Control of Myopia Using Novel Spectacle Lens Designs

Juvenile Myopia Clinical Trial

— CYPRESS  

Official title:

Efficacy and Safety Study of Novel Spectacle Lens Designs to Control of Myopia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03623074
• Other study ID #: CPRO-1802-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: SightGlass Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 266
• Est. completion date: June 30, 2024
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

• Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent

• SER error between -0.75 and -4.50 D

• SER power between the two eyes must be less than or equal to 1.50 D

• Willingness to participate in the trial for 3 years without content lens wear

Exclusion Criteria:

• Previous or current use of contact lenses

• Previous or current use of bifocals, progressive addition spectacles lenses

• Previous or current use of myopia control treatment

• Astigmatism worse then -1.25 DC in either eye

Related Conditions & MeSH terms

• Juvenile Myopia
• Myopia

Intervention

Device:
• Novel spectacle lens design
Use of lenses may reduce the rate of progression of juvenile myopia
• Spectacle lenses
Use of lenses may reduce the rate of progression of juvenile myopia

Locations

Country	Name	City	State
Canada	Center for Ocular Research & Education, School of Optometry, University of Waterloo School of Optometry & Vision Science	Waterloo	Ontario
United States	Dunes Eye Consultants	Dakota Dunes	South Dakota
United States	University of Houston College of Optometry	Houston	Texas
United States	Sabal Eye Care	Longwood	Florida
United States	Total Eye Care	Memphis	Tennessee
United States	SUNY School of Optometry	New York	New York
United States	Visual Performance Center	Pensacola	Florida
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	Dept of Clinical Research, South Shore Eye Care, LLP	Wantagh	New York
United States	Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept	West Monroe	Louisiana
United States	Golden Optometric Group	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
SightGlass Vision, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial length	Change in axial length from baseline	36 Months
Primary	Spherical equivalent refraction	Change in spherical equivalent refraction from baseline	36 Months