Control of Myopia Using Novel Spectacle Lens Designs (CYPRESS)

April 17, 2024 updated by: SightGlass Vision, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3G1
        • Center for Ocular Research & Education, School of Optometry, University of Waterloo School of Optometry & Vision Science
  • United States
    • California
      • Whittier, California, United States, 90606
        • Golden Optometric Group
    • Florida
      • Longwood, Florida, United States, 32779
        • Sabal Eye Care
      • Pensacola, Florida, United States, 32503
        • Visual Performance Center
    • Kansas
      • Pittsburg, Kansas, United States, 66762
        • Kannarr Eye Care
    • Louisiana
      • West Monroe, Louisiana, United States, 71291
        • Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept
    • Missouri
      • Raytown, Missouri, United States, 64133
        • Advanced Eyecare, PC
    • New York
      • New York, New York, United States, 10036
        • SUNY School of Optometry
      • Vestal, New York, United States, 13850
        • Sacco Eye Group
      • Wantagh, New York, United States, 11793
        • Dept of Clinical Research, South Shore Eye Care, LLP
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Dunes Eye Consultants
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Total Eye Care
    • Texas
      • Houston, Texas, United States, 77204
        • University of Houston College of Optometry
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • William J Bogus, OD, FAAO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Arm 1
Single vision, impact-resistant spectacle lenses
Device: Novel spectacle lens design
Use of lenses may reduce the rate of progression of juvenile myopia
Experimental: Test Arm 2
Single vision, impact-resistant spectacle lenses
Device: Novel spectacle lens design
Use of lenses may reduce the rate of progression of juvenile myopia
Other: Test Arm 3
Single vision, impact-resistant spectacle lenses
Device: Spectacle lenses
Use of lenses may reduce the rate of progression of juvenile myopia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial length
Time Frame: 36 Months
Change in axial length from baseline
36 Months
Spherical equivalent refraction
Time Frame: 36 Months
Change in spherical equivalent refraction from baseline
36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SightGlass Vision, Inc.

Investigators

  • Study Chair: Joseph Rappon, OD, MS, FAAO, SightGlass Vision, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2018

Primary Completion (Actual)

May 15, 2022

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

August 3, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPRO-1802-001

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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