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RECRUITING
NCT06781931
NA

DG1 Spectacle Lens for Myopia Progression Control in Children

Sponsor: HOYA Lens Thailand LTD.

View on ClinicalTrials.gov

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

DEVICE

DG1 Spectacle Lens

DG1 spectacle lens, daily wear for 36 months

DEVICE

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