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| Name | Class |
|---|---|
| National Taiwan University Hospital | OTHER |
| Chang Gung Memorial Hospital | OTHER |
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The objective of this study is to investigate the efficacy and safety of soft lens in myopia control.
This is a prospective, randomized, paired eye comparison, double-blind study aims to evaluate the efficacy and safety of "Soft Lens" in myopia control among schoolchildren. A total of 118 eyes are planned to be enrolled and the expect duration of subject participation will be 48 weeks not including two weeks of screening period. Data such as refractive error, axial length, visual acuity, average wearing hours, self-assessment, adverse events etc. will be collected during the study. A total of 10 visits, i.e. a screening visit, a randomization visit, and 8 treatment visits are planned. Subjects will be encouraged to complete all planned visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | Intervention name: multifocal soft contact lens/single vision soft contact lens Left eye: multifocal soft contact lens Right eye: single vision soft contact lens |
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| Group B | Other | Intervention name: multifocal soft contact lens/single vision soft contact lens Left eye: single vision soft contact lens Right eye: multifocal soft contact lens |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soft contact lens | Device | Group A Group B |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective cycloplegic refractive error | Changes in objective cycloplegic refractive error between the two eyes in 48 weeks | 48 weeks |
| Axial length | Changes in axial length between the two eyes in 48 weeks | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cycloplegic refractive error | Changes in objective cycloplegic refractive error between the two eyes from baseline after treatment | 12, 24, and 36 weeks |
| Axial length | Changes in axial length between the two eyes from baseline after treatment |
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Inclusion Criteria:
Exclusion Criteria:
Eye disease or vision problem that may contraindicate/interfere with contact lens wearing, for example:
Use of bifocals, progressive addition lenses, rigid gas permeable contact lenses, orthokeratology lenses, atropine, pirenzepine or any other myopia control treatment within 1 month prior to screening visit
Systemic disease that may affect vision or contact lens wearing (e.g. diabetes, Down syndrome), autoimmune disease, infectious disease, or immunosuppressive diseases recorded in medical charts or informed by caregiver
Surgically altered eyes (e.g. corneal or refractive surgery, not including stye removal surgery)
Receiving any medication for long-term use which may interfere with contact lens wearing, tear film production, pupil size, accommodation or refractive state, such as nasal decongestants (e.g. pseudoephedrine, phenylephrine), antihistamines (e.g. chlorpheniramine, diphenhydramine), Prednisolone or Ritalin (methyphenidate)
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| Name | Affiliation | Role |
|---|---|---|
| Tzu-Hsun Tsai, M.D. | National Taiwan University Hospital | Study Chair |
| Tzu-Hsun Tsai, M.D. | National Taiwan University Hospital | Principal Investigator |
| Chao-Wen Lin, M.D. | National Taiwan University Hospital | Principal Investigator |
| Ken-Kuo Lin, M.D. | Taipei Chang Gung Memorial Hospital | Principal Investigator |
| Jiahn-Shing Lee, M.D. | Chang Gung Memorial Hospital | Principal Investigator |
| Chiun-Ho Hou, M.D. | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tzu-Hsun Tsai M.D. | Taipei | 100 | Taiwan | |||
| Ken-Kuo Lin M.D. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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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 comparison
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| 12, 24, and 36 weeks |
| Myopia progression and axial elongation | Percent reductions of myopia progression and axial elongation | during 48 weeks |
| Self-assessment by questionnaire 1 | Analysis of subject self-assessment | during 48 weeks |
| Self-assessment by questionnaire 2 | Average wearing hours across the study period | during 48 weeks |
| Self-assessment by questionnaire 3 | Reasons and rate for discontinued wear during the study period | during 48 weeks |
| Taipei |
| 105 |
| Taiwan |
| Jiahn-Shing Lee M.D. | Taoyuan | 333 | Taiwan |