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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of the study is to measure the difference in the lag of accommodation between DOT spectacle lenses and control spectacles.

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 data supports the effectiveness of DOT Spectacle Lenses for Nearsightedness?

Research shows that spectacle lenses with aspherical lenslets can help control myopia (nearsightedness) in children, suggesting that similar technology in DOT Spectacle Lenses might also be effective for managing nearsightedness. ^{1 2 3 4 5}

How do DOT Spectacle Lenses for Nearsightedness differ from other treatments?

DOT Spectacle Lenses are unique because they contain multiple small peripheral elements designed specifically for controlling myopia (nearsightedness) in children, which is different from standard lenses that only correct vision. These lenses aim to manage the progression of myopia by altering how light enters the eye, potentially slowing down the worsening of nearsightedness over time. ^{6 7 8 9 10}

Eligibility Criteria

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

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Comparison between "readables" aspheric spectacle lenses and conventional spherical spectacle lenses for overcorrection of presbyopic single-vision contact lens wearers. [2006]

2. England pubmed.ncbi.nlm.nih.gov

Change in function and spectacle-use 2 months after providing presbyopic spectacles in rural Tanzania. [2021]

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

Effect of patient motivation on near vision in pseudophakic patients. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Visual acuity, near phoria and accommodation in myopic children using spectacle lenses with aspherical lenslets: results from a randomized clinical trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Spectacle lenses with slightly aspherical lenslets for myopia control: clinical trial design and baseline data. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The impact of spectacle lenses for myopia control on visual functions. [2022]

7. England pubmed.ncbi.nlm.nih.gov

One-year myopia control efficacy of spectacle lenses with aspherical lenslets. [2022]

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

Mechanical design of a power-adjustable spectacle lens frame. [2019]

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

Manufacturing Application-Driven Foveated Near-Eye Displays. [2019]

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

Low-vision aid using a high-minus intraocular lens. [2018]