Apply to Trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

30 Participants Needed

DOT Spectacle Lenses for Nearsightedness
(ASH-2 Trial)

Overseen ByAsiya Jabeen

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: SightGlass Vision, Inc.

Must not be taking: Atropine eye drops

Disqualifiers: Myopia control, Amblyopia, Diabetes, others

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

Trial Summary

What is the purpose of this trial?

The objective of the study is to measure the effect of Diffusion Optics Technology (DOT) spectacle lenses on the choroidal thickness and choroidal vascularity index compared to control lenses.

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, like Atropine eye drops, you may not be eligible to participate.

What data supports the effectiveness of the DOT Pattern Spectacle Lens treatment for nearsightedness?

Research on a novel multi-segment spectacle lens, similar to the DOT Pattern Spectacle Lens, shows that it can slow the progression of myopia (nearsightedness) by using multiple small zones to improve optical properties.¹ ² ³ ⁴ ⁵

What makes DOT Pattern Spectacle Lenses unique for treating nearsightedness?

DOT Pattern Spectacle Lenses are unique because they use multiple small zones within the lens to slow the progression of myopia (nearsightedness), which is different from traditional lenses that primarily focus on correcting vision without addressing progression.³ ⁶ ⁷ ⁸ ⁹

Eligibility Criteria

This trial is for children aged 8-14 who can read or understand an assent document, have a parent or guardian to sign permission, and have near-sightedness within specific limits (+1.00D to -1.00D). They must be able to follow instructions.

Inclusion Criteria

Are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;

Are able to read (or be read to), understand and sign the assent document;

I am between 8 and 14 years old.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Diffusion Optics Technology (DOT) spectacle lenses or control lenses to measure their effect on choroidal thickness and choroidal vascularity index

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in choroidal thickness and choroidal vascularity index at 30 and 60 minutes after baseline

1 day

2 visits (in-person)

Treatment Details

Interventions

Control Spectacle Lens
Diffusion Optics Technology (DOT) Pattern Spectacle Lens

Trial OverviewThe study tests if DOT spectacle lenses affect the thickness and vascularity of the choroid (a part of the eye) compared to standard control lenses in children with near-sightedness.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment 1 - Diffusion Optics Technology (DOT) PatternExperimental Treatment1 Intervention

Group II: Treatment 2 - Control SpectaclesActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

SightGlass Vision, Inc.

Lead Sponsor

Trials

Recruited

1,100+

University of Waterloo

Collaborator

Trials

132

Recruited

221,000+

Findings from Research

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]