HOYA Lens Thailand LTD.
The goal of this clinical trial is to evaluate the safety and efficacy of the DG1 spectacle lens for myopia progression control in children. * To assess if the DG1 lens will slow the progression of myopia through an adjusted mean difference (e.g., age and baseline SER) of approximately 0.75D in cycloplegic spherical equivalent autorefraction refractive error compared to single-vision (SV) spectacles over the study period. * To assess if DG1 lens will slow the progression of myopia through an adjusted mean difference (e.g., age and baseline SER) of approximately 0.3mm in axial elongation compared to SV over the study period. The clinical trial will compare DG1 spectacle lens to single vision spectacle lens. Participants will wear spectacle lenses and return for visits at regularly scheduled intervals through a 36-month follow up visit. All subjects who complete the 36-month visit will continue in the study for an additional 12 months for the rebound evaluation.
Inclusion Criteria: 1. Subject and parent (or guardian) able and willing to provide assent and consent respectively. 2. The subject and parent (or guardian) must attend required study visits and adhere to study requirements. 3. Parent (or guardian) understands and accepts random allocation of grouping, and that subject and parent (or guardian) will not be told the group which the subject is randomized to. 4. The subject is able and willing to wear provided frames and lenses (spectacles), for an average of 10 hours per day for the entirety of the study. 5. Age of subject at time of parent (or…
DG1 spectacle lens, daily wear for 36 months
Single vision spectacle lens, daily wear for 36 months