Overview

Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents

Status:
Not yet recruiting
Trial end date:
2025-11-01
Target enrollment:
0
Participant gender:
All
Summary
To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Eye Disease Prevention and Treatment Center
Collaborators:
Peking University People's Hospital
Shandong University of Traditional Chinese Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Treatments:
Atropine
Criteria
Inclusion Criteria:

1. The age of the screening stage is 3-15 years, both sexes;

2. One eye met the diagnosis of myopic refractive error, the spherical equivalent was
between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far
vision was at least 0.8;

3. Have normal thinking and language communication ability, and can actively cooperate
with treatment and follow-up as required;

4. Informed consent from the guardian and the child.

Exclusion Criteria:

1. strabismus, amblyopia or other ocular abnormalities;

2. The presence of systemic disease abnormalities;

3. have taken myopia control treatment in the past month;

4. Allergic to low concentration atropine or sulfuric acid drugs.