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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
Led by HOYA Lens Thailand LTD. · Updated on 2025-06-24
240
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the DG1 spectacle lens in slowing the progression of myopia in children aged 7 to 10 years. The study aims to compare the DG1 lens with standard single vision spectacles by measuring changes in eye refraction and axial length over time. This clinical trial involves a randomized, double-masked design to ensure unbiased results and will be sponsored by HOYA Lens Thailand LTD. Participants will be randomly assigned to wear either the DG1 spectacle lens or a single vision spectacle lens. Both groups will wear their assigned lenses daily for 36 months. After completing this period, all participants will continue in the study for an additional 12 months to evaluate any rebound effects in myopia progression. The study focuses on lens wear as the main intervention for myopia control. Throughout the study, children will attend scheduled visits for eye measurements including cycloplegic spherical equivalent refraction and axial length assessments. Visual acuity will also be checked at 24 months. Researchers will monitor adherence by confirming that participants wear the spectacles for an average of 10 hours per day. The primary outcomes assessed at 36 months are changes in eye refraction and axial length, with safety and efficacy observed over the total 48-month study duration including the rebound evaluation.
CONDITIONS
Brief Title
DG1 Spectacle Lens for Myopia Progression Control in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject and parent or guardian able and willing to provide assent and consent respectively
- Subject and parent or guardian must attend required study visits and follow study requirements
- Parent or guardian understands and accepts random assignment to study groups
- Subject able and willing to wear provided spectacles for about 10 hours daily throughout the study
- Age between 7 and 10 years at time of consent and assent
- Cycloplegic spherical equivalent refraction between -1.00 and -5.00 diopters in each eye at screening
- Cycloplegic astigmatism of 1.50 diopters or less in each eye at screening
- Cycloplegic anisometropia of 1.50 diopters or less at screening
- Best corrected distance visual acuity of log MAR 0.10 or better in each eye at screening
You will not qualify if you...
- Allergy to fluorescein, benoxinate, proparacaine, cyclopentolate, or tropicamide eye drops
- Ocular or systemic abnormalities likely to affect vision or refractive development
- Prior or current treatment with myopia control medications, contact lenses, or special spectacle lenses
- History or presence of strabismus
- History of binocular vision or accommodation abnormalities
- History of amblyopia
- Participation in another clinical trial within 30 days before or during this study
- History of intraocular surgery
- Emotional, physiological, or anatomical conditions preventing participation or study suitability
- Pathological myopia with structural eye changes
- Individuals from the same household, employees or family of employees of investigator or sponsor, and non-readers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 months
Participants wear either the DG1 spectacle lens or the single vision spectacle lens daily as part of the trial intervention.
Regular visits to monitor lens wear and eye health as scheduled by the study team
Duration - 12 months
Participants are observed for one year following the intervention to evaluate any changes after stopping lens wear.
Periodic visits as scheduled by the study team
Trial Site Locations
Total: 10 locations
1
Irvine Vision Center
Irvine, California, United States, 92618
Actively Recruiting
2
Columbia Eye Associates & Family Focus Eye Care
Gainesville, Florida, United States, 32605
Actively Recruiting
3
Coan Eye Care and Optical Boutique
Ocoee, Florida, United States, 34761
Actively Recruiting
4
Illinois College of Optometry
Chicago, Illinois, United States, 60616
Actively Recruiting
5
Complete Eye Care of Medina
Medina, Minnesota, United States, 55340
Actively Recruiting
6
Oculus Research, Inc.
Garner, North Carolina, United States, 27529
Actively Recruiting
7
ProCare Vision Centers, Inc.
Granville, Ohio, United States, 43023
Actively Recruiting
8
EyeCare Professionals of Powell
Powell, Ohio, United States, 43065
Actively Recruiting
9
Southern College of Optometry
Memphis, Tennessee, United States, 38104
Actively Recruiting
10
Virginia Pediatric Eye Center
Virginia Beach, Virginia, United States, 23452
Actively Recruiting
Research Team
W
William Zhou, Global Head of Clinical Affairs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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