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Atropine Sulfate Eye Drops (0.01%, 0.02%, 0.04% Concentrations): Safety and Efficacy in Myopia Prevention for High-Risk Children

Atropine Sulfate Eye Drops (0.01%, 0.02%, 0.04% Concentrations): Safety and Efficacy in Myopia Prevention for High-Risk Children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109268
Enrollment
Unknown
Registered
2025-09-16
Start date
2025-09-16
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myopia

Interventions

placebo group:Placebo (Unit Concentration: 0.5 mL, Preservative-Free)
0.01% Atropine Group:0.01% Atropine Sulfate Eye Drops (Unit Concentration: 0.5 mL, Preservative-Free)
0.02% Atropine Group:0.02% Atropine Sulfate Eye Drops (Unit Concentration: 0.5 mL, Preservative-Free)
0.04% Atropine Group:0.04% Atropine Sulfate Eye Drops (Unit Concentration: 0.5 mL, Preservative-Free)

Sponsors

Hospital Affiliated to Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 10 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1.For children aged >=6 years and =0.3 mm per year or >=0.15 mm per 6 months (with a follow-up period of at least half a year); 7.Participants must voluntarily take part in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1.Previous use of atropine or pirenzepine - type medications; 2.Complicated with ocular diseases, such as amblyopia, strabismus, congenital cataract, glaucoma, uveitis, fundus diseases, ocular tumors, and any other ocular diseases that affect visual function; 3.A history of any ocular surgery; 4.Patients with systemic diseases leading to immunocompromise (e.g., diabetes, Down syndrome, rheumatoid arthritis, psychiatric disorders, or other conditions deemed unsuitable for receiving atropine by the researcher); 5.Use of any myopia intervention methods (e.g., atropine, red light therapy) within 3 months; 6.Inability to undergo regular ocular examinations; 7.Abnormal intraocular pressure (IOP) (IOP 21 mmHg, or IOP difference between the two eyes > 5 mmHg); 8.Subjects deemed ineligible by the researcher.

Design outcomes

Primary

MeasureTime frame
Axial Length;spherical equivalent refractive error (SER);—

Secondary

MeasureTime frame
Myopia Incidence Rate;Myopic Shift Percentage;—

Countries

China

Contacts

Public ContactXinting Liu

School of Ophthalmology & Optometry (School of Biomedical Engineering), Wenzhou Medical University; Eye Hospital Affiliated to Wenzhou Medical UniversityCenter, and Deputy Director of the Myopia Prevention and Control Specialty, Eye Hospital Affiliated t

liuxt@eye.ac.cn+86 138 1972 7596

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026