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The study is aimed to observe the short-term clinical performance of MiSightâ„¢ multifocal soft contact lens compared with Proclearâ„¢ 1day, including objective examination, subjective acceptability of wearers, and doctors' evaluation of the clinical manifestations of lenses.
Compared with Proclearâ„¢ 1day, observe the short-term clinical performance of MiSightâ„¢ multifocal soft contact lens including objective examination, subjective acceptability of wearers, and doctors' evaluation of the clinical manifestations of lenses in 1 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | one group for contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiSight mutifocal soft contact lens | Device | Subjects will wear MiSightâ„¢ multifocal soft contact lenses for 1 month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the contrast sensitivity visual function (CSF) relative to baseline at 1 month | Proclear baseline;VMisight baseline; 1 week; 1month |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' subjective acceptability to multifocal soft contact lens | The patients will be asked to complete questionnaires at each visit regarding vision, lens comfort, the difficulty of lens insert and removal, etc. of the multifocal contact lens. | Proclear baseline; Misight baseline; 1 week; 1month |
| Doctors' clinical evaluation to multifocal soft contact lens |
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Inclusion Criteria:
• Prior to being considered eligible to participate in this study, each subject MUST:
Be between 8 and 12 years of age inclusive at the baseline examination.
Have:
Have their parent or legal guardian:
Along with their parent or guardian, be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol.
Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study.
Agree to wear the assigned contact lenses for the duration of the 1-month study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.)
Meet the following refractive criteria determined by cycloplegic autorefraction at baseline:
Best-corrected visual acuity :≥0.8.
Exclusion Criteria:
• Subjects may not be considered eligible if ANY of the following apply:
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| Name | Affiliation | Role |
|---|---|---|
| Xiao Yang, PhD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | 510060 | China |
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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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| Proclear 1 Day soft contact lens | Device | Proclearâ„¢ 1 Day soft contact lens will be worn for baseline evaluation. |
|
The doctors will be asked to complete questionnaires regarding the difficulty of fitting procedure and general impression of the multifocal contact lens. |
| Proclear baseline; Misight baseline; 1 week; 1month |
| Change in the contact lens corrected visual acuity relative to baseline | Patients will wear contact lens when they are tested | Proclear baseline;Misight baselineï¼›1 week;1month |