Spectacle Lens Visual Acuity Assessments Study

Not Applicable

Active, not recruiting

• Conditions: Myopia Progression; Juvenile Myopia; Myopia
• Interventions: Device: Novel spectacle lens design; Device: Spectacle lenses

• Registration Number: NCT05650190
• Lead Sponsor: SightGlass Vision, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-12-06
• Study Start: 2022-12-08
• Study First Posted: 2022-12-14
• Primary Completion: 2023-02-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Arm	Novel spectacle lens design	Single vision, impact resistant spectacle lenses; Test Arm
Control Arm	Spectacle lenses	Single vision, impact resistant spectacle lenses; Control Arm

Primary Outcome Measures

Name	Time	Method
Visual Acuity	15 minutes	Reading Speed (maximum words per minute)

Secondary Outcome Measures

Name	Time	Method
Near Visual Acuity with Glare	15 minutes	Mean and Standard Deviation at 15 minutes (short duration test)

Trial Locations

Locations (6)

SUNY School of Optometry; 🇺🇸 New York, New York, United States

Kannarr Eye Care; 🇺🇸 Pittsburg, Kansas, United States

Advanced Eyecare PC; 🇺🇸 Raytown, Missouri, United States

Vision Optique; 🇺🇸 Houston, Texas, United States

Sabal Eye Care; 🇺🇸 Longwood, Florida, United States

William J Bogus, OD, FAAO; 🇺🇸 Salt Lake City, Utah, United States