Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial
DONUT
3 other identifiers
interventional
664
1 country
14
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2026
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2026
CompletedFirst Posted
Study publicly available on registry
May 5, 2026
CompletedStudy Start
First participant enrolled
May 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 15, 2028
July 13, 2026
July 1, 2026
2 years
April 28, 2026
July 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Time to event in incident myopes (measured by spherical equivalent by Myopia Master)
2 years
Progression of spherical equivalent (by Myopia Master)
2 years
Study Arms (2)
0.05% Atropine
EXPERIMENTAL0.05% atropine instilled in each eye nightly at bedtime
Placebo
PLACEBO COMPARATORPlacebo drops instilled in each eye nightly at bedtime
Interventions
Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State Universitylead
- National Eye Institute (NEI)collaborator
Study Sites (14)
University of Alabama School of Optometry
Birmingham, Alabama, 35233, United States
University of California, Berkeley, School of Optometry
Berkeley, California, 94720, United States
Southern California College of Optometry at Marshall B. Ketchum University
Fullerton, California, 92831, United States
Stanford University
Palo Alto, California, 94303, United States
Illinois College of Optometry
Chicago, Illinois, 60616, United States
Indiana University
Bloomington, Indiana, 47405, United States
New England College of Optometry
Boston, Massachusetts, 02115, United States
State University of New York College of Optometry
New York, New York, 10036, United States
Case Western Reserve Department of Ophthalmology
Cleveland, Ohio, 44106, United States
The Ohio State University College of Optometry
Columbus, Ohio, 43210, United States
Pennsylvania College of Optometry at Drexel University
Elkins Park, Pennsylvania, 19027, United States
Southern College of Optometry
Memphis, Tennessee, 38104, United States
University of Houston College of Optometry
Houston, Texas, 77004, United States
Rosenberg College of Optometry at the University of Incarnate Word
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Bottles to be distributed are masked at the pharmacy. Only pharmacy personnel and data coordinating center personnel have access to the assigned treatment groups.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2026
First Posted
May 5, 2026
Study Start
May 27, 2026
Primary Completion (Estimated)
May 15, 2028
Study Completion (Estimated)
May 15, 2028
Last Updated
July 13, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- Access Criteria
- Data will be available for access on Vivli.
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.