New Glasses for Nearsightedness

(CYPRESS Trial)

Not currently recruiting at 13 trial locations

Overseen By Vanessa Tasso, MA, MBA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: SightGlass Vision, Inc.

Disqualifiers: Allergy to proparacaine, others

Compensation: Varies

Number of Visits: Unknown

Duration: 36 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests special glasses designed to slow the progression of nearsightedness in children. It compares two types of glasses: one featuring the new SightGlass Vision Diffusion Optics Technology (DOT) Spectacles and a standard type. The goal is to determine if these new glasses can safely and effectively aid children with nearsightedness over three years. Children who completed a previous study with these glasses and can wear them daily for up to 10 hours may be suitable candidates. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could benefit children with nearsightedness.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that SightGlass Vision Diffusion Optics Technology (DOT) Spectacles are safe for reducing juvenile myopia?

Research has shown that SightGlass Vision Diffusion Optics Technology (DOT) Spectacles are generally safe for children. In an 18-month study, more than half of the children wearing these glasses did not experience significant worsening of their nearsightedness, suggesting the glasses are effective without causing harm.

Additionally, data from a 12-month study confirmed that these glasses are safe and help slow the progression of nearsightedness. They also offer a visual experience similar to regular glasses, allowing children to wear them comfortably without major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard glasses for nearsightedness, which typically just correct vision, SightGlass Vision Diffusion Optics Technology (DOT) Spectacles are unique because they use a special lens technology that aims to slow the progression of nearsightedness. Most treatments focus on helping people see clearly in the present, but these spectacles utilize a diffusion optics method that changes how light is focused on the retina, potentially limiting the worsening of vision over time. Researchers are excited about this innovation because it not only helps with current vision needs but also addresses the underlying progression of nearsightedness, offering a proactive approach to managing this common eye condition.

What evidence suggests that SightGlass Vision DOT Spectacles are effective for reducing juvenile myopia?

Research has shown that SightGlass Vision Diffusion Optics Technology (DOT) Glasses can slow the progression of nearsightedness in children. One study found that kids wearing DOT lenses experienced significantly less worsening of their nearsightedness compared to those with regular glasses. Over half of the children using DOT lenses showed no significant decline in their vision. Another study discovered that these glasses also slowed eye growth, which is crucial for controlling nearsightedness. In the CYPRESS Extension Test Arm, participants will receive DOT Glasses, while those in the CYPRESS Extension Control Arm will wear regular spectacle lenses. These findings suggest that DOT Glasses could be an effective option for managing nearsightedness in children. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for kids who were in the CYPRESS study and can commit to wearing special glasses for up to 3 years, at least 10 hours a day. They shouldn't have been out of the previous study for over 30 days and must not wear contact lenses during this time. Parents or guardians need to consent.

Inclusion Criteria

Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day)

Willingness to participate in the trial for up to 3 years without contact lens wear

Previously a successfully completed participant in the CYPRESS study (NCT03623074) and having not exited this study for more than 30 days

Exclusion Criteria

Known allergy to proparacaine, tetracaine, or tropicamide.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SightGlass Vision Diffusion Optics Technology (DOT) Spectacles to evaluate their efficacy in reducing juvenile myopia progression

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• SightGlass Vision Diffusion Optics Technology (DOT) Spectacles
• Spectacle lenses

Trial Overview The trial tests SightGlass Vision Diffusion Optics Technology (DOT) Spectacles' long-term ability to slow down worsening near-sightedness in children compared with regular glasses, monitored over a period of three years.

How Is the Trial Designed?

Group I: CYPRESS Extension Test Arm Experimental Treatment 1 Intervention

Single vision, impact resistant spectacle lenses; CYPRESS Test Arm 1 and CYPRESS Test Arm 2 will move into CYPRESS Extension Test Arm

Group II: CYPRESS Extension Control Arm Placebo Group 1 Intervention

Single vision, impact resistant spectacle lenses; CYPRESS Control Arm remains in control lenses as the CYPRESS Extension Control Arm

Who Is Running the Clinical Trial?

SightGlass Vision, Inc.

Lead Sponsor

Trials

11

Recruited

1,100+

Published Research Related to This Trial

In a study of 11-year-old children with myopia, using monovision spectacles resulted in significantly slower myopia progression in the near corrected eye compared to the distance corrected eye, with a difference of 0.36 D/year.

While monovision did not effectively reduce accommodation, it suggests that maintaining myopic defocus can help slow down the axial elongation of the eye, which is a key factor in myopia progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monovision slows juvenile myopia progression unilaterally. Phillips, JR.[2018]

Citations

1. sightglassvision.com sightglassvision.com/releases/new-studies-demonstrate-75-myopia-management-efficacy-with-chinese-children-after-12-months-and-no-evidence-of-rebound-effect-in-north-american-children-for-sightglass-vision-dot-lenses/

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, ...

2. 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 ...

3. 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 ...

4. sightglassvision.com sightglassvision.com/releases/three-new-peer-reviewed-papers-expand-myopia-management-evidence-for-sightglass-vision-diffusion-optics-technology/

Three New Peer Reviewed Papers Expand Myopia ... The study demonstrates that DOT 0.2 spectacle lenses are safe and effective at reducing myopia progression, significantly slowing eye growth, ...

5. myopiaprofile.com myopiaprofile.com/articles/All-we-learnt-in-a-year-about-the-SightGlass-Vision-Diffusion-Optics-Technology-spectacle-lens

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 ...

6. sightglassvision.com sightglassvision.com/diffusion-optics-technology/

Diffusion Optics Technology™ | Myopia Treatment for ... Diffusion Optics Technology™ is a breakthrough technology for slowing down myopia progression for your kids through contrast management.

7. bjo.bmj.com bjo.bmj.com/content/107/11/1709

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.