Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device
- Conditions
- Myopia
- Registration Number
- NCT05425108
- Lead Sponsor
- Kubota Vision Inc.
- Brief Summary
Kubota Vision Inc. has developed a spectacle-like prototype device which is designed to be used as a light-based therapy to reduce myopia progression. In this study, we aim to observe the ocular biometric and refractive changes following binocular part-time wear of the clinical prototype device over a course of 12 months and compare that to 12 months of no clinical prototype device use (control).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
- Spherical equivalent -0.50 to -5.50 diopters
- visual acuity of at least 20/25 in each eye
- history of ocular trauma or major eye surgery
- active ocular infection
- any prior history or participation in myopia control treatments within the past 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Central axial length 12 months Cycloplegic refraction 12 months
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Manhattan Vision Associates/Institute of Vision Research
🇺🇸New York, New York, United States
Manhattan Vision Associates/Institute of Vision Research🇺🇸New York, New York, United StatesStudy CoordinatorContact212-688-4277