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| ID | Type | Description | Link |
|---|---|---|---|
| 2019yj001J-5 | Other Grant/Funding Number | Beijing Bethune Charitable Foundation |
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| Name | Class |
|---|---|
| Beijing Tongren Hospital | OTHER |
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To evaluate the effectiveness and safety of DIMS, low concentration atropine eye drops,and atropine combined with DIMS in controlling axial length and refraction in children with moderate to high myopia.
In this study, stratified block randomization was employed for random grouping, and the total sample size required as calculated was 410 individuals. Firstly, 410 subjects were assigned ID numbers ranging from 1 to 410. SPSS.26 statistical software was utilized to apply the "random number generator" by setting the "fixed seed number" to "20231121", and subsequently generate random numbers. Once the random numbers were obtained, random sampling and grouping were conducted. This study was a multicenter trial, with block randomization stratified by center. The total sample size of 410 was distributed across 4 cities, and the samples collected in each city were randomly allocated into 5 treatment groups (groups A, B, C, D, and E), with approximately 20 individuals in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The DIMS Group | Experimental | wear DIMS ,and use placebo,once nightly, both eye |
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| 0.02% ATP | Experimental | wear SP, and use 0.02%ATP eye drops, once nightly, both eye |
|
| 0.04%ATP | Experimental | wear SP, and use 0.04%ATP eye drops, once nightly, both eye |
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| 0.02%ATP+DIMS | Experimental | wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye |
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| 0.04%ATP+DIMS | Experimental | wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIMS | Device | wear DIMS ,and use placebo,once nightly, both eye |
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| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity | Best Corrected Visual Acuity | up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meinan He | Contact | +8613672135765 | hmn509@tmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Eye Hospital | Recruiting | Tianjin | Tianjin Municipality | 120120 | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| The 0.02% ATP Group |
| Drug |
wear SP, and use 0.02%ATP eye drops, once nightly, both eye |
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| The 0.04% ATP Group | Drug | wear SP, and use 0.04%ATP eye drops, once nightly, both eye |
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| 0.02%ATP+DIMS | Combination Product | wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye |
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| 0.04%ATP+DIMS | Combination Product | wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye |
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