Delaying the Onset of Nearsightedness Until Treatment Study
- Registration Number
- NCT06029530
- Lead Sponsor
- Ohio State University
- 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%).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
-
Age: 6-11 years
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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
● Myopic
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.01% Atropine Atropine Ophthalmic 0.01% atropine eye drops 0.03% Atropine Atropine Ophthalmic 0.03% atropine eye drops 0.05% atropine Atropine Ophthalmic 0.05% atropine eye drops
- Primary Outcome Measures
Name Time Method Compliance percentage 30 days A comparison of the compliance percentage with eye drop administration
- Secondary Outcome Measures
Name Time Method