DG1 Spectacle Lens for Near-sightedness

Recruiting at 8 trial locations

Overseen By William Zhou, Global Head of Clinical Affairs

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: HOYA Lens Thailand LTD.

Must not be taking: Atropine

Disqualifiers: Strabismus, Amblyopia, Pathological myopia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 36

Duration: 36 months

240 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used myopia control medications or lenses before or during the study.

What makes the DG1 Spectacle Lens treatment unique for near-sightedness?

The DG1 Spectacle Lens is unique because it likely uses a gradient refractive index (GRIN) technology, which allows for precise control of light focusing, potentially offering better vision correction compared to traditional lenses. This technology can provide a more customized visual experience by adjusting the lens's refractive properties across its surface. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for children with near-sightedness (myopia). It's not clear what specific age range or other health conditions might be included or excluded, as the provided information lacks detailed eligibility criteria.

Inclusion Criteria

Cycloplegic spherical equivalent autorefraction (SER) anisometropia of 1.50 D or less at the screening visit

Subject and parent (or guardian) able and willing to provide assent and consent respectively

Subject and parent (or guardian) must attend required study visits and adhere to study requirements

Exclusion Criteria

Subjects with, or a medical history of, strabismus

Subjects who have participated in a clinical trial within 30 days prior to entry into this study or during participation

I have had eye surgery in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear DG1 spectacle lenses or single vision spectacle lenses to evaluate myopia progression control

36 months

Regularly scheduled visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

36-month follow-up visit

Rebound Evaluation

Participants continue in the study for an additional 12 months to evaluate rebound effects

12 months

Treatment Details

Interventions

• DG1 Spectacle Lens

Trial Overview The study tests if DG1 spectacle lenses can slow down myopia progression in children compared to standard single vision lenses. Kids will wear these glasses and have their eye growth checked over a period of 36 months, with an additional 12-month follow-up.

Participant Groups

Group I: DG1 Spectacle Lens Experimental Treatment 1 Intervention

Group II: Single Vision Spectacle Lens Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

HOYA Lens Thailand LTD.

Lead Sponsor

Trials

4

Recruited

670+

Findings from Research

The study establishes a theoretical relationship between lateral magnification and object distance for gradient refractive index (GRIN) lenses, specifically square and rod types, which is crucial for understanding their optical properties.

The central refractive indices of the GRIN square lens and GRIN rod lens were measured to be 1.611 and 1.609, respectively, with high accuracy (to 10^-3), along with their focusing constants, indicating precise control over light manipulation in these lenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gradient refractive index square lenses. II. Imaging. Liu, A., Lv, H., Tong, J., et al.[2018]

A new bifocal lens has been developed that includes an additional prism in the near segment, enhancing close-range vision.

This lens can provide increased magnification of up to +8.0 diopters, potentially improving the visual experience for tasks requiring detailed close-up work.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A new bifocal lens with the effect of a prism and a magnifying-lens in the near segment (author's transl)]. Reiner, J.[2009]

A new general equation for the local magnification matrix of optical instruments, like spectacle lenses, has been developed to account for large gaze angles and oblique light incidence, which is crucial for everyday use.

This equation includes correction factors for oblique rays that are not considered in traditional paraxial optics, making it applicable to a wider range of optical scenarios and improving the understanding of how light interacts with complex lens systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical magnification matrix: near objects and strongly oblique incidence. Becken, W., Altheimer, H., Esser, G., et al.[2008]

The study modeled an accommodating intraocular lens (IOL) that can achieve near vision through anterior movement within the capsular bag, showing that this design can effectively provide accommodation.

Results indicated that the amount of accommodation is directly related to lens movement and is influenced by corneal and IOL powers, while image quality remains largely unaffected by the degree of accommodation achieved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical analysis of an accommodating intraocular lens. Hunter, JJ., Campbell, MC., Geraghty, E.[2008]

In a study of 110 myopic individuals with esophoria, it was found that increasing the strength of near addition lenses (from 0D to +2.50D) significantly reduced both accommodative lag and near phoria, indicating improved visual comfort and performance.

The research established a linear correlation between the optimal strength of near addition lenses and the initial levels of accommodative lag and near phoria, providing a mathematical basis for customizing lens prescriptions for young myopic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The strategy of determining the customized near addition lens for juvenile esophoric myopes]. Wang, DM., Wang, P., Lan, WZ., et al.[2010]

References

1. United States pubmed.ncbi.nlm.nih.gov

Gradient refractive index square lenses. II. Imaging. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

[A new bifocal lens with the effect of a prism and a magnifying-lens in the near segment (author's transl)]. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Optical magnification matrix: near objects and strongly oblique incidence. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Optical analysis of an accommodating intraocular lens. [2008]

5. China pubmed.ncbi.nlm.nih.gov

[The strategy of determining the customized near addition lens for juvenile esophoric myopes]. [2010]