Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05425108

Enrollment

Registered

2022-06-21

Start date

2022-06-23

Completion date

2023-08-31

Last updated

2022-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

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).

Interventions

DEVICEBinocular CP1

Binocular active projection of defocused image in the peripheral visual field

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

7 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Central axial length	12 months
Cycloplegic refraction	12 months

Countries

United States

Contacts

Primary ContactClinical Trials Helpdesk

ClinicalTrails@kubotavision.com(206) 805-8310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026