Skip to content

Research on the effect of low concentration atropine on the progression of myopia in children and its correlation with accommodative function

Research on the effect of low concentration atropine on the progression of myopia in children and its correlation with accommodative function

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101777
Enrollment
Unknown
Registered
2025-04-29
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

Child myopia

Interventions

Group 1: 0.01% atropine sulfate eye drops, once daily.
Group 2:0.004% atropine sulfate eye drops, once daily.

Sponsors

Hebei Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Written informed consent signed by the child and legal guardian has been obtained. 2. Children aged 6 to 12 years (including the cut-off value). 3. After cycloplegia, the binocular spherical power measured by computer optometry: myopia diopter is greater than or equal to 50 degrees and less than or equal to 400 degrees. 4. Binocular astigmatism detected by computer optometry after cycloplegia = 15-0.25* age.

Exclusion criteria

Exclusion criteria: 1. Subjects who may suffer from eye diseases that affect vision or refractive error (such as cataract and other lens damage diseases, glaucoma, maculopathy, keratopathy, retinitis pigmentosa, retinal detachment, severe vitreous opacity, etc.). 2. Systemic diseases: immune system diseases, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary function, severe liver and kidney dysfunction. 3. Both eyes or one eye have dominant strabismus or any other pathological changes of the eye or acute inflammatory diseases of the eye. 4. Have used myopia control treatment methods and drugs in recent half a year or three months: such as atropine or pirenzepine; Instrument treatment: orthokeratology lens, multifocal soft lens, multifocal hard lens, functional frame glasses, etc. 5. Drugs that have been used systemically or locally within 3 months before screening to affect the efficacy evaluation, such as anticholinergic drugs: atropine, pirenzepine;Choline mimetics: pilocarpine, etc. 6. Those who are allergic to atropine, tropicamide and other drugs used in this study. 7. Those who have participated in clinical trials of other drugs within 3 months before screening. 8. Other circumstances that the researcher deems inappropriate.

Design outcomes

Primary

MeasureTime frame
48/2000 Correlation between the variation of system parameters and equivalent sphere, AL change in December;

Secondary

MeasureTime frame
Trends in changes in regulatory system parameters (adjustment range, adjustment sensitivity, etc.) at different follow-up nodes compared to the baseline;

Countries

China

Contacts

Public ContactLi Shanxue

Hebei Eye Hospital

ykyysjb@126.com+86 319 3237995

Outcome results

None listed

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