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DG1 Spectacle Lens for Myopia Progression Control in Children
Sponsor: HOYA Lens Thailand LTD.
Summary
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.
Official title: DG1 Spectacle Lens for Myopia Progression Control in Children: A Three-year Multicenter, Prospective, Randomized, Double-masked, Controlled Clinical Trial to Evaluate the Efficacy and Safety Followed by a One-year Rebound Evaluation
Key Details
Gender
All
Age Range
7 Years - 10 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2025-01-21
Completion Date
2030-01
Last Updated
2025-06-24
Healthy Volunteers
No
Conditions
Interventions
DG1 Spectacle Lens
DG1 spectacle lens, daily wear for 36 months
Single Vision Spectacle Lens
Single vision spectacle lens, daily wear for 36 months
Locations (10)
Irvine Vision Center
Irvine, California, United States
Columbia Eye Associates & Family Focus Eye Care
Gainesville, Florida, United States
Coan Eye Care and Optical Boutique
Ocoee, Florida, United States
Illinois College of Optometry
Chicago, Illinois, United States
Complete Eye Care of Medina
Medina, Minnesota, United States
Oculus Research, Inc.
Garner, North Carolina, United States
ProCare Vision Centers, Inc.
Granville, Ohio, United States
EyeCare Professionals of Powell
Powell, Ohio, United States
Southern College of Optometry
Memphis, Tennessee, United States
Virginia Pediatric Eye Center
Virginia Beach, Virginia, United States