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DG1 Spectacle Lens for Myopia Progression Control in Children
NCT06781931 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DEVICE DG1 Spectacle Lens
- DEVICE Single Vision Spectacle Lens
Study Locations (10)
Florida
- Columbia Eye Associates & Family Focus Eye Care — Gainesville
- Coan Eye Care and Optical Boutique — Ocoee
Ohio
- ProCare Vision Centers, Inc. — Granville
- EyeCare Professionals of Powell — Powell
California
- Irvine Vision Center — Irvine
Illinois
- Illinois College of Optometry — Chicago
Minnesota
- Complete Eye Care of Medina — Medina
North Carolina
- Oculus Research, Inc. — Garner
Tennessee
- Southern College of Optometry — Memphis
Virginia
- Virginia Pediatric Eye Center — Virginia Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2025-01-21 |
| Est. Completion | 2030-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06781931
The ClinicalTrials.gov registry entry for NCT06781931 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HOYA Lens Thailand, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Myopia appearing as the primary indexed condition, and to 2 interventions — of which DG1 Spectacle Lens is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06781931 reports 10 study locations spanning 8 distinct geographic areas — top geographies include Florida, Ohio, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06781931 about?
NCT06781931 is a clinical study titled "DG1 Spectacle Lens for Myopia Progression Control in Children". 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 cyc...
What is the current status of trial NCT06781931?
This trial is currently recruiting. It is a NA study. The enrollment target is 240 participants. The study started on 2025-01-21. Estimated completion is 2030-01.
What conditions does trial NCT06781931 study?
This clinical trial studies the following conditions: Myopia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06781931?
The interventions under investigation include: DG1 Spectacle Lens (DEVICE), Single Vision Spectacle Lens (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06781931?
This trial is sponsored by HOYA Lens Thailand, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06781931 being conducted?
This trial has 10 study locations across California, Florida, Illinois, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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