RecruitingNot ApplicableNCT06781931

DG1 Spectacle Lens for Myopia Progression Control in Children

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


Sponsor

HOYA Lens Thailand LTD.

Enrollment

240 participants

Start Date

Jan 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 7 YearsMax Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called DG1 Spectacle Lens and a medical device called Single Vision Spectacle Lens for people with myopia. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEDG1 Spectacle Lens

DG1 spectacle lens, daily wear for 36 months

DEVICESingle 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06781931


Related Trials