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

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment to see how well it works for younger children. The study will look at results over time to predict how effective the treatment will be in the long term. The trial involves multiple sites to ensure accurate results.

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 data supports the effectiveness of the treatment using novel spectacle lenses for myopia?

Research shows that impact-resistant spectacle lenses, especially those made from plastic materials, are effective in preventing eye injuries during activities with a risk of impact. This suggests that the lenses used in the trial may offer protective benefits, although their specific effectiveness in slowing myopia progression is not directly addressed in the provided studies. ^{1 2 3 4 5}

Are spectacle lenses generally safe for humans?

Spectacle lenses are generally safe, but there is a small risk of eye injuries, especially during sports or high-impact activities. Using impact-resistant materials like polycarbonate can reduce this risk, and it's important to be cautious if you have certain eye conditions or a history of eye surgery. ^{1 3 6 7 8}

How do novel spectacle lenses for myopia differ from other treatments?

The novel spectacle lenses for myopia are unique because they are designed to be impact-resistant, which means they are less likely to break or shatter compared to regular lenses. This feature makes them particularly suitable for individuals who engage in activities with a higher risk of eye injury, providing both vision correction and enhanced safety. ^{1 2 9 10 11}

Eligibility Criteria

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 have a condition called strabismus, which means your eyes do not align properly.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Spectacle-related eye injuries, spectacle-impact performance and eye protection. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Ballistic impact resistance of selected organic ophthalmic lenses. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Material and thickness: the important factors in the impact resistance of spectacle lenses. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Impact resistance: an overview. [2006]

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Effect of Ultraviolet Exposure on Impact Resistance of Ophthalmic Lenses. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Prescription compliance in ophthalmic lenses. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Shatter resistance of spectacle lenses. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of multiple antireflection coatings on impact resistance of Hoya Phoenix spectacle lenses. [2015]

11. Germany pubmed.ncbi.nlm.nih.gov

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