Myopia in children
Conditions
Interventions
Experimental Group One:0.04% atropine eye drops, once a night, instill into both eyes before going to bed.
Experimental Group Two:0.02% atropine eye drops, once a night, instill into both eyes before going to bed.
Randomize after stratifying according to the response for the group that is converted to cont
Control Group:The vehicle of atropine eye drops, once a night, instill into both eyes before going to bed.
Sponsors
The General Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
4 Years to 9 Years
Inclusion criteria
Inclusion criteria: 1. A written informed consent form signed by the child and the legal guardian has been obtained. 2. Age: 4 to 9 years old (including the critical values). 3. The spherical equivalent refraction of both eyes after cycloplegia is: 0 to +1.00 diopters (D) (including the critical values). 4. The astigmatism of both eyes after cycloplegia is less than 1.0 diopter (D). 5. The anisometropia of both eyes after cycloplegia is less than or equal to 1.0 diopter (D). 6. At least one of the parents is myopic. 7. The best corrected visual acuity of both eyes is less than or equal to 0.1 logMAR. 8. The intraocular pressure of both eyes is between 10 and 21 mmHg, and the difference between the two eyes is less than or equal to 5 mmHg.
Exclusion criteria
Exclusion criteria: 1. Subjects who may have ocular diseases that affect vision or refractive errors (such as lens injury diseases like cataracts, glaucoma, retinal detachment, etc.). 2. Systemic diseases: subjects with a history of immune system diseases, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary dysfunction, or severe liver and kidney dysfunction. 3. Subjects with manifest strabismus in both eyes or one eye, or any other pathological changes in the eyeball or acute inflammatory ocular diseases. 4. Subjects who have used myopia prevention and control methods, including drug treatments such as atropine or pirenzepine; and device treatments such as orthokeratology lenses, multifocal soft contact lenses, multifocal rigid contact lenses, and functional frame glasses. 5. Subjects who have used drugs that affect the evaluation of efficacy systemically or locally within 3 months before screening, such as anticholinergic drugs like atropine, pirenzepine, etc.; and cholinomimetic drugs like pilocarpine, etc. 6. Subjects who are allergic to drugs used in this study, such as atropine, cyclopentolate, etc. 7. Subjects who have participated in other drug clinical trials within 3 months before screening. 8. Other situations that are considered inappropriate by the researchers. 9. Subjects with chronic mental disorders or mental abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in spherical equivalent (SE, in diopters, D) compared to the baseline at 12 months.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence rate of adverse reactions;The change value of the axial length of the eye at 12 months compared with the baseline;The incidence rate of myopia at 12 months, which is defined as the spherical equivalent refractive error = -0.5 diopters (D).; | — |
Countries
China
Contacts
Public ContactYan Hua
The General Hospital of Tianjin Medical University
Outcome results
None listed