Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device

Kubota Vision Inc.45 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myopia

Interventions

Binocular CP1DEVICE

Binocular active projection of defocused image in the peripheral visual field

Eligibility

Sex: ALLMin age: 7 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Manhattan Vision Associates/Institute of Vision Research

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Central axial length

Time frame: 12 months

Cycloplegic refraction

Time frame: 12 months

Central Contacts

Clinical Trials Helpdesk

CONTACT

(206) 805-8310 ClinicalTrails@kubotavision.com

Data from ClinicalTrials.gov

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