Myopia Control Spectacle Lens Cessation Study (BIRCH)

Myopia Control Spectacle Lens Use Cessation Study

To quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses.

To quantify axial length progression following cessation of use of specific spectacle lenses.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia; Myopia Progression; Juvenile Myopia
• Intervention / Treatment: Device: Spectacle Lenses

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• 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
  • Missouri
    • Raytown, Missouri, United States, 64133
      • Advanced Eyecare PC
  • New York
    • Vestal, New York, United States, 13850
      • Sacco Eye Group
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care
  • Texas
    • Houston, Texas, United States, 77205
      • Vision Optique
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • William J Bogus, OD, FAAO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Previously a successfully completed participant in the CYPRESS Extension study;
• 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 12 months 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
Active Comparator: Test Lens Group	Device: Spectacle Lenses; Standard Spectacle Lenses
Active Comparator: Control Lens Group	Device: Spectacle Lenses; Standard Spectacle Lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cycloplegic Spherical Equivalent Refraction (cSER)	Change in cSER	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cycloplegic Spherical Equivalent Refraction (cSER)	Change in cSER	6 months
Axial Length (AL)	Change in AL	12 months

Collaborators and Investigators

• Sponsor: SightGlass Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 8, 2023

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-2303-001

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.: Yes