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NCT05650190 Clinical Trial

Spectacle Lens Visual Acuity Assessments Study

Myopia Clinical Trial

— CEDAR  

Official title:
Spectacle Lenses Visual Acuity Assessments Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05650190
Other study ID # CPRO-2209-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 8, 2022
Est. completion date April 5, 2023

Study information
Verified date December 2023
Source SightGlass Vision, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a two-arm parallel group, non-dispensing study. Participants will be existing active CYPRESS Extension (CPRO-1802-002) subjects. Subjects will undergo additional visual performance assessments.

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date April 5, 2023
Est. primary completion date February 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 14 Years
Eligibility Inclusion Criteria: - Existing subject from the CYPRESS Extension study (CPRO-1802-002) - Ability to comply with study assessments - The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed coy of the form Exclusion Criteria: - Any current ocular infection, inflammation or irritation likely to affect vision

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Novel spectacle lens design
Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia
• Spectacle lenses
Single vision, impact resistant spectacle lenses

Locations
Country Name City State
United States Vision Optique Houston Texas
United States Sabal Eye Care Longwood Florida
United States SUNY School of Optometry New York New York
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

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 Visual Acuity Reading Speed (maximum words per minute) 15 minutes
Secondary Near Visual Acuity with Glare Mean and Standard Deviation at 15 minutes (short duration test) 15 minutes
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