Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073840
Enrollment
Unknown
Registered
2023-07-24
Start date
2023-05-14
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

Premyopia

Interventions

experimental group:phase1:0.01% atropine eye drops (morning) + 0.01% atropine eye drops (evening)
frequency control group:phase1:Placebo (morning) + 0.01% atropine eye drops (evening)
Concentration control group:phase1:Placebo (morning) + 0.04% atropine eye drops (evening)
blank control group:phase1:Placebo (morning) + Placebo (evening)
Framed glasses treatment group:phase 2: for subjects in blank control group with myopia progression<-0.50D, integrated mesh defocusing lenses will be used in the second year.

Sponsors

Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Children aged 6-12 years who have voluntarily participated in the premyopia (cylindrical muscle paralysis after cycloplegia spherical diopter +0.75D~-0.50D, cylindrical diopter <= 1.50D, refractive difference <= 1.50D) who have stopped the intervention for 3 months or more; 2. Children participating in the study had the consent of their guardians and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have eye diseases (e.g. cataracts, congenital retinal diseases, amblyopia, and strabismus); 2. Children with turbidity of refractive medium or surgery related to refractive media intervention, such as cataract surgery, corneal transplantation, corneal leukoplakia, keratoconus, etc.; 3. The presence of systemic diseases that may affect the refractive state, such as Marfan syndrome, Marcheshani syndrome, type 1 diabetes, etc.; 4. Those who are allergic to hyoscyamine; 5. Shallow anterior chamber, glaucoma, and family history of glaucoma; 6. Children who cannot cooperate with the examination, children who quit halfway.

Design outcomes

Primary

MeasureTime frame
Equivalent spherical lens;

Secondary

MeasureTime frame
axial length;

Countries

China

Contacts

Public ContactLi Xiaoman

Eye Hospital of Wenzhou Medical University

lixiaomanxixi@126.com+86 137 3632 1850

Outcome results

None listed

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