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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.
The main questions this double-blind, randomized controlled clinical study aims to answer are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.01% atropine | Experimental | 0.01% atropine eye drop |
|
| 0.02% atropine | Experimental | 0.02% atropine eye drop |
|
| 0.04% atropine | Experimental | 0.04% atropine eye drop |
|
| placebo | Placebo Comparator | placebo eye drop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low concentration atropine (0.01%) | Drug | low concentration atropine (0.01%) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Myopia | Effectiveness Evaluation | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in SE (after cycloplegia) | Effectiveness Evaluation | 1 year |
| Changes in AL | Effectiveness Evaluation | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Photophobia Incidence Rate | Safety Evaluation | 1 year |
| Changes in Blurred Vision Incidence Rate | Safety Evaluation | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangui He | Contact | +8615000755422 | xianhezi@163.com | |
| Jingjing Wang | Contact | +8613011220922 | 13011220922@163.com |
| Name | Affiliation | Role |
|---|---|---|
| He Xiangui | Shanghai Eye Disease Prevention and Treatment Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangui He | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D047728 | Myopia, Degenerative |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| low concentration atropine (0.02%) |
| Drug |
low concentration atropine (0.02%) |
|
| low concentration atropine (0.04%) | Drug | low concentration atropine (0.04%) |
|
| Placebo | Drug | Placebo eye drop |
|
| Changes in visual acuity | Effectiveness Evaluation | 1 year |
| Changes in Choroidal Thickness | Effectiveness Evaluation | 1 year |
| change in amplitude of accommodation | Safety Evaluation | 1 year |
| change in pupil size | Safety Evaluation | 1 year |
| change in ocular surface health | Safety Evaluation | 1 year |