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Control of Myopia Using Novel Spectacle Lens Designs (CYPRESS)

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ClinicalTrials.gov Identifier: NCT03623074
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
SightGlass Vision, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Juvenile Myopia Device: Novel spectacle lens design Device: Spectacle lenses Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked.
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Novel Spectacle Lens Designs to Control of Myopia
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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

Test Arm 3
Single vision, impact-resistant spectacle lenses
Device: Spectacle lenses
Use of lenses may reduce the rate of progression of juvenile myopia




Primary Outcome Measures :
  1. Axial length [ Time Frame: 36 Months ]
    Change in axial length from baseline

  2. Spherical equivalent refraction [ Time Frame: 36 Months ]
    Change in spherical equivalent refraction from baseline



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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623074


Contacts
Contact: Joseph Rappon, OD, MS, FAAO 678-643-9117 joe@sightglassvision.com
Contact: Vanessa Tasso, MA, MBA 949-751-7039 vanessa@sightglassvision.com

Locations
United States, California
Golden Optometric Group Recruiting
Whittier, California, United States, 90606
Contact: David Ardaya, OD, MHA    562-692-1208    dca@goldenoptometric.com   
Principal Investigator: David Ardaya, OD, MHA         
United States, Florida
Sabal Eye Care Recruiting
Longwood, Florida, United States, 32779
Contact: Christopher Pearson, OD    407-869-4733      
Contact: Renee       sabaleyecare@gmail.com   
Visual Performance Center Recruiting
Pensacola, Florida, United States, 32503
Contact: Amanda Neel    850-791-6751    a.neel@outlook.com   
Principal Investigator: Katie Spear, OD         
United States, Kansas
Kannarr Eye Care Recruiting
Pittsburg, Kansas, United States, 66762
Contact: Jamie Torrance    620-235-1737    jtorrance@kannarreyecare.com   
Principal Investigator: Shane Kannarr, OD         
United States, Louisiana
Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept Recruiting
West Monroe, Louisiana, United States, 71291
Contact: Rebecca Webb    800-247-5878    rajohnson@eyenela.com   
Contact: Rebecca Morris       rmorris@eyenela.com   
Principal Investigator: Jonathan Scogin, OD         
United States, Missouri
Advanced Eyecare, PC Recruiting
Raytown, Missouri, United States, 64133
Contact: Tamara Urias    816-353-1872    tammy@bso-ae.com   
Contact: Richard Wilson       rwilsone@bso-ae.com   
Principal Investigator: Richard Wilson, OD         
United States, New York
SUNY School of Optometry Recruiting
New York, New York, United States, 10036
Contact: C Ray    212-938-4052    Clinicresearch@sunyopt.edu   
Principal Investigator: Xiaoying Zhu, Od, Phd, MS, MD         
Sacco Eye Group Recruiting
Vestal, New York, United States, 13850
Contact: Staci Sacco    607-798-1987    Researchcoordinator@saccoresearch.com   
Principal Investigator: Andrew Sacco, OD         
Dept of Clinical Research, South Shore Eye Care, LLP Recruiting
Wantagh, New York, United States, 11793
Contact: Cara Fidnarick    516-785-3900 ext 124    researchssec@gmail.com   
Principal Investigator: Michelle Mijares, OD         
United States, South Dakota
Dunes Eye Consultants Recruiting
Dakota Dunes, South Dakota, United States, 57049
Contact: Andrea       andrea@duneseye.com   
Contact: Tracie       tracie@duneseye.com   
Principal Investigator: Steven Ferguson, OD         
United States, Tennessee
Total Eye Care Recruiting
Memphis, Tennessee, United States, 38119
Contact: David Evans, OD    901-761-4620    tneyedoc@mac.com   
Principal Investigator: David Evans, OD         
United States, Texas
University of Houston College of Optometry Recruiting
Houston, Texas, United States, 77204
Contact: Sonia Huerta    713-743-2736    shuerta@optometry.uh.edu   
Contact: Eric Ritchey, OD, PhD    713-743-1933    erritchey@uh.edu   
Principal Investigator: Eric Ritchey, OD, PhD         
United States, Utah
William J Bogus, OD, FAAO Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Cris Bogus       crisbogus@msn.com   
Principal Investigator: William Bogus, OD, FAAO         
Canada, Ontario
Center for Ocular Research & Education, School of Optometry, University of Waterloo School of Optometry & Vision Science Recruiting
Waterloo, Ontario, Canada, N2L 3G1
Contact: Jessica Rosa-Vecchiarelli    519-888-4567 ext 37187    COREstudies@uwaterloo.ca   
Principal Investigator: Lyndon Jones, PhD, FCOptom         
Sponsors and Collaborators
SightGlass Vision, Inc.
Investigators
Study Chair: Joseph Rappon, OD, MS, FAAO SightGlass Vision, Inc.

Responsible Party: SightGlass Vision, Inc.
ClinicalTrials.gov Identifier: NCT03623074     History of Changes
Other Study ID Numbers: CPRO-1802-001
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by SightGlass Vision, Inc.:
Myopia

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases