CYPRESS Efficacy and Safety Study Extension (CYPRESS)

Control of Myopia Using Peripheral Diffusion Lenses: 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia; Juvenile Myopia
• Intervention / Treatment: Device: Novel spectacle lens design; Device: Spectacle lenses

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Ocular Research and Education
• United States
  • California
    • Whittier, California, United States, 90606
      • Golden Optometric Group
  • Florida
    • Longwood, Florida, United States, 32779
      • Omega Vision Center, PA
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • Louisiana
    • West Monroe, Louisiana, United States, 71291
      • Haik Humble
  • Missouri
    • Raytown, Missouri, United States, 64133
      • Advanced Eyecare PC
  • New York
    • New York, New York, United States, 10036
      • SUNY School of Optometry
    • Vestal, New York, United States, 13850
      • Sacco Eye Group
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
      • Dunes Eye Consultants
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care
  • Texas
    • Houston, Texas, United States, 77205
      • Dr. Bridgitte Shen Lee (PI)
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • William J Bogus, OD, FAAO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CYPRESS Extension Test Arm; Single vision, impact resistant spectacle lenses; CYPRESS Test Arm 1 and CYPRESS Test Arm 2 will move into CYPRESS Extension Test Arm	Device: Novel spectacle lens design; Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia
Placebo Comparator: CYPRESS Extension Control Arm; Single vision, impact resistant spectacle lenses; CYPRESS Control Arm remains in control lenses as the CYPRESS Extension Control Arm	Device: Spectacle lenses; Single vision, impact resistant spectacle lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	Test vs. control axial length change from baseline	72 months
Spherical equivalent refraction (SER)	Test vs. control spherical equivalent refraction (SER) change from baseline	72 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	Change from baseline	42 months
SER	Change from baseline	60 months

Collaborators and Investigators

• Sponsor: SightGlass Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CPRO-1802-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No