Control of Myopia Using Novel Spectacle Lens Designs
- Conditions
- Juvenile Myopia
- Interventions
- Device: Spectacle lensesDevice: Novel spectacle lens design
- Registration Number
- NCT03623074
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 266
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Arm 3 Spectacle lenses Single vision, impact-resistant spectacle lenses Test Arm 1 Novel spectacle lens design Single vision, impact-resistant spectacle lenses Test Arm 2 Novel spectacle lens design Single vision, impact-resistant spectacle lenses
- Primary Outcome Measures
Name Time Method Spherical equivalent refraction 36 Months Change in spherical equivalent refraction from baseline
Axial length 36 Months Change in axial length from baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Golden Optometric Group
🇺🇸Whittier, California, United States
Sabal Eye Care
🇺🇸Longwood, Florida, United States
Visual Performance Center
🇺🇸Pensacola, Florida, United States
Kannarr Eye Care
🇺🇸Pittsburg, Kansas, United States
Advanced Eyecare, PC
🇺🇸Raytown, Missouri, United States
SUNY School of Optometry
🇺🇸New York, New York, United States
Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept
🇺🇸West Monroe, Louisiana, United States
Sacco Eye Group
🇺🇸Vestal, New York, United States
Total Eye Care
🇺🇸Memphis, Tennessee, United States
Dunes Eye Consultants
🇺🇸Dakota Dunes, South Dakota, United States
Dept of Clinical Research, South Shore Eye Care, LLP
🇺🇸Wantagh, New York, United States
University of Houston College of Optometry
🇺🇸Houston, Texas, United States
Center for Ocular Research & Education, School of Optometry, University of Waterloo School of Optometry & Vision Science
🇨🇦Waterloo, Ontario, Canada
William J Bogus, OD, FAAO
🇺🇸Salt Lake City, Utah, United States