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Active, Not Recruiting

NCT Number: NCT04947735

CYPRESS Efficacy and Safety Study Extension

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Juvenile Myopia Eye Diseases Myopia Refractive Errors

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Ocular Research and Education, Waterloo, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Novel spectacle lens design

Device

Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia

Spectacle lenses

Device

Single vision, impact resistant spectacle lenses

Primary outcomes

  1. Axial length

    Time frame: 72 months

    Test vs. control axial length change from baseline

  2. Spherical equivalent refraction (SER)

    Time frame: 72 months

    Test vs. control spherical equivalent refraction (SER) change from baseline

Secondary outcomes

  1. Axial length

    Time frame: 42 months

    Change from baseline

  2. SER

    Time frame: 60 months

    Change from baseline

Sponsors and collaborators

Lead sponsor

SightGlass Vision, Inc.

Industry

Registry information

Official study title

Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study Extension

Acronym: CYPRESS

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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