Novel Spectacle Lenses for Near-sightedness

(CHERRY Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: SightGlass Vision, Inc.

Disqualifiers: Common cold, active allergies, fatigue

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Diurnal variations in the thickness of the choroid have been reported in the literature, and, more recently, the role of the choroid has been studied with respect to its role in myopia (near-sightedness) progression.

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 data supports the effectiveness of the treatment Novel Spectacle Lens for near-sightedness?

Research shows that spectacle lenses with aspherical lenslets, similar to the Novel Spectacle Lens, have been effective in slowing the progression of myopia (near-sightedness) in clinical trials. These lenses, like the defocus incorporated multiple segments (DIMS) lenses, have demonstrated significant results in controlling myopia. ^{1 2 3 4 5}

Is there any safety data available for Novel Spectacle Lenses?

The study on spectacle lenses with slightly aspherical lenslets for myopia control mentions a clinical trial design, but it does not provide specific safety data. However, it suggests that the lenses are being evaluated for safety and effectiveness in controlling myopia. ^{1 6 7 8 9}

What makes the Novel Spectacle Lens treatment unique for near-sightedness?

The Novel Spectacle Lens treatment is unique because it incorporates lenslets in its design, which helps control myopia (near-sightedness) by creating myopic defocus and contrast modulation. This approach is different from traditional lenses, which do not use lenslets to manage the progression of near-sightedness. ^{10 11 12 13 14}

Research Team

Lyndon Jones, PhD, FCoptom

Principal Investigator

Centre for Ocular Research & Education, Canada

Jill Woods, BSc, MCOptom

Principal Investigator

Centre for Ocular Research & Education, Canada

Eligibility Criteria

This trial is for individuals already enrolled in the CPRO-1802-001 study who have near-sightedness, including degenerative or progressive myopia. Participants must be minors who've given their assent and whose parents or guardians have signed a consent letter. Those with temporary health issues affecting the eyes like colds, allergies, or fatigue cannot join.

Inclusion Criteria

Read and signed an Assent and their parent/guardian has signed an information consent letter

Participating in the CPRO-1802-001 (Cypress_SG) study at CORE

Exclusion Criteria

I currently have a temporary health issue affecting my eyes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear novel spectacle lenses designed to inhibit myopia progression

3 years

Regular visits for choroidal thickness measurements and visual field assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Novel Spectacle Lens

Trial Overview The study is testing a new type of spectacle lens designed to control the progression of myopia by examining changes in choroidal thickness (a layer at the back of the eye) throughout the day.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Subjects wearing novel spectacle lenses will be assessed

Who Is Running the Clinical Trial?

SightGlass Vision, Inc.

Lead Sponsor

Trials

11

Recruited

1,100+

University of Waterloo

Collaborator

Trials

132

Recruited

221,000+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Spectacle lenses with slightly aspherical lenslets for myopia control: clinical trial design and baseline data. [2022]

2. 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]

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

The Efficacy of Defocus Incorporated Multiple Segments Lenses in Slowing Myopia Progression: Results from Diverse Clinical Circumstances. [2023]

4. China pubmed.ncbi.nlm.nih.gov

Effectiveness of peripheral defocus spectacle lenses in myopia control: a Meta-analysis and systematic review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The association between refractive cutoffs for spectacle provision and visual improvement among school-aged children in South Africa. [2022]

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

Comparison of adverse events with daily disposable hydrogels and spectacle wear: results from a 12-month prospective clinical trial. [2017]

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

Orthokeratology vs. spectacles: adverse events and discontinuations. [2012]

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

Adverse events during 2 years of daily wear of silicone hydrogels in children. [2021]

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

Accommodative intraocular lenses: considerations on use, function and design. [2007]

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

Mechanical design of a power-adjustable spectacle lens frame. [2019]

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

Manufacturing Application-Driven Foveated Near-Eye Displays. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Recent trends in progressive power lenses. [2006]

13. England pubmed.ncbi.nlm.nih.gov

Optical characterisation of two novel myopia control spectacle lenses. [2023]

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

Spectacle lens design: a review. [2018]