Skip to content

An interventional study of 0.01% atropine eye drops combined with visual training in children with myopia with accommodation abnormalities

Safety and efficacy of 0.01% atropine eye drops in combination with visual training in children with myopia with abnormal accommodation function

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108504
Enrollment
Unknown
Registered
2025-09-01
Start date
2025-02-10
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

myopia

Interventions

Test group:0.01% atropine eye drops for both eyes, once before bedtime every night, one drop per time
Visual training (using the lens reading method to increase adjustment range and the reversal shooting training method to increase adjustment sensitivity), 5 times a week (including 1 training guided b

Sponsors

The First Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: To be enrolled, subjects must meet all of the following criteria 1. written informed consent signed by the child and legal guardian has been obtained. 2. be between the ages of 6 and 12 years old (including the threshold). 3. After ciliary muscle paralysis, computer optometry was used to detect the degree of binocular spherical lens: -4.00D <= spherical lens degree <= -1.00D. 4. Refractive error (in terms of equivalent spherical lens power) <=1.50D, astigmatism <=1.50D. 5. Abnormal adjustment function: symptoms such as eye fatigue and blurred vision after reading or close-up eye use, and at least 1 of the following conditions is met (1) Accommodative Amplitude (AA) negative lens method: one eye is 2D or more below the minimum value for the corresponding age (minimum value for the corresponding age: 15 - 0.25 × age). (2) Accommodative Facility (AF) Monocular Flipper -2.0D passes with difficulty, MAF <6 cpm. (3) MAF +2.00D passing difficulty, with over-adjustment.

Exclusion criteria

Exclusion criteria: Subjects will not be enrolled or excluded from observation if they meet any of the following criteria: 1. subjects with ocular diseases that may affect vision or refractive error (e.g., lens-damaging diseases such as cataracts, glaucoma, macular degeneration, keratoconus, uveitis, retinal detachment, severe vitreous clouding, etc.) 2. systemic diseases: immune system diseases, central nervous system diseases, Down's syndrome, asthma, severe cardiopulmonary, hepatic and renal dysfunction. 3. have dominant strabismus or any other ocular pathology or acute inflammatory disease of the eye in both eyes or in one eye. 4. change of myopia control/treatment method in the 3 months prior to enrollment and during the observation period, which interferes with the observation, e.g., change of monocular correction to keratoplasty or functional frames. 5. systemic or topical use of drugs that affect the evaluation of efficacy within 3 months prior to screening, e.g., anticholinergics: atropine, pirenzepine, etc.; cholinomimetics: mauve rutaecarpine, etc. 6. those who are allergic to drugs used in this study such as atropine and cyclopentolate. 7. those who have participated in clinical trials of other drugs within 3 months prior to screening. 8. other conditions deemed unsuitable by the investigator.

Design outcomes

Primary

MeasureTime frame
Amplitude of Accommodation;Accommodative Facility;Accommodative response;Positive relative accommodation;Negative Relative Accommodation;

Secondary

MeasureTime frame
Spherical Equivalent;Axial Length;Vision;

Countries

China

Contacts

Public ContactLu Zhili

The First Hospital of Dalian Medical University, Dalian, Liaoning, China

zhililu89@163.com+86 180 9887 6507

Outcome results

None listed

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