Low Concentration Atropine in the Prevention of Myopia in Children.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The main questions this double-blind, randomized controlled clinical study aims to answer are:
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To evaluate the effect of low concentration atropine on the incidence of myopia in pre myopia children.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 0.01% atropine 0.01% atropine eye drop |
Drug: low concentration atropine (0.01%)
low concentration atropine (0.01%)
|
| Experimental: 0.02% atropine 0.02% atropine eye drop |
Drug: low concentration atropine (0.02%)
low concentration atropine (0.02%)
|
| Experimental: 0.04% atropine 0.04% atropine eye drop |
Drug: low concentration atropine (0.04%)
low concentration atropine (0.04%)
|
| Placebo Comparator: placebo placebo eye drop |
Drug: Placebo
Placebo eye drop
|
Outcome Measures
Primary Outcome Measures
- Cumulative Incidence of Myopia [1 year]
Effectiveness Evaluation
Secondary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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The age of the screening stage is 6-9 years, both sexes;
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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;
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At least one of parents suffers from myopia (SE of at least one eye <=-3.00D);
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Parents have signed informed consent and agree to participate in screening and follow-up.
Exclusion Criteria:
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Parents disagree to sign the informed consent;
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Presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery;
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Presence of other eye or systemic diseases;
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Allergies to low concentration atropine or sulfuric acid drugs;
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Histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month;
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Presence of other situations that the researchers think is not appropriate for patients to be included in the project.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xiangui He | Shanghai | Shanghai | China | 200040 |
Sponsors and Collaborators
- Shanghai Eye Disease Prevention and Treatment Center
Investigators
- Study Director: He Xiangui, Shanghai Eye Disease Prevention and Treatment Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- jafakfakfa