Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device

Not Applicable

• Conditions: Myopia
• Interventions: Device: Binocular CP1

• Registration Number: NCT05425108
• Lead Sponsor: Kubota Vision Inc.

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Study Start: 2022-06-23
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-06
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CP1 device	Binocular CP1	-

Primary Outcome Measures

Name	Time	Method
Central axial length	12 months
Cycloplegic refraction	12 months

Trial Locations

Locations (1)

Manhattan Vision Associates/Institute of Vision Research; 🇺🇸 New York, New York, United States