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A prospective multicenter study design was adopted. Children aged 6-9 years with premyopia who met the criteria were screened and administered after completion of baseline assessment. Phase I: 0-24 weeks (0-6M). 0.01% atropine eye drops, once daily, at point in both eyes. Phase II: 24-48 weeks (6-12M). According to the rate of myopia progression at 0-24 weeks (6M), the atropine concentration was increased in steps; once daily, at point in both eyes. Group A: ( SE ≤ 0.25D), continued to maintain 0.01% atropine. Group B: (0.25D < SE ≤ 0.375D), converted to 0.02% atropine. Group C: ( SE > 0.375D), converted to 0.04% atropine. Followed up 5 times (0, 3, 6, 9, 12 months), collected refractive, ocular axis, intraocular pressure and other data, and recorded adverse events and cost information synchronously. Statistical analysis was carried out by covariance analysis and multivariate model, and pharmacoeconomic evaluation and drug proportion analysis were carried out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.01% atropine | Experimental | 0.01% atropine eye drops nightly both eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.01% Atropine | Drug | 0.01% atropine eye drops nightly both eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in SER at 12 months compared to baseline | Change in SER at 12 months compared to baseline | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in AL at 12 months compared to baseline | Change in AL at 12 months compared to baseline | 12 month |
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Inclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meinan He | Contact | 02286428750 | hmn509@tmu.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 19, 2026 | Feb 25, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 4, 2026 | Feb 25, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |