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A prospective, randomised, double-blinded clinical trial was conducted including 115 children (55 male and 60 female) aged 8 to 15 years. The newest multifocal contact lenses were assigned to experimental group, and another commercial dual-focus optical designed contact lenses were assigned to control group to be worn for at least 8 hours per day, 7 days a week, for a period of 1 year. All contact lenses were replaced with new lenses every day. Measurements obtained using a LogMAR vision meter, including automated computerised optometry, handheld retinoscopy, high (96%) and low (12%) contrast sensitivity visual acuity values at a distance, and near-visible acuity values were used to evaluate the corneal curvature using a corneal mapper. Additionally, the axial length(AXL) of the eye was measured, and the tear quality was assessed using a slit lamp, including tear break-up time, tear river height, and observation of blink frequency. Furthermore, the eye's anterior surface was examined by slit lamp using the Efron grading scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Disposable Multifocal Soft Contact lenses, PEGAVISION, Taiwan | Experimental | Subjects will be asked to wear the lenses for 8 hours a day, at least 7 days a week. Contact lenses are worn and replaced every day. All subjects will be followed for 1 year after device allocation and will undergo brief clinical assessments at 1 day, 1 week, 1, 3, 6, 9, and 12 months. |
|
| Omafilcon A, dual-focus optical design, USA | Active Comparator | Subjects will be asked to wear the lenses for 8 hours a day, at least 7 days a week. Contact lenses are worn and replaced every day. All subjects will be followed for 1 year after device allocation and will undergo brief clinical assessments at 1 day, 1 week, 1, 3, 6, 9, and 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soft contact lens | Other | soft contact lens |
|
| 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.(700GL Slit Lamp, Takagi Europe) | 12 months |
Inclusion Criteria:
Subjects must be between the ages of 8 and 15 (both 8 and 15 years old).
Subject's best corrected visual acuity must be at least LogMAR 0.10 or higher in both eyes.
The subject's eyes must be healthy and normal, and "normal eyes" is defined as having the following characteristics.
No topical eye drops are currently being used.
The subject and his/her legal representative (if the subject is under 20 years old) are willing to sign the subject's consent form.
Legal guardians of subjects under 12 years of age are willing to sign the informed consent form.
Meet the following refractive criteria determined by cycloplegic autorefraction at baseline
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min yen Hsu, PhD | Chung Shan Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University Hospital | Taichung | 402 | Taiwan |
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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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