Myopia
Conditions
Keywords
prevention
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.
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.
Interventions
DRUGAtropine Sulfate 0.05% Oph Soln
Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy
DRUGPlacebo
Placebo drop with same formulation as treatment minus the atropine
Sponsors
Ohio State University
National Eye Institute (NEI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Placebo-controlled randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of myopia (spherical equivalent by Myopia Master) | Two years | Cumulative incidence of myopia as measured by cycloplegic autorefraction comparison between treatment and placebo |
| Axial elongation (by Myopia Master) | Two years | Axial elongation comparison between treatment and placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to event in incident myopes (measured by spherical equivalent by Myopia Master) | 2 years | A comparison of the time to myopia onset between the treatment and placebo groups |
| Progression of spherical equivalent (by Myopia Master) | 2 years | Spherical equivalent progression (change) comparison between treatment and placebo |
Countries
United States
Contacts
CONTACTLisa A Jordan, PhD
STUDY_CHAIRDavid A Berntsen, OD PhD
University of Houston College of Optometry
STUDY_CHAIRJeffrey J Walline, OD PhD
The Ohio State University College of Optometry
Outcome results
None listed