DG1 Spectacle Lens for Myopia Progression Control in Children

Launched by HOYA LENS THAILAND LTD. · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a special type of glasses called the DG1 spectacle lens to see if they can help slow down the worsening of myopia (nearsightedness) in children aged 7 to 10 years. Myopia is a common vision problem where distant objects appear blurry. The goal is to find out if wearing these lenses can reduce the increase in myopia compared to regular single-vision glasses. Participants will wear the DG1 lenses for about 10 hours a day and will have regular check-ups over a period of 36 months, with the possibility of continuing for another year to see how their vision changes after the study.

To be eligible, children need to be between 7 and 10 years old, have a specific level of myopia, and be able to wear the glasses consistently. Parents or guardians must be willing to provide consent and ensure their child attends all necessary visits. This study is currently recruiting participants, and it's important to note that the children will be randomly assigned to either the DG1 lenses or regular glasses without knowing which one they received. This helps researchers understand the true effects of the DG1 lenses on myopia progression.

Gender

ALL

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.