A Prospective, Single-center, Randomized, Double-blind, Controlled, Optimal Clinical Study to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression
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.
⁃ Participants must meet all criteria to be enrolled in the study at the screening visit:
• Age 8\
⁃ 13 years old (including boundary values), gender is not limited;
• The spherical degree of subjective optometry in both eyes with cycloplegic muscle paralysis was between -1.00D and -6.00D (including the boundary value) (based on the mean value of subjective optometry), and the equivalent spherical difference of both eyes was less than 1.50D;
• Optimal corrected visual acuity ≥1.0 in left and right eye after ciliary muscle paralysis;
• In both eyes with cycloplegia, the degree of the column lens was ≤1.50 days;
• Voluntarily participate in the clinical study, sign the informed consent, and obtain the written consent of the guardian;