Back to resultsMyopia Control Spectacle Lens Cessation Study (BIRCH)
Primary Purpose
Myopia, Myopia Progression, Juvenile Myopia
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spectacle Lenses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
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.
Sites / Locations
- Golden Optometric Group
- Omega Vision Center PA
- Kannarr Eye Care
- Advanced Eyecare PC
- Sacco Eye Group
- Dunes Eye Consultants
- Total Eye Care
- Vision Optique
- William J Bogus, OD, FAAO
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Test Lens Group
Control Lens Group
Arm Description
Outcomes
Primary Outcome Measures
Cycloplegic Spherical Equivalent Refraction (cSER)
Change in cSER
Secondary Outcome Measures
Cycloplegic Spherical Equivalent Refraction (cSER)
Change in cSER
Axial Length (AL)
Change in AL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05893979
Brief Title
Myopia Control Spectacle Lens Cessation Study
Acronym
BIRCH
Official Title
Myopia Control Spectacle Lens Use Cessation Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 30, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SightGlass Vision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Myopia Progression, Juvenile Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Lens Group
Arm Type
Active Comparator
Arm Title
Control Lens Group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Spectacle Lenses
Intervention Description
Standard Spectacle Lenses
Primary Outcome Measure Information:
Title
Cycloplegic Spherical Equivalent Refraction (cSER)
Description
Change in cSER
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cycloplegic Spherical Equivalent Refraction (cSER)
Description
Change in cSER
Time Frame
6 months
Title
Axial Length (AL)
Description
Change in AL
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer S Hill, BS
Phone
6783614877
Email
jhill@sightglassvision.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Tasso, MA, MBA
Phone
949-751-7039
Email
vtasso@sightglassvision.com
Facility Information:
Facility Name
Golden Optometric Group
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
Omega Vision Center PA
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Advanced Eyecare PC
City
Raytown
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Sacco Eye Group
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Dunes Eye Consultants
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Vision Optique
City
Houston
State/Province
Texas
ZIP/Postal Code
77205
Country
United States
Facility Name
William J Bogus, OD, FAAO
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Myopia Control Spectacle Lens Cessation Study
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