Back to resultsBinocular Peripheral Myopic Defocus Using a Clinical Prototype Device
Primary Purpose
Myopia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Binocular CP1
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
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
Sites / Locations
- Manhattan Vision Associates/Institute of Vision ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
CP1 device
Control
Arm Description
Outcomes
Primary Outcome Measures
Central axial length
Cycloplegic refraction
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05425108
Brief Title
Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device
Official Title
Effectiveness of Binocular Peripheral Myopic Projected Defocus on Ocular Biometrics Using a Clinical Prototype Device
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kubota Vision Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CP1 device
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Binocular CP1
Intervention Description
Binocular active projection of defocused image in the peripheral visual field
Primary Outcome Measure Information:
Title
Central axial length
Time Frame
12 months
Title
Cycloplegic refraction
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Helpdesk
Phone
(206) 805-8310
Email
ClinicalTrails@kubotavision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arkady Selenow, OD
Organizational Affiliation
Manhattan Vision Associates/Institute of Vision Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Vision Associates/Institute of Vision Research
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
212-688-4277
12. IPD Sharing Statement
Learn more about this trial
Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device
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