Pre-myopia
Conditions
Interventions
0.02% atropine group:0.02% Atropine Sulfate Ophthalmic Solution
0.04% atropine group:0.04% Atropine Sulfate Ophthalmic Solution
Placobo group:Atropine Sulfate Ophthalmic Solution Vehicle
Sponsors
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1.Children aged 6-12 years; 2.Cycloplegic spherical equivalent refraction of both eyes > -0.50 D and =+0.75 D; 3.Astigmatism of both eyes < 1.50 D; 4.Intraocular pressure (IOP) of both eyes = 21mmHg.
Exclusion criteria
Exclusion criteria: 1.Presence of other ocular abnormalities beyond refractive error (e.g., keratoconus, cataract, glaucoma, suspicious angle closure, macular degeneration, retinal detachment, severe vitreous opacity, etc.); 2.Diagnosis of strabismus, amblyopia, or acute inflammatory ocular diseases; 3.History of any myopia control or prevention intervention within the past year, including pharmacological treatments (e.g., atropine or pirenzepine), myopia control spectacles, orthokeratology lenses, multifocal soft contact lenses, or repeated low-level red light therapy; 4.Suffering from severe systemic or psychiatric diseases, including severe immune system disorders, central nervous system disorders, Down syndrome, asthma, severe cardiopulmonary dysfunction, severe hepatic and renal dysfunction, depression, etc.; 5.Systemic or local use of medications that may affect efficacy assessment within 3 months prior to screening, such as atropine, pirenzepine, pilocarpine, etc.; 6.Allergy to atropine, cyclopentolate, or other medications used in this study; 7.Participation in other drug clinical trials within 3 months prior to screening; 8.Other conditions deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myopia Incidence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Spherical equivalent refraction;Incidence of rapid myopic shift; | — |
Countries
China
Contacts
Public ContactXiao Yang
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Outcome results
None listed