Study of Two Diverse Segments Defocus Optimization Spectacle Lenses to Slow Myopia in Children Ages 6 to 14

What this Trial Is About

Researchers are evaluating the effectiveness and safety of two types of Diverse Segments Defocus Optimization D.S.D.O. spectacle lenses in slowing the progression of myopia in children aged 6 to 14 years. The study aims to determine whether these lenses can reduce the worsening of myopia by measuring changes in cycloplegic refraction and axial length over a 12-month period. The research compares two optical designs of D.S.D.O. lenses to see which design better controls myopia progression. Participants will be randomly assigned to wear one of the two D.S.D.O. spectacle lens designs daily for 12 months, except during sleep or unavoidable situations. These lenses provide full refractive correction for distance vision while modifying peripheral retinal defocus to potentially slow myopia. The study includes visits at baseline and follow-up assessments at 3, 6, 9, and 12 months to monitor progress and safety. During the study, participants will attend clinic visits for comprehensive eye exams and maintain a daily diary to record wear time, visual symptoms, and any adverse events. Researchers will closely monitor changes in spherical equivalent refraction as the primary outcome to assess lens effectiveness. Safety and adherence to lens wear and follow-up visits will also be tracked throughout the trial period, which lasts one year.

Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression