College of Optometry
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • Case Western Reserve Department of Ophthalmology
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University College of Optometry
        • Contact:
    • Pennsylvania
      • Elkins Park, Pennsylvania, United States, 19027
        • Not yet recruiting
        • Pennsylvania College of Optometry at Drexel University
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Recruiting
        • Southern College of Optometry
        • Contact:
    • Texas
      • Houston, Texas, United States, 77004
        • Recruiting
        • University of Houston College of Optometry
        • Contact:
          • Onose Okoeguale
          • Phone Number: 713-743-1994
          • Email: donut@uh.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.05% Atropine
0.05% atropine instilled in each eye nightly at bedtime
Drug: Atropine Sulfate 0.05% Oph Soln
Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy
Placebo Comparator: Placebo
Placebo drops instilled in each eye nightly at bedtime
Drug: Placebo
Placebo drop with same formulation as treatment minus the atropine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of myopia (spherical equivalent by Myopia Master)
Time Frame: Two years
Cumulative incidence of myopia as measured by cycloplegic autorefraction comparison between treatment and placebo
Two years
Axial elongation (by Myopia Master)
Time Frame: Two years
Axial elongation comparison between treatment and placebo
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to event in incident myopes (measured by spherical equivalent by Myopia Master)
Time Frame: 2 years
A comparison of the time to myopia onset between the treatment and placebo groups
2 years
Progression of spherical equivalent (by Myopia Master)
Time Frame: 2 years
Spherical equivalent progression (change) comparison between treatment and placebo
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

National Eye Institute (NEI)

Investigators

  • Study Chair: David A Berntsen, OD PhD, University of Houston College of Optometry
  • Study Chair: Jeffrey J Walline, OD PhD, The Ohio State University College of Optometry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2026

Primary Completion (Estimated)

May 15, 2028

Study Completion (Estimated)

May 15, 2028

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DONUTCT
  • UG1EY037202 (U.S. NIH Grant/Contract)
  • UG1EY037201 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The final dataset to be shared will include self-reported demographic and participant activity and compliance to treatment data from interviews with participants' parent or guardian, eye examination data, and refraction data. The investigators will share de-identified individual-participant level (IPD) data. Appropriate measures such as providing only participant age and not providing clinical site of data collection will be used for data de-identification and sharing, and informed consent forms will reflect those plans. Calculated fields, rather than the component fields, will be available for a more accessible dataset.

IPD Sharing Time Frame

Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the contribution of the data to Vivli.

IPD Sharing Access Criteria

Data will be available for access on Vivli.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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