Actively Recruiting
DG1 Spectacle Lens for Myopia Progression Control in Children
Led by HOYA Lens Thailand LTD. · Updated on 2025-06-24
240
Participants Needed
10
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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.
- The subject and parent (or guardian) must attend required study visits and adhere to study requirements.
- 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.
- 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.
- Age of subject at time of parent (or guardian) consent and subject assent: 7 to 10 years old (inclusive).
- Cycloplegic autorefraction spherical equivalent refraction (SER): -1.00 to -5.00 D in each eye at the screening visit.
- Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye at the screening visit.
- Cycloplegic spherical equivalent autorefraction (SER) anisometropia of 1.50 D or less at the screening visit.
- Monocular cycloplegic best corrected distance visual acuity (BCDVA) equal to or better than log MAR 0.10 in each eye at the screening visit.
You will not qualify if you...
- Subjects with allergy to fluorescein, benoxinate, proparacaine, cyclopentolate or tropicamide eye drops.
- Subjects with ocular or systemic abnormalities that might be expected to affect visual functions or refractive development.
- Subjects who have received treatment of myopia control pharmaceutical medication (e.g., atropine), myopia control contact lenses, other myopia control spectacles, orthokeratology lenses, progressive addition lenses, bifocal lenses, or single vision contact lens prior to entry into the study or during the duration of the study.
- Subjects with, or a medical history of, strabismus.
- Subjects with a medical history of binocular vision abnormalities or accommodation abnormalities based on the opinion of the investigator.
- Subjects with, or history of, amblyopia.
- Subjects who have participated in a clinical trial within 30 days prior to entry into this study or during participation.
- Subjects with a history of intraocular surgery.
- Subjects who, in the judgment of the investigator, have any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment.
- Subjects with pathological myopia (myopia that leads to structural changes in the posterior segment of the eye including posterior staphyloma, myopic maculopathy, and high myopia-associated optic neuropathy).
- Individuals from the same household (i.e., siblings), employees (or family members of employees) of the Principal Investigator/site, employees (or family members of employees) of the Sponsor, and non-readers.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here