Spectacle Lenses for Nearsightedness

(BIRCH Trial)

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

90 Participants Needed

Trial Summary

What is the purpose of this trial?

To quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses. To quantify axial length progression following cessation of use of specific spectacle lenses.

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 Spectacle Lenses for Nearsightedness?

Research shows that spectacle lenses, including those with special designs like highly aspherical lenslets, can slow the progression of myopia (nearsightedness) compared to conventional lenses. Additionally, studies on similar lenses for other vision issues, like presbyopia (difficulty seeing close objects), indicate improved visual comfort and function, suggesting potential benefits for nearsightedness as well. ^{1 2 3 4 5}

Are spectacle lenses safe for humans?

Research comparing spectacle lenses to contact lenses found that spectacles generally have fewer adverse events (unwanted side effects) over time, suggesting they are safe for human use. ^{6 7 8 9 10}

How do spectacle lenses for nearsightedness differ from other treatments?

Spectacle lenses for nearsightedness, particularly those with peripheral defocus, are unique because they aim to control myopia (nearsightedness) by altering how light focuses on the retina, potentially slowing the progression of the condition. This approach is different from traditional lenses that only correct vision without addressing myopia progression. ^{3 5 11 12 13}

Eligibility Criteria

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

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)

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

Known allergy to proparacaine, tetracaine, or tropicamide

Timeline

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

References

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

Behavioral effects of children's nearpoint lenses. [2005]

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

Comparison between "readables" aspheric spectacle lenses and conventional spherical spectacle lenses for overcorrection of presbyopic single-vision contact lens wearers. [2006]

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

Visual function after correction of distance refractive error with ready-made and custom spectacles: a randomized clinical trial. [2022]

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

Change in function and spectacle-use 2 months after providing presbyopic spectacles in rural Tanzania. [2021]

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. Germany pubmed.ncbi.nlm.nih.gov

Safety of DIMS Spectacle Lenses and Atropine as Combination Therapy for Myopia Progression. [2022]

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

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

10. England pubmed.ncbi.nlm.nih.gov

Safety of soft contact lenses in children: retrospective review of six randomized controlled trials of myopia control. [2021]

11. China pubmed.ncbi.nlm.nih.gov

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

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

Lenses for correcting chromatic aberration of the eye. [2018]

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

One-year myopia control efficacy of spectacle lenses with aspherical lenslets. [2022]