Delaying the Onset of Nearsightedness Until Treatment Study

DONUT

Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.

2024-01-01

2024-08-31

2024-08-31

Withdrawn

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will receive one of three concentrations of atropine (0.01%, 0.03%, or 0.05%)', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'De-identified bottles will be sent to the sites with randomization codes. The key will be kept at the data coordinating center.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2024-04-16