Active — Not RecruitingNot Applicable

CYPRESS Efficacy and Safety Study Extension

United States200 participantsStarted 2021-07-19

Plain-language summary

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.

Who can participate

Age range6 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Previously a successfully completed participant in the CYPRESS study (NCT03623074) and having not exited this study for more than 30 days; * 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; * 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.

What they're measuring

Axial length

Timeframe: 72 months

Spherical equivalent refraction (SER)

Timeframe: 72 months

Trial details

NCT IDNCT04947735

SponsorSightGlass Vision, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-31

View on ClinicalTrials.gov More Juvenile Myopia trials