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Clinical Study of Low-Concentration Atropine Eye Drops in Myopia Control

Clinical Study of Low-Concentration Atropine Eye Drops in Myopia Control

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113604
Enrollment
Unknown
Registered
2025-12-01
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Myopia

Interventions

0.01% Atropine Group:Use 0.01% atropine eye drops once daily at night.
0.025% Atropine Group:Use 0.025% atropine eye drops once daily at night.
0.05% Atropine Group:Use 0.05% atropine eye drops once daily at night.

Sponsors

Henan Provincial Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Age between 8 and 12 years old (inclusive of the boundary values). (2) After cycloplegia (compound tropicamide eye drops), binocular spherical refraction measured by computerized refractometry: -4.00D =4.9, with a difference in best-corrected visual acuity between eyes <= 0.1. (4) Voluntary participation in this trial, ability to communicate effectively with the investigator and comply with all trial requirements, and submission of a written informed consent form signed by the child or legal guardian.

Exclusion criteria

Exclusion criteria: (1) patients with central nervous system diseases, Down's syndrome, epilepsy, craniocerebral injury, asthma, congenital heart disease and other serious systemic diseases. (2) may have eye diseases affecting vision or diopter (such as cataract or other lens diseases, glaucoma, corneal diseases, uveitis, retinal and vitreous diseases). (3) strabismus and amblyopia. (4) acute infectious eye diseases. (5) myopic medication (including atropine, pelenzepine, anisodamine, etc.) or device therapy for myopia within 3 months; Wear functional glasses or orthokeratology lenses. (6) Allergic to cycloplegic atropine, Saberjet or compound tropicamide eye drops. (7) previous strabismus surgery, refractive surgery or intraocular surgery. (8) Intraocular pressure (IOP) > 21mmHg. (9) participated in another clinical trial within 30 days before screening.

Design outcomes

Primary

MeasureTime frame
Axial length;Refractive power;

Secondary

MeasureTime frame
Retinal defocus state;The Accommodation Function ;Choroidal thickness;

Countries

China

Contacts

Public ContactLei Zhu

Henan Provincial Eye Hospital

hnyks135@126.com+86 185 3829 8272

Outcome results

None listed

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