RECRUITING

DG1 Spectacle Lens for Myopia Progression Control in Children

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-21

Study Completion:2030-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06781931

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 10 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

William Zhou, Global Head of Clinical Affairs

CONTACT

833-341-5463

william.zhou@hoya.com

Study Locations (Sites)

Columbia Eye Associates & Family Focus Eye Care

Gainesville, Florida, 32605

United States

Illinois College of Optometry

Chicago, Illinois, 60616

United States

Complete Eye Care of Medina

Medina, Minnesota, 55340

United States

Oculus Research, Inc.

Garner, North Carolina, 27529

United States

EyeCare Professionals of Powell

Powell, Ohio, 43065

United States

Southern College of Optometry

Memphis, Tennessee, 38104

United States

Virginia Pediatric Eye Center

Virginia Beach, Virginia, 23452

United States

Collaborators and Investigators

Sponsor: HOYA Lens Thailand LTD.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-21

Study Completion Date2030-01

Study Record Updates

Study Start Date2025-01-21

Study Completion Date2030-01

Terms related to this study

Additional Relevant MeSH Terms

Myopia