Myopia Control Spectacle Lens Cessation Study

Myopia Clinical Trial

— BIRCH  

Official title:

Myopia Control Spectacle Lens Use Cessation Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05893979
• Other study ID #: CPRO-2303-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 23, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: November 2023
• Source: SightGlass Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Juvenile Myopia
• Myopia
• Myopia Progression

Intervention

Device:
• Spectacle Lenses
Standard Spectacle Lenses

Locations

Country	Name	City	State
United States	Vision Optique	Houston	Texas
United States	Omega Vision Center PA	Longwood	Florida
United States	Total Eye Care	Memphis	Tennessee
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Advanced Eyecare PC	Raytown	Missouri
United States	William J Bogus, OD, FAAO	Salt Lake City	Utah
United States	Sacco Eye Group	Vestal	New York
United States	Golden Optometric Group	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
SightGlass Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cycloplegic Spherical Equivalent Refraction (cSER)	Change in cSER	12 months
Secondary	Cycloplegic Spherical Equivalent Refraction (cSER)	Change in cSER	6 months
Secondary	Axial Length (AL)	Change in AL	12 months