DOT Spectacle Lenses for Nearsightedness

(ASH Trial)

Overseen By Jill Woods, MCOptom

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: SightGlass Vision, Inc.

Must not be taking: Atropine eye drops

Disqualifiers: Myopia control, Amblyopia, Ocular disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 90 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of glasses to assess their impact on the eyes' ability to focus on nearby objects. Participants will wear either DOT spectacle lenses or regular glasses to measure differences in focus adjustment. The trial seeks young individuals with normal vision (neither too nearsighted nor farsighted) who haven't undergone recent eye treatments. Those without treatments for myopia in the past year and without conditions like lazy eye may qualify. As an unphased trial, this study provides a unique opportunity to contribute to understanding vision correction in young people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using any medications that might affect the study results, you may not be eligible to participate.

What prior data suggests that DOT spectacle lenses are safe for nearsightedness?

Research has shown that DOT spectacle lenses are safe for use. A 12-month study found that these lenses not only are safe but also help slow the progression of nearsightedness. Another study found no serious eye problems in children who wore these lenses for 18 months. These findings suggest that DOT spectacle lenses are well-tolerated and have a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about DOT Spectacle Lenses for nearsightedness because they offer a new approach to correcting vision. Unlike traditional corrective lenses that simply refocus light on the retina, DOT Spectacle Lenses use a special dot pattern to potentially slow down the progression of nearsightedness. This innovative design could not only correct vision but also address the underlying progression of the condition, which is something standard lenses do not do. This dual action is what makes DOT Spectacle Lenses a promising option for those looking to manage their nearsightedness more effectively.

What evidence suggests that this trial's treatments could be effective for nearsightedness?

Research has shown that DOT spectacle lenses, one of the treatments in this trial, effectively control nearsightedness (myopia) in children. Studies have found that these lenses significantly slow the progression of myopia over time. For example, more than half of the children who wore DOT lenses did not experience significant worsening of their nearsightedness over an 18-month period. Additionally, the lenses reduced myopia progression over 36 months in children as young as six years old. These findings suggest that DOT lenses can be a powerful tool for managing myopia in young patients. Participants in this trial will receive either DOT spectacle lenses or control spectacles to evaluate their effectiveness. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for children and teenagers aged 6-18 who can read or understand consent documents, with nearsightedness within specific limits (+1.00D to -1.00D). They must be able to follow instructions and have no history of myopia treatment in the past year, amblyopia, binocular vision disorders, active eye diseases/infections, or systemic conditions like diabetes that could affect results.

Inclusion Criteria

Should be emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D.

I am under 17 and my parent or guardian can sign the consent form.

Have a history of myopia control treatment in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants are fitted with either DOT spectacle lenses or control spectacles to measure the lag of accommodation

90 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any immediate effects post-treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Control Spectacles
• DOT Spectacle Lenses

Trial Overview

The study aims to compare how DOT spectacle lenses versus control spectacles affect the lag of accommodation (eye's ability to focus on close objects) in young individuals with near-sightedness.

How Is the Trial Designed?

Group I: Treatment 1 - DOT Pattern Experimental Treatment 1 Intervention

Spectacle lens or treatment 1

Group II: Treatment 2 - Control Spectacles Active Control 1 Intervention

Comparator lens or control arm

Who Is Running the Clinical Trial?

SightGlass Vision, Inc.

Lead Sponsor

Trials

11

Recruited

1,100+

University of Waterloo

Collaborator

Trials

132

Recruited

221,000+

Published Research Related to This Trial

Power-adjustable spectacle lenses utilizing the Alvarez-Lohmann principle offer a cost-effective solution for measuring and correcting refractive errors in vision.

A newly designed mechanical frame enhances the functionality of these lenses by allowing for adjustment of interpupillary distance, and it can be produced using affordable plastic injection molding techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical design of a power-adjustable spectacle lens frame. Zapata, A., Barbero, S.[2019]

Citations

1.

sightglassvision.com

sightglassvision.com/releases/academy-25-dot-spectacle-lens-18-month-data-affirm-powerful-myopia-control/

Academy '25: DOT™ Spectacle Lens 18-Month Data Affirm ...

12-month results from a study of North American children and a study of Chinese children showed that DOT lenses slowed myopic progression but ...

2.

reviewofmm.com

reviewofmm.com/sightglass-visions-18-month-data/

SightGlass Vision's 18-Month Data on DOT Spectacles ...

The data showed that more than half of children wearing DOT spectacle lenses experienced no clinically meaningful myopia progression—nearly four ...

3.

optometrytimes.com

optometrytimes.com/view/sightglass-vision-studies-find-dot-spectacle-lenses-as-highly-effective-for-myopia-management-show-no-evidence-of-rebound

SightGlass Vision studies find DOT spectacle lenses ...

Previous findings have demonstrated that the DOT lenses significantly reduce myopia progression over 36 months in children as young as 6 years ...

4.

myopiaprofile.com

myopiaprofile.com/articles/DOT-lens-four-year-efficacy

Myopia control with diffusion optics spectacle lenses

Conclusions: DOT 0.2 spectacle lenses are safe and effective at reducing myopia progression, with additional benefit evident in year 4 of wear.

5.

bjo.bmj.com

bjo.bmj.com/content/early/2025/09/05/bjo-2025-327629

Efficacy of spectacle lenses for myopia control: a meta- ...

DIMS lenses demonstrated a statistically significant reduction in SER in our meta-analysis, supporting their effectiveness in slowing myopia ...

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.

bmjophth.bmj.com

bmjophth.bmj.com/content/9/1/e001790

Control of myopia using diffusion optics spectacle lenses

Conclusion DOT 0.2 spectacle lenses are safe and effective at reducing myopia progression, with additional benefit evident in year 4 of wear.