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| Name | Class |
|---|---|
| Suzhou Mingshi Optical Technology Co., Ltd | UNKNOWN |
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The objective of this clinical trial was to evaluate the efficacy and safety of defocusing lenses for delaying myopia progression in children and adolescents. A total of 156 subjects meeting the requirements of the study protocol were included. During the study, subjects were required to wear the test product (defocus lens A or defocus lens B) or the control product (aspheric lens) for 12 months, and regular follow-up was required during the wearing process, including various ophthalmological examinations and subjective feelings about wearing the lens. During the study period, the product status, ocular conditions, adverse events and serious adverse events were continuously observed to evaluate the safety and effectiveness of the test product in clinical use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial Group A | Experimental | 12-month defocusing lens (microstructured lens A) |
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| Trial Group B | Experimental | 12-month defocusing lens (microstructured lens B) |
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| Control group | Active Comparator | 12 months wearing aspherical lens |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microstructure lens A | Device | Subjects randomized to Trial Group A will be required to wear microstructural lens A (microstructural design type with low defocus ratio) for 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change value of equivalent spherical lens after cycloplegia (subjective refraction) | Subjective optometry after ciliary paralysis was measured by blind researchers (who did not participate in the screening and treatment of subjects), and the final equivalent spherical degree was recorded, and the difference between the subjective optometric equivalent spherical results after ciliary paralysis in the baseline period (before wearing lenses) was recorded. | After 12 months of wearing glasses |
| Measure | Description | Time Frame |
|---|---|---|
| Equivalent spherical lens strength after ciliary paralysis (subjective optometry) | The subjects were subjected to subjective refraction after ciliary paralysis by the investigator, and the corresponding value of equivalent spherical mirror was recorded. | Screening period and wearing glasses for 3 months, 6 months, 12 months |
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Inclusion Criteria:
Participants must meet all criteria to be enrolled in the study at the screening visit:
Exclusion Criteria:
Subjects who met any of the following criteria at the time of the screening visit were excluded from the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingyan Yao | Contact | +86 13862578532 | yaojingyan@suda.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | District, Suzhou City, Jiangsu Province | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Microstructure lens B | Device | Subjects randomized to Trial B will be required to wear microstructural lens B (high defocus ratio microstructural design type) for 12 months |
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| Control group | Other | Subjects randomized to the control group will be required to wear aspherical single-light lenses for 12 months |
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| Axis length |
The length of the eye axis was measured by the researcher and the corresponding value was recorded. |
| Screening period and wearing glasses for 3 months, 6 months, 12 months |
| Regulating sensitivity | The researchers conducted sensitivity adjustment tests on the subjects and recorded the test results. | Screening period and wearing glasses for 3 months, 6 months, 12 months |
| Stereopsis | The researchers tested the subjects' near-stereoscopic vision and recorded the test results. | Screening period and wearing glasses for 3 months, 6 months, 12 months |
| Corneal curvature | The subjects were examined for corneal curvature by the investigator and the results were recorded. | Screening period and wearing glasses for 3 months, 6 months, 12 months |
| Subjective perception rating for wearing a mirror | According to their subjective feelings, the subjects were evaluated by Visual Analogue Scales (VAS). The VAS score is on a 10cm scale marked with the words "0" and "10" at each end. "0" is comfortable, "10" is unbearable. | On the day of wearing the glasses and 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months after wearing the glasses |
| D008722 | Methods |