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 explores a new design for spectacle lenses to assess their effectiveness for people with nearsightedness (difficulty seeing far away). The study will determine which part of the lens is used most, regardless of the task. The trial tests single vision, impact-resistant lenses. Children aged 7-14 who need glasses with specific lens power and have had an eye exam in the last two years may qualify.

As an unphased trial, this study provides a unique opportunity to contribute to innovative lens design that could enhance vision for many.

Will I have to stop taking my current medications?

If you are using any medications that affect eye health, you may not be eligible for the trial. The protocol does not specify if you need to stop taking your current medications, but it does exclude those using medications that impact eye health.

What prior data suggests that this spectacle lens design is safe?

Research has shown that the new type of glasses is safe for people. In one study, children wore these glasses for a year without any major safety issues. Another report found that after a year and a half, more than half of the children experienced no significant eye problems. The glasses are designed to resist impacts, adding extra safety. So far, evidence suggests that the glasses are well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about these spectacle lenses for nearsightedness because they offer a novel design that could change how we manage this common vision issue. Unlike traditional corrective lenses that simply refocus light to improve vision, these lenses are impact-resistant and designed to potentially slow the progression of myopia. This innovative approach could lead to longer-term benefits for eye health and reduce the need for stronger prescriptions over time.

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

Research has shown that the new spectacle lenses, which participants in this trial may receive, can help slow the progression of nearsightedness, also known as myopia. In a one-year study, these lenses significantly slowed myopia compared to regular single vision lenses. Another study found that after two years, many children wearing these lenses experienced stable vision changes. Early results from a large trial in China also showed that these lenses effectively slowed myopia in children. Overall, these findings suggest that these lenses can help manage and control nearsightedness in young patients.23467

Are You a Good Fit for This Trial?

This trial is for children aged 7-14 who are nearsighted and need glasses within a specific power range. They must be able to see well with their current glasses or when corrected, have had an eye exam in the last two years, and not have any health conditions or medications that affect their eyes.

Inclusion Criteria

I am between 7-14 years old, need glasses within the study's range, can follow instructions, have had an eye exam in the last 2 years, and my vision corrects to 20/40 or better.

Exclusion Criteria

I can complete study tasks and have no diseases or use medications that affect my eye health. I am not aphakic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are provided with single vision, impact-resistant spectacle lenses to assess viewing behavior

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Novel spectacle lens design
Trial Overview The study is testing how kids use different parts of spectacle lenses during various tasks. It compares standard lens designs with a new type of lens to see if there's a difference in viewing behavior.
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 ...
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, ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36126105/
Control of myopia using diffusion optics spectacle lensesConclusion: 12-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 ...Early results from a 2-year RCT involving 186 children aged 6-13 years in China showed DOT™ spectacle lenses significantly slowed myopia ...
NCT03623074 | Control of Myopia Using Novel Spectacle ...3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of ...
SightGlass Vision Reports Positive Four-Year Clinical Trial ...CHANGSHA, China, September 6, 2023—SightGlass Vision today reported positive four-year outcomes from its pivotal CYPRESS study extension, which ...
SightGlass Vision Presents Latest Data on DOT Lenses at ...SightGlass Vision shared data from four studies on its DOT lenses at the Association for Research in Vision and Ophthalmology.
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