DG1 spectacle lens for controlling myopia 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

This study is testing if a special pair of glasses can help slow down worsening eyesight in children aged 7 to 10 who are nearsighted.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 7 Years to 10 Years
• Sex: All
• Sponsor: HOYA Lens Thailand LTD. (Industry-sponsored)
• Locations: 10 sites (Irvine, California and 9 other locations)
• Trial ID: NCT06781931 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of the DG1 spectacle lens in slowing myopia progression in children aged 7 to 10 years. Participants will be randomly assigned to wear either the DG1 lens or single vision spectacles for an average of 10 hours a day over a 36-month period, with follow-up visits scheduled at regular intervals. The study aims to measure differences in refractive error and axial elongation between the two groups to determine the effectiveness of the DG1 lens.

Who should consider this trial

Good fit: Ideal candidates are children aged 7 to 10 years with myopia between -1.00 to -5.00 D and minimal astigmatism.

Not a fit: Patients with myopia outside the specified range or those unable to comply with study requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a new method for controlling myopia progression in children, potentially reducing the risk of severe vision impairment later in life.

How similar studies have performed: Other studies have shown promise in using specialized lenses to manage myopia progression, indicating that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Subject and parent (or guardian) able and willing to provide assent and consent respectively.
2. The subject and parent (or guardian) must attend required study visits and adhere to study requirements.
3. 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.
4. 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.
5. Age of subject at time of parent (or guardian) consent and subject assent: 7 to 10 years old (inclusive).
6. Cycloplegic autorefraction spherical equivalent refraction (SER): -1.00 to -5.00 D in each eye at the screening visit.
7. Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye at the screening visit.
8. Cycloplegic spherical equivalent autorefraction (SER) anisometropia of 1.50 D or less at the screening visit.
9. Monocular cycloplegic best corrected distance visual acuity (BCDVA) equal to or better than log MAR 0.10 in each eye at the screening visit.

Exclusion Criteria:

1. Subjects with allergy to fluorescein, benoxinate, proparacaine, cyclopentolate or tropicamide eye drops.
2. Subjects with ocular or systemic abnormalities that might be expected to affect visual functions or refractive development.
3. 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.
4. Subjects with, or a medical history of, strabismus.
5. Subjects with a medical history of binocular vision abnormalities or accommodation abnormalities based on the opinion of the investigator.
6. Subjects with, or history of, amblyopia.
7. Subjects who have participated in a clinical trial within 30 days prior to entry into this study or during participation.
8. Subjects with a history of intraocular surgery.
9. 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.
10. 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).
11. 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.

Where this trial is running

Irvine, California and 9 other locations

• Irvine Vision Center — Irvine, California, United States (Recruiting)
• Columbia Eye Associates & Family Focus Eye Care — Gainesville, Florida, United States (Recruiting)
• Coan Eye Care and Optical Boutique — Ocoee, Florida, United States (Recruiting)
• Illinois College of Optometry — Chicago, Illinois, United States (Recruiting)
• Complete Eye Care of Medina — Medina, Minnesota, United States (Recruiting)
• Oculus Research, Inc. — Garner, North Carolina, United States (Recruiting)
• ProCare Vision Centers, Inc. — Granville, Ohio, United States (Recruiting)
• EyeCare Professionals of Powell — Powell, Ohio, United States (Recruiting)
• Southern College of Optometry — Memphis, Tennessee, United States (Recruiting)
• Virginia Pediatric Eye Center — Virginia Beach, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: William Zhou, Global Head of Clinical Affairs

Conditions Myopia