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sIRB determined feasibility study could not be done because of no benefits of the treatment drops in short time violated FDA requirements
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| Name | Class |
|---|---|
| University of Houston | OTHER |
| State University of New York | OTHER |
| Pennsylvania College of Optometry | INDUSTRY |
| Southern California College of Optometry at Marshall B. Ketchum University |
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Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.
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%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.01% Atropine | Active Comparator | 0.01% atropine eye drops |
|
| 0.03% Atropine | Active Comparator | 0.03% atropine eye drops |
|
| 0.05% atropine | Active Comparator | 0.05% atropine eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine Ophthalmic | Drug | eye drops to be administered once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compliance percentage | A comparison of the compliance percentage with eye drop administration | 30 days |
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Inclusion Criteria:
Age: 6-11 years
Refractive error measured in spherical equivalent, one eye meets criterion
Anisometropia: spherical equivalent <1.50 D
Astigmatism: <1.50 in both eyes
Myopia: Less myopic than -0.74 D, both eyes
Exclusion Criteria:
● Myopic
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey J Walline, OD PhD | Ohio State University | Study Chair |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| OTHER |
| University of California, Berkeley | OTHER |
| Stanford University | OTHER |
| Case Western Reserve University | OTHER |
| Illinois College of Optometry | OTHER |
| Indiana University | OTHER |
| New England College of Optometry | OTHER |
| University of the Incarnate Word | OTHER |
| Southern College of Optometry | OTHER |
| University of Missouri, St. Louis | OTHER |
Participants will receive one of three concentrations of atropine (0.01%, 0.03%, or 0.05%)
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De-identified bottles will be sent to the sites with randomization codes. The key will be kept at the data coordinating center.