CYPRESS Efficacy and Safety Study Extension

Not Applicable

Active, not recruiting

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

• Registration Number: NCT04947735
• Lead Sponsor: SightGlass Vision, Inc.

Brief Summary

This is an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of SightGlass Vision Diffusion Optics Technology (DOT) Spectacles in reducing the progression of juvenile myopia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-07-01
• Study Start: 2021-07-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-04-30
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Previously a successfully completed participant in the CYPRESS study (NCT03623074) and having not exited this study for more than 30 days;
• 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 3 years 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CYPRESS Extension Control Arm	Spectacle lenses	Single vision, impact resistant spectacle lenses; CYPRESS Control Arm remains in control lenses as the CYPRESS Extension Control Arm
CYPRESS Extension Test Arm	Novel spectacle lens design	Single vision, impact resistant spectacle lenses; CYPRESS Test Arm 1 and CYPRESS Test Arm 2 will move into CYPRESS Extension Test Arm

Primary Outcome Measures

Name	Time	Method
Axial length	72 months	Test vs. control axial length change from baseline
Spherical equivalent refraction (SER)	72 months	Test vs. control spherical equivalent refraction (SER) change from baseline

Secondary Outcome Measures

Name	Time	Method
Axial length	42 months	Change from baseline
SER	60 months	Change from baseline

Trial Locations

Locations (12)

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

Golden Optometric Group; 🇺🇸 Whittier, California, United States

Dr. Bridgitte Shen Lee (PI); 🇺🇸 Houston, Texas, United States

Sacco Eye Group; 🇺🇸 Vestal, New York, United States

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

Centre for Ocular Research and Education; 🇨🇦 Waterloo, Ontario, Canada

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

Omega Vision Center, PA; 🇺🇸 Longwood, Florida, United States

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

Dunes Eye Consultants; 🇺🇸 Dakota Dunes, South Dakota, United States

Haik Humble; 🇺🇸 West Monroe, Louisiana, United States

Total Eye Care; 🇺🇸 Memphis, Tennessee, United States