Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial
Purpose
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.
Condition
- Myopia
Eligibility
- Eligible Ages
- Between 6 Years and 11 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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 Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Placebo-controlled randomized clinical trial
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Bottles to be distributed are masked at the pharmacy. Only pharmacy personnel and data coordinating center personnel have access to the assigned treatment groups.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 0.05% Atropine |
0.05% atropine instilled in each eye nightly at bedtime |
|
|
Placebo Comparator Placebo |
Placebo drops instilled in each eye nightly at bedtime |
|
Recruiting Locations
Birmingham, Alabama 35233
Fullerton, California 92831
Chicago, Illinois 60616
Bloomington, Indiana 47405
Boston, Massachusetts 02115
Columbus, Ohio 43210
More Details
- Status
- Recruiting
- Sponsor
- Ohio State University
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.