Recruiting

Observational Study

Sponsor:

Kubota Vision Inc.

Code:

NCT05425108

Conditions

Myopia

Eligibility Criteria

Sex: All

Age: 7 - 12

Healthy Volunteers: Not accepted

Interventions

Binocular CP1

Study Details

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).

Conditions

Myopia

Study ID

NCT05425108

Start date

Jun 23, 2022

Status verified date

Jun, 2022

Completion date

Aug, 2023

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 12

Healthy Volunteers: Not accepted

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

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: CP1 device

no intervention: Control

Interventions

Binocular CP1

Binocular active projection of defocused image in the peripheral visual field

Primary outcome measure

  • Central axial length [ Time Frame: 12 months ]
  • Cycloplegic refraction [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Helpdesk

(206) 805-8310ClinicalTrails@kubotavision.com

Locations

Manhattan Vision Associates/Institute of Vision Research

Recruiting

New York, New York, United States, 10022

Contacts

Study Coordinator

212-688-4277

More Information

Sponsor

Kubota Vision Inc.

Last update posted

Jul 6, 2022

Last verified

Jun, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kubota Vision Inc. on 2022-07-06.