Novel Spectacle Lenses for Near-sightedness

(CYPRESS Trial)

Not currently recruiting at 13 trial locations

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: SightGlass Vision, Inc.

Disqualifiers: Contact lenses, Bifocals, Myopia control, others

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

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 a new type of eyeglass lens to determine if it can safely slow the progression of nearsightedness (myopia) in children. Researchers will divide participants into three groups, each trying different versions of these special lenses. The goal is to identify which lens works best over three years. Children aged 6 to 10 with mild to moderate nearsightedness who do not currently use contact lenses or bifocals are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity for children to potentially benefit from innovative lens technology.

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 this spectacle lens design is safe for reducing the progression of juvenile myopia?

Research shows that these new glasses are generally safe for use. Previous studies have found that these glasses, designed to slow worsening nearsightedness, are comfortable to wear. No major reports of side effects or discomfort have emerged. One study showed that they work better than regular single-vision glasses at slowing nearsightedness. Although new, they have a good safety record based on past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these novel spectacle lenses because they offer a new approach to managing near-sightedness, also known as myopia. Unlike traditional corrective lenses that only focus on improving vision clarity, these lenses are impact-resistant and designed to potentially slow the progression of myopia. This unique feature could be significant in reducing the long-term complications associated with worsening vision, making it a promising option for people with near-sightedness.

What evidence suggests that this trial's treatments could be effective for reducing juvenile myopia?

Research has shown that new types of eyeglass lenses can slow the progression of nearsightedness in children. This trial will evaluate novel spectacle lens designs, which studies have found to be more effective than regular single-vision lenses in reducing the rate of nearsightedness progression. Specifically, one study found that certain lens designs, such as HAL and DIMS, were particularly effective in slowing nearsightedness in children. Notably, DIMS lenses reduced the progression of nearsightedness by 62% over two years. These findings suggest that these new eyeglass lenses could be a strong option for managing nearsightedness. ^{1 2 3 6 7}

Who Is on the Research Team?

Joseph Rappon, OD, MS, FAAO

Principal Investigator

SightGlass Vision, Inc.

Are You a Good Fit for This Trial?

This trial is for children aged 6-10 with near-sightedness, having a specific range of short-sighted prescription (-0.75 to -4.50 D). They must not have more than a 1.50 D difference between their eyes and be willing to participate for 3 years without wearing contact lenses.

Inclusion Criteria

SER power between the two eyes must be less than or equal to 1.50 D

SER error between -0.75 and -4.50 D

Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive novel spectacle lens designs to evaluate their efficacy in reducing the progression of juvenile myopia

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Novel spectacle lens design
• Spectacle lenses

Trial Overview The study tests new spectacle lens designs meant to slow down the worsening of near-sightedness in kids. It's a masked, three-group comparison lasting for three years where neither participants nor observers know who gets which type of glasses.

How Is the Trial Designed?

Group I: Test Arm 3 Experimental Treatment 1 Intervention

Single vision, impact-resistant spectacle lenses

Group II: Test Arm 2 Experimental Treatment 1 Intervention

Single vision, impact-resistant spectacle lenses

Group III: Test Arm 1 Experimental Treatment 1 Intervention

Single vision, impact-resistant spectacle lenses

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 involving 8 myopic participants, bifocal contact lenses (MCL) showed a general decrease in visual acuity (VA) and contrast sensitivity (CS) compared to single vision lenses (SV), indicating they may not be as effective for all gaze positions.

The defocus incorporated multiple segments (DIMS) lenses performed similarly to SV lenses at straight gaze (0°), but both DIMS and MCL resulted in decreased VA and CS at nasal and temporal gaze, suggesting that while DIMS can be effective, they may not provide a significant advantage over traditional lenses in all viewing conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision tests on spectacle lenses and contact lenses for optical myopia correction: a pilot study. Kaymak, H., Neller, K., Schütz, S., et al.[2022]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666914525002386

One-Year Myopia Control Efficacy of a New Defocus ... Myocontrol spectacle lenses, incorporating a novel optical design, were more effective than single-vision lenses in slowing myopia progression ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4696394/

Spectacle Lenses Designed to Reduce Progression of Myopia We present data on the progression of myopia with novel spectacle lens designs that manipulate the curvature of the peripheral image shell while maintaining ...

3. bjo.bmj.com bjo.bmj.com/content/early/2025/09/05/bjo-2025-327629

Efficacy of spectacle lenses for myopia control: a meta- ... Among the different lens designs, both HAL and DIMS lenses demonstrated statistically significant efficacy in slowing myopia progression.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03623074

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 ...

5. reviewofmm.com reviewofmm.com/the-proliferation-of-myopia-management-spectacles/

The Proliferation of Myopia Management Spectacles The landmark two-year randomized controlled trial, published in 2020, showed DIMS lenses to slow the progression of myopia in children by 62%.

6. bmjophth.bmj.com bmjophth.bmj.com/content/9/1/e001790

Control of myopia using diffusion optics spectacle lenses Conclusion DOT 0.2 spectacle lenses are safe and effective at reducing myopia progression, with additional benefit evident in year 4 of wear.

7. reviewofmm.com reviewofmm.com/how-safe-and-effective-are-next-generation-spectacle-lenses-for-myopia-management/

How Safe and Effective Are Next-Generation Spectacle ... Dr. Paudel shares the clinical trial results of five different designs of next-generation spectacle lenses for myopia management.