Actively Recruiting
Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial
Led by Ohio State University · Updated on 2026-05-08
664
Participants Needed
14
Research Sites
105 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
N
National Eye Institute (NEI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to 11 years
- Refractive error (cycloplegic autorefraction, spherical equivalent) within specified ranges by age (6 years: -0.74 to +0.75 D; 7-8 years: -0.74 to +0.50 D; 9-10 years: -0.74 to +0.25 D; 11 years: -0.74 to plano)
- Neither eye has -0.75 D or more myopia (spherical component)
- Anisometropia less than 1.50 D difference between eyes
- Astigmatism less than 1.50 DC in both eyes
- Completed run-in period with at least 90% adherence to artificial tears for 2 to 4 weeks
You will not qualify if you...
- Randomization visit not completed within 4 weeks of baseline eligibility visit
- Presence of strabismus (intermittent or constant) by cover test
- Known allergy to atropine
- Systemic diseases affecting eye accommodation or convergence (e.g., multiple sclerosis, myasthenia gravis, Graves ophthalmopathy, diabetes, Parkinson's, Down syndrome)
- Ocular diseases such as congenital glaucoma, retinal disease, nystagmus, amblyopia
- History of ocular surgery (e.g., cataracts, strabismus surgery)
- Previous myopia prevention or control treatments for more than one month
- Pregnancy by self-report
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 14 locations
1
University of Alabama School of Optometry
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
University of California, Berkeley, School of Optometry
Berkeley, California, United States, 94720
Not Yet Recruiting
3
Southern California College of Optometry at Marshall B. Ketchum University
Fullerton, California, United States, 92831
Not Yet Recruiting
4
Stanford University
Palo Alto, California, United States, 94303
Not Yet Recruiting
5
Illinois College of Optometry
Chicago, Illinois, United States, 60616
Not Yet Recruiting
6
Indiana University
Bloomington, Indiana, United States, 47405
Not Yet Recruiting
7
New England College of Optometry
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
8
State University of New York College of Optometry
New York, New York, United States, 10036
Not Yet Recruiting
9
Case Western Reserve Department of Ophthalmology
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
10
The Ohio State University College of Optometry
Columbus, Ohio, United States, 43210
Actively Recruiting
11
Pennsylvania College of Optometry at Drexel University
Elkins Park, Pennsylvania, United States, 19027
Not Yet Recruiting
12
Southern College of Optometry
Memphis, Tennessee, United States, 38104
Not Yet Recruiting
13
University of Houston College of Optometry
Houston, Texas, United States, 77004
Not Yet Recruiting
14
Rosenberg College of Optometry at the University of Incarnate Word
San Antonio, Texas, United States, 78229
Not Yet Recruiting
Research Team
L
Lisa A Jordan, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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