Delay nearsightedness in high-risk children with nightly low-dose eye drops

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DONUT trial is a multicenter, randomized, placebo-controlled Phase 3 trial enrolling 606 children aged 6–11 who are at high risk for developing myopia. Participants are randomized to nightly 0.05% atropine eye drops or matching placebo and are followed every six months for at least two years to measure refractive error and axial length. The primary outcome is the two-year cumulative incidence of myopia; a key secondary outcome is the rate of axial elongation. A short run-in period with unit-dose artificial tears confirms participants can reliably administer nightly drops before randomization.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama School of Optometry
  Birmingham, Alabama, United States Recruiting
• University of California, Berkeley, School of Optometry
  Berkeley, California, United States Recruiting
• Southern California College of Optometry at Marshall B. Ketchum University
  Fullerton, California, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting
• Illinois College of Optometry
  Chicago, Illinois, United States Recruiting
• Indiana University
  Bloomington, Indiana, United States Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating a device for screening vision problems in young children

  This study is testing a new device to see if it can effectively find vision problems in children aged 3 to 8, whether they wear glasses or not.

  Recruiting Essilor International · Nancy, France and 1 other locations · NCT06882408

• Optimizing light exposure to prevent and control myopia in children

  This study tests if changing classroom lighting to mimic sunlight or using a smartphone app to guide light exposure can help prevent and control myopia in primary school children.

  Recruiting at 5 sites National University of Singapore · Singapore and 4 other locations · NCT06631339

• Hyperopic reserve screening for kindergartners in Beijing

  A population-wide screening tests whether senior kindergarten children in Beijing have enough hyperopic reserve to help prevent future myopia.

  Recruiting Beijing Tongren Hospital · Beijing · NCT07851532

• Do dual-focus multifocal contact lenses improve hand-eye coordination and sports vision compared with your usual lenses

  This study tests whether wearing dual-focus multifocal contact lenses improves hand-eye coordination and sports vision in adults who play baseball or softball and normally wear contact lenses.

  Recruiting Ohio State University · Columbus, Ohio · NCT07840209

• Two monthly silicone hydrogel multifocal toric contact lenses in wearers with astigmatism and myopia

  This study tests whether two popular soft multifocal toric contact lenses perform differently in adults who need vision correction for astigmatism and myopia.

  Recruiting CooperVision International Limited (CVIL) · New York, New York and 2 other locations · NCT07829419

• Seeing clearly in low light after Ray-Tracing guided LASIK

  A trial tests how well WaveLight Plus LASIK works for people with myopia and astigmatism and whether patients are satisfied after the procedure.

  Recruiting Phase 4 Vance Thompson Vision · Sioux Falls, South Dakota · NCT07790185

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.