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Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia
Two-hundered and forty children aged 6-13 will be recruited and allocated to three groups. Subjects that were randomized to receive Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) or single vision frame glasses, respectively.
Primary outcome measure ocular axial length and the secondary indicator is spherical equivalent after cycloplegia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Circular cylindrical mirror modulated frame glasses (compact) | Experimental | Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (compact) throughout the entire course of the study. |
|
| Circular cylindrical mirror modulated frame glasses (strong defocus) | Experimental | Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (strong defocus) throughout the entire course of the study. |
|
| single vision frame glasses | Experimental | Subjects that were randomized to receive the single vision frame glasses throughout the entire course of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circular cylindrical mirror modulated frame glasses (compact) | Device | Circular cylindrical mirror modulated frame glasses (compact) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in ocular axial length in a year | The ocular axial length was measured by AL-scan | baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cycloplegic objective spherical equivalent in a year | The cycloplegic objective spherical equivalent was evaluated by a autorefractor | baseline, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoqin Chen, MD | Tianjin Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Eye Hospital | Tianjin | 300020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33811039 | Background | Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2. | |
| 38429067 | Derived | Muller J, Chen X, Ohlendorf A, Li L, Wahl S. Method comparison and overview of refractive measurements in children: implications for myopia management. BMJ Open Ophthalmol. 2024 Mar 1;9(1):e001322. doi: 10.1136/bmjophth-2023-001322. |
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| Circular cylindrical mirror modulated frame glasses (strong defocus) | Device | Circular cylindrical mirror modulated frame glasses (strong defocus) |
|
| single vision frame glasses | Device | single vision frame glasses |
|
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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