Myopia, Progressive
Conditions
Brief 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.
Interventions
0.01% atropine eye drop
DRUGlow concentration atropine (0.025%)
0.025% atropine eye drop
DRUGlow concentration atropine (0.05%)
0.05% atropine eye drop
DRUGPlacebo
Placebo eye drop
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Peking University People's Hospital
Shandong University of Traditional Chinese Medicine
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of SE changes over -0.75D | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| AL change | 2 years |
Contacts
Primary ContactHaidong Zou
Outcome results
None listed