Novel Spectacle Lenses for Myopia

(EUCALYPTUS Trial)

Recruiting at 13 trial locations

Overseen By Vanessa Tasso, MA, MBA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: SightGlass Vision, Inc.

Must not be taking: Atropine

Disqualifiers: Contact lenses, Bifocals, Amblyopia, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of new spectacle lenses for children with myopia (nearsightedness). The study will compare two groups of children wearing single vision, impact-resistant lenses over 12 months, with predictions extending up to three years. It seeks children aged 6 to 8 with a specific range of myopia who are willing to wear the glasses regularly. Participants should not have worn contact lenses before and must not have used other myopia treatments. The researchers aim to confirm findings from earlier trials and improve future myopia management. As an unphased trial, this study offers a unique opportunity for children to contribute to advancing myopia management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using any myopia control treatments like atropine, you would not be eligible to participate.

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

Research shows that single vision, impact-resistant glasses are generally well-tolerated. Studies on similar glasses have examined their ability to slow the progression of nearsightedness in children. While these studies primarily assess effectiveness, they also provide crucial safety information.

For instance, a study with children from North America and China found that these glasses effectively slowed nearsightedness over a year, with no major safety concerns reported. Another long-term study on similar glasses, known as DIMS lenses, demonstrated continued control of nearsightedness over six years, again without significant safety issues.

Overall, these findings suggest that the glasses used in this trial are likely safe for children. They have been tested in various settings and have not caused notable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these spectacle lenses for myopia because they combine single vision correction with impact-resistant materials, offering durability alongside vision improvement. Unlike traditional lenses that may not withstand physical stress, these lenses are designed to be more resilient, making them ideal for active lifestyles. This combination could enhance the quality of life for people with myopia by providing clearer vision with added protection.

What evidence suggests that these spectacle lenses could be effective for myopia?

Research has shown that special glasses designed to control nearsightedness (myopia) can help slow its progression in children. Studies have found that these glasses significantly reduce the growth of the eye's length from front to back, which is linked to worsening myopia, compared to regular glasses. One study discovered that these special lenses reduced the worsening of myopia in schoolchildren within a year. Another study over five years showed that these lenses effectively slowed myopia progression. This trial will test single vision, impact-resistant spectacle lenses designed to manage myopia in children. These findings suggest that specially designed glasses could be a promising way to manage myopia in children. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children aged 6-8 with mild to moderate near-sightedness (myopia) who have good vision with glasses and no more than a small difference in prescription between their eyes. They must be able to wear the study glasses at least 10 hours a day, not use contact lenses, and have no eye conditions or systemic diseases affecting vision.

Inclusion Criteria

Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye

You are willing to not wear contact lenses for the entire 24-month trial period.

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

Exclusion Criteria

I currently use or have used bifocals or progressive glasses.

I have a 'lazy eye'.

You are allergic 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 single vision, impact-resistant spectacle lenses

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Single vision, impact-resistant spectacle lenses

Trial Overview The study tests if special spectacle lenses can control worsening myopia in young children compared to regular single-vision lenses. It's a masked study where neither participants nor observers know which type of lens each child gets, randomly assigning kids into two groups equally.

How Is the Trial Designed?

Group I: Test Arm 2 Experimental Treatment 1 Intervention

Single vision, impact-resistant spectacle lenses

Group II: 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

A review identified 695 cases of ocular trauma related to spectacles, particularly during sports activities involving medium- to high-impact forces, highlighting the need for awareness among spectacle wearers about potential risks.

Polycarbonate lenses are recommended as the safest material for spectacles due to their impact resistance, and there is a need for improved performance guidelines to prevent spectacle-related injuries, especially for individuals with specific risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spectacle-related eye injuries, spectacle-impact performance and eye protection. Hoskin, AK., Philip, S., Dain, SJ., et al.[2015]

Polycarbonate lenses showed superior impact resistance compared to other spectacle lenses tested, including glass and allyl resin plastic, under conditions simulating routine use with various projectiles.

The study, which involved 348 lens impacts, indicates that many lenses currently meeting ANSI standards may not withstand the impact energies expected in everyday situations, suggesting a need to reevaluate these safety standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shatter resistance of spectacle lenses. Vinger, PF., Parver, L., Alfaro, DV., et al.[2016]

The study tested the impact resistance of Hoya Phoenix spectacle lenses with different thicknesses and coatings, finding that industrial thickness lenses had a higher threshold breakage speed (63.2 m/s) compared to dress thickness lenses (55.1 m/s).

