A Double-blind, Randomized Controlled Study of Low Concentration Atropine in the Prevention of Myopia in Pre-myopia Children.

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This double-blind, randomized controlled clinical study is to evaluate the effectiveness and safety of low concentration atropine in preventing myopia in pre-myopia children, and to explore whether there is a dose effect relationship between different concentrations of atropine in preventing myopia.

2023-04-01

2024-04-01

2024-04-01

Recruiting

428

Inclusion Criteria: 1. The age of the screening stage is 6-9 years, both sexes; 2. One eye met the diagnosis of pre-myopia, the spherical equivalent was between -0.50D and +0.75D, the astigmatism was ≥-1.50D, and the best corrected far vision was at least 1.0; 3. At least one of parents suffers from myopia (SE of at least one eye \<=-3.00D); 4. Parents have signed informed consent and agree to participate in screening and follow-up. Exclusion Criteria: 1. Parents disagree to sign the informed consent; 2. Presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery; 3. Presence of other eye or systemic diseases; 4. Allergies to low concentration atropine or sulfuric acid drugs; 5. Histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month; 6. Presence of other situations that the researchers think is not appropriate for patients to be included in the project.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 428, 'type': 'ESTIMATED'}}

2023-07-11