Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device

Sponsor
Kubota Vision Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05425108
Collaborator
(none)
45
1
2
13.3
3.4

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Binocular CP1
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Binocular Peripheral Myopic Projected Defocus on Ocular Biometrics Using a Clinical Prototype Device
Actual Study Start Date :
Jun 23, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CP1 device

Device: Binocular CP1
Binocular active projection of defocused image in the peripheral visual field

No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. Central axial length [12 months]

  2. Cycloplegic refraction [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Manhattan Vision Associates/Institute of Vision Research New York New York United States 10022

Sponsors and Collaborators

  • Kubota Vision Inc.

Investigators

  • Principal Investigator: Arkady Selenow, OD, Manhattan Vision Associates/Institute of Vision Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kubota Vision Inc.
ClinicalTrials.gov Identifier:
NCT05425108
Other Study ID Numbers:
  • CP1 Pilot
First Posted:
Jun 21, 2022
Last Update Posted:
Jul 6, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2022