Novel Spectacle Lenses for Nearsightedness

(CEDAR Trial)

Not currently recruiting at 5 trial locations

Overseen By Vanessa Tasso, MA, MBA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: SightGlass Vision, Inc.

Disqualifiers: Ocular infection, inflammation, irritation

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of a new type of glasses for people with nearsightedness (difficulty seeing far away). Participants will receive either the new spectacle lenses or standard lenses to compare visual performance. It is ideal for those already part of the CYPRESS Extension study who can complete all required vision tests. As an unphased study, this trial offers a unique opportunity to contribute to innovative research in vision correction.

Do I need to stop my current medications for the trial?

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

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

Research has shown that the new type of glasses used in this trial has undergone safety testing in other studies. For example, one study found that these glasses safely and effectively slow the progression of nearsightedness over several years. Another study also showed positive results, with no serious safety issues reported over four years of use. This suggests that users generally tolerate the glasses well. While no treatment is entirely risk-free, these findings offer reassurance about the safety of these glasses based on previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the novel spectacle lenses for nearsightedness because they introduce a new lens design that aims to improve vision correction beyond standard single vision lenses. Unlike traditional lenses, which primarily focus on correcting distance vision, these novel lenses have a unique design that could potentially slow the progression of nearsightedness. This means they not only help you see clearly but might also help prevent your eyesight from getting worse over time. This dual function makes them a promising advancement in the treatment of nearsightedness.

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

This trial will compare novel spectacle lens designs with regular single-vision lenses. Research has shown that new types of eyeglass lenses can greatly slow the worsening of nearsightedness in children. One study found that these lenses reduced the progression of nearsightedness and the growth of the eye compared to regular single-vision lenses. Another study showed that certain lens designs, such as HAL and DIMS, effectively slowed the progression of nearsightedness. These lenses change how light focuses on the eye, which seems to help control eye growth. Overall, evidence suggests these lenses can be a promising option for managing nearsightedness. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for people who were already part of the CYPRESS Extension study and can follow through with the study's assessments. They must have consent from a parent or legal guardian if required. Those with current eye infections, inflammation, or irritation that could affect vision cannot participate.

Inclusion Criteria

Existing subject from the CYPRESS Extension study (CPRO-1802-002)

Ability to comply with study assessments

The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed coy of the form

Exclusion Criteria

I do not have any eye infections or conditions affecting my vision.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Visual Performance Assessment

Participants undergo visual performance assessments using single vision, impact resistant spectacle lenses

15 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after visual performance assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Novel spectacle lens design
• Spectacle lenses

Trial Overview The study is testing a new spectacle lens design against standard lenses in a two-arm parallel group setup. Participants will not keep the glasses but will undergo visual performance evaluations to compare effectiveness.

How Is the Trial Designed?

Group I: Test Arm Experimental Treatment 1 Intervention

Single vision, impact resistant spectacle lenses; Test Arm

Group II: Control Arm Placebo Group 1 Intervention

Single vision, impact resistant spectacle lenses; 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 involving 581 myopic children aged 7-15 years wearing daily disposable hydrogel contact lenses, no significant or serious ocular adverse events were reported over 816 patient years, indicating a high safety profile for these lenses.

The overall rate of ocular adverse events was low at 10.6 per 100 patient years, with only two non-significant corneal infiltrative events, suggesting that daily disposable soft contact lenses are a safe option for children compared to a lower incidence of 1.8 per 100 patient years for spectacle wearers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of soft contact lenses in children: retrospective review of six randomized controlled trials of myopia control. Cheng, X., Brennan, NA., Toubouti, Y., et al.[2021]

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]

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]

Citations

1. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(25)00238-6/fulltext

One-Year Myopia Control Efficacy of a New Defocus ... The primary outcome was the 1-year change in SER from baseline to 12 months. Secondary outcomes included changes in axial length (AL), ...

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

One-Year Myopia Control Efficacy of a New Defocus ... MYOGEN spectacle lenses significantly reduced myopia progression and axial elongation in schoolchildren compared with SV spectacle lenses. The ...

5. 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 ...

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. sightglassvision.com sightglassvision.com/releases/sightglass-vision-reports-positive-four-year-clinical-trial-outcomes-for-myopia-control-dot-spectacle-lenses/

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 ...