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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05893979
Other study ID # CPRO-2303-001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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