Spectacle Lens Visual Acuity Assessments Study (CEDAR)

Spectacle Lenses Visual Acuity Assessments Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia; Myopia Progression; Juvenile Myopia
• Intervention / Treatment: Device: Novel spectacle lens design; Device: Spectacle lenses

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Longwood, Florida, United States, 32779
      • Sabal Eye Care
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • Missouri
    • Raytown, Missouri, United States, 64133
      • Advanced Eyecare PC
  • New York
    • New York, New York, United States, 10036
      • SUNY School of Optometry
  • Texas
    • Houston, Texas, United States, 77205
      • Vision Optique
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • William J Bogus, OD, FAAO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Arm; Single vision, impact resistant spectacle lenses; Test Arm	Device: Novel spectacle lens design; Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia
Placebo Comparator: Control Arm; Single vision, impact resistant spectacle lenses; Control Arm	Device: Spectacle lenses; Single vision, impact resistant spectacle lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Reading Speed (maximum words per minute)	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near Visual Acuity with Glare	Mean and Standard Deviation at 15 minutes (short duration test)	15 minutes

Collaborators and Investigators

• Sponsor: SightGlass Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Actual): February 10, 2023
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CPRO-2209-001

Drug and device information, study documents

• 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.: No