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Compensation: Varies

Number of Visits: 1

51 Participants Needed

Novel Spectacle Lenses for Nearsightedness
(CEDAR Trial)

Recruiting at 5 trial locations

Overseen ByVanessa Tasso, MA, MBA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: SightGlass Vision, Inc.

Disqualifiers: Ocular infection, inflammation, irritation

Trial Summary

What is the purpose of this trial?

This is a two-arm parallel group, non-dispensing study. Participants will be existing active CYPRESS Extension (CPRO-1802-002) subjects. Subjects will undergo additional visual performance assessments.

Do I need to stop my current medications for the trial?

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 for nearsightedness?

The study on optical and imaging properties of a novel multi-segment spectacle lens shows that these lenses are designed to slow the progression of myopia (nearsightedness), suggesting potential effectiveness in managing this condition.¹ ² ³ ⁴ ⁵

Is it safe to use novel spectacle lenses for nearsightedness?

A review of spectacle lens design suggests that efforts are made to minimize side effects associated with their wear, indicating a focus on safety in their development.¹ ³ ⁶ ⁷ ⁸

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

These novel spectacle lenses, such as MiYOSMART and Stellest, are unique because they use lenslets to create myopic defocus, which helps control the progression of nearsightedness. This approach is different from traditional lenses that only correct vision without addressing the progression of the condition.² ³ ⁵ ⁹ ¹⁰

Eligibility Criteria

This trial is for people who were already part of the CYPRESS Extension study and can follow through with the study's assessments. They must have consent from a parent or legal guardian if required. Those with current eye infections, inflammation, or irritation that could affect vision cannot participate.

Inclusion Criteria

Existing subject from the CYPRESS Extension study (CPRO-1802-002)

Ability to comply with study assessments

The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed coy of the form

Exclusion Criteria

I do not have any eye infections or conditions affecting my vision.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Visual Performance Assessment

Participants undergo visual performance assessments using single vision, impact resistant spectacle lenses

15 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after visual performance assessments

4 weeks

Treatment Details

Interventions

Novel spectacle lens design
Spectacle lenses

Trial Overview The study is testing a new spectacle lens design against standard lenses in a two-arm parallel group setup. Participants will not keep the glasses but will undergo visual performance evaluations to compare effectiveness.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Test ArmExperimental Treatment1 Intervention

Single vision, impact resistant spectacle lenses; Test Arm

Group II: Control ArmPlacebo Group1 Intervention

Single vision, impact resistant spectacle lenses; Control Arm

Find a Clinic Near You

Who Is Running the Clinical Trial?

SightGlass Vision, Inc.

Lead Sponsor

Trials

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]

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]