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NCT05425108 Clinical Trial

Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device

Myopia Clinical Trial

Official title:
Effectiveness of Binocular Peripheral Myopic Projected Defocus on Ocular Biometrics Using a Clinical Prototype Device

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05425108
Other study ID # CP1 Pilot
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 23, 2022
Est. completion date August 2023

Study information
Verified date June 2022
Source Kubota Vision Inc.
Contact Clinical Trials Helpdesk
Phone (206) 805-8310
Email ClinicalTrails@kubotavision.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 45
Est. completion date August 2023
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 7 Years to 12 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Binocular CP1
Binocular active projection of defocused image in the peripheral visual field

Locations
Country Name City State
United States Manhattan Vision Associates/Institute of Vision Research New York New York

Sponsors (1)
Lead Sponsor Collaborator
Kubota Vision Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Central axial length 12 months
Primary Cycloplegic refraction 12 months
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