Myopia
Conditions
Interventions
Experimental group S:0.02% atropine eye drops, 1 time a day, on both eyes.
Experimental group C:0.04% atropine eye drops, 1 time a day, on both eyes.
Control group P:Atropine eye drops solvent, 1 time a day, on both eyes.
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
4 Years to 9 Years
Inclusion criteria
Inclusion criteria: 1. Children aged 4-9 years old (not more than 9 years old); 2. Computed refraction equivalent spherical refraction after ciliary muscle paralysis of both eyes: -0.50D= 0.6 (4-6 years old) in both eyes, and uncorrected visual acuity >= 0.8 (7-9 years old); 6. Intraocular pressure of 10-21mmHg in both eyes; 7. Written informed consent signed by the child and legal guardian has been obtained.
Exclusion criteria
Exclusion criteria: 1. Subjects who may have eye diseases that affect visual acuity or refractive errors (such as lens damage diseases such as cataracts, glaucoma, retinal detachment, etc.); 2. Systemic diseases: immune system diseases, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary function, severe liver and kidney dysfunction; 3. Overt strabismus or any other pathological changes in the eye or acute inflammatory disease of the eye in both eyes or in one eye; 4. Have used myopia prevention and control methods and drug treatment: such as atropine or piperazepine; Instrumental treatment: orthokeratology, multifocal soft lenses, multifocal hard lenses, functional glasses, etc; 5. Systemic or topical use of drugs that affect the efficacy evaluation within 3 months before screening, such as anticholinergics: atropine, piperazepine and other drugs; Cholinermic drugs: pilocarpine, ruta, etc; 6. Those who are allergic to drugs used in this study, such as atropine and cyclopentropite; 7. Those who have participated in other drug clinical trials within 3 months before screening; 8. Other conditions deemed unsuitable by the investigator; 9. Those with chronic mental illness or mental abnormalities; 10. Any chronic disease (such as asthma or syndrome) that requires concomitant medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of myopia at 48/96 weeks;Change from baseline in equivalent spherical refraction after ciliary muscle palsy at 48/96 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of onset of myopia;Safety: Cumulative incidence of adverse reactions;Change from baseline in axial length at 48/96 weeks;Proportion of rapid progression of equivalent spherical refractive in the direction of myopia after ciliary muscle palsy at 48/96 weeks; | — |
Countries
China
Contacts
Public ContactChen Zhi;Zhou Xingtao
Eye & ENT Hospital of Fudan University
Outcome results
None listed