A Double Masked, Randomised, Longitudinal Comparative Study to Evaluate the Wearability and Myopia Progression of ZEISS MyoCare Spectacle Lenses Versus Two ZEISS Single Vision Spectacle Lenses in Children With Myopia
This is a clinical trial evaluating the wearability and effectiveness of three types of ZEISS spectacle lenses in controlling myopia progression. This study compares ZEISS MyoCare spectacle lenses with two types of single-vision spectacle lenses over a 6-month period. This trial aims to evaluate how well these lenses are worn and their impact on myopia progression, including changes in axial length and refractive error. Participants will be randomly assigned to wear one of three types of ZEISS spectacle lenses. The study will require five visits to the eye clinic over a 6-month period and two virtual follow-up visits.
• be accompanied by a parent or guardian who is able to read and comprehend Vietnamese/English and sign a record of informed consent/assent;
• at baseline, be within the age range of 7 to 13 years old inclusive;
• be diagnosed as myopic having cycloplegic spherical equivalent between -0.75 dioptre (D) and -5.00 dioptre (D);
• astigmatism ≤1.50D;
• anisometropia of not more than 1.50D;
• be willing to comply with the wearing of clinical trial spectacles and clinical trial visit schedule as directed by the investigator;
• have ocular findings deemed to be normal;
• vision correctable to at least 0.8 or better in each eye with spectacles.