Novel Spectacle Lenses for Nearsightedness

JH
Overseen ByJennifer Hill
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: SightGlass Vision, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well children perform daily activities while wearing special glasses designed to slow nearsightedness, compared to regular glasses. The study will test two types of impact-resistant spectacle lenses, including Myopia Control Spectacle Lenses. Children aged 6 to 12 who have not previously used myopia control treatments and have good vision with corrected lenses may qualify. Participants must not have any eye diseases or take medications affecting eye health. As an unphased trial, this study offers a unique opportunity for children to potentially benefit from innovative eyewear designed to enhance daily life.

Will I have to stop taking my current medications?

If you are using any medications that affect eye health or have anti-muscarinic properties, you will need to stop them at least 7 days before joining the study. This includes certain eye drops and oral medications like atropine and dicyclomine.

What prior data suggests that these spectacle lenses are safe for children?

Studies have shown that myopia control glasses are safe for children. Data from 18 months of use revealed that more than half of the children wearing these glasses experienced no major side effects. Other research has confirmed their safety over 12 months, highlighting both their safety and effectiveness in slowing the progression of nearsightedness. Additionally, these glasses have been used safely for up to four years, providing further evidence of their tolerance. This indicates that children can use them without significant issues.12345

Why are researchers excited about this trial?

Researchers are excited about the Myopia Control Spectacle Lenses because they offer a unique approach to managing nearsightedness. Unlike traditional glasses that simply correct vision, these lenses are designed to slow the progression of myopia by altering how light enters the eye, potentially reducing the risk of severe vision issues later in life. Both test arms, SightGlass Vision Test Arm 1 and 2, utilize single vision, impact-resistant lenses, which not only provide durability but also aim to address the underlying progression of myopia, setting them apart from conventional corrective lenses.

What evidence suggests that these spectacle lenses are effective for nearsightedness?

This trial will compare different spectacle lenses designed to control nearsightedness. Research has shown that special glasses for controlling nearsightedness can significantly slow its progression in children. For example, one study found that these glasses reduced the worsening of nearsightedness by about 30–60% on average. Another study revealed that after two years, more than half of the children wearing these glasses had stable vision, with only minor changes in their prescription. Additionally, the results indicated that these glasses effectively managed nearsightedness, with no signs of worsening after discontinuation. Overall, these glasses are considered safe and effective for slowing the progression of nearsightedness in children.16789

Are You a Good Fit for This Trial?

This trial is for children with near-sightedness. Specific eligibility details are not provided, but typically participants would need to have a certain level of myopia and be within a specific age range.

Inclusion Criteria

I am between 6 and 12 years old.
The subject's parent(s) or legal guardian(s) must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
Participant can achieve a corrected visual acuity of 20/20 best-corrected (or equivalent logMAR)
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Exclusion Criteria

I have used medication in the last week that could affect my eyes.
I have used eye drops with anti-muscarinic properties in the last 7 days.
Participant has known developmental delays
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear single vision or myopia control spectacle lenses to evaluate mobility performance in daily activities

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Myopia Control Spectacle Lenses
  • Spectacle Lenses
Trial Overview The study compares the effect of regular single vision spectacle lenses (control) with novel myopia control spectacle lenses (test) on children's ability to perform daily activities.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: SightGlass Vision Test Arm 2Experimental Treatment1 Intervention
Group II: SightGlass Vision Test Arm 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

SightGlass Vision, Inc.

Lead Sponsor

Trials
11
Recruited
1,100+

Citations

Academy '25: DOT™ Spectacle Lens 18-Month Data ...After two years, the proportion of patients with stable refraction (0.50D change or less) was 52% for younger children aged 6-7 and 62% for ...
Next-Generation Spectacle Lenses for Myopia ControlTaken together, the clinical data show that these advanced spectacle lenses slow myopia progression by approximately 30–60% on average, ...
New Studies Demonstrate 75% Myopia Management ...The results showed a significant slowing of myopia progression when using DOT™ lenses compared to single vision spectacle lenses. Specifically, ...
Myopia control with diffusion optics spectacle lensesConclusions: DOT 0.2 spectacle lenses are safe and effective at reducing myopia progression, with additional benefit evident in year 4 of wear.
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 ...
6.sightglassvision.comsightglassvision.com/
SightGlass Vision | Slow Down Myopia Progression in ...The first spectacles lenses that have demonstrated significant reduction of myopia progression over 36 months in a multi centre, multi-ethnicity study.
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36126105/
Control of myopia using diffusion optics spectacle lenses12-month results from this ongoing trial demonstrate the safety and effectiveness of DOT spectacles for reducing myopic progression.
All we've learnt in a year about the SightGlass Vision ...Explore new research on SightGlass Vision DOT™ lenses, their efficacy in myopia control, and clinical insights.
Control of myopia using diffusion optics spectacle lensesConclusion DOT 0.2 spectacle lenses are safe and effective at reducing myopia progression, with additional benefit evident in year 4 of wear.
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