Spectacle Lenses for Nearsightedness

(BIRCH Trial)

Not currently recruiting at 8 trial locations

Overseen By Vanessa Tasso, MA, MBA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: SightGlass Vision, Inc.

Disqualifiers: Allergy to proparacaine, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effects of stopping the use of special glasses (spectacle lenses) on individuals with nearsightedness. It aims to understand changes in vision when these glasses are no longer worn, focusing on alterations in eye shape and vision strength (myopic progression). Individuals who participated in a previous study and can wear specific glasses for at least 10 hours a day, except during activities like sleeping or swimming, may qualify. Participants should also be willing to avoid contact lenses for up to a year. As an unphased study, this trial offers a unique opportunity to contribute to understanding vision changes without the constraints of traditional trial phases.

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 these spectacle lenses are safe for use?

Research shows that special glasses designed to control nearsightedness are generally safe. For example, studies on DOT 0.2 lenses have found them effective in slowing the progression of nearsightedness over several years. In one study, children who wore these lenses for 18 months experienced little to no significant increase in their nearsightedness. Another type of lens, called DIMS lenses, proved safe over six years, with no reported side effects. These findings suggest that both DOT and DIMS lenses are well-tolerated and safe for long-term management of nearsightedness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these spectacle lenses because they could offer a fresh approach to managing nearsightedness, also known as myopia. Unlike traditional corrective lenses that simply adjust vision by bending light to focus on the retina, these lenses may be designed to slow the progression of nearsightedness itself. This could be a game-changer, as managing myopia's progression might reduce the risk of developing more severe vision problems in the future. If successful, these lenses could provide a dual benefit: clear vision now and healthier eyes in the long term.

What evidence suggests that these spectacle lenses are effective for myopic progression?

Research has shown that certain eyeglass lenses can slow the progression of nearsightedness, also known as myopia. In a 5-year study, these lenses reduced the rate of myopia progression, effectively preventing three years' worth of vision decline. Another combined analysis confirmed that these lenses significantly slowed both the eye's lengthening and changes in vision strength. In this trial, participants will join either the Test Lens Group or the Control Lens Group to evaluate the effectiveness of different spectacle lenses. Additionally, one study found that more than half of the children using special DOT lenses experienced little to no significant worsening in their vision. These findings suggest that specific eyeglass lenses can help manage and control the progression of nearsightedness in children. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who previously participated in the CYPRESS Extension study, have near-sightedness, and are willing to wear special glasses daily for up to a year. They must not use contact lenses during this period and need consent from parents or guardians if underage.

Inclusion Criteria

Previously a successfully completed participant in the CYPRESS Extension study

I am willing to not wear contact lenses for up to 12 months.

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)

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 use specific spectacle lenses to control myopia

6 months

Cessation

Participants cease the use of specific spectacle lenses to measure myopic progression

6 months

Follow-up

Participants are monitored for changes in axial length and cycloplegic spherical equivalent refraction

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Spectacle Lenses

Trial Overview The study tests what happens to near-sightedness (both eye prescription changes and eye length growth) after people stop using certain spectacle lenses they were wearing before.

How Is the Trial Designed?

Group I: Control Lens Group Active Control 1 Intervention

Group II: Test Lens Group Active Control 1 Intervention

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]

DIMS spectacle lenses, when used alone or in combination with 0.01% atropine, do not significantly impair corrected distance visual acuity (CDVA) or contrast sensitivity, making them safe for road traffic participation.

The study found that glare sensitivity was not adversely affected by DIMS lenses or atropine, indicating that these lenses maintain visual safety under conditions that could be challenging for drivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of DIMS Spectacle Lenses and Atropine as Combination Therapy for Myopia Progression. Kaymak, H., Mattern, AI., Graff, B., et al.[2022]

The study involving 119 Vietnamese children showed that highly aspherical lenslet (HAL) spectacles significantly slowed myopia progression compared to conventional single vision (SV) spectacles, particularly during the second stage of the trial.

There was no evidence of myopia rebound when children switched from HAL to SV, indicating that HAL spectacles are a safe and effective option for managing myopia in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spectacle Lenses With Highly Aspherical Lenslets for Slowing Myopia: A Randomized, Double-Blind, Cross-Over Clinical Trial: Parts of these data were presented as a poster at the Annual Research in Vision and Ophthalmology meeting, 2022. Sankaridurg, P., Weng, R., Tran, H., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40038807/

Myopia control efficacy of spectacle lenses with highly ... In this 5-year study, HAL spectacles reduced the rate of myopia progression and axial elongation, preventing the equivalent of 3 years of ...

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

Efficacy of spectacle lenses for myopia control: a meta- ... The pooled results demonstrated that myopia control spectacle lenses significantly reduced both AL elongation and spherical SER progression ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39799796/

Real-world outcomes on myopia management efficacy of ... Myopia control effect in DSDO group was 47%-69% and 33%-62% in DIMS group compared to historical SVS lenses. Conclusions: Both DSDO and DIMS ...

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. 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39384223/

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. 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), ...

8. myopiaprofile.com myopiaprofile.com/articles/DOT-lens-four-year-efficacy

Myopia control with diffusion optics spectacle lenses Conclusions: DOT 0.2 spectacle lenses are safe and effective at reducing myopia progression, with additional benefit evident in year 4 of wear.

9. nature.com nature.com/articles/s41598-023-32700-7

Long-term myopia control effect and safety in children ... The results supported that DIMS lenses provided sustained myopia control without adverse effects over the 6-year study period.