Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: CP1 device
|
Device: Binocular CP1
Binocular active projection of defocused image in the peripheral visual field
|
No Intervention: Control
|
Outcome Measures
Primary Outcome Measures
- Central axial length [12 months]
- Cycloplegic refraction [12 months]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Manhattan Vision Associates/Institute of Vision Research | New York | New York | United States | 10022 |
Sponsors and Collaborators
- Kubota Vision Inc.
Investigators
- Principal Investigator: Arkady Selenow, OD, Manhattan Vision Associates/Institute of Vision Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP1 Pilot