While applying a multilayer antireflection (MAR) coating reduced the impact resistance of the lenses, they still met safety standards for eye protection, making them suitable for industrial use despite the slight decrease in durability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of multiple antireflection coatings on impact resistance of Hoya Phoenix spectacle lenses. Chou, BR., Hovis, JK.[2015]

A new testing method for impact resistance of eyewear using higher drop-ball heights can reduce the sample size needed to demonstrate lens safety, making the testing process more efficient.

This alternative method is statistically sound and utilizes inexpensive, readily available equipment, providing a viable option for assessing the quality of both prescription and nonprescription eyewear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statistical procedures for impact resistance testing at increased drop-ball heights. Stephens, GL.[2019]

In a study of 446 cases of penetrating ocular injuries over ten years, only 3.6% were caused by spectacles, primarily affecting adult male amateur athletes (40%).

The research found that plastic lenses are the most impact-resistant, while non-tempered glass lenses are the least, suggesting that using plastic lenses with adequate thickness in plastic frames is recommended for both children and adults participating in sports to reduce the risk of eye injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Material and thickness: the important factors in the impact resistance of spectacle lenses. Christianson, MD., Parker, JA., Arndt, J.[2016]

A study measuring 679 plano lenses from seven suppliers found significant variability in compliance with Australian standards, with failure rates ranging from <0.0001% to 77.5%, indicating potential quality control issues in lens manufacturing.

The results suggest that a failure rate of up to 12.6% for certain lens types is unsatisfactory, highlighting the need for better quality checks before lenses are distributed, especially for thicker lenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription compliance in ophthalmic lenses. Yuen, GS., Chou, BR., Ngo, TP., et al.[2015]

The study assessed the impact resistance of coated and uncoated mid-index spectacle lenses using a ballistic impact test, revealing that thicker lenses generally had higher impact resistance, but performance varied significantly among different materials.

Interestingly, a scratch-resistant coating on CR39 lenses actually reduced their impact resistance, while the effect of antireflection coatings depended on the type of base coating used, indicating that lens coatings can influence safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ballistic impact resistance of selected organic ophthalmic lenses. Chou, BR., Yuen, GS., Dain, SJ.[2015]

Research indicates that the actual strength of both treated and untreated lenses is significantly lower than the theoretical strength of glass, highlighting a gap in expected performance.

The standard drop ball test used by the FDA to evaluate lens impact resistance may not be sufficient, prompting researchers to propose alternative testing methods for better assessment of ophthalmic lens durability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact resistance: an overview. Innes, AL.[2006]

The new plastic single-vision lens series features an aspherically designed front surface, which enhances comfort and non-optical properties for users with weak to medium-strength positive prescriptions.

Despite the design changes, the lenses maintain high image quality comparable to traditional spectacle lenses, ensuring that visual clarity is not compromised.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aspherical single-strength eyeglasses with improved wearing comfort]. Guilino, G.[2009]

Extended exposure to ultraviolet radiation (UVR) significantly reduces the impact resistance of various organic ophthalmic lens materials, with uncoated CR39 lenses showing the greatest reduction in fracture velocity by 10.3 m/s after UVR exposure.

Protective lenses, especially those with scratch-resistant coatings, should be regularly replaced after prolonged UVR exposure to ensure optimal safety, as even lenses without visible damage can lose their protective capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Ultraviolet Exposure on Impact Resistance of Ophthalmic Lenses. Chou, BR., Dain, SJ., Cheng, BB.[2018]

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/40912901/

Efficacy of spectacle lenses for myopia control: a meta ... Results: This meta-analysis included 23 RCTs with a total of 13.315 subjects. Compared with SVLs, myopia control lenses significantly reduced AL ...

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

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

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

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

5. 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 ...

6. 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 ... 12-month results from a study of North American children and a study of Chinese children showed that DOT lenses slowed myopic progression but ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10887607/

Effectiveness of a Spectacle Lens with a Specific Asymmetric ... This study aims to evaluate the short-term efficacy of a new design of ophthalmic lens with asymmetric myopic peripheral defocus (MPDL) on ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07120737

Efficacy and Safety of Spectacle Lenses With H.A.L.T. MAX ... To evaluate the efficacy, safety and compliance of H.A.L.T. MAX lenses in delaying myopia progression in children with high myopia, and to ...

9. myopiaprofile.com myopiaprofile.com/articles/the-next-generation-dims-and-halt-technology-spectacle-lenses-for-myopia-control

The next generation spectacle lenses for myopia control The 6-year published data showed that DIMS spectacle lenses provided a sustained myopia control effect in children who continuously wore the ...