Clincosm LogoSign in Get a demo

BIRCH: Myopia Control Spectacle Lens Cessation Study

Sponsor
SightGlass Vision, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05893979
Collaborator
(none)
90
Enrollment
9
Locations
2
Arms
19.1
Anticipated Duration (Months)
10
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Spectacle Lenses
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Myopia Control Spectacle Lens Use Cessation Study
Anticipated Study Start Date :
Jun 30, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Jan 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Cycloplegic Spherical Equivalent Refraction (cSER) [12 months]

    Change in cSER

Secondary Outcome Measures

  1. Cycloplegic Spherical Equivalent Refraction (cSER) [6 months]

    Change in cSER

  2. Axial Length (AL) [12 months]

    Change in AL

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Golden Optometric Group Whittier California United States 90606
2 Omega Vision Center PA Longwood Florida United States 32779
3 Kannarr Eye Care Pittsburg Kansas United States 66762
4 Advanced Eyecare PC Raytown Missouri United States 64133
5 Sacco Eye Group Vestal New York United States 13850
6 Dunes Eye Consultants Dakota Dunes South Dakota United States 57049
7 Total Eye Care Memphis Tennessee United States 38119
8 Vision Optique Houston Texas United States 77205
9 William J Bogus, OD, FAAO Salt Lake City Utah United States 84106

Sponsors and Collaborators

  • SightGlass Vision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SightGlass Vision, Inc.
ClinicalTrials.gov Identifier:
NCT05893979
Other Study ID Numbers:
  • CPRO-2303-001
First Posted:
Jun 8, 2023
Last Update Posted:
Jun 8, 2023
Last Verified:
May 1, 2023
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
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Jun 8, 2023