New Glasses for Nearsightedness

(CYPRESS Trial)

Recruiting at 13 trial locations

Overseen By Vanessa Tasso, MA, MBA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: SightGlass Vision, Inc.

Disqualifiers: Allergy to proparacaine, others

Compensation: Varies

Number of Visits: Unknown

Duration: 36 months

200 Participants Needed

Trial Summary

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 SightGlass Vision Diffusion Optics Technology (DOT) Spectacles for nearsightedness?

Research on similar treatments, like Defocus Incorporated Multiple Segments (DIMS) lenses, shows they can significantly slow down the worsening of nearsightedness in children. This suggests that special types of glasses, like the DOT Spectacles, might also be effective in managing nearsightedness. ^{1 2 3 4 5}

Are SightGlass Vision Diffusion Optics Technology (DOT) Spectacles safe for humans?

The research on self-adjustable glasses, which are similar to SightGlass Vision DOT Spectacles, suggests they are generally safe for humans. However, they may not be suitable for correcting high myopia (severe nearsightedness) or astigmatism (a condition where the eye does not focus light evenly on the retina). ^{6 7 8 9 10}

What makes SightGlass Vision Diffusion Optics Technology (DOT) Spectacles unique for treating nearsightedness?

SightGlass Vision Diffusion Optics Technology (DOT) Spectacles are unique because they use a novel approach to manage nearsightedness by potentially incorporating advanced optics that may enhance visual adaptation and correction, unlike traditional glasses that only passively correct vision. ^{11 12 13 14 15}

What is the purpose of this trial?

This is an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of SightGlass Vision Diffusion Optics Technology (DOT) Spectacles in reducing the progression of juvenile myopia.

Eligibility Criteria

This trial is for kids who were in the CYPRESS study and can commit to wearing special glasses for up to 3 years, at least 10 hours a day. They shouldn't have been out of the previous study for over 30 days and must not wear contact lenses during this time. Parents or guardians need to consent.

Inclusion Criteria

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)

Willingness to participate in the trial for up to 3 years without contact lens wear

Previously a successfully completed participant in the CYPRESS study (NCT03623074) and having not exited this study for more than 30 days

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 receive SightGlass Vision Diffusion Optics Technology (DOT) Spectacles to evaluate their efficacy in reducing juvenile myopia progression

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• SightGlass Vision Diffusion Optics Technology (DOT) Spectacles
• Spectacle lenses

Trial Overview The trial tests SightGlass Vision Diffusion Optics Technology (DOT) Spectacles' long-term ability to slow down worsening near-sightedness in children compared with regular glasses, monitored over a period of three years.

Participant Groups

Group I: CYPRESS Extension Test Arm Experimental Treatment 1 Intervention

Single vision, impact resistant spectacle lenses; CYPRESS Test Arm 1 and CYPRESS Test Arm 2 will move into CYPRESS Extension Test Arm

Group II: CYPRESS Extension Control Arm Placebo Group 1 Intervention

Single vision, impact resistant spectacle lenses; CYPRESS Control Arm remains in control lenses as the CYPRESS Extension Control Arm

Who Is Running the Clinical Trial?

SightGlass Vision, Inc.

Lead Sponsor

Trials

11

Recruited

1,100+

Findings from Research

In a study of 11-year-old children with myopia, using monovision spectacles resulted in significantly slower myopia progression in the near corrected eye compared to the distance corrected eye, with a difference of 0.36 D/year.

While monovision did not effectively reduce accommodation, it suggests that maintaining myopic defocus can help slow down the axial elongation of the eye, which is a key factor in myopia progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monovision slows juvenile myopia progression unilaterally. Phillips, JR.[2018]

References

1. 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]

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

Effect of patient motivation on near vision in pseudophakic patients. [2015]

3. Denmark pubmed.ncbi.nlm.nih.gov

Longterm results of 1 CU accommodative intraocular lens implantation: 2-year follow-up study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Monovision slows juvenile myopia progression unilaterally. [2018]

6. England pubmed.ncbi.nlm.nih.gov

FDA regulation of labeling and promotional claims in therapeutic color vision devices: a tutorial. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Self-adjustable glasses in the developing world. [2021]

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

Light-adjustable lens. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Development of smart spectacles to monitor and modify myopia-related health behaviour in children. [2023]

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

Self-adjustable Spectacle Wearing Compliance and Associated Factors among Rural School Children in Ghana. [2020]

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

Dynamic opto-mechanical eye model with peripheral refractions. [2023]

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

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

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

Design of see-through near-eye display for presbyopia. [2018]

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

Cortical adaptation and visual enhancement. [2018]

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

See-through near-eye displays enabling vision correction. [2018]