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

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: Myopia
• Intervention / Treatment: Drug: Atropine Sulfate 0.05% Oph Soln; Drug: 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.

• Study Type: Interventional
• Enrollment (Estimated): 664
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lisa A Jordan, PhD; Phone Number: 614-247-7321; Email: jordan.646@osu.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Not yet recruiting
      • University of Alabama School of Optometry
      • Contact: Safal Khanal, OD PhD; Phone Number: 205-934-4558; Email: skhanal@uab.edu
  • California
    • Berkeley, California, United States, 94720
      • Not yet recruiting
      • University of California, Berkeley, School of Optometry
      • Contact: Sarah Singh, OD PhD; Phone Number: 510-664-5501; Email: sarah_singh@berkeley.edu
    • Fullerton, California, United States, 92831
      • Not yet recruiting
      • Southern California College of Optometry at Marshall B. Ketchum University
      • Contact: Angela Chen, OD; Phone Number: 714-463-7569; Email: angelachen@ketchum.edu
    • Palo Alto, California, United States, 94303
      • Not yet recruiting
      • Stanford University
      • Contact: Tawna Roberts, OD PhD; Phone Number: 650-498-3154; Email: tawnar@stanford.edu
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Not yet recruiting
      • Illinois College of Optometry
      • Contact: Jennifer Harthan, OD; Phone Number: 312-949-7137; Email: jharthan@ico.edu
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Not yet recruiting
      • Indiana University
      • Contact: Katie Connolly, OD; Phone Number: 812-856-0976; Email: ksconnol@iu.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Not yet recruiting
      • New England College of Optometry
      • Contact: Kristen Kerber, OD; Phone Number: 617-587-5764; Email: kerberk@neco.edu
  • New York
    • New York, New York, United States, 10036
      • Not yet recruiting
      • State University of New York College of Optometry
      • Contact: Xiaoying Zhu, OD PhD MD; Phone Number: 212-938-5541; Email: xzhu@sunyopt.edu
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Not yet recruiting
      • Case Western Reserve Department of Ophthalmology
      • Contact: Adam J Peiffer, OD; Phone Number: 440-684-1743; Email: adam.peiffer@uhhospitals.org
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University College of Optometry
      • Contact: Heather Anderson, OD PhD; Phone Number: 614-247-5825; Email: anderson.3881@osu.edu
  • Pennsylvania
    • Elkins Park, Pennsylvania, United States, 19027
      • Not yet recruiting
      • Pennsylvania College of Optometry at Drexel University
      • Contact: Erin Jenewein, OD, MS; Email: ej468@drexel.edu
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Not yet recruiting
      • Southern College of Optometry
      • Contact: Marie Bodack, OD; Phone Number: 901-722-3349; Email: mbodack@sco.edu
  • Texas
    • Houston, Texas, United States, 77004
      • Not yet recruiting
      • University of Houston College of Optometry
      • Contact: Eric Ritchey, OD PhD; Phone Number: 713-743-1933; Email: erritche@central.uh.edu
    • San Antonio, Texas, United States, 78229
      • Not yet recruiting
      • Rosenberg College of Optometry at the University of Incarnate Word
      • Contact: Michelle Aaron, OD; Phone Number: 210-283-6821; Email: mtaaron@uiwtx.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	Cumulative incidence of myopia as measured by cycloplegic autorefraction comparison between treatment and placebo	Two years
Axial elongation (by Myopia Master)	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)	A comparison of the time to myopia onset between the treatment and placebo groups	2 years
Progression of spherical equivalent (by Myopia Master)	Spherical equivalent progression (change) comparison between treatment and placebo	2 years

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Estimated): May 6, 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): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: prevention
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Organic Chemicals; Heterocyclic Compounds; Alkaloids; Aza Compounds; Heterocyclic Compounds, Bridged-Ring; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Atropine
• 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