Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device

Kubota Vision

Status: Enrolling

Conditions: Myopia

Treatments: Device: Binocular CP1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05425108

CP1 Pilot

Details and patient eligibility

About

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).

Enrollment: 45 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

CP1 device

Active Comparator group

Treatment:

Device: Binocular CP1

Control

No Intervention group