Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device

Status unconfirmed · Not applicable

Conditions studied: Myopia

In brief

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).

Key facts

Study ID

NCT05425108

Run by

Kubota Vision Inc.

People needed

45

Starts

2022-06-23

Expected to finish

2023-08-01

Last updated by the study team

2022-07-06

Who can join

Age: 7 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Spherical equivalent -0.50 to -5.50 diopters
• visual acuity of at least 20/25 in each eye

You may not qualify if…

• 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

Where it is running

• Manhattan Vision Associates/Institute of Vision Research — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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