Novel Spectacle Lenses for Near-sightedness

(CYPRESS Trial)

Recruiting at 13 trial locations

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: SightGlass Vision, Inc.

Disqualifiers: Contact lenses, Bifocals, Myopia control, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 36 months

266 Participants Needed

Trial Summary

What is the purpose of this trial?

Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.

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 design, Spectacle lenses for near-sightedness?

Research shows that a novel spectacle lens design, specifically the 'defocus incorporated multiple segments (DIMS)' technology, has been reported to achieve a significant effect in reducing myopia (near-sightedness) in children. ^{1 2 3 4 5}

Is the novel spectacle lens design safe for humans?

A review of spectacle lens design discusses efforts to minimize side effects associated with their wear, suggesting that safety is a consideration in their development. ^{2 5 6 7 8}

How is the novel spectacle lens treatment for near-sightedness different from other treatments?

The novel spectacle lenses for near-sightedness are unique because they incorporate lenslets in their design, which helps control myopia (near-sightedness) by creating myopic defocus and contrast modulation. This approach differs from traditional lenses by aiming to slow the progression of myopia rather than just correcting vision. ^{2 4 9 10 11}

Research Team

Joseph Rappon, OD, MS, FAAO

Principal Investigator

SightGlass Vision, Inc.

Eligibility Criteria

This trial is for children aged 6-10 with near-sightedness, having a specific range of short-sighted prescription (-0.75 to -4.50 D). They must not have more than a 1.50 D difference between their eyes and be willing to participate for 3 years without wearing contact lenses.

Inclusion Criteria

SER power between the two eyes must be less than or equal to 1.50 D

SER error between -0.75 and -4.50 D

Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive novel spectacle lens designs to evaluate their efficacy in reducing the progression of juvenile myopia

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Novel spectacle lens design
• Spectacle lenses

Trial Overview The study tests new spectacle lens designs meant to slow down the worsening of near-sightedness in kids. It's a masked, three-group comparison lasting for three years where neither participants nor observers know who gets which type of glasses.

Participant Groups

Group I: Test Arm 3 Experimental Treatment 1 Intervention

Single vision, impact-resistant spectacle lenses

Group II: Test Arm 2 Experimental Treatment 1 Intervention

Single vision, impact-resistant spectacle lenses

Group III: 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

In a study involving 8 myopic participants, bifocal contact lenses (MCL) showed a general decrease in visual acuity (VA) and contrast sensitivity (CS) compared to single vision lenses (SV), indicating they may not be as effective for all gaze positions.

The defocus incorporated multiple segments (DIMS) lenses performed similarly to SV lenses at straight gaze (0°), but both DIMS and MCL resulted in decreased VA and CS at nasal and temporal gaze, suggesting that while DIMS can be effective, they may not provide a significant advantage over traditional lenses in all viewing conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision tests on spectacle lenses and contact lenses for optical myopia correction: a pilot study. Kaymak, H., Neller, K., Schütz, S., et al.[2022]

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

Vision tests on spectacle lenses and contact lenses for optical myopia correction: a pilot study. [2022]

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

Spectacle lens design: a review. [2018]

3. 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]

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

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

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

The Adaptation and Acceptance of Defocus Incorporated Multiple Segment Lens for Chinese Children. [2022]

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

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

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

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

8. 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]

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

Recent trends in progressive power lenses. [2006]

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

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

11. England pubmed.ncbi.nlm.nih.gov

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