Myopia, Progressive
Conditions
Brief summary
This double-blind, randomized controlled clinical study is to evaluate the effectiveness and safety of low concentration atropine in preventing myopia in pre-myopia children, and to explore whether there is a dose effect relationship between different concentrations of atropine in preventing myopia.
Detailed description
The main questions this double-blind, randomized controlled clinical study aims to answer are: 1. To evaluate the effect of low concentration atropine on the incidence of myopia in pre myopia children. 2. To evaluate the effectiveness of low concentration atropine in controlling refractive and axial progression. Patients are randomly divided into three treatment groups with different atropine concentrations(0.01%, 0.02%, 0.04%) and one control group with atropine dissolvant. Patients are required to use the eye drops every night for one year and record after daily usage.
Interventions
low concentration atropine (0.01%)
DRUGlow concentration atropine (0.02%)
low concentration atropine (0.02%)
DRUGlow concentration atropine (0.04%)
low concentration atropine (0.04%)
DRUGPlacebo
Placebo eye drop
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
1. The age of the screening stage is 6-9 years, both sexes; 2. One eye met the diagnosis of pre-myopia, the spherical equivalent was between -0.50D and +0.75D, the astigmatism was ≥-1.50D, and the best corrected far vision was at least 1.0; 3. At least one of parents suffers from myopia (SE of at least one eye \<=-3.00D); 4. Parents have signed informed consent and agree to participate in screening and follow-up.
Exclusion criteria
1. Parents disagree to sign the informed consent; 2. Presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery; 3. Presence of other eye or systemic diseases; 4. Allergies to low concentration atropine or sulfuric acid drugs; 5. Histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month; 6. Presence of other situations that the researchers think is not appropriate for patients to be included in the project.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Incidence of Myopia | 1 year | Effectiveness Evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in SE (after cycloplegia) | 1 year | Effectiveness Evaluation |
| Changes in AL | 1 year | Effectiveness Evaluation |
| Changes in visual acuity | 1 year | Effectiveness Evaluation |
| Changes in Choroidal Thickness | 1 year | Effectiveness Evaluation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Photophobia Incidence Rate | 1 year | Safety Evaluation |
| Changes in Blurred Vision Incidence Rate | 1 year | Safety Evaluation |
| change in amplitude of accommodation | 1 year | Safety Evaluation |
| change in pupil size | 1 year | Safety Evaluation |
| change in ocular surface health | 1 year | Safety Evaluation |
Countries
China
Contacts
Primary ContactXiangui He
Backup ContactJingjing Wang
Outcome results
None listed