An interventional study of Microstructure lens A and Microstructure lens B in Myopia, sponsored by Suzhou Kerui Medical Technology Co., Ltd. Recruiting at 1 site in China. Open to participants aged 8 Years to 13 Years. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by Suzhou Kerui Medical Technology Co., Ltd · Not applicable, Interventional, and Supportive care
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 156 is above the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Suzhou Kerui Medical Technology Co., Ltd is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
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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:
12-month defocusing lens (microstructured lens A)
Device: Microstructure lens A
12-month defocusing lens (microstructured lens B)
Device: Microstructure lens B
12 months wearing aspherical lens
Other: Control group
Subjects randomized to Trial Group A will be required to wear microstructural lens A (microstructural design type with low defocus ratio) for 12 months
Subjects randomized to Trial B will be required to wear microstructural lens B (high defocus ratio microstructural design type) for 12 months
Subjects randomized to the control group will be required to wear aspherical single-light lenses for 12 months
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.
Time frame: After 12 months of wearing glasses
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.
Time frame: Screening period and wearing glasses for 3 months, 6 months, 12 months
Axis length
The length of the eye axis was measured by the researcher and the corresponding value was recorded.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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Suzhou Kerui Medical Technology Co., Ltd