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| Name | Class |
|---|---|
| National Taiwan University Hospital | OTHER |
| Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | OTHER |
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The objective of this study is to demonstrate that the Ticon Aspherical Daily Disposable Soft Contact Lens could retard myopia progress in youth
This study is designed as a prospective, multicenter, randomized, double blinded, controlled, paired-eye comparison study. At least 60 evaluable subjects with myopia progression ≧ 0.75 D in the past 12 months will be recruited from 2 study sites. The experimental soft contact lens with aspherical design (Ticon Aspherical) will be randomly assigned to either the right eye or the left eye of the subject , then the fellow eye will be assigned a control lens with a single vision distance (SVD) soft contact lens (Ticon). Both lenses will be worn at least 8 hours a day, 5 days a week for 1 year. All lenses will be replaced every day. Brief assessment of the clinical findings will be followed up for one year at 1 day, 1 week, 1, 3, 6, 9, 12 months upon allocation. The primary efficacy outcome is change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months. The secondary outcome is change in axial eye length (AXL) measured over 12 months. The secondary outcome measure is used to corroborate any changes in SER
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticon Aspherical Daily Disposable Soft Contact Lens | Experimental | The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months. |
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| Ticon Daily Soft Contact Lens | Placebo Comparator | The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soft contact lens | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spherical Equivalent Refraction (SER) | The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Axial Eye Length (AXL) | The change in axial eye length (AXL) measured over 12 months. Axial length is measured after cycloplegia using optical biometry. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Primary safety Endpoints | All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates will be measured. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tzu-Hsun Tsai, M.D. | National Taiwan University Hospital | Study Chair |
| Elizabeth P Shen, M.D. | Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Principal Investigator |
| Hsiao-Sang Chu, M.D. | National Taiwan University Hospital | Principal Investigator |
| Han-Chih Cheng, M.D. | Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35737291 | Derived | Shen EP, Chu HS, Cheng HC, Tsai TH. Center-for-Near Extended-Depth-of-Focus Soft Contact Lens for Myopia Control in Children: 1-Year Results of a Randomized Controlled Trial. Ophthalmol Ther. 2022 Aug;11(4):1577-1588. doi: 10.1007/s40123-022-00536-5. Epub 2022 Jun 23. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
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| ID | Term |
|---|---|
| D003263 | Contact Lenses, Hydrophilic |
| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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paired-eye design
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