Myopia
Conditions
Brief summary
Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.
Detailed description
Participants will be identified through screening that fit the criteria of a pre-myopic child, which will depend on age and the amount of refractive error at that time. These children will be randomized for a pilot study measuring compliance in nightly eye drop administration. The outcome will be thirty days after randomization, and will assess whether or not there is a difference in compliance between one of three dosages of atropine (0.01%, 0.03%, and 0.05%).
Interventions
eye drops to be administered once daily
Sponsors
University of Houston
State University of New York
Pennsylvania College of Optometry
Southern California College of Optometry at Marshall B. Ketchum University
University of California, Berkeley
Stanford University
Case Western Reserve University
Illinois College of Optometry
Indiana University
New England College of Optometry
University of the Incarnate Word
Southern College of Optometry
University of Missouri, St. Louis
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
De-identified bottles will be sent to the sites with randomization codes. The key will be kept at the data coordinating center.
Intervention model description
Participants will receive one of three concentrations of atropine (0.01%, 0.03%, or 0.05%)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 6-11 years * Refractive error measured in spherical equivalent, one eye meets criterion * 6 years old: 0.50 to +0.38 * 7 years old: 0.50 to +0.25 * 8-11 years old: 0.50 to plano * Anisometropia: spherical equivalent \<1.50 D * Astigmatism: \<1.50 in both eyes * Myopia: Less myopic than -0.74 D, both eyes
Exclusion criteria
● Myopic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance percentage | 30 days | A comparison of the compliance percentage with eye drop administration |
Outcome results
None listed