A Randomized Controlled Study on the Effectiveness, Safety and Adaptability of Double Helix Design Defocus Lens Spectacle Frames for Correction of Visual Acuity in Children and Adolescents, and Control of Myopia.
This study uses 1.585 double helix defocus lens PC lenses with a unique optical design that includes a globally coherent visible area and complementary left and right helices that can form clear images. In addition, the helical arrangement and reduced slit area can generate defocusing signals, inhibiting the development of myopia. Therefore, based on previous research, this study plans to evaluate the safety and effectiveness of 1.585 double helix defocus lens PC frame eyeglasses in controlling the progression of myopia in children and adolescents through a randomized controlled clinical trial.
⁃ Race: Chinese children and adolescents.
⁃ Age 6-13 years, gender unrestricted.
⁃ Cycloplegic refraction SER: -0.75DS\
• 5.0DS in both eyes.
⁃ Best corrected visual acuity of both eyes reaches 1.0 (0.00 logMAR 6/6).
⁃ Refractive astigmatism and astigmatism are no more than 1.5D.
⁃ During the study period, willing to wear glasses provided by the researcher only (\>10 hours) and without additional interventions.
⁃ Willing to be randomly assigned.
⁃ Able to sign an informed consent form with the accompaniment and understanding of parents or guardians.