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

Kubota Vision Inc.1 site in 1 country45 target enrollmentJune 23, 2022

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Kubota Vision Inc.
Enrollment: 45
Locations: 1
Primary Endpoint: Central axial length
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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).

Registry

clinicaltrials.gov

Start Date

June 23, 2022

End Date

August 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kubota Vision Inc.

Responsible Party

Sponsor

Eligibility 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