DG1 Spectacle Lens for Near-sightedness

Recruiting at 9 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of glasses lens, the DG1 spectacle lens, to determine if it can slow the progression of nearsightedness (myopia) in children. Researchers aim to discover if these glasses are more effective than regular single-vision glasses in preventing the deterioration of children's vision over time. Children aged 7 to 10 who are nearsighted and can wear these glasses for about 10 hours a day may be suitable for this study. Participants will undergo regular check-ups over approximately four years to assess the lenses' effectiveness. As an unphased trial, this study provides a unique opportunity for children to potentially benefit from innovative lenses while contributing to significant vision research.

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 prior data suggests that the DG1 spectacle lens is safe for children with myopia?

Research shows that the DG1 spectacle lens is designed to slow the progression of nearsightedness in children. Other studies with similar lenses have shown these lenses to be safe and effective over a year, with no major safety issues reported. Although this specific trial has not yet produced clear results for the DG1 lens, past experiences with similar lenses suggest they are usually well-tolerated. Children in these studies generally do not experience serious side effects, making these lenses a promising option for managing nearsightedness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The DG1 Spectacle Lens is unique because it offers an innovative approach to managing near-sightedness (myopia) compared to traditional single vision lenses. Unlike standard lenses that simply correct vision, the DG1 Spectacle Lens may employ a specialized design or technology aimed at slowing the progression of myopia. Researchers are excited about this treatment because it holds the potential to not only improve current vision but also address the long-term progression of near-sightedness, which could reduce the risk of more severe vision issues later in life.

What evidence suggests that the DG1 spectacle lens is effective for controlling myopia progression in children?

Research shows that special glasses designed to control nearsightedness can significantly slow its progression in children. In this trial, participants will receive either the DG1 Spectacle Lens or regular single-vision glasses. Compared to regular single-vision glasses, these special lenses have reduced the eye's lengthening by about 0.15 mm and slowed the worsening of vision clarity by around 0.31 diopters. This suggests that the DG1 glasses could effectively control the worsening of nearsightedness. Previous studies with similar glasses have demonstrated a nearly 50% reduction in nearsightedness progression over a year, with fewer children experiencing significant vision worsening. These findings provide promising evidence that the DG1 glasses could effectively manage nearsightedness in children. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

Subjects with, or a medical history of, strabismus

I have had eye surgery in the past.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06781931

Study Details | NCT06781931 | DG1 Spectacle Lens for ... 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 ...

2. withpower.com withpower.com/trial/dg1-spectacle-lens-for-near-sightedness-f03c4

DG1 Spectacle Lens for Near-sightedness The goal of this clinical trial is to evaluate the safety and efficacy of the DG1 spectacle lens for myopia progression control in children.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40912901/

Efficacy of spectacle lenses for myopia control: a meta ... Compared with SVLs, myopia control lenses significantly reduced AL (-0.15 mm; 95% CI -0.20 to -0.09; p<0.00001) and SER progression (-0.31 D; 95 ...

4. withpower.com withpower.com/clinical-trials/for-myopia

Top Myopia Clinical Trials | Power The goal of this clinical trial is to evaluate the safety and efficacy of the DG1 spectacle lens for myopia progression control in children. ... effectiveness ...

5. myopiaprofile.com myopiaprofile.com/articles/CARE-spectacles-myopia-control-one-year

CARE myopia control spectacle lenses: one year data Two designs of CARE lenses reduced myopia progression by just under 50% after one year, with only around 15% progressing more than 0.75D.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36126105/

Control of myopia using diffusion optics spectacle lenses 12-month results from this ongoing trial demonstrate the safety and effectiveness of DOT spectacles for reducing myopic progression.

7. centerwatch.com centerwatch.com/clinical-trials/listings/location/united-states/OH/Granville

Granville, Ohio Clinical Research Trials DG1 Spectacle Lens for Myopia Progression Control in Children. Phase. N/A. Span. 263 weeks. Sponsor. HOYA Lens Thailand LTD. Granville, Ohio. Recruiting. READ ...

8. clinconnect.io clinconnect.io/trials/NCT06781931

DG1 Spectacle Lens for Myopia Progression Control in The goal of this clinical trial is to evaluate the safety and efficacy of the DG1 spectacle lens for myopia progression control in children.