NCT05425108UnknownNot Applicable
Effectiveness of Binocular Peripheral Myopic Projected Defocus on Ocular Biometrics Using a Clinical Prototype Device
Kubota Vision Inc.1 site in 1 country45 target enrollmentStarted: June 23, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Central axial length
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 7 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Spherical equivalent -0.50 to -5.50 diopters
- •visual acuity of at least 20/25 in each eye
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Central axial length
Time Frame: 12 months
Cycloplegic refraction
Time Frame: 12 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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