Efficacy and safety of low-concentration atropine eye drops at different frequency for the prevention and control of myopia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300073459

Enrollment

Unknown

Registered

2023-07-11

Start date

2023-05-13

Completion date

Unknown

Last updated

2025-12-01

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

Conditions

Myopia

Interventions

experimental group:phase1:0.01% atropine eye drop, OU, BID(twice a day)+monofocal glasses

frequency control group:phase1:0.01% atropine eye drop, OU, QD(once a day)+monofocal glasses

concentration control group:phase1:0.04% atropine eye drop, OU, QD(once a day)+monofocal glasses

Continuing treatment group:phase 2 : For subjects with good control of myopia progression (i.e. myopia progression = -0.50D), the original treatment plan will continue to be implemented

Joint application group::phase 2: for subjects with myopia progression<-0.50D, integrated mesh defocusing lenses will be used in combination in the second year.

Eligibility

Sex/Gender

All

Age

6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children aged 6-12 with myopia (spherical refractive error -0.50D ~ -6.00D, cylindrical refractive error <= 1.50D, anisometropia <= 1.50D) who voluntarily participate. Children participating in the study must obtain consent from their guardians and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have used any myopia prevention and control methods within 1.3 months, such as medication, peripheral defocusing frames, and contact lenses; 2. Suffering from eye diseases (such as cataracts, congenital retinal diseases, amblyopia, and strabismus); 3. Children with cloudy refractive media or those who have undergone refractive media intervention related surgeries, such as cataract surgery, corneal transplantation surgery, corneal leukoplakia, keratoconus, etc; 4. There are systemic diseases that may affect the refractive status, such as Marfan syndrome, Marchesoni syndrome, type 1 diabetes, etc; 5. Individuals allergic to scopolamine; 6. Patients with shallow anterior chamber, glaucoma, and a family history of glaucoma; 7. Children who cannot cooperate with the examination and children who withdraw midway.

Design outcomes

Primary

Measure	Time frame
Equivalent spherical lens;	—

Secondary

Measure	Time frame
axial length;	—

Countries

China

Contacts

Public ContactChen Jie

Eye Hospital of Wenzhou Medical University

cj@mail.eye.ac.cn+86 138 5772 1998

Outcome results

None listed

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